REMS

Question 1

Alosetron (Lotronex)

Answer 1

Serious GI adverse effects: ischemic colitis

Question 2

testosterone undecanoate (aveed)

Answer 2

Serious pulmonary oil microembolism (POME) reactions: cough, dyspnea, throat tightening, syncope after administration.

Question 3

Blinatumomab (Blincyto)

Answer 3

Risk of life-threatening or fatal cytokine release syndrome and/or fatal neurological toxicities.

Question 4

Buprenorphine

Answer 4

To ensure risks outweigh benefits

Question 5

Clozapine

Answer 5

severe neutropenia: monitor ANC, enroll in registry.

Question 6

Isotretinoin

Answer 6

Pregnancy risks: birth defects

Question 7

Tolvaptan (Jynarque)

Answer 7

Hepatotoxicity (do not use for autosomal dominant polycystic kidney disease)

Question 8

Tisagenlecleucel (Kymriah)

Answer 8

Cytokine release syndrome and neurological toxicities

Question 9

Alemtuzumab (Lemtrada)

Answer 9

Autoimmunity, infusion reactions, malignancies

Question 10

Alosetron (Lotronex)

Answer 10

ischemic colitis

Question 11

Mifepristone

Answer 11

Risk of serious complications: bacterial infections, bleeding

Question 12

Mycophenolate

Answer 12

Embryo-fetal toxicity

Question 13

PTH (natpara)

Answer 13

risk of osteosarcoma

Question 14

Romiplostim (Nplate)

Answer 14

progression of myelodysplastic syndrome to AML, bone marrow fibrosis and reticulin fomration, worsened thrombocytopenia on cessation, med errors, and thrombotic/thromboembolic complications

Question 15

Opioid Analgesics

Answer 15

educate prescribers on treatment and monitoring

Question 16

Palforzia (peanut allergen powder)

Answer 16

mitigate anaphylaxis w/epinephrine on hand, observing for at least 60 minutes

Question 17

Pomalidomide (pomalyst)

Answer 17

Embryo-fetal exposure

Question 18

Buprenorphine (Probuphine)

Answer 18

complications: migration, protrusion, expulsion, nerve damage (with insertion and removal)
also opioid analgesic risks

Question 19

Denosumab (Prolia)

Answer 19

risks of hypocalcemia, jaw osteonecrosis, atypical femoral fractures, serious infections, dermatologic reactions

Question 20

Phentermine and topiramate (Qsymia)

Answer 20

congenital malformations, pregnancy prevention

Question 21

Lenalidomide (Revlimid)
and Thalomid (Thalidomide)

Answer 21

Embryo-fetal exposure

Question 22

Sodium oxybate (Xyrem)

Answer 22

CNS and respiratory depression
contraindication with sedative hypnotics and alcohol
potential for abuse and misuse.

Question 23

Esketamine (Spravato)

Answer 23

Sedation and dissociation. Only administered in HCF

Question 24

Buprenorphine extended release (sublocade) and buprenorphine and naloxone/buprenorphine)

Answer 24

Accidental overdose

injection (for non-naloxone product)

Question 25

Inotersen (Tegsedi)

Answer 25

Mitigate risks of serious bleeding w/thrombocytopenia | mitigate glomerulonephritis

Question 26

Natalizumab (Tysabri)

Answer 26

Progressive multifocal leukoencephalopathy (PML), increased risk with longer treatment do not use with antineoplastics, immunosuppressants, or immunomodulators

Question 27

Vigabatrin (Sabril)

Answer 27

mitigate vision loss increased risk with longer exposure

Question 28

Naltrexone (Vivitrol)

Answer 28

Severe injection site reactions

Question 29

Collagenase clostridium histolyticum (Xiaflex)

Answer 29

Corporal rupture (penis fracture)

Question 30

Idelalisib (Zydelig)

Answer 30

Serious/fatal hepatotoxicity, diarrhea/colitis, pneumonitis, infections, intestinal perforation

Question 31

Olanzapine (Zyprexa Relprevv)

Answer 31

Post-injection delirium/sedation syndrome only in HCF