Drugs List

Therapeutic Indications

Uses

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.

Administration

For subcutaneous injection

Contraindications

Children under 12 years
Suicidal ideation
Decompensated liver disease
Severe depression

Precautions and Warnings

Children aged 12 to 18 years
Sepsis
Severe infection
Alcoholism
Cardiac disorder
Depression
Epileptic disorder
Hepatic impairment
History of depression
History of seizures
Metastatic carcinoma
Monoclonal IgM gammopathy
Myelosuppression
Pregnancy
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

Pregnancy

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.

Lactation

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
Abscess
Acute hepatic injury
Alopecia
Anaemia
Anaphylactic reaction
Anorexia
Anxiety
Arthralgia
Asthenia
Back pain
Bronchospasm
Capillary leak syndrome
Cardiomyopathy
Chest pain
Chills
Confusion
Conjunctivitis
Constipation
Convulsions
Cough increased
Decreased blood glucose
Depression
Diarrhoea
Dizziness
Dysmenorrhoea
Dyspnoea
Ear pain
Elevated triglyceride levels
Emotional lability
Fever
Gamma glutamyl transferase (GGT) increased
Glomerulosclerosis
Headache
Hepatic failure
Hepatitis
Hypertension
Hyperthyroidism
Hypertonia
Hypothyroidism
Impotence
Increase in serum ALT/AST
Infections
Inflammation (injection site)
Influenza-like symptoms
Injection site reactions
Insomnia
Leucopenia
Local pain (injection site)
Lupus erythematosus
Lymphadenopathy
Malaise
Menstrual disturbances
Metrorrhagia
Migraine
Myalgia
Myasthenia
Nausea
Necrosis (injection site)
Nephrotic syndrome
Neutropenia
Pain
Painful extremities
Palpitations
Pancreatitis
Paraesthesia
Peripheral oedema
Personality change
Proteinuria
Pruritus
Pulmonary artery hypertension
Rash
Serum bilirubin increased
Sinusitis
Skin discolouration
Skin disorder
Suicidal tendencies
Sweating
Tachycardia
Thrombocytopenia
Thrombotic microangiopathy
Thyroid abnormalities
Upper respiratory tract infection
Urinary frequency
Urinary incontinence
Urinary retention
Urinary urgency
Urticaria
Vasodilation
Visual disturbances
Vomiting
Weight changes

Presentation

Injections containing interferon beta-1b

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

Drugs List

Therapeutic Indications

Uses

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.

Dosage

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.

Adults

Administration

For subcutaneous injection

Contraindications

Children under 12 years
Suicidal ideation
Decompensated liver disease
Severe depression

Precautions and Warnings

Children aged 12 to 18 years
Sepsis
Severe infection
Alcoholism
Cardiac disorder
Depression
Epileptic disorder
Hepatic impairment
History of depression
History of seizures
Metastatic carcinoma
Monoclonal IgM gammopathy
Myelosuppression
Pregnancy
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

Pregnancy

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.

Lactation

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
Abscess
Acute hepatic injury
Alopecia
Anaemia
Anaphylactic reaction
Anorexia
Anxiety
Arthralgia
Asthenia
Back pain
Bronchospasm
Capillary leak syndrome
Cardiomyopathy
Chest pain
Chills
Confusion
Conjunctivitis
Constipation
Convulsions
Cough increased
Decreased blood glucose
Depression
Diarrhoea
Dizziness
Dysmenorrhoea
Dyspnoea
Ear pain
Elevated triglyceride levels
Emotional lability
Fever
Gamma glutamyl transferase (GGT) increased
Glomerulosclerosis
Headache
Hepatic failure
Hepatitis
Hypertension
Hyperthyroidism
Hypertonia
Hypothyroidism
Impotence
Increase in serum ALT/AST
Infections
Inflammation (injection site)
Influenza-like symptoms
Injection site reactions
Insomnia
Leucopenia
Local pain (injection site)
Lupus erythematosus
Lymphadenopathy
Malaise
Menstrual disturbances
Metrorrhagia
Migraine
Myalgia
Myasthenia
Nausea
Necrosis (injection site)
Nephrotic syndrome
Neutropenia
Pain
Painful extremities
Palpitations
Pancreatitis
Paraesthesia
Peripheral oedema
Personality change
Proteinuria
Pruritus
Pulmonary artery hypertension
Rash
Serum bilirubin increased
Sinusitis
Skin discolouration
Skin disorder
Suicidal tendencies
Sweating
Tachycardia
Thrombocytopenia
Thrombotic microangiopathy
Thyroid abnormalities
Upper respiratory tract infection
Urinary frequency
Urinary incontinence
Urinary retention
Urinary urgency
Urticaria
Vasodilation
Visual disturbances
Vomiting
Weight changes

Overdosage

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

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: https://www.mhra.gov.uk
Last accessed: 6 October 2015.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501168/
Interferon Beta Last revised: 31st October 2018
Last accessed: 9 December 2019.