THERAPY

Rebif

Interferon Beta 1a

Protocols

Before Initiation of Therapy :

  • CBC, liver enzymes, bilirubin, TSH
  •  HBsAg, anti-HBc, anti-HBs, Hepatits C, HIV, VZV serology
  • Vaccination status verified and updated if necessary
  • Negative pregnancy test and counsel with regards to contraception

Monitoring During Therapy :

  • CBC, Liver enzymes, bilirubin Q1month X6 then Q6 months
  • TSH Q6 months
  • Nabs any time after 12 months

Discontinue Therapy :

  • AL T>5X ULN or jaundice
  • Nabs (+) 
  • Severe thrombocytopenia especially in setting of fever and encephalopathy (R/O TTP)
  • Severe leukopenia or pancytopenia
  • Depression or suicidal ideation
  • Unexplained cardiomyopathy with /out congestive heart failure
  • Pregnancy
  • Seizure

Product Monograph

Specific Concerns

Storage :

  •  Should be stored in a refrigerator but can be kept at room temperature for up to one week. Extremes temperature and exposure to ligth should be avoided

Patient Selection :

  • Should be used with caution in patients with prior seizure disorder, liver disease, ongoing depression or concomitantly with other potentially liver toxic therapies

Adverse Events :

  • Most frequent adverse event is flu like symptoms which tend to diminish in severity and frequency with time
  • Decreased peripheral blood counts in all cell lines, including very rare pancytopenia and thrombocytopenia have been reported from post-marketing experience
  • Elevated liver enzymes from hepatic injury or hepatitis including hepatic failure have been reported
  • Can lead to autoimmune disorders such as drug induced SLE, autoimmune hepatitis, hyper or hypothyroidism, thrombotic thrombocytopenic purpura  and haemolytic uraemic syndrome. These events can may occur after several weeks to several years after starting treatment with interferon beta.
  • Anaphylaxis has been reported as a rare complication. Other allergic reactions have included dyspnea, orolingual edema, skin rash and urticaria
  • Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) have been reported during treatment with interferon-beta products.
  • Rare cases of secondary systemic capillary leak sydrome (Clarkson syndrome) has been reported with interferon beta administration to patients with underlying monoclonal gammopathy