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Business Acumen GBA 113/114 > Breo PI > Flashcards

Breo PI Flashcards

0
Q

What are the contraindications for Breo

A

Severe hypersensitivity to milk proteins

Hypersensitivity to either FF, vilanterol or any excipients of Breo Ellipta

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1
Q

What is the dosing and administration of Breo

A

1 inhalation once daily by the orally inhaled route only.

Taken the same time everyday

Not to be used more than 1 time every 24 hours.

Mouth should be rinsed with water without swallowing to help reduce the risk of oropharyngeal candidiasis

No dosage adjustment is required for geriatric patients, patients with hepatic impairment, or renally impaired patients.

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2
Q

What are the 16 warnings and precautions

A 
Asthma related death
Deterioration of disease acute episodes
Excessive use of Breo Ellipta and use with other LABAs
Local effects of inhaled corticosteroids
Pneumonia
Imunosupression
Transferring patients from systemic corticosteroids therapy
Hypercorticism and adrenal suppression 
Drug interactions with strong cytochrome p450 3A4 inhibitors
Paradoxical bronchospasm
Hypersensitivity reactions
Cardiovascular effects
Reduction in BMD 
Glaucoma and cataracts 
Coexisting conditions
Hypokalemia and hyperglycemia
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3
Q

What should CYP 3A4 inhibitors be used with caution?

A

The following may occur

Increase systemic corticosteroid effect increase cardiovascular effects

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4
Q

What do you do with paradoxical bronchi spasm

A

Immediate treatment with short acting bronchodilator
Immediate discontinuation of Breo Ellipta
Initiation of alternative therapy

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5
Q

Cardiovascular effects seem with Breo

A

Increased pulse rate
Systolic or diastolic blood pressure
Cardiac arrhythmia and extrasystoles
If such effects occur Breo may need to be discontinued.
Electrocardiograph is changes have been reported with beta agonist use

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6
Q

Bone mineral density

A

If patient has significant reductions in BMD and treatment with Breo Ellipta is medically necessary then osteoporosis treatment should be strongly considered.

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7
Q

Glaucoma and cataracts

A

In patients with COPD long term use had shown
IOP
Glaucoma
Cataracts

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8
Q

Coexisting conditions

A

Thyrotoxicosis

Diabetes mellitus and Ketoacifosis

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9
Q

What pregnancy category is Breo

A

C

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10
Q

Hypoadrenalism

A

Babies

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11
Q

Based on In bistro and vivid models FF demonstrated what:

A

Activation of the glucocorticoid response element

Inhibition of pro inflammatory transcription factors
I hibition of antigen induced lung eosinophilia

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12
Q

Mechanism of vilsnterol

A

Relaxation of bronchial smooth muscle

Inhibiting of release of mediators of immediate hypersensitivity from cells , ESP mast cells

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13
Q

Plasma levels of FF

A

FF
Peak plasma 05 to 1 hour
Absolutely bio 15.2
Oral bio 1.3 low due to extensive first pass metabolism
Systemic exposure in patients with COPD 46% lower than healthy patients

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14
Q

Pharma kinetics : absorption vilanterol

A

Plasma levels do not predict therapeutic effect
Peak plasma 10 minutes after inhalation
Absolute bioavailability 27.3
Oral bio <2
Low due to extensive first pass
Systemic exposure in patients with COPD 24% higher than in health patients

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15
Q

Metabolism

A

Metabolized by CYP3A4

16
Q

Pharmacokinetics: elimination plasma elimination phase half life.

A

FF-24 hours

V-21.3 hours

17
Q

Pharma kinetics special population

A

90 % ci

8.6-8.7 I. PI

18
Q

Mean volume distribution at steady state 661. L

A

FF

19
Q

Mean volume distribution at steady state was 165 L

A

Vilanterol

20
Q

Non clinical toxicology

A

No studies were conducted for Breo Ellipta in regards to carcinogen edits, mutagenesis and impairment of fertility

21
Q

7700 patients were studied

A

Dose ranging trials

Confirmatory trisls

22
Q

What were the copromary end points for the lung function trials 1 & 2.

A

Weighted mean FEV 1 (0-4 hours) post dose on day 168

Change from baseline in trough FEV1 on day 169

23
Q

For trials 1 & 2 lung function trials what were the findings for weighted mean FEV1 (0-4 hours) on day 168 for Breo Ellipta 100/25 compared with placebo and FF 100

A

On day 169 in both trials, Breo Ellots 100/25 demonstrated significant increases in trough FEV 1 compared with placebo.

In both trials improvements in trough FEV1 for Breo Ellipta 100/25 compared with vilanterol 25 did not achieve statistical significance

24
Q

What was the primary end point for the exacerbation trial 3 & 4

A

Annual rate of moderate to severe exacerbation a.

25
Q

For trials 3 & 4 what were the results regarding the annual rate of moderate/severe exacerbations of COpd for Breo Ellipta 100/25 compared with 25 mcg alone

A

Patients treated with Breo Ellipta 100/25 had a lower annual rate of moderate/severe COPD exacerbations compared with vilanterol 25 mcg in both trials.

26
Q

Patient counseling info

A

Asthma related death
Not meant for relief of acute symptoms of COPD
Do not use additional LABAs
Risks associated with corticosteroid therapy
Risks associated with beta agonist therapy.

27
Q

Describe how 0-4 hour post dose weighted mean FEV 1 on day 168 was calculated in the lung function trials

A

Weighted mean FEV1 0-4 hour post dose is derived by
Calculating the AUC from FEV1 measured 5,15 and 30 minutes and 1,2 and 4 hours post dose and
Then dividing the AUC by the time interval.

28
Q

Describe how change from baseline in trough FEV1 on day 169 was calculated in the lung function trials

A

Trough FEV1 is the mean of FEV1 values obtained at 23 and 24 hours after dosing on day 168.

Baseline FEV1 is the mean of two assessments at 30 and 5 minutes precise on treatment day 1

Change from baseline is the difference between day 169mean values and day 1 predose values

29
Q

Kerwin Study

A

Nasopharyngitis
URTI
Headache

30
Q

True or False

A

In trial 3 & 4 Breo Ellipta 100/25 mcg had a lower mean annual rate of moderate to severe exacerbations vrs VI- true

31
Q

In trial 3 the mean annual rate of moderate/ severe exacerbations for Breo Ellipta 100/25 and VI were _ and _, which represents a ratio vs VI of

A

0.90, 1.14, 0.69

32
Q

In trial 4 the mean annual rate of moderate to severe exacerbations for Breo Ellipta 100/25 mcg were and. Which represents a ratio vs VI of _.

A

0.70, 1.05;0.66

Business Acumen GBA 113/114 (4 decks)

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