Drugs List

Therapeutic Indications

Uses

Infection prophylaxis in chronic granulomatous disease
Reduction of infection frequency in malignant osteopetrosis

Indicated as adjunctive therapy (with antibacterials) to reduce the frequency of serious infections in patients with chronic granulomatous disease (CGD).

Indicated for the reduction in frequency of serious infections in patients with severe, malignant osteopetrosis.

Administration

For subcutaneous injection. Optimum sites of injection are the right and left deltoid and anterior thigh.

Interferon gamma-1b may be administered by patient or family member once trained in the administration of subcutaneous injection.

Contraindications

Breastfeeding
Children under 6 months - if treating chronic granulomatous disease
Pregnancy

Precautions and Warnings

Children under 18 years
Cardiac arrhythmias
Cardiac disorder
Compromised central nervous system function
History of congestive cardiac failure
Ischaemic heart disease
Myelosuppression
Seizures
Severe hepatic impairment
Severe renal impairment

Administration of live vaccines is not recommended
Advise ability to drive/operate machinery may be affected by side effects
Monitor cardiac function before and regularly during treatment
Monitor haematological parameters before and during treatment
Monitor hepatic function before treatment and regularly during treatment
Monitor renal function before treatment and regularly during treatment
Perform regular urinalysis
Antibodies to ingredient may develop
May affect immune response to live vaccines
May cause impaired fertility
Male & female: Ensure adequate contraception during treatment

The use of interferon gamma-1b does not exclude the need for additional antimicrobial coverage that might be required for the management of CGD.

Patients with pre-existing cardiac disease may experience an acute self-limiting exacerbation of their cardiac condition at doses above 250 micrograms/ square metre BSA/ day.

Concurrent use of interferon gamma-1b and other serum protein preparations or immunologic preparations (e.g. vaccines) increases the risk of an amplified immune response.

As an exogenous protein, interferon gamma-1b may induce the formation of antibodies during treatment. However, to date there have been no reports of significant induction or neutralising antibodies at the recommended dose.

Elevations of AST and/or ALT have been observed in patients receiving interferon gamma-1b, the incidence appeared to be higher in children under 1 years of age.

Pregnancy and Lactation

Pregnancy

Interferon gamma-1b is contraindicated in pregnancy.

At the time of writing there is insufficient information on the use of interferon gamma-1b in human pregnancy. The manufacturer recommends use only if vitally indicated.

In animal studies, high doses of interferon gamma-1b have been associated with higher rates of abortion, foetal haematological toxicity, decreased foetal weight, inhibition or retardation of eye formation and foetal haematomas.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Interferon gamma 1b is contraindicated in breastfeeding.

At the time it is unknown whether interferon gamma-1b is excreted in human breast milk, a risk to neonates cannot be excluded.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Acute renal failure (reversible)
Antibody formation
Arthralgia
Atrioventricular block
Back pain
Bronchospasm
Cardiac failure
Chest discomfort
Chills
Confusion
Convulsions
Deep vein thrombosis (DVT)
Depression
Dermatitis
Dermatomyositis
Diarrhoea
Disorientation
Erythema at injection site
Fatigue
Fever
Gait abnormality
Gastro-intestinal haemorrhage
Hallucinations
Headache
Hepatic failure
Hyperglycaemia
Hypertriglyceridaemia
Hyponatraemia
Hypotension
Increase in serum ALT/AST
Influenza-like symptoms
Interstitial lung disease
Local pain (injection site)
Maculopapular rash
Myalgia
Myocardial infarction
Nausea
Neutropenia
Pancreatitis
Proteinuria
Pulmonary embolism
Pustular rash
Rash
Swelling (injection site)
Syncope
Systemic lupus erythematosus
Tachyarrhythmia
Tachypnoea
Thrombocytopenia
Transient ischaemic attack
Tremor
Vomiting

Presentation

Injections of interferon gamma-1b

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

Drugs List

Therapeutic Indications

Uses

Infection prophylaxis in chronic granulomatous disease
Reduction of infection frequency in malignant osteopetrosis

Indicated as adjunctive therapy (with antibacterials) to reduce the frequency of serious infections in patients with chronic granulomatous disease (CGD).

Indicated for the reduction in frequency of serious infections in patients with severe, malignant osteopetrosis.

Dosage

Whilst the doses stated below are those recommended by the manufacturer, local network protocols for the relevant indication should be consulted.

Adults

Elderly

Children

Additional Dosage Information

Administration

For subcutaneous injection. Optimum sites of injection are the right and left deltoid and anterior thigh.

Interferon gamma-1b may be administered by patient or family member once trained in the administration of subcutaneous injection.

Contraindications

Breastfeeding
Children under 6 months - if treating chronic granulomatous disease
Pregnancy

Precautions and Warnings

Children under 18 years
Cardiac arrhythmias
Cardiac disorder
Compromised central nervous system function
History of congestive cardiac failure
Ischaemic heart disease
Myelosuppression
Seizures
Severe hepatic impairment
Severe renal impairment

Administration of live vaccines is not recommended
Advise ability to drive/operate machinery may be affected by side effects
Monitor cardiac function before and regularly during treatment
Monitor haematological parameters before and during treatment
Monitor hepatic function before treatment and regularly during treatment
Monitor renal function before treatment and regularly during treatment
Perform regular urinalysis
Antibodies to ingredient may develop
May affect immune response to live vaccines
May cause impaired fertility
Male & female: Ensure adequate contraception during treatment

The use of interferon gamma-1b does not exclude the need for additional antimicrobial coverage that might be required for the management of CGD.

Patients with pre-existing cardiac disease may experience an acute self-limiting exacerbation of their cardiac condition at doses above 250 micrograms/ square metre BSA/ day.

Concurrent use of interferon gamma-1b and other serum protein preparations or immunologic preparations (e.g. vaccines) increases the risk of an amplified immune response.

As an exogenous protein, interferon gamma-1b may induce the formation of antibodies during treatment. However, to date there have been no reports of significant induction or neutralising antibodies at the recommended dose.

Elevations of AST and/or ALT have been observed in patients receiving interferon gamma-1b, the incidence appeared to be higher in children under 1 years of age.

Pregnancy and Lactation

Pregnancy

Interferon gamma-1b is contraindicated in pregnancy.

At the time of writing there is insufficient information on the use of interferon gamma-1b in human pregnancy. The manufacturer recommends use only if vitally indicated.

In animal studies, high doses of interferon gamma-1b have been associated with higher rates of abortion, foetal haematological toxicity, decreased foetal weight, inhibition or retardation of eye formation and foetal haematomas.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Interferon gamma 1b is contraindicated in breastfeeding.

At the time it is unknown whether interferon gamma-1b is excreted in human breast milk, a risk to neonates cannot be excluded.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Acute renal failure (reversible)
Antibody formation
Arthralgia
Atrioventricular block
Back pain
Bronchospasm
Cardiac failure
Chest discomfort
Chills
Confusion
Convulsions
Deep vein thrombosis (DVT)
Depression
Dermatitis
Dermatomyositis
Diarrhoea
Disorientation
Erythema at injection site
Fatigue
Fever
Gait abnormality
Gastro-intestinal haemorrhage
Hallucinations
Headache
Hepatic failure
Hyperglycaemia
Hypertriglyceridaemia
Hyponatraemia
Hypotension
Increase in serum ALT/AST
Influenza-like symptoms
Interstitial lung disease
Local pain (injection site)
Maculopapular rash
Myalgia
Myocardial infarction
Nausea
Neutropenia
Pancreatitis
Proteinuria
Pulmonary embolism
Pustular rash
Rash
Swelling (injection site)
Syncope
Systemic lupus erythematosus
Tachyarrhythmia
Tachypnoea
Thrombocytopenia
Transient ischaemic attack
Tremor
Vomiting

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: September 2015

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 26 May 2015.

Martindale: The Complete Drug Reference (online) London: Brayfield A (ed). Pharmaceutical Press. Accessed on 26 May 2015.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications. Accessed on 26 May 2015.

Summary of Product Characteristic: Immukin. Boehringer Ingelheim Limited. Revised November 2013.