Betaferon

Recombinant interferon β-1b

Treatment of patients w/ a single demyelinating event w/ an active inflammatory process, if it is severe enough to warrant treatment w/ IV corticosteroids, if alternative diagnoses have been excluded, & if they are determined to be at high risk of developing clinically definite multiple sclerosis; relapsing-remitting multiple sclerosis & ≥2 relapses w/in the last 2 yr; secondary progressive multiple sclerosis w/ active disease, evidenced by relapses.

Adult 250 mcg (8 million IU) SC every other day. Dose titration: Initially 62.5 mcg (0.25 mL) SC every other day, increased slowly to 250 mcg (1 mL) every other day.

History of hypersensitivity to natural or recombinant interferon β or human albumin. Current severe depression &/or suicidal ideation. Decompensated liver disease.

Risk of systemic capillary leak symptoms in patients w/ pre-existing monoclonal gammopathy. Rare cases of pancreatitis often associated w/ hypertriglyceridaemia. Potential risk for transmission of viral diseases. Patients w/ previous or current depressive disorders, particularly those w/ antecedents of suicidal ideation; history of seizures & those receiving treatment w/ anti-epileptics, particularly if epilepsy is not adequately controlled w/ anti-epileptics; severe renal failure; pre-existing cardiac disorders. Regularly perform thyroid function tests, or as clinically indicated, in patients w/ history of thyroid dysfunction. Perform complete blood count & differential WBC counts, platelet counts & blood chemistries, including liver function tests prior to initiation & at regular intervals following introduction of Betaferon therapy, & then periodically thereafter in the absence of clinical symptoms. Asymptomatic elevations of serum transaminases; monitor patients for signs of hepatic injury. Risk of nephrotic syndrome w/ different underlying nephropathies; thrombotic microangiopathy; serious hypersensitivity reactions; inj site necrosis. Potential for immunogenicity. Might influence the ability to drive & use machines in susceptible patients. Pregnancy. Should not be used in childn or adolescents.

Flu-like symptom complex (fever, chills, arthralgia, malaise, sweating, headache, or myalgia); inj site reactions (redness, swelling, discolouration, inflammation, pain, hypersensitivity, necrosis & non-specific reactions).

Use w/ immunomodulators other than corticosteroids or ACTH is not recommended. Use w/ caution when co-administered w/ medicinal products that have narrow therapeutic index & are largely dependent on hepatic CYP450 system for clearance (eg, anti-epileptics); medication which has an effect on the haematopoietic system.

Vaccines, Antisera & Immunologicals

L03AB08 - interferon beta-1b ; Belongs to the class of interferons. Used as immunostimulants.

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