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
Author
VASUpharm14
ID
341674
Card Set
REMS (Risk Evaluation and Mitigation Strategy)
Description
FDA Amendments Act of 2007 - ensure benefits outweigh its risks and if not sufficient through warnings and MedGuides
Updated