REMS (Risk Evaluation and Mitigation Strategy)

  1. 4 parts of REMS
    • communication plans,
    • implementation plans,
    • elements to assure safe use (ETASU),
    • MedGuides
  2. thalidomide
    • Thalomid
    • Risk: severe birth defects
    • REMS: Thalomid REMS, negative preggo test
  3. isotretinoin
    • Absorica, Amnesteem, Claravis, Myorisan, Zenatane
    • Risk: severe birth defects
    • REMS: iPledge Program, negative preggo test
  4. clozapine
    • Clozaril,¬†FazaClo,¬†Versacloz
    • Risk: neutropenia
    • REMS: Clozapine REMS Program, monitor ANC
  5. phentermine/topiramate
    • Qsymia
    • Risk: severe birth defects
    • REMS: Qsymia REMS program, MedGuide req, healthcare training program, dispensed through certified pharmacies only
  6. liraglutide
    • Saxenda
    • Risk: risk of medullary thyroid carcinoma, risk of acute pancreatitis
    • REMS: Saxenda REMS Program
  7. flibanserin
    • Addyi
    • Risk: hypotension and syncope d/t an interaction with alcohol
    • REMS: Addyi REMS Program, no ETOH, all trained
  8. opioid analgesics
    • buprenorphine (Butrans), methadone (Dolophine), fentanyl (Duragesic), hydromorphone (Exalgo), hydrocodone bitartrate (Hysingla /ER, Zohydro ER), morphine (MS Contin, Kadian), methdone (Methadose), tapentadol (Nucynta ER), oxycodone (Oxycontin),¬† all other ER/LA opioid analgesics
    • Risk: high abuse potential, life-threatening respiratory depression
    • REMS: ER/LA Opioid Analgesics REMS Program, MedGuide, PRESCRIBERS must complete approved CE and must counsel patients
Card Set
REMS (Risk Evaluation and Mitigation Strategy)
FDA Amendments Act of 2007 - ensure benefits outweigh its risks and if not sufficient through warnings and MedGuides