REMS Flashcards
Alosetron (Lotronex)
Serious GI adverse effects: ischemic colitis
testosterone undecanoate (aveed)
Serious pulmonary oil microembolism (POME) reactions: cough, dyspnea, throat tightening, syncope after administration.
Blinatumomab (Blincyto)
Risk of life-threatening or fatal cytokine release syndrome and/or fatal neurological toxicities.
Buprenorphine
To ensure risks outweigh benefits
Clozapine
severe neutropenia: monitor ANC, enroll in registry.
Isotretinoin
Pregnancy risks: birth defects
Tolvaptan (Jynarque)
Hepatotoxicity (do not use for autosomal dominant polycystic kidney disease)
Tisagenlecleucel (Kymriah)
Cytokine release syndrome and neurological toxicities
Alemtuzumab (Lemtrada)
Autoimmunity, infusion reactions, malignancies
Alosetron (Lotronex)
ischemic colitis
Mifepristone
Risk of serious complications: bacterial infections, bleeding
Mycophenolate
Embryo-fetal toxicity
PTH (natpara)
risk of osteosarcoma
Romiplostim (Nplate)
progression of myelodysplastic syndrome to AML, bone marrow fibrosis and reticulin fomration, worsened thrombocytopenia on cessation, med errors, and thrombotic/thromboembolic complications
Opioid Analgesics
educate prescribers on treatment and monitoring
Palforzia (peanut allergen powder)
mitigate anaphylaxis w/epinephrine on hand, observing for at least 60 minutes
Pomalidomide (pomalyst)
Embryo-fetal exposure
Buprenorphine (Probuphine)
complications: migration, protrusion, expulsion, nerve damage (with insertion and removal)
also opioid analgesic risks
Denosumab (Prolia)
risks of hypocalcemia, jaw osteonecrosis, atypical femoral fractures, serious infections, dermatologic reactions
Phentermine and topiramate (Qsymia)
congenital malformations, pregnancy prevention
Lenalidomide (Revlimid) and Thalomid (Thalidomide)
Embryo-fetal exposure
Sodium oxybate (Xyrem)
CNS and respiratory depression
contraindication with sedative hypnotics and alcohol
potential for abuse and misuse.
Esketamine (Spravato)
Sedation and dissociation. Only administered in HCF
Buprenorphine extended release (sublocade) and buprenorphine and naloxone/buprenorphine)
Accidental overdose
injection (for non-naloxone product)
Inotersen (Tegsedi)
Mitigate risks of serious bleeding w/thrombocytopenia
mitigate glomerulonephritis
Natalizumab (Tysabri)
Progressive multifocal leukoencephalopathy (PML), increased risk with longer treatment
do not use with antineoplastics, immunosuppressants, or immunomodulators
Vigabatrin (Sabril)
mitigate vision loss
increased risk with longer exposure
Naltrexone (Vivitrol)
Severe injection site reactions
Collagenase clostridium histolyticum (Xiaflex)
Corporal rupture (penis fracture)
Idelalisib (Zydelig)
Serious/fatal hepatotoxicity, diarrhea/colitis, pneumonitis, infections, intestinal perforation
Olanzapine (Zyprexa Relprevv)
Post-injection delirium/sedation syndrome
only in HCF
