Interferon beta-1b


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : SC Relapsing-remitting and secondary progressive type of multiple sclerosis; Single demyelinating event suggestive of multiple sclerosis Initial: 62.5 mcg every other day, increased gradually over 3-6 wk up to 250 mcg every other day.
Dosage Details
Subcutaneous
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.
Reconstitution
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.
Contraindications
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.
MonitoringParameters
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.
Action
Description: 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.
Storage
Store between 20-25°C. Do not freeze.
ATC Classification
L03AB08 - interferon beta-1b ; Belongs to the class of interferons. Used as immunostimulants.
Disclaimer: This information is independently developed by MIMS based on Interferon beta-1b from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
  • Betaferon
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