Active Ingredient: Caplacizumab
Caplacizumab is indicated for the treatment of adults and adolescents of 12 years of age and older weighing at least 40 kg experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 10 milligrams caplacizumab, one dose, over the duration of 1 day. Afterwards, subcutaneous, 10 milligrams caplacizumab, once daily.
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 immunosuppression 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 71 days consecutively. Data on re-treatment with caplacizumab are available.
The first dose of caplacizumab should be administered intravenously before the initial plasma exchange. If the administration of the first intravenous dose of caplacizumab is missed and plasma exchange is already administered, the first caplacizumab dose should still be administered intravenously after the plasma exchange is complete and the next dose should be administered subcutaneously on the following day according to the usual dosing schedule. If a dose of caplacizumab 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.
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.
The first dose of caplacizumab 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.
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