Generic Name and Formulations:
Interferon beta-1a 8.8mcg/0.2mL, 22mcg/0.5mL, 44mcg/0.5mL; soln for SC inj; contains albumin (human); preservative-free.
EMD Serono, Inc.
Indications for REBIF:
Relapsing forms of multiple sclerosis (MS), to decrease the frequency of clinical exacerbations and delay accumulation of physical disability.
Pre-medicate with analgesics and/or antipyretics on treatment days to ameliorate flu-like symptoms. Give by SC inj at least 48hrs apart, preferably in the PM. Rotate inj site. Initially 4.4mcg 3 times per week for 2 weeks, titrate to target 22mcg 3 times per week by Week 5; or, initially 8.8mcg 3 times per week for 2 weeks, titrate to target 44mcg 3 times per week by Week 5. See full labeling. May need dose reduction if SGPT >5xULN or leukopenia occurs.
Depression; consider discontinuing if occurs. Suicidal ideation. Discontinue immediately if jaundice or other signs of liver dysfunction occur. Active or history of liver disease. Increased serum SGPT >2.5xULN. Alcohol abuse. Seizure disorders. Risk of thrombotic microangiopathy; discontinue if occurs. History of thyroid dysfunction; do thyroid tests every 6 months. Monitor blood counts and liver function at 1, 3, and 6 months after initiation, then periodically thereafter. If myelosuppression, monitor CBCs with differential and platelets more intensively. Elderly. Pregnancy (Cat.C). Nursing mothers.
Risk of hepatic injury with concomitant hepatotoxic drugs or alcohol.
Inj site reaction/necrosis, flu-like symptoms, abdominal pain, depression, elevated liver enzymes, hematologic abnormalities; rare: hepatic failure, anaphylaxis (discontinue if occurs).
Prefilled syringe (22mcg, 44mcg)—1, 12; Rebidose autoinjector (22mcg, 44mcg)—12; Titration Pack: Prefilled syringes or Rebidose autoinjectors (6x8.8mcg + 6x22mcg)—1