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Interferon beta-1b injection

Updated 2 Feb 2023 | Interferon beta


Injections containing interferon beta-1b

These products have been produced by recombinant technology using E.coli.

Drugs List

  • BETAFERON 300microgram (9.6 million units) powder + solvent for solution for injection vial
  • EXTAVIA 300microgram (9.6 million units) powder + solvent for solution for injection vial
  • interferon beta-1b 300microgram (9.6 million units) powder + solvent for solution for injection vial
  • Therapeutic Indications


    Single severe demyelinating event with active inflammatory process
    Treatment of relapsing-remitting multiple sclerosis
    Treatment of secondary progressive multiple sclerosis

    Patients with a single demyelinating event with an active inflammatory process, if it is severe enough to be treated with intravenous corticosteroids, if alternative diagnoses have been excluded and if they are determined to be at high risk of developing clinically definite multiple sclerosis.

    Patients with relapsing remitting multiple sclerosis who have had two or more relapses within the last two years.

    Patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.


    Treatment is not recommended in patients with relapsing remitting multiple sclerosis with less than 2 exacerbations in the previous 2 years or in patients with secondary progressive multiple sclerosis who have had no active disease in the previous 2 years.


    250 micrograms subcutaneously three times a week.

    The following dose titration is recommended at the start of treatment:
    Days 1, 3 and 5: 62.5 micrograms (0.25ml).
    Days 7, 9 and 11: 125 micrograms (0.5ml).
    Days 13, 15 and 17: 187.5 micrograms (0.75ml).
    Day 19 onwards: 250 micrograms (1ml).

    The optimal dose has not been fully clarified. At the present time, it is not known for how long the patient should be treated.


    For subcutaneous injection


    Children under 12 years
    Suicidal ideation
    Decompensated liver disease
    Severe depression

    Precautions and Warnings

    Children aged 12 to 18 years
    Severe infection
    Cardiac disorder
    Epileptic disorder
    Hepatic impairment
    History of depression
    History of seizures
    Metastatic carcinoma
    Monoclonal IgM gammopathy
    Severe renal impairment
    Thyroid dysfunction

    Monoclonal gammopathy: Cytokine administration may be fatal
    Advise ability to drive/operate machinery may be affected by side effects
    Treatment to be initiated and supervised by a specialist
    Needle cover contains a derivative of latex
    Derived from human proteins - transmission of infective agents possible
    Advise patient to report injection site reactions where the skin breaks
    Record name and batch number of administered product
    Monitor full blood count and differential WBC before and during therapy
    Monitor hepatic function before treatment and regularly during treatment
    Monitor renal function before treatment and regularly during treatment
    Monitor thyroid function at baseline and where clinically indicated
    Monitor cardiac function in patients with cardiac disease
    Monitor closely patient with pre-existing renal impairment
    Monitor closely patients who develop neutropenia
    Monitor for signs of nephrotic syndrome
    Monitor patient for signs and symptoms of depression
    Monitor serum biochemistry regularly
    Monitor thyroid function regularly if history of dysfunction
    Review self injection technique periodically, especially if reactions occur
    Advise patient to report any new or worsening depression/suicidal ideation
    Advise patient to report symptoms of thrombotic microangiopathy
    Advise patients/carers to seek medical advice if changes in behaviour/mood
    Consider discontinuing if depression develops
    Consider discontinuing treatment if nephrotic syndrome occurs
    Consider discontinuing treatment if serum transaminase levels rise
    Discontinue if jaundice or other clinical symptoms of hepatic injury
    Neutralising antibodies may develop that decrease clinical efficacy
    Risk of pancreatitis
    Discontinue at first signs of thrombotic microangiopathy
    Discontinue if cardiomyopathy occurs
    Discontinue if multiple injection site lesions present until healing occurs
    Discontinue if severe hypersensitivity reactions occur

    Treatment should be discontinued if patients fail to respond for example: if a steady state progression in Expanded Disability Status Scale (EDSS) for 6 months occurs or 3 or more courses of adrenocorticotropic hormone (ACTH) or corticosteroids are required in a one year period.

    Nephrotic syndrome with differing underlying nephropathies have been reported during treatment with interferon beta products, at varying points during and for several years following treatment. Monitoring for the early signs of nephrotic syndrome e.g. oedema, proteinuria and impaired renal function is recommended. If nephrotic syndrome does occur prompt treatment is required and discontinuation of treatment should be considered.

    The product is made from human albumin and therefore carries the potential risk for transmission of viral diseases. A risk of transmission of CJD cannot be excluded.

    Cases of thrombotic microangiopathy (TMA) have been reported and may occur several weeks to years after commencing treatment. Cases may manifest as thrombocytopenic purpura or haemolytic uraemic syndrome. Early symptoms include thrombocytopenia, new onset hypertension, fever and central nervous system symptoms. If such symptoms develop testing of blood platelet levels, serum LDH, blood films and renal function should be carried out. Interferon beta-1b should be discontinued if TMA is diagnosed and immediate treatment is required (consider plasma exchange).

    Pregnancy and Lactation


    Use interferon beta-1b with caution during pregnancy.

    The manufacturer states that the use of interferon beta-1b during pregnancy may be considered if clinically required. Human data suggests no increased risk of major congenital abnormalities during the first trimester due to interferon beta-1b. Experience during the second than third trimester is very limited.

    Animal studies have shown interferon beta may possibly increase the risk of spontaneous abortion and low birth weight when administered in the first trimester. The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot be evaluated based on the currently available data, but does not currently suggest an increase.


    Interferon beta-1b is considered safe for use during breastfeeding.

    The manufacturer states that interferon beta-1b can be used during breastfeeding. It is suggested that the levels of interferon beta-1b secreted into human breast milk is negligible.

    Schaefer suggests that due to the large molecular weight of interferon beta it is not excreted into human milk.

    LactMed reported no adverse effects in partially breastfed infants when breastfeeding mothers received interferon beta-1b. Therefore, no special precautions appear to be necessary while using interferon beta-1b.

    Side Effects

    Abdominal pain
    Acute hepatic injury
    Anaphylactic reaction
    Back pain
    Capillary leak syndrome
    Chest pain
    Cough increased
    Decreased blood glucose
    Ear pain
    Elevated triglyceride levels
    Emotional lability
    Gamma glutamyl transferase (GGT) increased
    Hepatic failure
    Increase in serum ALT/AST
    Inflammation (injection site)
    Influenza-like symptoms
    Injection site reactions
    Local pain (injection site)
    Lupus erythematosus
    Menstrual disturbances
    Necrosis (injection site)
    Nephrotic syndrome
    Painful extremities
    Peripheral oedema
    Personality change
    Pulmonary artery hypertension
    Serum bilirubin increased
    Skin discolouration
    Skin disorder
    Suicidal tendencies
    Thrombotic microangiopathy
    Thyroid abnormalities
    Upper respiratory tract infection
    Urinary frequency
    Urinary incontinence
    Urinary retention
    Urinary urgency
    Visual disturbances
    Weight changes


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: October 2015

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 6 October 2015.

    Summary of Product Characteristics: Betaferon 250 microgram/ml powder and solvent for solution for injection. Bayer plc. Revised September 2019.

    Summary of Product Characteristics: Extavia 250 microgram/ml powder and solvent for solution for injection. Novartis Pharmaceuticals UK Ltd. Revised September 2019.

    MHRA Drug Safety Update October 2014
    Available at:
    Last accessed: 6 October 2015.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Interferon Beta Last revised: 31st October 2018
    Last accessed: 9 December 2019.

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