-
4 parts of REMS
- communication plans,
- implementation plans,
- elements to assure safe use (ETASU),
- MedGuides
-
thalidomide
- Thalomid
- Risk: severe birth defects
- REMS: Thalomid REMS, negative preggo test
-
isotretinoin
- Absorica, Amnesteem, Claravis, Myorisan, Zenatane
- Risk: severe birth defects
- REMS: iPledge Program, negative preggo test
-
clozapine
- Clozaril, FazaClo, Versacloz
- Risk: neutropenia
- REMS: Clozapine REMS Program, monitor ANC
-
phentermine/topiramate
- Qsymia
- Risk: severe birth defects
- REMS: Qsymia REMS program, MedGuide req, healthcare training program, dispensed through certified pharmacies only
-
liraglutide
- Saxenda
- Risk: risk of medullary thyroid carcinoma, risk of acute pancreatitis
- REMS: Saxenda REMS Program
-
flibanserin
- Addyi
- Risk: hypotension and syncope d/t an interaction with alcohol
- REMS: Addyi REMS Program, no ETOH, all trained
-
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
|
|
