Drugs List

Therapeutic Indications

Uses

Lupus erythematosus - systemic
Lupus nephritis

Adjunct therapy for treatment of active autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (positive anti-dsDNA and low complement) despite standard therapy.

In combination with background immunosuppressive therapies for the treatment of active lupus nephritis in adult patients.

Administration

For subcutaneous injection only.

Transition from intravenous to subcutaneous administration
Systemic lupus erythematosus
The first subcutaneous injection should be administered 1 to 4 weeks after the last intravenous dose.

Lupus nephritis
The first subcutaneous dose of 200mg should be administered 1 to 2 weeks after the last intravenous dose. This transition should occur any time after the patient completes the first 2 intravenous doses.

Contraindications

Children under 18 years
History of progenitor cell transplantation
Organ transplant recipients
Severe infection
Within 30 days of live vaccines
Breastfeeding
History of hepatitis B
History of hepatitis C
Hypogammaglobulinaemia
Immunoglobulin A deficiency
Positive HIV status
Pregnancy

Precautions and Warnings

Allergic disposition
Elderly
History of recurrent infection
Infection
History of neoplasm
Latent or healed tuberculosis
Malignant neoplasm
Severe renal impairment

Do not administer if live vaccine given within last 30 days
Consider pneumococcal vaccination prior to starting treatment
Treatment to be initiated and supervised by a specialist
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Self-admin. - only if adequately trained and have access to expert advice
Consider PTLD or PML if new or worsening neurological symptoms occur
Monitor and discontinue if appropriate if psychiatric or CNS problems occur
Monitor closely any patient who develops new infection while on treatment
Monitor for mental changes, suicidal depression and antisocial behaviour
Monitor retreated patients for symptoms of delayed hypersensitivity
Advise patient of the risk of late onset adverse reactions
Advise patient to report headaches, seizures, confusion, visual disturbance
Advise patients/carers to seek medical advice if changes in behaviour/mood
Immunosuppressive drugs may increase risk of malignancy
May affect immune response to live vaccines
Discontinue if Progressive multifocal leukoencephalopathy (PML) develops
Consider interrupting treatment if infection occurs
Female: Contraception required during and for 4 months after treatment
Advise patient to read the leaflet in the pack
Advise patients that hypersensitivity reactions may be life threatening

Progressive multifocal leukoencephalopathy syndrome (PML) has been reported in some patients treated with this agent. If patients present with symptoms indicating PML such as worsening neurological, cognitive or behavioural signs or symptoms, an MRI should be performed. If PML is diagnosed, treatment should be permanently discontinued.

Pregnancy and Lactation

Pregnancy

Belimumab is contraindicated during pregnancy.

The manufacturer does not recommend using belimumab during pregnancy unless the potential benefit justifies the risk to the foetus. At the time of writing there is limited published information regarding the use of belimumab during pregnancy. Potential risks are unknown. However, except the expected pharmacological effect (reduced B cells), animal studies do not indicate reproductive toxicity.

Lactation

Belimumab is contraindicated during breastfeeding.

The manufacturer advises that the patient either discontinues belimumab or discontinues breastfeeding. The presence of belimumab in human breast milk and the effects on exposed infants are unknown. However, animal data reports belimumab is present in breast milk. Belimumab is a large protein molecule with a molecular weight of 147,000 Da, the amount in milk is likely to be very low. Absorption is unlikely as it is probably destroyed in the infants gastrointestinal tract. LactMed (2020) suggest belimumab is not a reason to discontinue with breastfeeding but should be used with caution.

Side Effects

Angioedema
Arthralgia
Bradycardia
Bronchitis
Delayed hypersensitivity reactions
Depression
Diarrhoea
Dizziness
Dyspnoea
Facial oedema
Fatigue
Gastro-enteritis
Headache
Hypersensitivity reactions including anaphylaxis
Hypertension
Hypotension
Increased risk of neoplasms
Increased susceptibility to infection
Infusion-related symptoms
Injection site reactions
Leucopenia
Migraine
Myalgia
Nasopharyngitis
Nausea
Painful extremities
Pharyngitis
Progressive multifocal leukoencephalopathy (PML)
Pruritus
Psychiatric disorders
Pyrexia
Rash
Suicidal tendencies
Upper respiratory tract infection
Urinary tract infections
Urticaria

Presentation

Injections of belimumab.

These products have been produced by recombinant technology using mammalian cell line (NSO).

Drugs List

Therapeutic Indications

Uses

Lupus erythematosus - systemic
Lupus nephritis

Adjunct therapy for treatment of active autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (positive anti-dsDNA and low complement) despite standard therapy.

In combination with background immunosuppressive therapies for the treatment of active lupus nephritis in adult patients.

Dosage

Adults

Administration

For subcutaneous injection only.

Transition from intravenous to subcutaneous administration
Systemic lupus erythematosus
The first subcutaneous injection should be administered 1 to 4 weeks after the last intravenous dose.

Lupus nephritis
The first subcutaneous dose of 200mg should be administered 1 to 2 weeks after the last intravenous dose. This transition should occur any time after the patient completes the first 2 intravenous doses.

Contraindications

Children under 18 years
History of progenitor cell transplantation
Organ transplant recipients
Severe infection
Within 30 days of live vaccines
Breastfeeding
History of hepatitis B
History of hepatitis C
Hypogammaglobulinaemia
Immunoglobulin A deficiency
Positive HIV status
Pregnancy

Precautions and Warnings

Allergic disposition
Elderly
History of recurrent infection
Infection
History of neoplasm
Latent or healed tuberculosis
Malignant neoplasm
Severe renal impairment

Do not administer if live vaccine given within last 30 days
Consider pneumococcal vaccination prior to starting treatment
Treatment to be initiated and supervised by a specialist
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Self-admin. - only if adequately trained and have access to expert advice
Consider PTLD or PML if new or worsening neurological symptoms occur
Monitor and discontinue if appropriate if psychiatric or CNS problems occur
Monitor closely any patient who develops new infection while on treatment
Monitor for mental changes, suicidal depression and antisocial behaviour
Monitor retreated patients for symptoms of delayed hypersensitivity
Advise patient of the risk of late onset adverse reactions
Advise patient to report headaches, seizures, confusion, visual disturbance
Advise patients/carers to seek medical advice if changes in behaviour/mood
Immunosuppressive drugs may increase risk of malignancy
May affect immune response to live vaccines
Discontinue if Progressive multifocal leukoencephalopathy (PML) develops
Consider interrupting treatment if infection occurs
Female: Contraception required during and for 4 months after treatment
Advise patient to read the leaflet in the pack
Advise patients that hypersensitivity reactions may be life threatening

Progressive multifocal leukoencephalopathy syndrome (PML) has been reported in some patients treated with this agent. If patients present with symptoms indicating PML such as worsening neurological, cognitive or behavioural signs or symptoms, an MRI should be performed. If PML is diagnosed, treatment should be permanently discontinued.

Pregnancy and Lactation

Pregnancy

Belimumab is contraindicated during pregnancy.

The manufacturer does not recommend using belimumab during pregnancy unless the potential benefit justifies the risk to the foetus. At the time of writing there is limited published information regarding the use of belimumab during pregnancy. Potential risks are unknown. However, except the expected pharmacological effect (reduced B cells), animal studies do not indicate reproductive toxicity.

Lactation

Belimumab is contraindicated during breastfeeding.

The manufacturer advises that the patient either discontinues belimumab or discontinues breastfeeding. The presence of belimumab in human breast milk and the effects on exposed infants are unknown. However, animal data reports belimumab is present in breast milk. Belimumab is a large protein molecule with a molecular weight of 147,000 Da, the amount in milk is likely to be very low. Absorption is unlikely as it is probably destroyed in the infants gastrointestinal tract. LactMed (2020) suggest belimumab is not a reason to discontinue with breastfeeding but should be used with caution.

Side Effects

Angioedema
Arthralgia
Bradycardia
Bronchitis
Delayed hypersensitivity reactions
Depression
Diarrhoea
Dizziness
Dyspnoea
Facial oedema
Fatigue
Gastro-enteritis
Headache
Hypersensitivity reactions including anaphylaxis
Hypertension
Hypotension
Increased risk of neoplasms
Increased susceptibility to infection
Infusion-related symptoms
Injection site reactions
Leucopenia
Migraine
Myalgia
Nasopharyngitis
Nausea
Painful extremities
Pharyngitis
Progressive multifocal leukoencephalopathy (PML)
Pruritus
Psychiatric disorders
Pyrexia
Rash
Suicidal tendencies
Upper respiratory tract infection
Urinary tract infections
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: April 2021

Reference Sources

Summary of Product Characteristics: Benlysta 200mg solution for injection. GlaxoSmithKline UK Ltd. Revised July 2021.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK500583/
Belimumab Last revised: 21 September 2020
Last accessed: 14 April 2021