Brand Name
Cablivi
Generic Name
Caplacizumab
View Brand Information FDA approval date: February 06, 2019
Form: Kit
What is Cablivi (Caplacizumab)?
CABLIVI is indicated for the treatment of adult and pediatric patients 12 years of age and older with acquired thrombotic thrombocytopenic purpura , in combination with plasma exchange and immunosuppressive therapy. CABLIVI is a von Willebrand factor -directed antibody fragment indicated for the treatment of adult and pediatric patients 12 years of age and older with acquired thrombotic thrombocytopenic purpura , in combination with plasma exchange and immunosuppressive therapy.
Approved To Treat
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Brand Information
Cablivi (caplacizumab)
1INDICATIONS AND USAGE
CABLIVI is indicated for the treatment of adult and pediatric patients 12 years of age and older with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
2DOSAGE FORMS AND STRENGTHS
For injection: 11 mg as a white lyophilized powder in a single-dose vial.
3CONTRAINDICATIONS
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
4ADVERSE REACTIONS
The following clinically significant adverse reactions are also discussed in other sections of the labeling:
- Hemorrhage
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
4.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of CABLIVI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to caplacizumab-yhdp exposure.
General disorders and administration site conditions:
- Injection site reactions including injection site pain, injection site bruising and injection site erythema
5OVERDOSAGE
In case of overdose, based on the pharmacological action of CABLIVI, there is the potential for an increased risk of bleeding
6DESCRIPTION
Caplacizumab-yhdp is a von Willebrand factor (vWF)-directed antibody fragment that consists of two identical humanized building blocks, linked by a three-alanine linker. Caplacizumab-yhdp is produced in
CABLIVI (caplacizumab-yhdp) for injection is a sterile, white, preservative-free, lyophilized powder. Each single-dose vial delivers 11 mg caplacizumab-yhdp, anhydrous citric acid (0.18 mg), polysorbate 80 (0.10 mg), sucrose (62 mg), and trisodium citrate dihydrate (4.91 mg). After reconstitution with 1 mL of Sterile Water for Injection, USP, the final concentration is 11 mg/mL, at a pH of approximately 6.5.
7CLINICAL STUDIES
The efficacy of CABLIVI for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange and immunosuppressive therapy was established in a pivotal multicenter, randomized, double-blind, placebo-controlled trial (HERCULES) (NCT02553317).
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Instructions for Use).
9PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 58468-0225-1
Cablivi
For Intravenous and Subcutaneous Use
Must be reconstituted with diluent provided.
Single-dose vial. Discard unused portion.
Each carton contains:
- One 11 mg Cablivi single-dose vial
- One 1 mL Sterile Water for Injection, USP,
- One sterile vial adapter
- One sterile hypodermic needle (30 gauge)
- Two individually packaged alcohol swabs
11 mg
per vial
sanofi
