Systemic Steroid & Autoimmune Conditions Flashcards

Question 1

Q

class:
Indications:
MOA:
Dosage forms:
Dosing:
Max dose:
Contraindications:
Warnings:
Side Effects:
Monitoring:
Pearls/Notes:
Drug-Drug/Food interactions:

Answer

A

class:
Indications:
MOA:
Dosage forms:
Dosing:
Max dose:
Contraindications:
Warnings:
Side Effects:
Monitoring:
Pearls/Notes:
Drug-Drug/Food interactions:

Question 2

Q

Systemic steroids comprise of _______

Answer

A

drugs as a tablet taken orally by mouth or drugs which are injected.

Question 3

Q

Systemic steroids are strong anti-inflammatory drugs used to treat a variety of conditions:

Inflammatory conditions
Immune Suppression after a transplant
Adrenal Insufficiency

Question 4

Q

Adrenal Insufficiency:

Answer

A

to replace endogenous (naturally produced in the body) steroids that the adrenal gland is NOT producing in adequate amounts.

Question 5

Q

The 2 primary endogenous steroids that can require replacement are:

Answer

A

1) Cortisol

2) Aldosterone

Question 6

Q

Cortisol can be replaced with ___________

Answer

A

giving any steroid (Glucocorticoid) (e.g. prednisone)

Question 7

Q

Aldosterone can be replaced with _________

Answer

A

giving fludrocortisone (mineralocorticoid)

Question 8

Q

Aldosterone is a hormone in the body that has its primarily function to regulate Na and Water balance to help maintain blood pressure.

Question 9

Q

Fludrocortisone mimics aldosterone. Has __________ activity

Answer

A

Mineralcorticoid activity
- which is to maintain a balance of water and electrolytes.
- this helps keep blood pressure stable.

Question 10

Q

Fludrocortisone (Florinef) is FDA-approved for _______

Answer

A

Addisons Disease

is used off-label for orthostatic hypotension

Question 11

Q

Glucocorticoid Activity:

Answer

A

-has more anti-inflammatory effects

Question 12

Q

Glucocorticoids can cause HPA axis Suppression:

What produces cortisol?

systemic steroids can cause the adrenal gland to stop producing cortisol due to feedback inhibition.

Answer

A

remember: adrenal glands sit right on top of the kidneys

Adrenal glands produce Cortisol.

When the body senses that we have enough cortisol or too much cortisol, it will send a negative feedback message to up to the-

Pituitary gland
&
Hypothalamus

to shut off production of Cortisol.

This is important because when we use High doses of Systemic Steroids long term, you have to taper the dose slowly when you are discontinuing the medication and that is to prevent an Addisonian crisis which can be fatal.

So if you stop a steroid that has been used long term abruptly, you have not given Adrenal Glands sufficient time to adapt and start producing cortisol.

Question 13

Q

Addison’s disease:

the adrenal gland is NOT making enough cortisol.

So if you stop a steroid that has been used long term abruptly, you have not given Adrenal Glands sufficient time to adapt and start producing cortisol.

This can cause an Addisonian Crisis
Hallmarks of an Addisonian Crisis are ________

Answer

A

volume depletion and hypotension which can be fatal.

Question 14

Q

Cushing’s Syndrome:

Can develop when _________

“Is the opposite of Addison’s Disease”

Answer

A

the adrenal gland produces too much cortisol, on its own

OR

if exogenous steroids are taken in doses HIGHER than the normal amount of endogenous steroid.

Question 15

Q

Cushing’s Syndrome: [Adverse effects of Long-Term Steroids]

Answer

A

acne
fat deposits in face (called moon face)
fat deposits in upper back (called buffalo hump)
-pink-purple stretch marks (striae) on abdomen, thighs, breasts, and arms, thin skin that easily bruises
diabetes
growth retardation, muscle wasting (thin arms and legs relative to rest of the body).
impaired wound healing, infection
poor bone health
GI bleeding/esophagitis/ulcers
glaucoma, cataracts
## psychiatric changes (anxiety, depression, delirium, psychoses), headache, intracranial hypertension (ICH), hypothyroidism

Question 16

Q

Ways to Reduce Systemic Steroid Risks:

## Use alternate day dosing (skip every other day); this decreases Cushing-like side effects-For joint inflammation, inject into the joint so drug stays local
-
## For a condition in the gut, use a steroid with low-systemic absorption, such as budesonide (Entocort EC).
## For the treatment of asthma, use inhaled steroids that mostly stay in the lungs
For conditions that require long-term steroids (e.g. transplant, a severe autoimmune condition), use the lowest possible dose for the shortest possible time.

Question 17

Q

Systemic Steroids (PO, IV) Dose Equivalent:

Remember

“Cute Hot Pharmacists & Physicians Marry Together Delivering Babies”

Answer

A

Cortisone 25mg LEAST POTENT

Hydrocortisone 20mg

Prednisone 5mg

Prednisolone 5mg

Methylprednisolone 4mg

Triamcinolone 4mg

Dexamethasone 0.75mg

Betamethasone 0.6mg MOST POTENT

Question 18

Q

Cortisone is a Prodrug of _________

Answer

A

Cortisol (our endogenous steroid = naturally produced by the body)

Question 19

Q

Prednisone is a Prodrug of _________

Answer

A

Prednisolone

Question 20

Q

## -

Answer

A

can worsen diabetes, hypertension, glaucoma, psychiatric conditions
increased appetite/weight gain, emotional instability, insomnia

Question 21

Q

Immunosuppression from Steroids:

A patient is considered immunosuppressed from a steroid when using:

Answer

A

greater than or equal to 2mg/kg/day

OR

greater than or equal to 20mg/day of prednisone [or prednisone equivalent] for greater than 2 weeks.

Question 22

Q

Patients who are Immunosuppressed are _____

Answer

A

NOT ALLOWED to receive LIVE VACCINES.

remember LIVE vaccines replicate after administration in order to produce an antibody response and make a patient immune to that particular infection that they have been vaccinated against.

An immunosuppressed patient can have uncontrolled replication and actually end up developing that infection/disease they were trying to prevent in the first place.

Steroid Tampers are essential, especially if taking steroids for greater than 2 weeks.

Question 23

Q

What tapering strategies can be used to prevent that adrenal HPA axis suppression and Addisonian Crisis?

Question 24

Q

Steroid Tampers:

“One size does NOT fit all”
really depends on the dose of steroid patient has been taking AND for how long they have been taking it.

Typical rule of thumb:
- decrease steroid dose by 10-20% every few days
- a typical taper can take a few weeks or few months depending
- tapers can last 7-14 days (or longer or shorter), depending on the condition being treated.

Answer

A

Due to HPA axis suppression, the steroid will need to be tapered slowly to tallow the adrenal gland to resume normal cortisol production. Otherwise, abrupt discontinuation can lead to the patient being at risk for “Addisonian Crisis” which can be FATAL.

Question 25

Q

Medrol dose Pak is NOT USED for tapering someone who has been on steroids for a long period of time.

Answer

A

” this is an example of a pre-designed pack that is for patients who need a high dose of steroid initially but then can be tapered relatively quickly over a few days to prevent any suppression of HPA axis”

Question 26

Q

Answer

A

Indications:

MOA:

Dosage forms:

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**

Drug-Drug/Food interactions:

Counseling points:

Question 27

Q

Decadron

class:
Indications:
MOA:
Dosage forms:
Dosing:
Max dose:
Contraindications:
Warnings:
Side Effects:
Monitoring:
Pearls/Notes:
Drug-Drug/Food interactions:

Answer

A

dexamethasone

Indications:

MOA:

Dosage forms: oral elixir 0.5mg/5mL (contains 5.1% alcohol v/v), brand name tablets discontinued.
generic tablets: 0.5mg/0.75mg/1mg/1.5mg/2mg/4mg/6mg tablets

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency: High potency
Duration of action: Long acting

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**

Drug-Drug/Food interactions:

Counseling points:
-artificial raspberry flavor
-

Question 28

Q

Dexamethasone Intensol

class:
Indications:
MOA:
Dosage forms:
Dosing:
Max dose:
Contraindications:
Warnings:
Side Effects:
Monitoring:
Pearls/Notes:
Drug-Drug/Food interactions:

Answer

A

dexamethasone

Indications:

MOA:

Dosage forms: oral solution 1mg/mL

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**

Drug-Drug/Food interactions:

Counseling points:
- use only calibrated dropper provided with this product

Question 29

Q

DoubleDex KIT, TopiDex KIT

class:
Indications:
MOA:
Dosage forms:
Dosing:
Max dose:
Contraindications:
Warnings:
Side Effects:
Monitoring:
Pearls/Notes:
Drug-Drug/Food interactions:

Answer

A

dexamethasone sodium phosphate

Indications:

MOA:

Dosage forms: For IV or IM use only [10mg/mL]

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**

Drug-Drug/Food interactions:

Counseling points:

Question 30

Q

DexPak 6, 10, 13 day

Answer

A

dexamethasone

Indications:

MOA:

Dosage forms:

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**

Drug-Drug/Food interactions:

Counseling points:

Question 31

Q

Hemady

Answer

A

dexamethasone

Indications: In combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM).

MOA:

Dosage forms: 20mg tablets

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**

Drug-Drug/Food interactions:

Counseling points:

Question 32

Q

Solu-Cortef

Answer

A

hydrocortisone sodium succinate

Indications:

MOA:

Dosage forms: lyophilized powder for reconstitution
For IM or IV use only

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**
-
- protect solution from light
- Unused solution should be discarded after 3 days
- Use solution only if it is Clear

Drug-Drug/Food interactions:

Counseling points:

Question 33

Q

Cortef

Answer

A

hydrocortisone

Indications:

MOA:

Dosage forms: oral tablets 5mg. 10mg, 20mg - scored
generic tablets: 5mg, 10mg, 20mg

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**

Drug-Drug/Food interactions:

Counseling points:

Question 34

Q

Alkindi Sprinkle

Answer

A

hydrocortisone

Indications:

MOA:

Dosage forms: capsules with granules

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**

Drug-Drug/Food interactions:

Counseling points:
-* capsules must be opened prior to administration
-* Do NOT swallow capsules, risk of choking
- Discard unused capsules after 60 days from opening manufacturer bottle

Question 35

Q

Medrol

Answer

A

methylprednisolone

Indications:

MOA:

Dosage forms: tablets 2mg/4mg/8mg/16mg/32mg

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**

Drug-Drug/Food interactions:

Counseling points:

Question 36

Q

Solu-Medrol

Answer

A

methylprednisolone sodium succinate powder

Indications:

MOA:

Dosage forms: powder for reconstitution solution (500mg/vial, 1g/vial)
For IM or IV

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**
-
- Use within 48 hours after mixing.
- Protect from Light

Drug-Drug/Food interactions:

Counseling points:

Question 37

Q

Depo-Medrol

Answer

A

methylprednisolone acetate

Indications:

MOA:

Dosage forms: suspension for IM injection, Intrasynovial and Soft Tissue Injection Only. NOT FOR IV USE.
- 40mg/mL, 80mg/mL

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**
- shake well immediately before use
- single dose vials

Drug-Drug/Food interactions:

Counseling points:

Question 38

Q

Deltasone

Answer

A

prednisone

Indications:

MOA:

Dosage forms: tablets
Brand: 20mg
generic: 1mg/ 2.5mg/5mg/10mg/20mg/50mg

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**
- * Prednisone is a PRODRUG of prednisolone

Drug-Drug/Food interactions:

Counseling points:

Question 39

Q

Prednisone Intensol

Answer

A

prednisone

Indications:

MOA:

Dosage forms: oral solution 5mg/mL
clear/colorless, slightly viscous solution.

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**
- * Prednisone is a PRODRUG of prednisolone

Drug-Drug/Food interactions:

Counseling points:

Question 40

Q

Rayos

Answer

A

prednisone delayed release tablets

Indications:

MOA:

Dosage forms: (DR)- delayed release tablets
1mg/2mg/5mg

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**
- swallow whole, do not crush, divide or chew.

Drug-Drug/Food interactions:

Counseling points:

Question 41

Q

Millipred

Answer

A

prednisolone

Indications:

MOA:

Dosage forms: tablets
Brand AND generic- 5mg tablets
- a oral solution is also available15mg/5mL

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**

Drug-Drug/Food interactions:

Counseling points:

Question 42

Q

Orapred ODT

Answer

A

prednisolone sodium phosphate ODT

Indications:

MOA:

Dosage forms: (ODT) oral disintegrating tablet
BRAND: 10mg, 15mg, 30mg (all are grape flavor)

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**
- Orapred ODT tablets are packaged in a blister. Patients should be instructed not to remove the tablet from the blister until just prior to dosing. May be swallowed whole as any conventional tablet or allowed to dissolve in the mouth.

Drug-Drug/Food interactions:

Counseling points:
friable (easily crumbled or pulverized), tablets are not intended to be cut, split or broken.

Question 43

Q

Kenalog-10, Kenalog-40, Kenalog-80

Answer

A

triamcinolone acetonide injectable suspension

Indications:

MOA:

Dosage forms:
Kenalog-10 = 50mg/5mL (10mg/mL)
Kenalog-40 = (40mg/mL)
Kenalog-80 = (80mg/mL)

suspension for intra-articular injection, soft tissue administration, intralesional administration
** NOT FOR IV USE**
- For IM or intra-articular use only

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**
- protect from light
- do not refrigerate
- shake well before use

Drug-Drug/Food interactions:

Counseling points:

Question 44

Q

Zilretta

Answer

A

triamcinolone acetonide (ER) suspension

Indications:

MOA:

Dosage forms: ER suspension
*Must be reconstituted with the supplied diluent
*For intra-articular injection only
32mg per 5mL vial

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**
- store in refrigerator or at room temp for up to 6 weeks

Drug-Drug/Food interactions:

Counseling points:

Question 45

Q

Hexatrione

Answer

A

triamcinolone hexacetonide

Indications:

MOA:

Dosage forms: injectable suspension
2mL (glass) ampoule 20mg/mL
ONLY for intra-articular administration

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**

Drug-Drug/Food interactions:

Counseling points:

Question 46

Q

Pro-C-Dure 5, Pro-C-Dure 6

Answer

A

triamcinolone

Indications:

MOA:

Dosage forms:

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**

Drug-Drug/Food interactions:

Counseling points:

Question 47

Q

Celestone Soluspan

Answer

A

betamethasone sodium phosphate AND betamethasone acetate suspension injection

Indications:

MOA:

Dosage forms: 30mg/5mL (6mg/mL)
For IM, intra-articular or soft tissue administration, intralesional, intrabursal and intradermal use

Dosing: “Varies by indication”
- ** Take oral doses WITH FOOD to decrease GI upset

Potency:
Duration of action:

Contraindications:
** Live Vaccines, serious systemic infections**

Warnings:
** Adrenal Suppression- HPA axis suppression may lead to adrenal crisis and death; if taking longer than 14 days, MUST TAPER SLOWLY**

Side Effects:

Short term SE:
- Increased appetite/weight gain
- emotional instability (euphoria, mood swings, irritability)
- insomnia
- *Increased (ICP) intraocular pressure
- fluid retention
- indigestion
- *bitter taste
- increased blood pressure
- increases blood glucose with higher doses
[can worsen diabetes, hypertension, glaucoma, psychiatric conditions]

LONG TERM SE:

Monitoring:
BP, weight, appetite, mood, growth (children

Pearls/Notes:
** retain Na (sodium) AND H2O (water) = reasoning for causing high blood pressure.
- we want to use the lowest dose possible for the shortest duration possible**
- shake well before using
- protect from light
- multi-dose vial

Drug-Drug/Food interactions:

Counseling points:

Question 48

Q

Question 49

Q

Systemic Steroids (PO, IV) Dose Equivalence:

remember:

“Cute Hot Pharmacists & Phyicians Marry Together Delivering Babies”

Answer

A

Cortisone 25mg
Hydrocortisone 20mg
Prednisone 5mg
Prednisolone 5mg
Methylprednisolone 4mg
Triamcinolone 4mg
Dexamethasone 0.75mg
Betamethasone 0.6mg

Question 50

Q

Medrol Therapy pack:

Question 51

Q

Autoimmune Conditions:

body’s immune system attacks healthy tissue

symptoms:
- fatigue
- weakness
- pain

Non-specific lab tests: indicate inflammatory condition, [NOT specific for one Autoimmune condition]

ESR - erythrocyte sedimentation rate
CRP - C-reactive protein
RF - rheumatoid factor
ANA - anti-nuclear antibody

Answer

A

(RA) Rheumatoid Arthritis*
(SLE) Systemic Lupus Erythematosus*
Multiple Sclerosis*
Celiac Disease
Sjogren’s Syndrome
Raynaud’s
Psoriasis

“Systemic symptoms common”*

Question 52

Q

Autoimmune Conditions: Treatment

Strong immunosuppressants:

Risks:
- reactivation of tuberculosis and hepatitis B and C
- [Boxed warnings for]: lymphomas and skin cancers
- infections (bacteria, fungal, viral)

vaccinations and timing

Question 53

Q

(RA) Rheumatoid Arthritis:

Chronic, progressive autoimmune disorder. Primarily affects joints [inflammatory process]

Clinical presentation:
- bilateral, symmetrical
- joint swelling
- pain
- **stiffness
- deformity in bones
(typically results in warm, tender, swollen and painful joints)
(articular pain usually presents in the smaller joints of the fingers, wrist, ankles and feet first)

Lab tests:
- RF [non-specific]- it may be elevated in those with RA, it does NOT tell us that someone has RA

(ACPA) Anti-citrullinated peptide antibody [more specific for RA]

Answer

A

“Like many of the autoimmune conditions, the disease course is highly variable, and some patients have much more aggressive disease than others”

body is attacking its own immune system, not picking and choosing which joints to attack

” unilateral presentation is consistent for OA”
OA does NOT cause prolonged stiffness like RA

Question 54

Q

(RA) Rheumatoid Arthritis: Drug Treatment

Treatment goal- remission of the disease

Drug Treatment: (DMARDs) Disease-Modifying Antirheumatic Drugs

Non-biologic DMARDs
(TNF) Tumor necrosis factor inhibitors
Non- TNF biologics
combination treatment

First line:

Answer

A

First line: (MTX) methotrexate

[If patient has Moderate-High Disease Activity, despite being on Methotrexate then]:

1) Combination of Non-Biologic DMARDs

or

2) TNF inhibitor *Biologic (common add on therapy)

or

3) Non-TNF *Biologic

** Never use 2 Biologics together**

Question 55

Q

Trexall

class:
Indications:
MOA:
Dosage forms:
Dosing:
Max dose:
Contraindications:
Warnings:
Side Effects:
Monitoring:
Pearls/Notes:
Drug-Drug/Food interactions:

Answer

A

methotrexate

Indications:
- (RA) Rheumatoid arthritis

MOA:
- methotrexate binds to and inhibits (DHF) dihydrofolate reductase, which inhibits the formation of reduced folates, and thymidylate synthetase, resulting in inhibition of purine and thymidylic acid synthesis thus interfering with DNA synthesis, repair, and cellular replication.
- methotrexate is cell cycle specific for the S phase.

*irreversibly binds and inhibits (DHF) dihydrofolate reductase, inhibiting folate, thymidylate synthase and purine.

Dosage forms: oral tablet: 5mg, 7.5mg, 10mg, 15mg,

Dosing:
weekly for RA, NEVER given daily**
** 7.5-20mg ONCE weekly (PO/SC/IM)**

Max dose:

Boxed warnings:
-* hepatotoxicity
-* myelosuppression
-* mucositis/stomatitis (painful ulcers/sores in the mouth)
-* pregnancy (teratogenic)

Contraindications:
- pregnancy, breastfeeding, alcoholism, chronic liver disease, blood dyscrasias, immunodeficiency syndrome

Warnings:

Side Effects: [vary by route and dosage]
- N/V/D. increased LFTs, stomatitis (painful swelling and sores inside the mouth), alopecia, photosensitivity,
arthralgia (joint pain),
myalgia (muscle aches and pain)

Monitoring:
- CBC, LFTs, (at baseline, every 2-4 weeks for the first 2 months or following dose increases, every 8-12 weeks for 3-6 months.
chest X-ray, hepatitis B and C serologies (if at high risk)

Pearls/Notes:
- when used in RA, doses used are much smaller.
-
- **Folate acid supplementation: give 5mg PO weekly on the day following Methotrexate administration (some take 1mg daily on non-methotrexate days). DONT TAKE FOLATE ON THE DAY OF TAKING METHOTREXATE, IT WILL BE DESTROYED. Giving Folate is to reduce hematological, GI and hepatic side effects. **

Drug-Drug/Food interactions:
- Should NOT be taken with alcohol** increases the risk of liver toxicity
- renal elimination is decreased by ASPIRIN/NSAIDS, beta-lactams and probenecid, resulting in methotrexate toxicity; Caution if using together
- sulfonamides and topical tacrolimus increase adverse effects of methotrexate. AVOID using together.
- methotrexate and cyclosporine levels will both increase when used together. Avoid using together.*

Question 56

Q

All patients with Rheumatoid Arthritis regardless of the severity get ______________ 1st line

Answer

A

Methotrexate

Question 57

Q

Otrexup

class:
Indications:
MOA:
Dosage forms:
Dosing:
Max dose:
Contraindications:
Warnings:
Side Effects:
Monitoring:
Pearls/Notes:
Drug-Drug/Food interactions:

Answer

A

methotrexate SC autoinjector

methotrexate

Indications:
- (RA) Rheumatoid arthritis

MOA:
- methotrexate binds to and inhibits (DHF) dihydrofolate reductase, which inhibits the formation of reduced folates, and thymidylate synthetase, resulting in inhibition of purine and thymidylic acid synthesis thus interfering with DNA synthesis, repair, and cellular replication.
- methotrexate is cell cycle specific for the S phase.

*irreversibly binds and inhibits (DHF) dihydrofolate reductase, inhibiting folate, thymidylate synthase and purine.

Dosage forms: 10mg/12.5mg/15mg,17.5mg,20mg,22.5mg,25mg/0.4mL

Dosing:
weekly for RA, NEVER given daily**
** 7.5-20mg ONCE weekly (PO/SC/IM)**

Max dose:

Boxed warnings:
-* hepatotoxicity
-* myelosuppression
-* mucositis/stomatitis
-* pregnancy (teratogenic)

Contraindications:
- pregnancy, breastfeeding, alcoholism, chronic liver disease, blood dyscrasias, immunodeficiency syndrome

Warnings:

Side Effects: [vary by route and dosage]
- N/V/D. increased LFTs, stomatitis (painful swelling and sores inside the mouth), alopecia, photosensitivity,
arthralgia (joint pain),
myalgia (muscle aches and pain)

Monitoring:
- CBC, LFTs, (at baseline, every 2-4 weeks for the first 2 months or following dose increases, every 8-12 weeks for 3-6 months.
chest X-ray, hepatitis B and C serologies (if at high risk)

Pearls/Notes:
- when used in RA, doses used are much smaller.
- injectables are commonly used to bypass GI tract, so patient has less GI side effects of nausea and vomiting.
- **Folate acid supplementation: give 5mg PO weekly on the day following Methotrexate administration (some take 1mg daily on non-methotrexate days). DONT TAKE FOLATE ON THE DAY OF TAKING METHOTREXATE, IT WILL BE DESTROYED. Giving Folate is to reduce hematological, GI and hepatic side effects. **
-
- remember autoinjector, so the needle doesn’t come out until injected into the skin. Once removed the needle pops back in device, never see the needle. (to protect patient from a needle stick).

Drug-Drug/Food interactions:
- Should NOT be taken with alcohol** increases the risk of liver toxicity
- renal elimination is decreased by ASPIRIN/NSAIDS, beta-lactams and probenecid, resulting in methotrexate toxicity; Caution if using together
- sulfonamides and topical tacrolimus increase adverse effects of methotrexate. AVOID using together.
- methotrexate and cyclosporine levels will both increase when used together. Avoid using together.*

*Counseling for administration use:
prepare injection site-

Step 1) Twist cap in order to remove and expose injection port that shields needle.

Step 2) Flip the safety clip off on other side of device, so it can be administered.

Step 3) Place the needle end flat against thigh or abdomen at 90 degree and firmly push device until fully depressed. You will hear a click when it is fully depressed, hold for 3 seconds and then remove.

can be given in abdomen or thigh

Question 58

Q

Xatmep

class:
Indications:
MOA:
Dosage forms:
Dosing:
Max dose:
Contraindications:
Warnings:
Side Effects:
Monitoring:
Pearls/Notes:
Drug-Drug/Food interactions:

Answer

A

methotrexate oral solution

methotrexate

Indications:
- (RA) Rheumatoid arthritis

MOA:
- methotrexate binds to and inhibits (DHF) dihydrofolate reductase, which inhibits the formation of reduced folates, and thymidylate synthetase, resulting in inhibition of purine and thymidylic acid synthesis thus interfering with DNA synthesis, repair, and cellular replication.
- methotrexate is cell cycle specific for the S phase.

*irreversibly binds and inhibits (DHF) dihydrofolate reductase, inhibiting folate, thymidylate synthase and purine.

Dosage forms: 2.5mg/mL oral solution For oral USE ONLY

Dosing:
weekly for RA, NEVER given daily**
** 7.5-20mg ONCE weekly (PO/SC/IM)**

Max dose:

Boxed warnings:
-* hepatotoxicity
-* myelosuppression
-* mucositis/stomatitis
-* pregnancy (teratogenic)

Contraindications:
- pregnancy, breastfeeding, alcoholism, chronic liver disease, blood dyscrasias, immunodeficiency syndrome

Warnings:

Side Effects: [vary by route and dosage]
- N/V/D. increased LFTs, stomatitis (painful swelling and sores inside the mouth), alopecia, photosensitivity,
arthralgia (joint pain),
myalgia (muscle aches and pain)

Monitoring:
- CBC, LFTs, (at baseline, every 2-4 weeks for the first 2 months or following dose increases, every 8-12 weeks for 3-6 months.
chest X-ray, hepatitis B and C serologies (if at high risk)

Pearls/Notes:
- when used in RA, doses used are much smaller.
- store refrigerated prior to dispensing
- once dispensed patient can keep in fridge or is good at room temperature for 60 days. Discard any remainder after 60 days.
- **Folate acid supplementation: give 5mg PO weekly on the day following Methotrexate administration (some take 1mg daily on non-methotrexate days). DONT TAKE FOLATE ON THE DAY OF TAKING METHOTREXATE, IT WILL BE DESTROYED. Giving Folate is to reduce hematological, GI and hepatic side effects. **

Drug-Drug/Food interactions:
- Should NOT be taken with alcohol** increases the risk of liver toxicity
- renal elimination is decreased by ASPIRIN/NSAIDS, beta-lactams and probenecid, resulting in methotrexate toxicity; Caution if using together
- sulfonamides and topical tacrolimus increase adverse effects of methotrexate. AVOID using together.
- methotrexate and cyclosporine levels will both increase when used together. Avoid using together. *

Question 59

Q

Rasuvo

class:
Indications:
MOA:
Dosage forms:
Dosing:
Max dose:
Contraindications:
Warnings:
Side Effects:
Monitoring:
Pearls/Notes:
Drug-Drug/Food interactions:

Answer

A

methotrexate SC autoinjector

methotrexate

Indications:
- (RA) Rheumatoid arthritis

MOA:
- methotrexate binds to and inhibits (DHF) dihydrofolate reductase, which inhibits the formation of reduced folates, and thymidylate synthetase, resulting in inhibition of purine and thymidylic acid synthesis thus interfering with DNA synthesis, repair, and cellular replication.
- methotrexate is cell cycle specific for the S phase.

*irreversibly binds and inhibits (DHF) dihydrofolate reductase, inhibiting folate, thymidylate synthase and purine.

Dosage forms: 7.5mg, 10mg, 12.5mg, 15mg, 17.5mg, 20mg, 22.5mg, 25mg, 27.5mg, 30mg

Dosing:
weekly for RA, NEVER given daily**
** 7.5-20mg ONCE weekly (PO/SC/IM)**

Max dose:

Boxed warnings:
-* hepatotoxicity
-* myelosuppression
-* mucositis/stomatitis
-* pregnancy (teratogenic)

Contraindications:
- pregnancy, breastfeeding, alcoholism, chronic liver disease, blood dyscrasias, immunodeficiency syndrome

Warnings:

Side Effects: [vary by route and dosage]
- N/V/D. increased LFTs, stomatitis (painful swelling and sores inside the mouth), alopecia, photosensitivity,
arthralgia (joint pain),
myalgia (muscle aches and pain)

Monitoring:
- *CBCs, *LFTs, (at baseline, every 2-4 weeks for the first 2 months or following dose increases, every 8-12 weeks for 3-6 months.
*chest X-ray (risk of pulmonary infections), hepatitis B and C serologies (if at high risk for reactivation)

Pearls/Notes:
- when used in RA, doses used are much smaller.
- injectables are commonly used to bypass GI tract, so patient has less GI side effects of nausea and vomiting.
- **Folate acid supplementation: give 5mg PO weekly on the day following Methotrexate administration (some take 1mg daily on non-methotrexate days). DONT TAKE FOLATE ON THE DAY OF TAKING METHOTREXATE, IT WILL BE DESTROYED. Giving Folate is to reduce hematological, GI and hepatic side effects. **
-
- - remember autoinjector, so the needle doesn’t come out until injected into the skin. Once removed the needle pops back in device, never see the needle (to protect patient from a needle stick).

Drug-Drug/Food interactions:
- Should NOT be taken with alcohol** increases the risk of liver toxicity
- renal elimination is decreased by ASPIRIN/NSAIDS, beta-lactams and probenecid, resulting in methotrexate toxicity; Caution if using together
- sulfonamides and topical tacrolimus increase adverse effects of methotrexate. AVOID using together.
- methotrexate and cyclosporine levels will both increase when used together. Avoid using together. *

Counseling:
Step 1) Remove yellow cap
Step 2) Prepare the injection site, going in at 90 degrees, WHILE PITCHING SKIN** Apply gentle pressure with pen until it depresses against skin. Then once depressed, press yellow button. You will be able to see that the medication is going down in pen and it is being injected.
Step 3) Inject Rasuvo holding button for 5 seconds. The guard will come out a little further than before.

can be injected in abdomen or thigh

Question 60

Q

Plaquenil

class:
Indications:
MOA:
Dosage forms:
Dosing:
Max dose:
Contraindications:
Warnings:
Side Effects:
Monitoring:
Pearls/Notes:
Drug-Drug/Food interactions:

Answer

A

hydroxychloroquine

Indications: RA- rheumatoid arthritis, SLE- Systemic Lupus Erythematosus

MOA:

Dosage forms: 200mg tablets

Dosing:
Take with food or milk
400-600mg/day initially, then 200-400mg/day for maintenance dose

Max dose:

Boxed Warnings:

Contraindications:

Warnings:
** Irreversible retinopathy**
myopathy and neuropathy, cardiomyopathy and QT prolongation, hypoglycemia, psychiatric events (including suicidal behavior)

Side Effects:
N/V/D

Monitoring:
** eye exam and muscle strength at baseline and every 3 months during prolonged therapy**

Pearls/Notes:
- can be used with methotrexate
- more commonly is used as an alternative to methotrexate WHEN WORRIED about LIVER DISEASE** or can’t tolerate methotrexate
- Lower risk of liver toxicity than methotrexate
- monotherapy: if low disease activity and symptoms < 24 months
- If inadequate or no response after 6 months, consider alternative

Drug-Drug/Food interactions:

Question 61

Q

Azulfidine, Azulfidine-EN

class:
Indications:
MOA:
Dosage forms:
Dosing:
Max dose:
Contraindications:
Warnings:
Side Effects:
Monitoring:
Pearls/Notes:
Drug-Drug/Food interactions:

Answer

A

sulfasalazine, sulfasalazine (DR) delayed release

Indications: Rheumatoid arthritis (RA),

MOA:

Dosage forms: 500mg tablets IR and DR

Dosing:
500-1000mg/day initially, then 1000mg BID
Take with food and 8oz of water to prevent crystalluria.

Max dose: 3000mg/day

Boxed Warnings:

Contraindications:
Sulfa Allergy will cross-react & cause a reaction in patients that have*
** Salicylate Allergy**
-GI or GU obstruction
- porphyria (when the body cannot convert compounds called porphyrins to heme)

Warnings:
- blood dyscrasias, severe skin reactions (SJS/TEN)
- hepatic failure
- pulmonary fibrosis
- Use CAUTION in patients with G6PD deficiency

Side Effects:
- headache, rash, anorexia, dyspepsia, N/V/D, oligospermia “low sperm count” (reversible), folate deficiency, arthralgia (pain in the joint), crystalluria (presence of crystals in urine)
- alopecia (hair loss)

Monitoring:
CBC and LFTs (baseline, then every other week for 3 months, then monthly for 3 months, then once every 3 months), renal function

Pearls/Notes:
-** Can cause yellow-orange coloration of skin/urine**
- Impairs Folate absorption, can give 1mg/day folate supplementation.

Drug-Drug/Food interactions:

Question 62

Q

Arava

class:
Indications:
MOA:
Dosage forms:
Dosing:
Max dose:
Boxed Warnings:
Contraindications:
Warnings:
Side Effects:
Monitoring:
Pearls/Notes:
Drug-Drug/Food interactions:

Answer

A

leflunomide

Indications: (RA) Rheumatoid Arthritis

MOA: Inhibits pyrimidine synthesis (resulting in anti-proliferative and anti-inflammatory effects)

Dosage forms: 10mg, 20mg, 100mg tablets

Dosing:
100mg PO x 3 days, then 20mg PO daily (can use 10mg PO daily if unable to tolerate 20mg)
- may OMIT loading dose if at higher risk of liver toxicity or myelosuppression

Boxed Warnings:
** Do NOT Use in pregnancy (teratogenic); Must test for and rule out pregnancy prior to starting therapy**
** Hepatotoxicity: Avoid in pre-existing liver disease or ALT > 2x upper limit of normal (ULN)

Contraindications:
**pregnancy
- severe hepatic impairment
- current teriflunomide therapy

Warnings:
- severe infections, serious skin reactions (SJS/TEN), peripheral neuropathy, interstitial lung disease, hypertension

Side Effects:
- increased LFTs, nausea, diarrhea, respiratory infections, rash, headache

Monitoring:

-** Patient must have NEGATIVE pregnancy test prior AND USE 2 forms of birth control during treatment; IF PREGNANCY IS DESIRED, MUST WAIT 2 YEARS after discontinuation or use accelerated drug elimination procedure
- **Prodrug of teriflunomide

Drug-Drug/Food interactions:

Question 63

Q

What is the Prodrug of teriflunomide?

Answer

A

leflunomide (Arava)

Question 64

Q

What is the Accelerated drug elimination options for leflunomide?

1)

2)

Answer

A

1) cholestyramine 8 grams PO TID x 11 days (use 4 g if 8g dose not tolerated)

2) Activated charcoal suspension 50g PO Q 12 hours x 11 days

Answer 58

A

tofacitinib

Indications: (RA) rheumatoid arthritis

MOA: drug inhibits Janus kinase enzymes, which stimulates immune cell function. By inhibiting JAK enzymes this suppresses the immune system.

Dosage forms:
Xeljianz- 5mg, 10mg IR tablets / oral solution 1mg/mL
Xeljianz XR- 11mg, 22mg extended release tablets

Do NOT initiate in patients if:
absolute lymphocyte count < 500 cells/mm3
Hgb is less than < 9g/dL
(ANC) absolute neutrophil count < 1000 cells/mm3

Dosing: for RA
IR- 5mg PO BID
XR- 11mg PO daily

(+/- non biologic DMARD)

Boxed Warnings:

** Serious infections** including tuberculosis (TB) fungal, viral, bacterial or other opportunistic infections; screen for active or latent TB and treat before starting.

** Malignancy** Increased risk for lymphomas and other malignancies

Thrombosis Increased risk of serious (sometimes fatal) blood clots, including pulmonary embolism (PE), deep vein thrombosis (DVT) and arterial thrombosis

Mortality and major adverse cardiovascular events: increased risk in patients greater than or equal to 50 years of age with greater than or equal to1 cardiovascular risk factor.

Warnings:
GI perforation, increased LFTs, hematologic toxicities, AVOID LIVE VACCINES

Side Effects:
Upper respiratory tract infections (URTIs), urinary tract infections (UTIs), diarrhea, HA, hypertension, increased lipids.

Monitoring:

Pearls/Notes:
-*** DO NOT USE WITH BIOLOGIC DMARDS OR POTENT IMMUNOSUPPRESSANTS. **
- Caution in patients of Asian descent (increased frequency of side effects)
- Always dispense with Medication Guide

Do not repackage (tablets)
Store in the original bottle to protect from light (oral solution)
Use contents of bottle within 60 days of opening (oral solution) Discard remaining after

Drug-Drug/Food interactions:

Counseling:
- risk of serious infections
- malignancies
- major adverse cardiovascular events
- thrombosis

Answer 59

A

baricitinib

Indications: RA

MOA: drug inhibits Janus kinase enzymes, which stimulates immune cell function. By inhibiting JAK enzymes this suppresses the immune system.

Dosage forms: 1mg/2mg/4mg tablets

Dosing:
For RA- 2mg PO daily

(+/- non biologic DMARD)

If GFR < 30mL/min = NOT recommended

Do NOT initiate in patients if:
absolute lymphocyte count < 500 cells/mm3
Hgb is less than < 8g/dL
(ANC) absolute neutrophil count < 1000 cells/mm3

Boxed Warnings:

** Serious infections** including tuberculosis (TB) fungal, viral, bacterial or other opportunistic infections; screen for active or latent TB and treat before starting.

** Malignancy** Increased risk for lymphomas and other malignancies

Thrombosis Increased risk of serious (sometimes fatal) blood clots, including pulmonary embolism (PE), deep vein thrombosis (DVT) and arterial thrombosis

Mortality and major adverse cardiovascular events: increased risk in patients greater than or equal to 50 years of age with greater than or equal to1 cardiovascular risk factor.

Contraindications:

Warnings:
GI perforation, increased LFTs, hematologic toxicities, AVOID LIVE VACCINES

Side Effects:
Upper respiratory tract infections (URTIs), urinary tract infections (UTIs), diarrhea, HA, hypertension, increased lipids.

Monitoring:

Pearls/Notes:
-*** DO NOT USE WITH BIOLOGIC DMARDS OR POTENT IMMUNOSUPPRESSANTS.
- Caution in patients of Asian descent (increased frequency of side effects)

Always dispense with Medication Guide

Drug-Drug/Food interactions:

Counseling:

Answer 60

A

upadacitinib

Indications: RA

MOA: drug inhibits Janus kinase enzymes, which stimulates immune cell function. By inhibiting JAK enzymes this suppresses the immune system.

Dosage forms: 15mg/30mg/45mg ER tablets

Dosing:
For RA - 15mg daily

Do NOT initiate in patients if:
absolute lymphocyte count < 500 cells/mm3
Hgb is less than < 8g/dL
(ANC) absolute neutrophil count < 1000 cells/mm3

(+/- non biologic DMARD)

Boxed Warnings:

** Serious infections** including tuberculosis (TB) fungal, viral, bacterial or other opportunistic infections; screen for active or latent TB and treat before starting.

** Malignancy** Increased risk for lymphomas and other malignancies

Thrombosis Increased risk of serious (sometimes fatal) blood clots, including pulmonary embolism (PE), deep vein thrombosis (DVT) and arterial thrombosis

Mortality and major adverse cardiovascular events: increased risk in patients greater than or equal to 50 years of age with greater than or equal to1 cardiovascular risk factor.

Warnings:
GI perforation, increased LFTs, hematologic toxicities, AVOID LIVE VACCINES

Side Effects:
Upper respiratory tract infections (URTIs), urinary tract infections (UTIs), diarrhea, HA, hypertension, increased lipids.

Monitoring:

Pearls/Notes:
- DO NOT USE WITH BIOLOGIC DMARDS OR POTENT IMMUNOSUPPRESSANTS.
- Caution in patients of Asian descent (increased frequency of side effects)

-** Dispense in original packaging** to protect from moisture
- manufacturer bottle cap is Flipped sideways
- Do NOT split/cut or chew tablets. Swallow whole
-
- 15mg ER (30 tablets in manufacturer bottle)
- 30mg ER (30 tablets in manufacturer bottle)
- 45mg ER (28 tablets in manufacturer bottle)
-
- Always dispense with Medication Guide

Drug-Drug/Food interactions:

Counseling:

Answer 61

A

Janus Kinase Inhibitors

Xeljanz and Olumiant

Answer 62

A

(Remicade) infliximab

?? Simponi Aria also given IV infusion

Answer 63

A

pregnancy registry

fetus

Answer 64

A

single dose prefilled syringe:
- (Enbrel) etanercept
- (Humira) adalimumab
- (Cimzia Starter Kit) certolizumab - 6 single dose prefilled glass syringes
- (Cimzia Prefilled) - 2 prefilled syringes
- (Simponi) golimumab [50mg/0.5mL, 100mg/mL]

single dose prefilled auto injector pen:
- (Enbrel SureClick) single dose prefilled autoinjector
- (Humira PEN) adalimumab
- (Simponi) golimumab [50mg/0.5mL, 100mg/mL]

vial kit for subcutaneous (SC) injection:
- (25mg/0.5mL) single dose vial (Enbrel SureClick)
- (200mg/vial) lyophilized powder (Cimzia)
-

prefilled cartridge:
- (Enbrel Mini) single dose prefilled cartridge for use with AutoTouch
-

vial for IV administration:
- (100mg per vial) (Remicade) infliximab
- (50mg/4mL vial) (Simponi ARIA) golimumab

Answer 65

A

1) Weekly-
- (Enbrel) etanercept

2) Every Other Week-
- (Humira) adalimumab
- (Cimzia) certolizumab

3)Monthly-
- (Simponi) golimumab

Answer 66

A

etanercept

Indications: (RA) rheumatoid arthritis
Methotrexate 1st line and Anti-TNF Biologics are ADD on therapy.

MOA: (anti-TNF Biologics) aka Tumor Necrosis Factor (TNF) alpha inhibitors

Dosage forms:
single dose prefilled syringe (25mg/0.5mL, 50mg/mL)
autoinjector (50mg/mL)- SureClick
prefilled cartridge (50mg/mL)- Mini
—————— ALL come in quantities of 4 ——————-
vial- (25mg/0.5mL)- - - 4 single dose vials

Dosing: For Subcutaneous Use ONLY ALL PRODUCTS

For RA- 50MG Subcutaneously WEEKLY

+/- (MTX) methotrexate

Boxed Warnings:
** Serious infections**, some fatal, including TB, fungal, viral, bacterial or opportunistic; screen for latent TB (and treat if needed) prior to therapy

** Malignancies and other lymphomas

Contraindications:
- Active systemic infection
- sepsis

Warnings:
-** Hepatitis B reactivation
-** Heart Failure
-** Hepatotoxicity
-** Lupus-like Syndrome
-** DO NOT USE WITH OTHER BIOLOGIC DMARDs or LIVE VACCINES**

Side Effects: (all parenteral)
- Injection site reactions (redness, rash, swelling, itching or bruising), headache, nausea,

Monitoring:
- ** Prior to initiation: TB skin test AND if (+) positive before starting therapy THEN TREAT TB**
-** Test for (HBV) Hepatitis B virus [HBsAg & anti-HBc]
- LFTs, signs and symptoms of infections, heart failure, malignancies
-* Routine: signs of infections: [CBC, LFTs, HBV, TB- annually if risk factors for TB are present), symptoms of heart failure, malignancies, vitals

Pearls/Notes:

Do not Shake (will denature/breakdown drug)
requires refrigeration
Do NOT refrigerate once warmed
- can be stored at room temp for a MAX of 14 days**
rotate injection sites

Drug-Drug/Food interactions:

Counseling for Use:

Leave out of the refrigerator for 15-30 minutes before injecting
DO NOT SHAKE
Wash your hands, & check the liquid/product expiration date
Prepare injection site 1 inch away from last injection site or from belly button, clean area with alcohol
Do NOT inject into damaged skin
inject into thigh or abdomen OR UPPER ARM.*
inject straight down (90 degrees), listen for a CLICK (indicates injection is starting) ** SO DONT REMOVE DEVICE **
WAIT for the right amount of time, once a 2nd CLICK is heard, the injection is complete**
Dispose of used pens/syringes into a sharp’s container

Notes for pharmacist:

What are the Biosimilars to this medication?
1) Erelzi
2) Eticovo

Answer 67

A

etanercept

Answer 68

A

adalimumab

Indications: (RA) rheumatoid arthritis
Methotrexate 1st line and Anti-TNF Biologics are ADD on therapy.

MOA: (anti-TNF Biologics) aka Tumor Necrosis Factor (TNF) alpha inhibitors

Dosage forms:
single dose prefilled autoinjector pen [40mg/0.4mL, 80mg/0.8mL]
single dose prefilled glass syringe (10mg/0.1mL, 20mg/0.2mL, 40mg/0.4mL)
- - - - - ALL come in packs of 2 pens or syringes- - - -

Dosing:
For RA- 40mg subcutaneously Every Other Week

If not taking methotrexate can increase dose to 40mg subcutaneously weekly.

+/- (MTX) methotrexate

Boxed Warnings:
** Serious infections**, some fatal, including TB, fungal, viral, bacterial or opportunistic; screen for latent TB (and treat if needed) prior to therapy

** Malignancies and other lymphomas

Contraindications:
Active systemic infection

Warnings:
-** Hepatitis B reactivation
-** Heart Failure
-** Hepatotoxicity
-** Lupus-like Syndrome
-** DO NOT USE WITH OTHER BIOLOGIC DMARDs or LIVE VACCINES**

Side Effects: (all parenteral)
- Injection site reactions (redness, rash, swelling, itching or bruising), headache, nausea,

Monitoring:
- ** Prior to initiation: TB skin test AND if (+) positive before starting therapy THEN TREAT TB**
-** Test for (HBV) Hepatitis B virus [HBsAg & anti-HBc]
- LFTs, signs and symptoms of infections, heart failure, malignancies
-* Routine: signs of infections: [CBC, LFTs, HBV, TB- annually if risk factors for TB are present), symptoms of heart failure, malignancies, vitals

Pearls/Notes:

Do not Shake (will denature/breakdown drug)
requires refrigeration
leave at room temp for 15-30 min before injecting
Do NOT refrigerate once warmed
can be stored at room temp for a MAX of 14 days**

Drug-Drug/Food interactions:

Counseling for Use:

Leave out of the refrigerator for 15-30minutes before injecting
DO NOT SHAKE or freeze
Wash your hands, & check the liquid/product expiration date
Prepare injection site 1 inch away last injection site or from belly button, clean area with alcohol
Do NOT inject into damaged skin
inject into thigh or abdomen
inject straight down (90 degrees), listen for a CLICK (indicates injection is starting) ** SO DONT REMOVE DEVICE **
WAIT for the right amount of time, once a 2nd CLICK is heard, the injection is complete**
Dispose used injection pens/syringes into a sharps container

Notes for pharmacist:
-* Cyltezo is FDA-approved as an interchangeable biosimilar to Humira. It can be substituted without a separate prescription or provider intervention.

What are the Biosimilars to this medication?
1) Hadlima
2) Abrilada
3) Hyrimoz
4) Amjevita
5) Hulio
6) Cyltezo

Answer 69

A

infliximab

Indications: (RA) rheumatoid arthritis
Methotrexate 1st line and Anti-TNF Biologics are ADD on therapy.

MOA: (anti-TNF Biologics) aka Tumor Necrosis Factor (TNF) alpha inhibitors

Dosage forms: 100mg per vial

Dosing:
For RA- given Intravenous (IV)
- - - 3mg/kg IV at weeks [Week 0, Week 2, Week 6] THEN every 8 weeks.
-** Premedicate
-** requires a Filter
-** stable in NS only
-** + (MTX) methotrexate

Boxed Warnings:
** Serious infections**, some fatal, including TB, fungal, viral, bacterial or opportunistic; screen for latent TB (and treat if needed) prior to therapy

** Malignancies and other lymphomas

Contraindications:
Active systemic infection

Warnings:
-** Hepatitis B reactivation
-** Heart Failure
-** Hepatotoxicity
-** Lupus-like Syndrome
-** DO NOT USE WITH OTHER BIOLOGIC DMARDs or LIVE VACCINES**

Side Effects: (all parenteral)
- Injection site reactions (redness, rash, swelling, itching or bruising), headache, nausea,

Monitoring:
- ** Prior to initiation: TB skin test AND if (+) positive before starting therapy THEN TREAT TB**
-** Test for (HBV) Hepatitis B virus [HBsAg & anti-HBc]
- LFTs, signs and symptoms of infections, heart failure, malignancies
-* Routine: signs of infections: [CBC, LFTs, HBV, TB- annually if risk factors for TB are present), symptoms of heart failure, malignancies, vitals

Pearls/Notes:
-** Infusion reactions, so required to premedicate with antihistamines or steroids and acetaminophen prior to administration**
[Infusion reactions include: hypotension, fever, chills, pruritus (itching)]

-** can cause Delayed Hypersensitivity reactions 3-12 days after administration (fever, rash, myalgia, HA, sore throat)

Drug-Drug/Food interactions:

Counseling for Use:

Leave out of the refrigerator for 15-30minutes before injecting
DO NOT SHAKE or freeze
Wash your hands, & check the liquid/product expiration date
Prepare injection site 1 inch away last injection site or from belly button, clean area with alcohol
Do NOT inject into damaged skin
IV

Notes for pharmacist:
- store unopened vials in refrigerator OR
at room temperature for 6 months
- must infuse over at least 2 hours with an in-line filter

What are the Biosimilars to this medication?
1Renflexis
2 Inflectra
3 Avsola

Answer 70

A

certolizumab pegol

Indications: (RA) rheumatoid arthritis
Methotrexate 1st line and Anti-TNF Biologics are ADD on therapy.

MOA: (anti-TNF Biologics) aka Tumor Necrosis Factor (TNF) alpha inhibitors

Dosage forms:
starter hit (3 prefilled syringes)-

Dosing:
For RA- Every Other Week after initial titration
400mg at Weeks [Week 0, Week 2, Week 4] THEN 200mg SC EOW
(can consider 400mg every 4 weeks)

Boxed Warnings:
** Serious infections**, some fatal, including TB, fungal, viral, bacterial or opportunistic; screen for latent TB (and treat if needed) prior to therapy

** Malignancies and other lymphomas

Contraindications:
Active systemic infection

Warnings:
-** Hepatitis B reactivation
-** Heart Failure
-** Hepatotoxicity
-** Lupus-like Syndrome
-** DO NOT USE WITH OTHER BIOLOGIC DMARDs or LIVE VACCINES**

Side Effects: (all parenteral)
- Injection site reactions (redness, rash, swelling, itching or bruising), headache, nausea,

Monitoring:
- ** Prior to initiation: TB skin test AND if (+) positive before starting therapy THEN TREAT TB**
-** Test for (HBV) Hepatitis B virus [HBsAg & anti-HBc]
- LFTs, signs and symptoms of infections, heart failure, malignancies
-* Routine: signs of infections: [CBC, LFTs, HBV, TB- annually if risk factors for TB are present), symptoms of heart failure, malignancies, vitals

Pearls/Notes:
- Do not Shake (will denature/breakdown drug)
- requires refrigeration
- leave at room temp for 15-30 min before injecting
- Do NOT refrigerate once warmed
- Rotate injection sites

Drug-Drug/Food interactions:

Counseling for How to use:

Leave out of the refrigerator for 15-30minutes before injecting
DO NOT SHAKE or freeze
Wash your hands, & check the liquid/product expiration date
Prepare injection site 1 inch away last injection site or from belly button, clean area with alcohol
Do NOT inject into damaged skin
inject into thigh or abdomen
given at a 45-degree angle
Inject the pre-filled syringe at a 45-degree angle and push the plunger until medication is injected
Dispose used injection syringe into a sharps container

Notes for pharmacist:

Answer 71

A

golimumab

Indications: (RA) rheumatoid arthritis
Methotrexate 1st line and Anti-TNF Biologics are ADD on therapy.

MOA: (anti-TNF Biologics) aka Tumor Necrosis Factor (TNF) alpha inhibitors

Dosage forms:

Dosing:
For RA- 50mg (SC) subcutaneously MONTHLY

-** + (MTX) methotrexate
- If for IV use then requires a filter**
- Simponi Aria (IV use): 2mg/kg infused over 30min at weeks 0, 4, then every 8 weeks

Max dose:

Boxed Warnings:
** Serious infections**, some fatal, including TB, fungal, viral, bacterial or opportunistic; screen for latent TB (and treat if needed) prior to therapy

** Malignancies and other lymphomas

Contraindications:
Active systemic infection

Warnings:
-** Hepatitis B reactivation
-** Heart Failure
-** Hepatotoxicity
-** Lupus-like Syndrome
-** DO NOT USE WITH OTHER BIOLOGIC DMARDs or LIVE VACCINES**

Side Effects: (all parenteral)
- Injection site reactions (redness, rash, swelling, itching or bruising), headache, nausea,

Monitoring:
- ** Prior to initiation: TB skin test AND if (+) positive before starting therapy THEN TREAT TB**
-** Test for (HBV) Hepatitis B virus [HBsAg & anti-HBc]
- LFTs, signs and symptoms of infections, heart failure, malignancies
-* Routine: signs of infections: [CBC, LFTs, HBV, TB- annually if risk factors for TB are present), symptoms of heart failure, malignancies, vitals

Pearls/Notes:
- Do not Shake (will denature/breakdown drug)
- requires refrigeration
- leave at room temp for 15-30 min before injecting
- Do NOT refrigerate once warmed

Drug-Drug/Food interactions:

Counseling for Use:

Leave out of the refrigerator for 15-30minutes before injecting
DO NOT SHAKE
Wash your hands, & check the liquid/product expiration date
Prepare injection site 1 inch away last injection site or from belly button, clean area with alcohol
Do NOT inject into damaged skin
inject into thigh or abdomen OR UPPER ARM.*
inject straight down (90 degrees), listen for a CLICK (indicates injection is starting) ** SO DONT REMOVE DEVICE **
WAIT for the right amount of time, once a 2nd CLICK is heard, the injection is complete**
Dispose used injection pens/syringes into a sharp’s container

Notes for pharmacist:

Simponi ARIA
- store in refrigerator
- do not freeze or shake
- keep in carton to protect from light
- single dose vial

Answer 72

A

rituximab

Indications: RA

MOA: [Drug binds to AND Depletes CD20 B cells]
- which are believed to have a role in RA development and progression.

Dosage forms: Injection for IV

Dosing: (Given with Methotrexate)
1000mg IV on Day 1with MTX and Day 15 with MTX
“Can repeat treatment if needed at 16 and 24 weeks.

Premedicate Required with:
- steroid
- acetaminophen
- antihistamine
For preventing serious/fatal infusion related reactions

Boxed Warnings:
-Serious and fatal infusion related reactions (usually with first infusion).
- (PML) Progressive Multifocal Leukoencephalopathy = due to a JC virus infection (can be fatal)
- Serious Skin Reactions (SJS/TEN)
- HBV reactivation, some cases resulting in fulminant (severe, sudden onset) hepatitis, hepatic failure and death

Warnings:
- Infections; DO NOT GIVE WITH other Biologic DMARDs or LIVE vaccine.

Side Effects:

Monitoring:

Pearls/Notes:

Drug-Drug/Food interactions:

What are the Biosimilars to this medication?

Answer 73

A

anakira

Indications: RA
Not first line

MOA: drug is an IL-1 receptor antagonist (IL-1 mediates immunologic reactions in RA)

Dosage forms: prefilled syringe

Dosing:
- 100mg SC daily (same time each day)
- Give only after failure of one or more DMARDs
- if CrCl < 30mL/min: 100mg SC every other day

Boxed Warnings:

Warnings:
-* Malignancies
-* Serious infections, discontinue if a serious infection develops, screen for TB prior to initiating therapy
-* DO NOT GIVE WITH other Biologics or LIVE vaccines

Side Effects:
- URTIs, headache, N/D, abdominal pain, injection site reactions, antibody development, arthralgias (pain in joint)

Monitoring:
- CBC, SCr, signs of infection

Pearls/Notes:
- Do NOT shake or freeze
- refrigerate prior to use
- protect from light

Drug-Drug/Food interactions:

Answer 74

A

abatacept

Indications: RA

MOA: drug binds to CD80 and CD86 on antigen presenting cells, which inhibits T-cell activation by blocking the interaction with CD28.

Dosage forms: single-dose prefilled syringe. auto injector, IV injection

Dosing:

Max dose:

Boxed Warnings:

Contraindications:

Warnings:

Side Effects:

Monitoring:

Pearls/Notes:

Drug-Drug/Food interactions:

Answer 75

A

tocilizumab

Indications: RA

MOA: (IL-6 receptor antagonist)

Dosage forms:

Dosing:

Max dose:

Boxed Warnings:

Contraindications:

Warnings:

Side Effects:

Monitoring:

Pearls/Notes:

Drug-Drug/Food interactions:

Answer 76

A

sarilumab

Indications: RA

MOA: (IL-6 receptor antagonist)

Dosage forms:

Dosing:

Max dose:

Boxed Warnings:

Contraindications:

Warnings:

Side Effects:

Monitoring:

Pearls/Notes:

Drug-Drug/Food interactions:

Answer 77

A

-is an autoimmune disease commonly referred to as lupus.
- very systemic condition
- primarily affects young women age 15-45 years (child-bearing years)
- more common in women of African-American and Asian decent
- Triggers [sunlight, certain drugs, viral infections]

Clinical presentation:
- butterfly rash (malar rash) and red patches on face, **

more common symptoms include: fatigue, depression, anorexia, weight loss, muscle pain and joint pain and stiffness.

Organs affected:
- kidneys (lupus nephritis)
- hematologic
- neurologic

Lab tests:

Anti-nuclear antibodies (ANA)
Anti-SSDNA and anti-dsDNA

Answer 78

A

M- Methimazole

P- Procainamide*

P- Propylthiouracil

M- Methyldopa

M- Minocycline

Q- Quinidine

I- Isoniazid

A- Anti-TNF agents

T- Terbinafine

H- Hydralazine* [alone, and in BiDil]

top drugs that cause DILE

BiDil is a combination product of hydralazine and a nitrate.

Answer 79

A

(+) antinuclear antibodies (ANA) - with titers greater than or equal to 1:160
(+) anti-single stranded DNA (anti-ssDNA)
(+) anti-double stranded DNA (anti-dsDNA)

————————————————- remember———–
ANA - is a NON-specific lab test, this indicates some inflammatory process/condition.

More SPECIFIC lab tests for Lupus would be:
(+) anti-single stranded DNA (anti-ssDNA)
(+) anti-double stranded DNA (anti-dsDNA)

Answer 80

A

belimumab

Indications: (SLE) Systemic Lupus Erythematosus, Lupus nephritis

MOA: [IgG1-lambda monoclonal antibody] drug prevents the survival of B-lymphocytes by blocking the binding of soluble human B lymphocyte stimulator protein (BLyS) to receptors on B lymphocytes; this reduces the activity of B-cell mediated immunity and the autoimmune response.

Dosage forms:
120mg vial, 400mg vial - IV use
200mg/mL injection - SC use

Dosing:

Max dose:

Warnings:
** Serious (sometimes fatal) infections, PML, acute hypersensitivity reactions, malignancy, psychiatric events,
** DO NOT GIVE WITH OTHER Biologic DMARDS or LIVE vaccines

Side Effects:
Nausea, diarrhea, fever, depression (including suicidal ideation), insomnia

Monitoring:

Pearls/Notes:
- cross the placenta, Caution with use in pregnancy

African American patients may have a lower response rate; use with Caution

Drug-Drug/Food interactions:

Answer 81

A

voclosporin

Indications: only approved for Lupus nephritis

MOA: drug suppresses immune system by inhibiting T-lymphocyte activation

Dosage forms: 7.9mg capsules

Dosing: 23.7mg (3 capsules) by mouth BID in combination with steroids and mycophenolate

Boxed Warnings:
** Serious (sometimes fatal) infections
** Malignancies

Warnings:
** Nephrotoxicity, neurotoxicity, hypertension, hyperkalemia, QT prolongation, red cell aplasia
** DO NOT GIVE WITH LIVE Vaccines

Side Effects:
*hypertension, *diarrhea, *headache, anemia, cough, UTI abdominal pain, *renal impairment

Monitoring:

Pearls/Notes:
- related to cyclosporine
- Avoid use in pregnancy; breastfeeding is NOT RECOMMENDED by the manufacturer

Drug-Drug/Food interactions:

Answer 82

A

Background: is a Chronic progressive autoimmune disease in which the patients immune system attacks the myelin sheath on the neurons.

[myelin sheath, is the fatty substance that surrounds and insulates nerve fibers of the brain and spinal cord axons.] As demyelination progresses, symptoms worsen because the nerves can no longer properly conduct electrical impulses.

Clinical Presentation:
- More common in women, age 20-40 years
- early symptoms include: fatigue, numbness, blurred vision, weakness
- as it worsens a variety of physical and psychological issues can make life very challenging, including deterioration of cognitive function, muscle spasms, pain, incontinence, gait instability (walking pattern not smooth).

Diagnosis
- MRI

Goal of Treatment: prevent progression (lost neuronal function is permanent)

Answer 83

A

Interferon beta formulations: (Betaseron, Avonex, Rebif, Extavia, Plegridy*)

(Glatopa) glatiramer acetate

parenteral drugs that have been the mainstream of treatment for patients with relapsing forms of MS.

Answer 84

A

glatiramer acetate

class:

Indications: (MS)

MOA:
drug is an immune modulator thought to INDUCE and ACTIVATE T-lymphocyte suppressor cells in relapsing forms of MS (exact mechanism is not well defined).

Dosage forms: single dose prefilled syringe
For Subcutaneous Injection ONLY

Dosing:
20mg SC daily
40mg SC 3 times per week (at least 48 hours apart)

** Glatopa 20mg/mL and Glatopa 40mg/mL ARE NOT INTERCHANGEABLE

Contraindications:
*HYPERSENSITIVITY TO MANNITOL

Warnings: *chest pain, immediate post-injection reaction, lipoatrophy

Side Effects: *Injection site reactions (inflammation, erythema, pain, pruritus, residual mass), flushing, diaphoresis, dyspnea, infection, pain, weakness,

Monitoring:

Pearls/Notes:
-** DO NOT ADMINISTER IV
- Preferred agent if treatment necessary during pregnancy
- Check solution for discoloration and discard if present
- ** Protect from light
- Keep refrigerated
- clear, colorless, slightly yellow solution
- can be kept at room temperature for up to one month, OR in the refrigerator (preferred); if cold, let it stand at room temp for 20 minutes prior to injecting.

Drug-Drug/Food interactions:

Answer 85

A

glatiramer acetate

class:

Indications: (MS) multiple sclerosis for the treatment of relapsing MS forms

MOA:
drug is an immune modulator thought to INDUCE and ACTIVATE T-lymphocyte suppressor cells in relapsing forms of MS (exact mechanism is not well defined)

Dosage forms: *Subcutaneous Injection
single dose prefilled syringe

Dosing: [Dosing schedule depends on the product strength that is selected]

**Copaxone 20mg/mL: Administer Subcutaneously 20mg once per day. **
- white plunger, 30-count cartons

**Copaxone 40mg/mL: Administer Subcutaneously 3 times per week and at least 48 hours apart. **
- blue plunger, 12 count cartons

“If increasing dose to 40mg, start 48 hours after the last 20mg dose”

Contraindications:
*HYPERSENSITIVITY TO MANNITOL

Warnings:
Chest pain, immediate post-injection reaction, lipoatrophy (

Side Effects:
*injection site reactions *(inflammation, erythema, pain, pruritus, residual mass), *flushing, *diaphoresis, *dyspnea, infection, pain, weakness, anxiety, rash, nausea, nasopharyngitis, vasodilation

Monitoring:

Pearls/Notes:
-* DO NOT ADMINISTER IV
-** Preferred agent if treatment is necessary during pregnancy**
-* Check solution for discoloration and discard if present*
- clear colorless, slightly yellow solution
- can be kept at room temperature for up to one month, OR in the refrigerator (preferred); if cold, let it stand at room temp for 20 minutes prior to injecting.
- ——most common drug for particular condition—-
Drug-Drug/Food interactions:

Counseling:
Post-injection reaction-
Advise patients that Glatopa may cause various symptoms after injection, including flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, constriction of the throat, and urticaria.

inject subcutaneously into upper arm, lower back, thighs or sides of abdomen

Answer 86

A

Interferon beta-1a

class:

Indications:

MOA:

Dosage forms:

Dosing:

Max dose:

Contraindications:

Warnings:
** psychiatric disorders (depression/suicide), *inject site necrosis, myelosuppression, *increased LFTs, *thyroid dysfunction (hyper and hypo), anaphylaxis, worsening cardiovascular disease, seizure risk

Side Effects:
** Flu-like symptoms following administration (lasting minutes to hours); deceases with continued treatment - can use Tylenol or NSAIDs prior to injection or start with lower doses and titrate weekly to target dose.

Monitoring:

Pearls/Notes:
- Refrigerate
- If Refrigerated, let stand at room temperature prior to injection.
- DO NOT EXPEL the small air bubble in prefilled syringes DUE TO LOSS OF DOSE

Drug-Drug/Food interactions:

Answer 87

A

Interferon beta-1a

class:

Indications:

MOA:

Dosage forms:

Dosing:

Max dose:

Boxed Warnings:

Contraindications:

Warnings:
** psychiatric disorders (depression/suicide), *inject site necrosis, myelosuppression, *increased LFTs, *thyroid dysfunction (hyper and hypo), anaphylaxis, worsening cardiovascular disease, seizure risk

Side Effects:
** Flu-like symptoms following administration (lasting minutes to hours); deceases with continued treatment - can use Tylenol or NSAIDs prior to injection or start with lower doses and titrate weekly to target dose.

Monitoring:

Pearls/Notes:
- Refrigerate
- If Refrigerated, let stand at room temperature prior to injection.
- DO NOT EXPEL the small air bubble in prefilled syringes DUE TO LOSS OF DOSE

Drug-Drug/Food interactions:

Answer 88

A

Interferon beta-1b

class:

Indications:

MOA:

Dosage forms:

Dosing:

Boxed Warnings:

Contraindications:

Warnings:
** psychiatric disorders (depression/suicide), *inject site necrosis, myelosuppression, *increased LFTs, *thyroid dysfunction (hyper and hypo), anaphylaxis, worsening cardiovascular disease, seizure risk

Side Effects:
** Flu-like symptoms following administration (lasting minutes to hours); deceases with continued treatment - can use Tylenol or NSAIDs prior to injection or start with lower doses and titrate weekly to target dose.

Monitoring:

Pearls/Notes:
- - ** Store at ROOM TEMPERATURE**
- If Refrigerated, let stand at room temperature prior to injection.
- ** DO NOT SHAKE**
- DO NOT EXPEL the small air bubble in prefilled syringes DUE TO LOSS OF DOSE

Drug-Drug/Food interactions:

Answer 89

A

Peginterferon beta-1a

class:

Indications:

MOA:

Dosage forms:

Dosing: [Every 14 days*]

Max dose:

Boxed Warnings:

Contraindications:

Warnings:

Side Effects:

Monitoring:

Pearls/Notes:
- longer half-life, pegylated form of interferon beta-1a

Drug-Drug/Food interactions:

Answer 90

A

teriflunomide
** Active metabolite of leflunomide**

class:

Indications: (MS) Multiple Sclerosis

MOA:
drug is a pyrimidine synthesis inhibitor: an anti-inflammatory, may reduce the number of activated lymphocytes in the CNS.

Dosage forms: tablet (oral option)

Dosing:

Max dose:

Boxed Warnings:

Contraindications:
-** pregnancy
-** severe hepatic impairment

Warnings:

Side Effects:

Monitoring:

Pearls/Notes:
- **Can use accelerated elimination to remove drug:

Drug-Drug/Food interactions:

Answer 91

A

fingolimod -imod

Indications: (MS) Multiple Sclerosis

MOA: drug blocks lymphocytes from exiting lymph nodes, reducing lymphocytes in the periphery; may limit lymphocyte migration into the CNS [exact mechanism in MS is not well defined]

Dosage forms: capsule (oral option

Dosing:

Contraindications:
** Some arrhythmias, or any of the following in the past 6 months:
[MI, Unstable Angina, Stroke/TIA or some HF (decompensation requiring hospitalization, or Class III/IV)]

Warnings:

Side Effects:

Monitoring:

Pearls/Notes:

Drug-Drug/Food interactions:

Answer 92

A

ozanimod -imod

class:

Indications:

MOA:

Dosage forms: capsule (oral option)

Dosing:

Max dose:

Boxed Warnings:

Contraindications:

Warnings:

Side Effects:

Monitoring:

Pearls/Notes:

Drug-Drug/Food interactions:

Answer 93

A

ponesimod -imod

class:

Indications:

MOA:

Dosage forms: tablet

Dosing:

Max dose:

Boxed Warnings:

Contraindications:

Warnings:

Side Effects:

Monitoring:

Pearls/Notes:

Drug-Drug/Food interactions:

Answer 94

A

siponimod -imod

class:

Indications:

MOA:

Dosage forms: tablet (oral option)

Dosing:

Max dose:

Boxed Warnings:

Contraindications:

Warnings:

Side Effects:

Monitoring:

Pearls/Notes:

Drug-Drug/Food interactions:

Answer 95

A

dimethyl fumarate

class:

Indications:

MOA:

Dosage forms:

Dosing:

Max dose:

Boxed Warnings:

Contraindications:

Warnings:

Side Effects:

Monitoring:

Pearls/Notes:
-** Swallow Capsules whole

Drug-Drug/Food interactions:

Answer 96

A

diroximel fumarate

class:

Indications:

MOA:

Dosage forms:

Dosing:

Max dose:

Boxed Warnings:

Contraindications:

Warnings:

Side Effects:

Monitoring:

Pearls/Notes:

Drug-Drug/Food interactions:

Answer 97

A

nifedipine ER or another CCB

Never nifedipine IR

Answer 98

A

Beta blockers
Bleomycin
Cisplatin
Sympathomimetics (due to the vasoconstriction) include: amphetamines, pseudoephedrine and illicit drugs (e.g. cocaine)

Answer 99

A

The FDA permits food products to be labeled “gluten free” only if the food contains less gluten than 20 parts per million.

Answer 100

A

dental caries, corneal ulceration, and chronic oral infections

Answer 101

A

cyclosporine

Answer 102

A

cyclosproine

Answer 103

A

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Systemic Steroid & Autoimmune Conditions Flashcards

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