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Siltuximab parenteral

Updated 2 Feb 2023 | Siltuximab


Infusions containing siltuximab.

Drugs List

  • siltuximab 100mg powder for concentrate for solution for infusion
  • siltuximab 400mg powder for concentrate for solution for infusion
  • SYLVANT 100mg powder for concentrate for solution for infusion
  • SYLVANT 400mg powder for concentrate for solution for infusion
  • Therapeutic Indications


    Multicentric Castleman's disease

    Treatment of multicentric Castleman's disease (MCD) in adult patients who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.


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


    11mg/kg siltuximab to be given as an intravenous infusion over 1 hour, every 3 weeks.

    Additional Dosage Information

    Treatment should be delayed prior to initial administration if:
    Absolute neutrophil count is less than 1 x 10 to the power of 9 /L.
    Haemoglobin levels greater than 170g/L (10.6 mmol/L).
    Platelet count is less than 75 x 10 to the power of 9/L.

    Retreatment should not begin until:
    Absolute neutrophil count is equal to or greater than 1 x 10 to the power of 9 /L.
    Haemoglobin level is equal to or less than 170g/L (10.6mmol/L).
    Platelet count is equal to or greater than 50 x 10 to the power of 9/L.

    Discontinuing siltuximab should be considered if there are more than 2 dose delays due to toxicities related to treatment during the first 48 weeks.


    To be administered as an intravenous infusion over 1 hour.


    Children under 17 years
    Haemoglobin concentration above 17g/dL (10.6mmol/L)
    Neutrophil count below 1.0 x 10 to the power of 9 / L at baseline
    Platelet count below 75 x 10 to the power of 9 / L at baseline
    Severe infection
    Within 4 weeks of live viral or bacterial vaccination
    Hereditary fructose intolerance
    Positive HIV status

    Precautions and Warnings

    Predisposition to gastrointestinal perforation
    Elevated serum bilirubin
    Elevated serum transaminases
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    Hepatitis B
    Renal impairment

    Treat and control infections prior to commencing therapy
    Treatment to be initiated and supervised by a specialist
    Preparation contains sucrose
    Dilute and use as an infusion
    Record name and batch number of administered product
    Reduce infusion rate if mild to moderate infusion reaction occurs
    Resuscitation facilities must be immediately available
    Advise patient to report signs of gastrointestinal perforation immediately
    Monitor blood count prior to each dose for 1st year then every 3rd cycle
    Monitor cholesterol and triglyceride levels
    Monitor hepatic function in patients with hepatic impairment
    Monitor patient for signs of serious infection
    Discontinue if severe cytokine release syndrome develops
    Reactivation of hepatitis B may occur in chronic carriers
    Discontinue if serious allergic or anaphylactic reaction occurs
    Discontinue permanently if life threatening infusion reactions occur
    Interrupt therapy if severe non-haematological reaction occurs
    Interrupt treatment if severe infection develops
    Female: Contraception required during and for 3 months after treatment

    Pregnancy and Lactation


    Siltuximab is contraindicated during pregnancy.

    The manufacturer does not recommend using siltuximab during pregnancy. At the time of writing there is limited published information regarding the use of siltuximab during pregnancy. Potential risks are unknown, however animal studies have shown that siltuximab crosses the placenta, therefore infants born to women treated with siltuximab may be at increased risk of infection and caution is recommended for the use of live vaccines in these infants.


    Siltuximab is contraindicated during breastfeeding.

    The manufacturer advises that the patient either discontinues siltuximab or discontinues breastfeeding. It is unknown whether siltuximab is excreted in human breast milk. Effects on exposed infants are unknown.

    Side Effects

    Abdominal pain
    Anaphylactic reaction
    Cytokine release syndrome
    Extremity pain
    Gastro-intestinal perforation
    Gastroesophageal reflux disease
    Hypersensitivity reactions
    Immunoglobulin abnormalities
    Increase of liver transaminases
    Infusion-related symptoms
    Mouth ulcers
    Oropharyngeal pain
    Reactivation of hepatitis B
    Renal impairment
    Serum bilirubin increased
    Upper respiratory tract infection
    Urinary tract infections
    Weight gain


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: January 2020

    Reference Sources

    Summary of Product Characteristics: Sylvant 100mg powder for concentrate for solution for infusion. Janssen-Cilag Ltd. Revised April 2019.

    Summary of Product Characteristics: Sylvant 400mg powder for concentrate for solution for infusion. Janssen-Cilag Ltd. Revised April 2019.

    NICE Evidence Services Available at: Last accessed: 16 January 2020

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