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REMS drugs
| Question | Answer |
|---|---|
| Zyprexa Relprevv (Olanzapine) | post-injection delirium sedation syndrome |
| Addyi | Increased risk of hypotension with alcohol |
| Bosentan | hepatotoxicity and embryo-fetal toxicity |
| Clozapine | neutropenia |
| Isotretinoin | teratogenicity |
| Juxtapid (lomitapide) | hepatotoxicity |
| Mycophenolate | embryo-fetal toxicity |
| Qysmia | embryo-fetal toxicity |
| Riociguat | embryo-fetal toxicity |
| Zulresso (Brexanolone) | Excessive sedation and sudden loss of consciousness |
| Zilbrysq (zilucoplan) | meningococcal infections |
| Yescarta and Tecartus (axicabtagene) | cytokine release syndrome and neurological toxicities |
| Xywav and Xyrem (calcium, magnesium, potassium, sodium oxybate) | CNS and respiratory depression |
| Xiaflex (collagenase clostridium histolyticum) | corporal rupture (penile fracture) |
| Voydeya (danicopan) | serious infections caused by encapsulated bacteria |
| Vigabatrin(vai-gab-ih-trin) | vision loss |
| Vanflyta (quizartininb) | QT prolongation, Torsades de Pointes, Cardiac Arrest |
| Ultomiris and Soliris (eculizumab) | meningococcal infections |
| Tysabri (natalizumab) | progressive multifocal leukoencephalopathy (PML) |
| Tyruko (natalizumab-sztn) | progressive multifocal leukoencephalopathy (PML) |
| Turalio (pexidartinib) | fatal liver injury |
| Tryvio (aprocitentan) | embryo-fetal toxicity |
| Transmucosal Immediate-Release Fentanyl (TIRF) | overdose |
| Thalomid (thalidomide) | embryo-fetal toxicity |
| Tegsedi (Inotersen) | serious bleeding with severe thrombocytopenia and the risk of glomerulonephritis |
| Tecvayli and Talvey (talquetamab-tgvs) | Cytokine Release Syndrome (CRS) and neurologic toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) |
| Sublocade (buprenorphine extended-release) | risk of serious harm or death that could result from intravenous self-administration |
| Spravato (esketamine) | sedation and dissociation |
| Sodium Oxybate | significant central nervous system (CNS) and respiratory depression |
| Siliq (brodalumab) | risk of suicidal ideation and behavior, including completed suicides |
| Prolia (denosumab) | severe hypocalcemia in patients with advanced chronic kidney disease (CKD) including dialysis-dependent patients |
| Probuphine (buprenorphine hydrochloride) | complications of migration, protrusion, expulsion and nerve damage associated with the insertion and removal |
| Pomalyst (pomalidomide) | embryo-fetal exposure |
| Palynziq (pegvaliase-pqpz) | risk of anaphylaxis |
| Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp) | risk of anaphylaxis |
| Myalept (metreleptin) | serious adverse sequelae (such as severe infections, excessive weight gain, glucose intolerance, diabetes mellitus) |
| Natpara (parathyroid hormone) | potential risk of osteosarcoma |
| Mifepristone | serious complications |
| Macitentan | embryo-fetal toxicity |
| Lumryz (sodium oxybate extended-release) | significant central nervous system (CNS) and respiratory depression |
| Lenalidomide | embryo-fetal exposure |
| Lemtrada (alemtuzumab) | risks of autoimmune conditions, infusion reactions, stroke, and malignancies |
| Kymriah (tisagenlecleucel) | cytokine release syndrome (CRS) and neurological toxicities |
| Jynarque (tolvaptan) | serious and potentially fatal liver injury |
| Hepzato (melphalan) | severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events |
| Gattex (teduglutide [rDNA origin]) | risks of possible acceleration of neoplastic growth and enhancement of colon polyp growth, gastrointestinal obstruction, and biliary and pancreatic disorders |
| Fintepla (fenfluramine hydrochloride) | valvular heart disease and pulmonary arterial hypertension |
| Filspari (sparsentan | hepatotoxicity and embryo-fetal toxicity |
| Fabhalta (iptacopan) | serious infections caused by encapsulated bacteria |
| Empaveli (Pegcetacoplan) | encapsulated bacteria infections (Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y and B and Haemophilus influenzae Type B) |
| Elrexfio (elranatamab-bcmm) | Cytokine Release Syndrome (CRS), and neurologic toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) |
| Dsuvia (sufentanil) | risk of respiratory depression resulting from accidental exposure |
| Copiktra (duvelisib) | risks of fatal and/or serious toxicities , including infections, diarrhea or colitis, cutaneous reactions, and pneumonitis |
| Carvykti (ciltacabtagene autoleucel) | risks of cytokine release syndrome (CRS) and neurological toxicities |
| Caprelsa (vandetanib) | serious risks of QT prolongation, Torsades de pointes, and sudden death |
| Camzyos (mavacamten) | heart failure due to systolic dysfunction |
| Buprenorphine Transmucosal Products for Opioid Dependence (BTOD) | accidental overdose, misuse, and abuse |
| Brixadi (buprenorphine) | mitigate the risk of serious harm or death |
| Breyanzi (lisocabtagene maraleucel) | risks of cytokine release syndrome (CRS) and neurological toxicities |
| Aveed (testosterone undecanoate) | pulmonary oil microembolism (POME) |
| Ambrisentan | embryo-fetal toxicity |
| Alvimopan Shared System REMS | myocardial infarction |
| Adasuve (loxapine) | negative outcomes (respiratory distress or respiratory arrest) |
| Abecma (Idecabtagene vicleucel) | risks of cytokine release syndrome (CRS) and neurologic toxicities |
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