- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Injections of caplacizumab.
These products have been produced by recombinant technology using E.coli.
Acquired thrombotic thrombocytopenic purpura
Acquired thrombotic thrombocytopenic purpura (aTTP) in conjunction with plasma exchange and immunosuppression.
10mg given as a intravenous injection prior to plasma exchange.
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 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.
Within 12 hours
Administer missed dose.
Over 12 hours
Do not administer missed dose, resume scheduled dosing regime.
Avoid injection around the navel area. Consecutive injection should not be administered in the same abdominal quadrant.
Children under 12 years
Weight below 40kg
Precautions and Warnings
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
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.
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.
Abdominal wall haematoma
Erythema at injection site
Haemorrhage (injection site)
Injection site reactions
Upper gastro-intestinal haemorrhage
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 ).
Last Full Review Date: October 2019
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
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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