IntramuscularRelapsing forms of multiple sclerosis, Single demyelinating event suggestive of multiple sclerosisAdult: As 30 mcg/0.5 mL solution for inj: 30 mcg once weekly. To lower the incidence and severity of flu-like symptoms, may initiate at a dose of 7.5 mcg once weekly on week 1, then increase in increments of 7.5 mcg once weekly on weeks 2-4 up to the recommended dose of 30 mcg once weekly. Alternatively, may initiate at a dose of 15 mcg once weekly before increasing to the recommended full dose. The recommended dose of 30 mcg once weekly is then maintained. Premedication of antipyretics/analgesics before inj is recommended. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability. Treatment guidelines may vary among individual products or between countries. Refer to local specific product information.
SubcutaneousSingle demyelinating event suggestive of multiple sclerosisAdult: As 8.8 mcg/0.2 mL, 22 mcg/0.5 mL and 44 mcg/0.5 mL solution for inj: Target dose of 44 mcg 3 times weekly: Initially, 8.8 mcg (20% of target dose) 3 times weekly on weeks 1-2, followed by 22 mcg (50% of target dose) 3 times weekly on weeks 3-4, then 44 mcg 3 times weekly on week 5 and onwards. Premedication of antipyretics/analgesics before inj is recommended. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability. Treatment guidelines may vary among individual products or between countries. Refer to local specific product information.
SubcutaneousRelapsing forms of multiple sclerosisAdult: As 8.8 mcg/0.2 mL, 22 mcg/0.5 mL and 44 mcg/0.5 mL solution for inj: Target dose of 44 mcg 3 times weekly: Initially, 8.8 mcg (20% of target dose) 3 times weekly on weeks 1-2, followed by 22 mcg (50% of target dose) 3 times weekly on weeks 3-4, then 44 mcg 3 times weekly on week 5 and onwards. As 8.8 mcg/0.2 mL and 22 mcg/0.5 mL solution for inj: Target dose of 22 mcg 3 times weekly: Initially, 4.4 mcg (20% of target dose) 3 times weekly on weeks 1-2, followed by 11 mcg (50% of target dose) 3 times weekly on weeks 3-4, then 22 mcg 3 times weekly on weeks 5 and onwards. Premedication of antipyretics/analgesics before inj is recommended. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability. Treatment guidelines may vary among individual products or between countries. Refer to local specific product information.
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Hypersensitivity to natural or recombinant interferon beta, or human albumin. Current severe depression and/or suicidal ideation.
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Patient with previous or current depressive disorder, pre-existing cardiac disease (e.g. angina, CHF, arrhythmia), history of seizure disorder, severe myelosuppression, thyroid dysfunction, history of alcohol abuse. SC use should not be substituted for IM administration. Hepatic and severe renal impairment. Pregnancy and lactation.
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Significant: Autoimmune disorders, including idiopathic thrombocytopenia, hyper- and hypothyroidism, and autoimmune hepatitis (rare); bone marrow suppression (e.g. leucopenia, thrombocytopenia, pancytopenia), flu-like symptoms, psychiatric effects (e.g. psychosis, depression, suicidal behaviour or ideation), seizures; nephrotic syndrome with different underlying nephropathies such as collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN), and membranous glomerulopathy (MGN); asymptomatic elevation of hepatic transaminases, hepatitis; severe inj site reactions (e.g. erythema, pain, oedema, abscess, cellulitis, necrosis). Rarely, severe hepatic injury, including hepatic failure; cardiomyopathy, CHF; allergic reactions, including anaphylaxis.
Blood and lymphatic system disorders: Neutropenia, lymphopenia, anaemia, lymphadenopathy.
Eye disorders: Visual disturbances.
Gastrointestinal disorders: Diarrhoea, nausea, vomiting, abdominal pain.
General disorders and administration site conditions: Fatigue, asthenia, night sweats, pain, chills, rigors, fever, malaise.
Investigations: Decreased haematocrit, increased BUN and blood K levels.
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia, muscle spasticity, back or neck pain, pain in extremity, musculoskeletal stiffness.
Nervous system disorders: Headache, hypoaesthesia, dizziness.
Psychiatric disorders: Insomnia.
Respiratory, thoracic and mediastinal disorders: Rhinorrhoea, sinusitis, bronchitis, upper respiratory tract infection.
Renal and urinary disorders: UTI.
Skin and subcutaneous tissue disorders: Pruritus, rash, erythematous rash, maculopapular rash, alopecia, increased sweating, contusion.
Vascular disorders: Flushing.
Potentially Fatal: Thrombotic microangiopathy that manifests as thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS).
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This drug may cause dizziness, if affected, do not drive or operate machinery.
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Monitor for signs and symptoms of autoimmune disorders, new-onset or worsening CV disease, thrombotic microangiopathy, and psychiatric disorder (including depression and/or suicidal ideation). Perform latent infection screening (e.g. hepatitis, TB) at baseline in countries with high TB burden or in high-risk populations. For IM inj: Check CBC with differential, thyroid function tests, LFTs and complete metabolic panel periodically. For SC inj: Obtain blood counts and LFTs at 1-, 3-, and 6-months intervals post-therapy initiation, then periodically thereafter; thyroid function at baseline and every 6 months or as clinically necessary.
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May interfere with the metabolism of drugs that have a narrow therapeutic index and are mainly dependent on the hepatic CYP450 system for clearance (e.g. antiepileptics, certain antidepressants).
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Description:
Mechanism of Action: Interferon beta-1a, a 166 amino acid glycoprotein with approx 22,500 daltons molecular weight, is produced by recombinant DNA technology. Its precise mechanism of action in multiple sclerosis is still unknown; however, it provides its biological effects by binding to specific receptors on the surface of human cells, thus initiating a complex cascade of intracellular events. These events result in the expression of numerous interferon-induced gene products and markers.
Onset: IM: 12 hours (based on biological response markers).
Duration: IM: 4 days (based on biological response markers).
Pharmacokinetics:
Absorption: Approx 50% of SC dose and approx 40% of an IM dose is absorbed. Time to peak plasma concentration: IM: Approx 15 hours (range: 6-36 hours); SC:16 hours.
Metabolism: Mainly metabolised in the liver and kidneys.
Excretion: Elimination half-life: IM: Approx 19 hours (range: 8-54 hours); 69 ± 37 hours (SC).
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Prefilled syringe/pen (IM inj): Store between 2-8°C. Do not freeze. Protect from light. If refrigeration is not available, may be stored between 15-30°C for up to 7 days. Prefilled syringe/pen/cartridge (SC inj): Store between 2-8°C. Do not freeze. Protect from heat and light. For ambulatory use, may be stored below 25°C for up to 14 days.
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L03AB07 - interferon beta-1a ; Belongs to the class of interferons. Used as immunostimulants.
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Anon. Interferon Beta-1a. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 21/10/2021. Avonex 30 mcg/0.5 mL Solution for Injection in Pre-filled Pen (Biogen Idec [Hong Kong] Pte Ltd). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 18/11/2021. Avonex 30 micrograms/0.5 mL Solution for Injection and Avonex 30 micrograms/0.5 mL Solution for Injection in Pre-filled Pen (Biogen Netherlands B.V.). MHRA. https://products.mhra.gov.uk. Accessed 21/10/2021. Avonex Pen, Injection Solution and Injection Solution (Biogen Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 21/10/2021. Buckingham R (ed). Interferon Beta. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 21/10/2021. Joint Formulary Committee. Interferon Beta. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 21/10/2021. Rebif 44 micrograms Solution for Injection in Cartridge (Merck Serono Limited). MHRA. https://products.mhra.gov.uk. Accessed 18/11/2021. Rebif 8.8 micrograms Solution for Injection in Pre-filled Pen and Rebif 22 micrograms Solution for Injection in Pre-filled Pen (Merck Serono Limited). MHRA. https://products.mhra.gov.uk. Accessed 21/10/2021. Rebif Injection, Solution and Rebif Rebidose Injection, Solution (EMD Serono, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 18/11/2021. Rebif Solution for Injection (Merck Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 21/10/2021.
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