Interferon beta-1b

Generic Medicine Info
Indications and Dosage
Relapsing remitting multiple sclerosis, Secondary progressive multiple sclerosis, Single demyelinating event suggestive of multiple sclerosis
Adult: Initially, 62.5 mcg (2 MIU) every other day, increased gradually over 3-6 wk to a target dose of 250 mcg/mL (8 MIU) every other day. Titration may be adjusted if significant AR occurs.
Inject 1.2 mL of the diluent provided (NaCl 0.54%) into the vial labelled as containing 300 mcg (9.6 MIU) to produce a soln containing 250 mcg/mL (8 MIU). Swirl gently to dissolve.
Hypersensitivity to natural or recombinant interferon beta or human albumin. Current severe depression and/or suicidal ideation, decompensated liver disease.
Special Precautions
Patient w/ previous or current depressive disorders, pre-existing CV disease, myelosuppression, thyroid dysfunction, history of seizure disorder. Hepatic impairment and severe renal failure. Pregnancy and lactation.
Adverse Reactions
Significant: Pancreatitis, hepatic injury (including hepatic failure), nephrotic syndrome, depression or suicidal ideation, CHF, immunogenicity, drug-induced lupus erythematosus, leucopenia, flu-like symptoms, severe hypersensitivity reactions (e.g. anaphylaxis, bronchospasm), inj site necrosis. Rarely, cardiomyopathy.
Nervous: Headache, incoordination, insomnia, asthenia, malaise.
CV: HTN, peripheral oedema.
GI: Abdominal pain.
Resp: Dyspnoea.
Hepatic: Increased SGOT/SGPT.
Genitourinary: Urinary urgency.
Endocrine: Impotence, metrorrhagia.
Haematologic: Decreased WBC, neutrophil, and lymphocyte counts.
Musculoskeletal: Hypertonia, myalgia.
Dermatologic: Rash, skin disorder.
Others: Lymphadenopathy, fever, pain.
Potentially Fatal: Thrombotic microangiopathy, systemic capillary leak syndrome (in patients w/ pre-existing monoclonal gammopathy).
IM/Parenteral/SC: C
Patient Counseling Information
May impair ability to drive or operate machinery.
Monitoring Parameters
Monitor CBC (including platelet count) and LFT at 1, 3, 6 mth following initiation of therapy and periodically thereafter. Assess thyroid function every 6 mth in patients w/ history of thyroid dysfunction or as clinically necessary. Monitor for flu-like symptoms, allergic reactions, inj site reactions, worsening of cardiac symptoms (in CHF patients) and for sign/symptoms of depression.
Drug Interactions
May decrease the metabolism of theophylline derivatives, except dyphylline. May decrease the metabolism and enhance the adverse effects of zidovudine.
Mechanism of Action: Interferon beta-1b is a cytokine w/ antiviral and immunomodulating activities. Its exact mechanism in the treatment of multiple sclerosis is unknown. However, its biological response-modifying properties are mediated through its interaction w/ specific cell receptors. This induces the expression of gene products which are believed to be mediators of its pleiotropic bioactivities. Additionally, it decreases the binding affinity and enhances internalisation and degradation of interferon-γ receptor. It also enhances the suppressor activity of peripheral blood mononuclear cells.
Absorption: Bioavailability: Approx 50%. Time to peak plasma concentration: 1-8 hr.
Excretion: Elimination half-life: 8 min to 4.3 hr.
Store between 20-25°C. Do not freeze.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
L03AB08 - interferon beta-1b ; Belongs to the class of interferons. Used as immunostimulants.
Anon. Interferon Beta-1b. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 05/06/2017.

Anon. Interferon Beta. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. Accessed 05/06/2017 .

Buckingham R (ed). Interferon Beta. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. Accessed 05/06/2017 .

Extavia (Novartis Pharmaceuticals Corporation). DailyMed. Source: U.S. National Library of Medicine. Accessed 05/06/2017 .

Extavia (Novartis Pharmaceuticals UK Ltd). eMC. Accessed 05/06/2017 .

Joint Formulary Committee. Interferon Beta. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. Accessed 05/06/2017 .

Rossi S (ed). Interferon Beta. Australian Medicines Handbook [online]. Adelaide. Australian Medicines Handbook Pty Ltd. Accessed 05/06/2017 .

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