Drugs List

Therapeutic Indications

Uses

Moderate to severe active rheumatoid arthritis-other regimens unsuitable

Moderately or severely active rheumatoid arthritis in adults with an inadequate response to, or who are intolerant of, one or more disease modifying anti rheumatic drugs (DMARDs).

Administration

For subcutaneous injection only. The recommended injection sites are abdomen, thigh, upper arm and should be rotated for each dose of administration.
Patients may self administer following appropriate training.

Contraindications

Children under 18 years
Neutrophil count below 2 x 10 to the power of 9 / L at baseline
Platelet count below 150 x 10 to the power of 9 / L at baseline
Serum transaminases above 1.5 times upper limit of normal at baseline
Uncontrolled systemic infection
Breastfeeding
Hereditary fructose intolerance
Pregnancy

Precautions and Warnings

Chronic infection
Elderly
History of recurrent infection
Predisposition to infection
Acute hepatic disorder
Diverticulitis
Hepatic impairment
History of gastrointestinal ulceration
Latent or healed tuberculosis
Positive HIV status
Severe renal impairment

Administration of live vaccines is not recommended
Consider anti-TB therapy in patients with latent TB
Before starting therapy ensure immunisations are up to date
Prior to starting therapy screen for latent tuberculosis
Treatment to be initiated and supervised by a specialist
Contains polysorbate
Preparation contains sucrose
Record name and batch number of administered product
Warm to room temperature prior to use
Advise patient to stop and contact Dr if severe/persistent abdominal pain
Monitor neutrophil count before initiation, at 1-2months, then periodically
Monitor platelet count after 1-2 months, then periodically
Monitor serum lipids after 1-2 months, then every 6 months
Monitor transaminases after 1-2 months, then every 3 months
Advise patient to stop therapy & contact Dr if hypersensitivity signs occur
Discontinue if a serious infection develops
Immunosuppressive drugs may increase risk of malignancy
Discontinue if ALT level exceeds 5 times the upper limit of normal
Discontinue if hypersensitivity reactions occur
Discontinue if neutrophil count less than 0.5 x 10 to the power of 9/L
Discontinue if platelet count less than 50x10 to the power of 9/L
Interrupt therapy if neutrophil count <1.0x10 to the power 9/L
Interrupt therapy if platelet count less than 100 x 10 to the power of 9/L
Suspend treatment if AST/ALT is 3-5 times upper limit of normal
Female: Contraception required during and for 3 months after treatment
Remind patient of importance of carrying Alert Card with them at all times

Use caution in patients who have been exposed to tuberculosis or who have lived in/travelled to areas of endemic tuberculosis or endemic mycoses. Prior to initiation assess all patients for tuberculosis risk factors and test for latent infection. Consider pre-treatment with anti-tuberculosis therapy in patients with a history of active/latent TB when previous treatment cannot be confirmed and in patients testing negative for latent tuberculosis but have risk factors for tuberculosis infection.

Monitor patients closely for signs of infection during treatment, particularly the elderly where infections are more common. Patients developing infections must undergo assessment and treatment appropriate for an immunocompromised patient. Discontinue treatment if the infection is serious or an opportunistic infection.

Gastrointestinal perforation, primarily as a complication of diverticulitis, has been reported. Promptly evaluate patients with new onset abdominal symptoms such as persistent pain with fever.

Pregnancy and Lactation

Pregnancy

Sarilumab is contraindicated during pregnancy.

The manufacturer advises that sarilumab should not be used during pregnancy unless the clinical condition of the woman requires treatment specifically with sarilumab. Animal studies do not indicate direct or indirect harmful effects. At the time of writing there is limited published information available regarding the use of sarilumab during human pregnancy. The potential risk is unknown.

Lactation

Sarilumab is contraindicated during breastfeeding.

Due to the limited data available, the manufacturer recommends either discontinuing sarilumab or discontinuing breastfeeding. Currently, it is unknown whether sarilumab is excreted in breast milk or absorbed systemically after ingestion. As sarilumab is a large protein molecule, the amount in milk is likely to be very low and any ingested drug will probably be destroyed in the infant's gastrointestinal tract.

Side Effects

Cellulitis
Erythema at injection site
Gastro-intestinal perforation
Hypercholesterolaemia
Hypersensitivity reactions
Hypertriglyceridaemia
Increase in serum transaminases
Itching (injection site)
Nasopharyngitis
Neutropenia
Opportunistic infections
Oral herpes
Pneumonia
Thrombocytopenia
Upper respiratory tract infection
Urinary tract infections

Presentation

Injections of sarilumab.

Drugs List

Therapeutic Indications

Uses

Moderate to severe active rheumatoid arthritis-other regimens unsuitable

Moderately or severely active rheumatoid arthritis in adults with an inadequate response to, or who are intolerant of, one or more disease modifying anti rheumatic drugs (DMARDs).

Dosage

Treatment is combined with methotrexate.
Monotherapy is permitted in patients where methotrexate is not tolerated or where treatment is inappropriate.

Adults

Additional Dosage Information

Administration

For subcutaneous injection only. The recommended injection sites are abdomen, thigh, upper arm and should be rotated for each dose of administration.
Patients may self administer following appropriate training.

Contraindications

Children under 18 years
Neutrophil count below 2 x 10 to the power of 9 / L at baseline
Platelet count below 150 x 10 to the power of 9 / L at baseline
Serum transaminases above 1.5 times upper limit of normal at baseline
Uncontrolled systemic infection
Breastfeeding
Hereditary fructose intolerance
Pregnancy

Precautions and Warnings

Chronic infection
Elderly
History of recurrent infection
Predisposition to infection
Acute hepatic disorder
Diverticulitis
Hepatic impairment
History of gastrointestinal ulceration
Latent or healed tuberculosis
Positive HIV status
Severe renal impairment

Administration of live vaccines is not recommended
Consider anti-TB therapy in patients with latent TB
Before starting therapy ensure immunisations are up to date
Prior to starting therapy screen for latent tuberculosis
Treatment to be initiated and supervised by a specialist
Contains polysorbate
Preparation contains sucrose
Record name and batch number of administered product
Warm to room temperature prior to use
Advise patient to stop and contact Dr if severe/persistent abdominal pain
Monitor neutrophil count before initiation, at 1-2months, then periodically
Monitor platelet count after 1-2 months, then periodically
Monitor serum lipids after 1-2 months, then every 6 months
Monitor transaminases after 1-2 months, then every 3 months
Advise patient to stop therapy & contact Dr if hypersensitivity signs occur
Discontinue if a serious infection develops
Immunosuppressive drugs may increase risk of malignancy
Discontinue if ALT level exceeds 5 times the upper limit of normal
Discontinue if hypersensitivity reactions occur
Discontinue if neutrophil count less than 0.5 x 10 to the power of 9/L
Discontinue if platelet count less than 50x10 to the power of 9/L
Interrupt therapy if neutrophil count <1.0x10 to the power 9/L
Interrupt therapy if platelet count less than 100 x 10 to the power of 9/L
Suspend treatment if AST/ALT is 3-5 times upper limit of normal
Female: Contraception required during and for 3 months after treatment
Remind patient of importance of carrying Alert Card with them at all times

Use caution in patients who have been exposed to tuberculosis or who have lived in/travelled to areas of endemic tuberculosis or endemic mycoses. Prior to initiation assess all patients for tuberculosis risk factors and test for latent infection. Consider pre-treatment with anti-tuberculosis therapy in patients with a history of active/latent TB when previous treatment cannot be confirmed and in patients testing negative for latent tuberculosis but have risk factors for tuberculosis infection.

Monitor patients closely for signs of infection during treatment, particularly the elderly where infections are more common. Patients developing infections must undergo assessment and treatment appropriate for an immunocompromised patient. Discontinue treatment if the infection is serious or an opportunistic infection.

Gastrointestinal perforation, primarily as a complication of diverticulitis, has been reported. Promptly evaluate patients with new onset abdominal symptoms such as persistent pain with fever.

Pregnancy and Lactation

Pregnancy

Sarilumab is contraindicated during pregnancy.

The manufacturer advises that sarilumab should not be used during pregnancy unless the clinical condition of the woman requires treatment specifically with sarilumab. Animal studies do not indicate direct or indirect harmful effects. At the time of writing there is limited published information available regarding the use of sarilumab during human pregnancy. The potential risk is unknown.

Lactation

Sarilumab is contraindicated during breastfeeding.

Due to the limited data available, the manufacturer recommends either discontinuing sarilumab or discontinuing breastfeeding. Currently, it is unknown whether sarilumab is excreted in breast milk or absorbed systemically after ingestion. As sarilumab is a large protein molecule, the amount in milk is likely to be very low and any ingested drug will probably be destroyed in the infant's gastrointestinal tract.

Side Effects

Cellulitis
Erythema at injection site
Gastro-intestinal perforation
Hypercholesterolaemia
Hypersensitivity reactions
Hypertriglyceridaemia
Increase in serum transaminases
Itching (injection site)
Nasopharyngitis
Neutropenia
Opportunistic infections
Oral herpes
Pneumonia
Thrombocytopenia
Upper respiratory tract infection
Urinary tract infections

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: January 2021

Reference Sources

Summary of Product Characteristics: Kevzara 150mg solution for injection in pre-filled pen. Genzyme Therapeutics. Revised September 2020.
Summary of Product Characteristics: Kevzara 150mg solution for injection in pre-filled syringe. Genzyme Therapeutics. Revised September 2020.
Summary of Product Characteristics: Kevzara 200mg solution for injection in pre-filled pen. Genzyme Therapeutics. Revised September 2020.
Summary of Product Characteristics: Kevzara 200mg solution for injection in pre-filled syringe. Genzyme Therapeutics. Revised September 2020.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK500915/
Sarilumab. Last revised: 17 August 2020.
Last accessed: 07 January 2021.