Caplacizumab

SCOPE: acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy — this page's primary indication, and the only indication dosed in the fetched label. VERBATIM §2.1: 'CABLIVI should be administered upon initiation of plasma exchange therapy... First day of treatment: 11 mg bolus intravenous injection at least 15 minutes prior to plasma exchange followed by an 11 mg subcutaneous injection after completion of plasma exchange on day 1. Subsequent days of treatment during daily plasma exchange: 11 mg subcutaneous injection once daily following plasma exchange. Treatment after plasma exchange period: 11 mg subcutaneous injection once daily continuing for 30 days following the last daily plasma exchange. If after initial treatment course, sign(s) of persistent underlying disease such as suppressed ADAMTS13 activity levels remain present, treatment may be extended for a maximum of 28 days. Discontinue CABLIVI if the patient experiences more than 2 recurrences of aTTP, while on CABLIVI. Avoid concomitant use of antiplatelet agents or anticoagulants.' (The '28 days' figure is a maximum treatment EXTENSION, not a dose ceiling, so it is not placed in maxDose; no maximum dose is stated anywhere in the fetched label.) MISSED DOSE (§2.1): 'If a dose of CABLIVI is missed during the plasma exchange period, it should be given as soon as possible. If a dose of CABLIVI is missed after the plasma exchange period, it can be administered within 12 hours of the scheduled time of administration. Beyond 12 hours, the missed dose should be skipped and the next daily dose administered according to the usual dosing schedule.' If the first intravenous dose is missed and plasma exchange has already been given, 'administer the first CABLIVI dose intravenously and administer the next dose subcutaneously on the following day according to the usual dosing schedule.' SURGERY (§2.2): 'Withhold CABLIVI treatment 7 days prior to elective surgery, dental procedures, or other invasive interventions.' PREPARATION (§2.3 / §3): 11 mg lyophilised powder in a single-dose vial; 'Reconstitute CABLIVI before administration using the provided syringe containing 1 mL Sterile Water for Injection, USP, to yield an 11 mg/mL single-dose solution'; 'Use the CABLIVI solution immediately. If not, use CABLIVI within 4 hours after reconstitution when stored in the refrigerator at 2°C to 8°C.' SELF-ADMINISTRATION: adult patients or adult caregivers may inject subcutaneously after proper instruction, if a healthcare provider judges it appropriate. PAGE CORRECTION: the live page currently states 10 mg IV then 10 mg SC once daily — every dose figure in the fetched label is 11 mg, and 11 mg is also the only vial strength (§3). US labelling — confirm against the UK SPC before UK use.

§8.4 Pediatric Use, verbatim: 'The safety and effectiveness of CABLIVI in pediatric patients 12 years of age and older with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy have been established... The safety and effectiveness of CABLIVI in pediatric patients less than 12 years of age have not been established.' NO separate paediatric dose figure — no weight band, no per-kg rule — appears anywhere in the fetched §2 Dosage and Administration, so no paediatric dose is asserted here and the weight-based calculator is deliberately disabled. Do not assume the adult 11 mg schedule transfers unchanged to adolescents: verify against the full prescribing information / UK SPC and a children's formulary. Concentration shown is the reconstituted solution strength from §2.3 ('to yield an 11 mg/mL single-dose solution'). §6: 'In pediatric patients, the most frequently reported adverse reactions are epistaxis and tachycardia.'