ReciGen®

(Interferon Beta-1a)

MORE CONFIDENCE, MORE SUCCESS

Description

Interferon beta-1a is an immunomodulator medicine which can enhance immune cell activities. Each pre-filled syringe of ReciGen^® containing 44µg (12 Million IU / 0.5 ml) recombinant human interferon beta-1a for subcutaneous injection, produced under EU GMP license.

Indications

• ReciGen^® (interferon beta-1a) is indicated for treatment of relapsing forms of multiple sclerosis to decrease the frequency of clinical exacerbations, delay the accumulation of physical disability, decrease the number and volume of active brain lesions and decrease overall disease burden.

Important safety information

• Increased ALT, AST and bilirubin have been reported. Obtain liver function tests at 1, 3, and 6 months’ post therapy initiation and periodically thereafter. Treatment should be suspended immediately if jaundice or symptoms of hepatic dysfunction occur. Consider dose reductions or temporary discontinuation if ALT >5 times ULN. Use with caution in patients with hepatic impairment or in those who abuse alcohol.
• Pancytopenia (rare), leukopenia, and thrombocytopenia have been reported. Monitor blood counts at 1, 3, and 6 months’ post therapy initiation and periodically thereafter. Events may recur with rechallenge.
• Flu-like symptoms have a high incidence while taking interferon beta-1a. Use of analgesics and/or antipyretics on treatment days may be helpful.
• Interferons have been associated with psychiatric adverse events (psychosis, depression, suicidal behavior/ideation) in patients with and without previous psychiatric symptoms; use with caution in patients with depression.
• Some patients have had seizures while taking interferon, including patients who have never had seizures. Use with caution in patients with a history of seizure disorder.
• Allergic reactions, including anaphylaxis, have been reported. Some reactions may occur after prolonged use. Discontinue therapy if anaphylaxis or other allergic reactions occur.
• Some people who take interferon beta-1a may get an infection. Urinary and upper respiratory tract infections are more common.
• Thyroid abnormalities may develop with use; may worsen pre-existing thyroid conditions. Monitor thyroid function tests every 6 months or as clinically necessary.
• In a scientific statement from the American Heart Association, interferon has been determined to be an agent that may either cause reversible direct myocardial toxicity or exacerbate underlying myocardial dysfunction (AHA [Page 2016]).
• Autoimmune disorders including idiopathic thrombocytopenia, hyper- and hypothyroidism and rarely autoimmune hepatitis have been reported. Consider discontinuation of treatment if patient develops a new autoimmune disorder.
• Severe injection site reactions have occurred, including pain, erythema, edema, cellulitis, abscess, and necrosis.
• Cases of thrombotic microangiopathy manifesting as thrombotic thrombocytopenic purpura (TTP) or hemolytic uremic syndrome (HUS) (some fatal) have been reported.
• formulations that contain albumin are contraindicated in albumin-sensitive patients.