Siltuximab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Infusions containing siltuximab.
Drugs List
Therapeutic Indications
Uses
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.
Dosage
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
Adults
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.
Administration
To be administered as an intravenous infusion over 1 hour.
Contraindications
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
Breastfeeding
Hereditary fructose intolerance
Positive HIV status
Pregnancy
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
Pregnancy
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.
Lactation
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
Arthralgia
Constipation
Cytokine release syndrome
Diarrhoea
Dizziness
Eczema
Extremity pain
Gastro-intestinal perforation
Gastroesophageal reflux disease
Headache
Hypercholesterolaemia
Hyperlipidaemia
Hypersensitivity reactions
Hypertension
Hypertriglyceridaemia
Hyperuricaemia
Immunoglobulin abnormalities
Increase of liver transaminases
Infusion-related symptoms
Mouth ulcers
Nasopharyngitis
Nausea
Neutropenia
Oedema
Oropharyngeal pain
Pneumonia
Pruritus
Rash
Reactivation of hepatitis B
Renal impairment
Sepsis
Serum bilirubin increased
Thrombocytopenia
Upper respiratory tract infection
Urinary tract infections
Vomiting
Weight gain
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 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: www.nice.org.uk Last accessed: 16 January 2020
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