Interferon beta-1b

Subcutaneous
Relapsing remitting multiple sclerosis, Secondary progressive multiple sclerosis, Single demyelinating event suggestive of multiple sclerosis

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.

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.

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

May impair ability to drive or operate machinery.

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.

May decrease the metabolism of theophylline derivatives, except dyphylline. May decrease the metabolism and enhance the adverse effects of zidovudine.

Description:
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.
Pharmacokinetics:
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.

Vaccines, Antisera & Immunologicals

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

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