Caplacizumab
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Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Dosing in liver impairment
Hepatic Impairment No formal studies with CABLIVI have been conducted in patients with severe acute or chronic hepatic impairment and no data regarding the use of CABLIVI in these populations are available. Due to a potential increased risk of bleeding, use of CABLIVI in patients with severe hepatic impairment requires close monitoring for bleeding [see Warnings and Precautions ] .
Preparation and administration
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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.
Adult patients may self-inject, or adult caregivers may inject CABLIVI subcutaneously after proper instruction on the preparation and administration of CABLIVI, including aseptic technique [see Instructions for Use ] if a healthcare provider determines that it is appropriate. In pediatric patients 12 years of age and older, CABLIVI must be administered by a healthcare provider or an adult caregiver.
If the carton was not stored at room temperature, allow the CABLIVI vial and diluent syringe to reach room temperature [25°C to 30°C (77°F to 86°F)] by holding them in your hands for 10 seconds. Do not use any other way to warm up the vial and syringe. 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 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).
Drug interactions
Check caplacizumab against a medication listLabel text (1 paragraph)
Concomitant use of anticoagulants or antiplatelet agents with CABLIVI may increase the risk of bleeding. Monitor closely for bleeding with concomitant use. ( 7 ) Concomitant Use of Anticoagulants, Thrombolytic Drugs, Heparin or Antiplatelet Agents Concomitant use of CABLIVI with any anticoagulant, thrombolytic drugs, heparin or antiplatelet agent may increase the risk of bleeding. Avoid concomitant use when possible. Assess and monitor closely for bleeding with concomitant use [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ] .
Contraindications
4 CONTRAINDICATIONS CABLIVI is contraindicated in patients with a previous severe hypersensitivity reaction to caplacizumab-yhdp or to any of the excipients. Hypersensitivity reactions have included urticaria [see Adverse Reactions (6.1) ] . Previous severe hypersensitivity reaction to caplacizumab-yhdp or any of the excipients. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely cause of clinically apparent acute liver injury.
Caplacizumab is a humanized single variable domain immunoglobulin (nanobody) against the von Willebrand factor, which is used to treat acquired thrombotic thrombocytopenic purpura. Caplacizumab increases the risk of minor and major bleeding episodes and is associated with a low rate of serum aminotransferase elevations during therapy, but has not been linked to instances of clinically apparent liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary 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 (see Clinical Considerations ) . In animal reproduction studies, there was no evidence of adverse developmental outcomes with intramuscular administration of caplacizumab-yhdp during organogenesis in guinea pigs at exposures approximately 30 times the AUC in humans at the recommended subcutaneous injection dose of 11 mg (see Data ) . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
The background rate of major birth defects and miscarriage in the indicated population is unknown. In the U.S. general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/neonatal adverse reactions CABLIVI may increase the risk of bleeding in the fetus and neonate. Monitor neonates for bleeding [see Warnings and Precautions (5.1) ] . Maternal adverse reactions All patients receiving CABLIVI, including pregnant women, are at risk for bleeding.
Pregnant women receiving CABLIVI should be carefully monitored for evidence of excessive bleeding [see Warnings and Precautions (5.1) ] . Data Animal data Two separate reproduction studies were conducted in pregnant guinea pigs with administration of caplacizumab-yhdp during the organogenesis period. In an embryo-fetal development study, caplacizumab-yhdp was administered intramuscularly at doses up to 20 mg/kg/day from gestational day (GD) 6 to GD 41 in guinea pigs. No maternal toxicity or adverse developmental outcomes were observed.
In a toxicokinetic study assessing the exposure of caplacizumab-yhdp in the dams and fetuses, caplacizumab-yhdp was administered once daily to female guinea pigs at doses up to 40 mg/kg/day (corresponding to a drug exposure of approximately 30 times the AUC in humans at the recommended dose of 11 mg) by intramuscular injection from GD 6 to GD 41 or GD 61. Exposure to caplacizumab-yhdp was observed in the dams and fetuses, with no effects on embryo-fetal development.
Breastfeeding (LactMed)
No information is available on the clinical use of caplacizumab during breastfeeding. Because caplacizumab is a large protein molecule with a molecular weight of about 28,000 Da, the amount in milk is likely to be extremely low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Use of the drug after 2 weeks postpartum may minimize transfer to the infant. Until more data become available, caplacizumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Some opinion recommends that patients with acquired thrombotic thrombocytopenic purpura not breastfeed because anti-platelet sIgA might be present in milk and may adversely affect the infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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