Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Ablynx NV, Technologiepark 21, 9052, Zwijnaarde, Belgium
Cablivi is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.
Treatment with Cablivi should be initiated and supervised by physicians experienced in the management of patients with thrombotic microangiopathies.
Intravenous injection of 10 mg of caplacizumab prior to plasma exchange.
Daily subcutaneous administration of 10 mg of caplacizumab after completion of each plasma exchange for the duration of daily plasma exchange treatment, followed by daily subcutaneous injection of 10 mg of caplacizumab for 30 days after stopping daily plasma exchange treatment.
If at the end of this period there is evidence of unresolved immunological disease, it is recommended to optimise the immunosupression regimen and continue daily subcutaneous administration of 10 mg of caplacizumab until the signs of underlying immunological disease are resolved (e.g. sustained normalisation of ADAMTS13 activity level).
In the clinical development program, caplacizumab has been administered daily for up to 65 days. No data on re-treatment with caplacizumab are available.
If a dose of Cablivi is missed, it can be administered within 12 hours. If more than 12 hours have passed since the dose was to have been given, the missed dose should NOT be administered and the next dose should be administered per the usual dosing schedule.
No dose adjustment is necessary for patients with renal impairment (see section 5.2).
No dose adjustment is necessary for patients with hepatic impairment (see section 5.2). See section 4.4 for special considerations in patients with severe hepatic impairment.
While experience with the use of caplacizumab in the elderly is limited, there is no evidence to suggest that dose adjustment or special precautions are needed for elderly patients(see section 5.2).
The safety and efficacy of caplacizumab in the paediatric population have not yet been established. No data are available.
The first dose of Cablivi is to be administered as an intravenous injection. Subsequent doses are to be administered via subcutaneous injection in the abdomen.
Injections into the area around the navel should be avoided and consecutive injections should not be administered in the same abdominal quadrant.
Patients or caregivers may inject the medicinal product after proper training in the subcutaneous injection technique.
For instructions on reconstitution of Cablivi before administration, see section 6.6.
In case of overdose, based on the pharmacological action of caplacizumab, there is the potential for an increased risk of bleeding. Close monitoring for signs and symptoms of bleeding is recommended. (see section 4.4).
Unopened vial: 4 years.
Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C. From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of user.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Store in the original package in order to protect from light.
Cablivi may be stored at a temperature not above 25°C for a single period of up to 2 months, but not beyond the expiry date. Do not return Cablivi to refrigerated storage after storage at room temperature
For storage conditions of the reconstituted medicinal product, see section 6.3.
Powder: Vial (type I glass) with a stopper (butyl rubber), a seal (aluminium) and a cap (polypropylene), containing 10 mg of caplacizumab.
Solvent: Pre-filled syringe (type I glass cartridge closed with a bromobutyl rubber stopper) with 1 mL of water for injections.
Pack size:
Not all pack sizes may be marketed.
For both intravenous and subcutaneuous administration,reconstitute the powder contained in the vial using the vial adapter and all solvent in the pre-filled syringe. The solvent should be added slowly and mixed gently to avoid foaming of the solution. Allow the vial with connected syringe to stand on a surface for 5 minutes at room temperature.
The reconstituted solution is clear, colourless, or slightly yellowish. It must be visually inspected for particulate matter. Do not use solution exhibiting particulates.
Transfer the entire volume of the reconstituted solution back to the glass syringe and immediately administer the entire volume of the syringe (see section 6.3).
Cablivi is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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