Drugs List

Therapeutic Indications

Uses

Cryopyrin-associated periodic syndromes
Familial Mediterranean fever
Rheumatoid arthritis when inadequate response to DMARDs incl. methotrexate
Still's disease

For the treatment of the signs and symptoms of rheumatoid arthritis (RA) in adults in combination with methotrexate, with an inadequate response to methotrexate alone.

For the treatment of Still's disease including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD) with moderate to severe symptoms or with continued disease activity after treatment with non-steroidal anti-inflammatory drugs or glucocorticoids, in patients aged 8 months or older with a body weight of 10kg or greater.

For the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, adolescents, children and infants aged 8 months and older with a body weight of 10kg or above, including:
Neonatal-Onset Multisystem Inflammatory Disease (NOMID)/Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA).
Muckle-Wells Syndrome (MWS).
Familial Cold Autoinflammatory Syndrome (FCAS).

For the treatment of Familial Mediterranean Fever (FMF). Anakinra should be given in combination with colchicine, if appropriate.

Administration

For subcutaneous injection. The dose should be administered at approximately the same time each day. Altering the injection site is recommended to avoid discomfort at the site of injection.

Contraindications

Children under 8 months
Children weighing less than 10kg
Neutrophil count below 1.5 x 10 to the power of 9 / L at baseline
Breastfeeding
Malignant neoplasm
Pregnancy

Precautions and Warnings

Children aged 8 months to 18 years
Elderly
History of recurrent infection
Predisposition to infection
Asthma
Renal impairment - creatinine clearance below 60ml/minute
Severe hepatic impairment

Administration of live vaccines is not recommended
Consider dosing on alternate days if creatinine clearance below 30ml/min
Before initiating screen at risk patients for hepatitis B infection
Prior to starting therapy screen for latent tuberculosis
Treatment to be initiated and supervised by a specialist
Do not use if solution is discoloured or particulates are apparent
Record name and batch number of administered product
Monitor closely patients who develop neutropenia
Monitor neutrophil count
Monitor patient for signs of serious infection
Still's disease: Consider monitoring hepatic enzymes during first month
Consider discontinuing treatment if serious infection occurs
Discontinue if neutrophil count < 1.5 x 10 to the power of 9/L
Discontinue if severe hypersensitivity reactions occur
Not licensed for all indications in all age groups
Female: Ensure adequate contraception during treatment

Neutrophil counts should be assessed prior to initiating anakinra treatment, and while receiving treatment, monthly during the first 6 months of treatment and quarterly thereafter. In patients who become neutropenic (ANC less than 1.5 x 10 to the power of 9 per litre) the ANC should be monitored closely and anakinra treatment should be discontinued.

CAPS
Assessments of inflammation of the CNS, including the inner ear (MRI or CT, lumbar puncture, and audiology) and eyes (ophthalmological assessments) are recommended after an initial 3 months of treatment, and thereafter every 6 months, until effective treatment doses have been identified. When patients are clinically well controlled, CNS and ophthalmological monitoring may be conducted yearly.

Pregnancy and Lactation

Pregnancy

Anakinra is contraindicated during pregnancy.

The manufacturer advises it is preferable to avoid the use of anakinra during pregnancy.There are limited data from the use of anakinra in pregnant women, however animal studies do not indicate harmful effects.

Lactation

Anakinra is contraindicated during breastfeeding.

The manufacturer advises that breastfeeding should be discontinued during treatment with anakinra. It is unknown whether anakinra or its metabolites are excreted in breast milk. Effects on exposed infants are unknown.

Side Effects

Allergic reaction
Anaphylactic reaction
Angioedema
Antibody formation (transient)
Ecchymosis (injection site)
Erythema
Headache
Hepatitis
Increase in plasma cholesterol
Increases in hepatic enzymes
Infections
Inflammation (injection site)
Injection site reactions
Local pain (injection site)
Neutropenia
Pruritus
Rash
Thrombocytopenia
Urticaria

Presentation

Injections of anakinra.

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

Drugs List

Therapeutic Indications

Uses

Cryopyrin-associated periodic syndromes
Familial Mediterranean fever
Rheumatoid arthritis when inadequate response to DMARDs incl. methotrexate
Still's disease

For the treatment of the signs and symptoms of rheumatoid arthritis (RA) in adults in combination with methotrexate, with an inadequate response to methotrexate alone.

For the treatment of Still's disease including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD) with moderate to severe symptoms or with continued disease activity after treatment with non-steroidal anti-inflammatory drugs or glucocorticoids, in patients aged 8 months or older with a body weight of 10kg or greater.

For the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, adolescents, children and infants aged 8 months and older with a body weight of 10kg or above, including:
Neonatal-Onset Multisystem Inflammatory Disease (NOMID)/Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA).
Muckle-Wells Syndrome (MWS).
Familial Cold Autoinflammatory Syndrome (FCAS).

For the treatment of Familial Mediterranean Fever (FMF). Anakinra should be given in combination with colchicine, if appropriate.

Dosage

Adults

Children

Patients with Renal Impairment

Administration

For subcutaneous injection. The dose should be administered at approximately the same time each day. Altering the injection site is recommended to avoid discomfort at the site of injection.

Contraindications

Children under 8 months
Children weighing less than 10kg
Neutrophil count below 1.5 x 10 to the power of 9 / L at baseline
Breastfeeding
Malignant neoplasm
Pregnancy

Precautions and Warnings

Children aged 8 months to 18 years
Elderly
History of recurrent infection
Predisposition to infection
Asthma
Renal impairment - creatinine clearance below 60ml/minute
Severe hepatic impairment

Administration of live vaccines is not recommended
Consider dosing on alternate days if creatinine clearance below 30ml/min
Before initiating screen at risk patients for hepatitis B infection
Prior to starting therapy screen for latent tuberculosis
Treatment to be initiated and supervised by a specialist
Do not use if solution is discoloured or particulates are apparent
Record name and batch number of administered product
Monitor closely patients who develop neutropenia
Monitor neutrophil count
Monitor patient for signs of serious infection
Still's disease: Consider monitoring hepatic enzymes during first month
Consider discontinuing treatment if serious infection occurs
Discontinue if neutrophil count < 1.5 x 10 to the power of 9/L
Discontinue if severe hypersensitivity reactions occur
Not licensed for all indications in all age groups
Female: Ensure adequate contraception during treatment

Neutrophil counts should be assessed prior to initiating anakinra treatment, and while receiving treatment, monthly during the first 6 months of treatment and quarterly thereafter. In patients who become neutropenic (ANC less than 1.5 x 10 to the power of 9 per litre) the ANC should be monitored closely and anakinra treatment should be discontinued.

CAPS
Assessments of inflammation of the CNS, including the inner ear (MRI or CT, lumbar puncture, and audiology) and eyes (ophthalmological assessments) are recommended after an initial 3 months of treatment, and thereafter every 6 months, until effective treatment doses have been identified. When patients are clinically well controlled, CNS and ophthalmological monitoring may be conducted yearly.

Pregnancy and Lactation

Pregnancy

Anakinra is contraindicated during pregnancy.

The manufacturer advises it is preferable to avoid the use of anakinra during pregnancy.There are limited data from the use of anakinra in pregnant women, however animal studies do not indicate harmful effects.

Lactation

Anakinra is contraindicated during breastfeeding.

The manufacturer advises that breastfeeding should be discontinued during treatment with anakinra. It is unknown whether anakinra or its metabolites are excreted in breast milk. Effects on exposed infants are unknown.

Side Effects

Allergic reaction
Anaphylactic reaction
Angioedema
Antibody formation (transient)
Ecchymosis (injection site)
Erythema
Headache
Hepatitis
Increase in plasma cholesterol
Increases in hepatic enzymes
Infections
Inflammation (injection site)
Injection site reactions
Local pain (injection site)
Neutropenia
Pruritus
Rash
Thrombocytopenia
Urticaria

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: July 2019

Reference Sources

Summary of Product Characteristics: Kineret 100mg solution for injection in a pre-filled syringe. Swedish Orphan Biovitrum Ltd. Revised Apil 2020.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 07 August 2020