Cablivi (caplacizumab-yhdp)

Common side effects of Cablivi include:

• nosebleed,
• headache,
• bleeding gums,
• fatigue,
• fever,
• injection site reactions (bleeding, itching),
• back pain,
• muscle pain,
• numbness and tingling,
• urinary tract infection (UTI),
• blood in the urine,
• abnormal vaginal bleeding,
• shortness of breath, and
• hives

Recommended Dose And Schedules

Cablivi should be administered upon initiation of plasma exchange therapy. The recommended dose of Cablivi is as follows:

• 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.

Missed Dose

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.

Discontinuation For Surgery And Other Interventions

Withhold Cablivi treatment 7 days prior to elective surgery, dental procedures, or other invasive interventions.

Reconstitution And Administration Instructions

The first dose of Cablivi should be administered by a healthcare provider as a bolus intravenous injection. Administer subsequent doses subcutaneously in the abdomen. Avoid injections around the navel. Do not administer consecutive injections in the same abdominal quadrant.

Patients or caregivers may inject Cablivi subcutaneously after proper training on the preparation and administration of Cablivi, including aseptic technique.

• Ensure the Cablivi vial and diluent syringe are at room temperature.
• 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.
• Using aseptic technique throughout the preparation of the solution, attach the vial adapter to the vial containing Cablivi.
• Remove the plastic cap from the syringe and attach it to the vial adapter by twisting it clockwise until it cannot twist any further.
• Slowly push the syringe plunger down until the syringe is empty. Do not remove the syringe from the vial adapter.
• Gently swirl the vial until the cake or powder is completely dissolved. Do not shake.
• Visually inspect that the reconstituted solution is clear and colorless.
• Withdraw all of the clear, colorless reconstituted solution from the vial into the syringe. Label the Cablivi syringe.
• Administer the full amount of reconstituted solution.
• For the initial intravenous injection, if using an intravenous line, the glass syringe should be connected to a standard Luer lock (and not a needleless connector) and flushed with either 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP.
• 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 (36°F to 46°F).

Concomitant Use Of Anticoagulants

Concomitant use of Cablivi with any anticoagulant may increase the risk of bleeding. Assess and monitor closely for bleeding with concomitant use.

• There are no available data on Cablivi use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. However, there are potential risks of hemorrhage in the mother and fetus associated with use of Cablivi.
• There is no information regarding the presence of caplacizumab-yhdp in human milk, the effects on the breastfed child or the effects on milk production.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Cablivi and any potential adverse effects on the breastfed child from Cablivi, or from the underlying maternal condition.