Caplacizumab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of caplacizumab.
These products have been produced by recombinant technology using E.coli.
Drugs List
Therapeutic Indications
Uses
Acquired thrombotic thrombocytopenic purpura
Acquired thrombotic thrombocytopenic purpura (aTTP) in conjunction with plasma exchange and immunosuppression.
Dosage
Adults
Initial dose
10mg given as a intravenous injection prior to plasma exchange.
Subsequent doses
10mg given as subcutaneous injection after each daily plasma exchange for the duration of plasma exchange treatment. Continue the same dosing regimen for 30 days after stopping daily plasma exchange.
Unresolved immunological disease
Continue daily subcutaneous administration of 10mg of caplacizumab until resolved.
Children
Children aged 12 to 18 years
Weight 40kg or above: (See Dosage; Adult)
Additional Dosage Information
After proper training in the subcutaneous injection technique, patients or caregivers may inject the product.
Missed doses
Within 12 hours
Administer missed dose.
Over 12 hours
Do not administer missed dose, resume scheduled dosing regime.
Administration
Avoid injection around the navel area. Consecutive injection should not be administered in the same abdominal quadrant.
Contraindications
Children under 12 years
Weight below 40kg
Breastfeeding
Pregnancy
Precautions and Warnings
Surgery
Severe hepatic impairment
Treatment to be initiated and supervised by a specialist
Monitoring advised in bleeding disorders
Discontinue at least 7 days prior to scheduled surgery
Suspend treatment if bleeding requiring medical treatment occurs
Advise patient to inform physician/dentist of their use of this medication
Initiation or continuation of treatment with oral anticoagulants or high dose heparin requires a benefit/risk assessment and close monitoring.
Concomitant treatment with anti-platelet agents and/or low molecular weight heparin (LMWH) requires a benefit/risk assessment and close monitoring.
Consider the use of von Willebrand factor concentrate to correct haemostasis if significant bleeding occurs or if surgery is required.
Pregnancy and Lactation
Pregnancy
Caplacizumab is contraindicated during pregnancy.
The manufacturer recommends that caplacizumab should be avoided during pregnancy. Animal studies did not indicate any signs of toxicity. At the time of writing there is limited published information regarding the use of caplacizumab during pregnancy. Potential risks are unknown.
Lactation
Caplacizumab is contraindicated during breastfeeding.
The manufacturer recommends that a decision should be made whether to discontinue the treatment or breastfeeding, taking into account the benefits of breastfeeding and the therapy. The presence of caplacizumab in human breast milk is unknown but due to its large molecular weight, transfer is not expected. A risk to the child cannot be excluded.
Side Effects
Abdominal wall haematoma
Cerebral infarct
Dyspnoea
Epistaxis
Erythema at injection site
Fatigue
Gingival bleeding
Haematemesis
Haematochezia
Haematoma
Haematuria
Haemoptysis
Haemorrhage (injection site)
Haemorrhoidal haemorrhage
Headache
Injection site reactions
Melaena
Menorrhagia
Myalgia
Ocular haemorrhage
Pruritus
Pyrexia
Rectal haemorrhage
Subarachnoid haemorrhage
Upper gastro-intestinal haemorrhage
Urticaria
Vaginal haemorrhage
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: October 2019
Reference Sources
Summary of Product Characteristics: Cablivi 10mg powder and solvent for solution for injection. Sanofi Genzyme. Revised June 2020.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Caplacizumab. Last revised: 14 October 2019
Last accessed: 28 February 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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