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Brand Name

Cablivi

Generic Name

Caplacizumab

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FDA approval date: February 06, 2019

Form: Kit

What is Cablivi (Caplacizumab)?

CABLIVI is indicated for the treatment of adult patients 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 patients with acquired thrombotic thrombocytopenic purpura , in combination with plasma exchange and immunosuppressive therapy.

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Related Clinical Trials

Efficacy and Safety of Immunosuppression, Caplacizumab and Plasma Infusion Without Therapeutic Plasma Exchange in Immune-mediated Thrombotic Thrombocytopenic Purpura: Multicentric Non-inferiority Single-arm Study

Enrollment Status: Recruiting

Publish Date: February 17, 2026

Intervention Type: Procedure

Study Phase: Not Applicable

Summary: Immune thrombotic thrombocytopenic purpura (iTTP) is caused by a severe, autoantibody-mediated deficiency of ADAMTS13 leading to an accumulation of ultra-large von Willebrand factor multimers in plasma and finally to microthrombi in blood vessels. The current standard of care of iTTP consists in the triple association of daily plasma exchange (PEX, 60 ml/kg/day), immunosuppressive agents and anti-...

Auto-immune Thrombotic Thrombocytopenic Purpura : Retrospective Epidemiological Study of Patients in the National Cohort of the French TMA Center, TWI-LIGHT

Enrollment Status: Recruiting

Publish Date: October 03, 2025

Objectives: 1. Primary: Assess the impact of cardiovascular risk factors (e.g., hypertension, diabetes) and ADAMTS13 activity on life expectancy in iTTP survivors. 2. Secondary: * Evaluate disease burden in underrepresented groups (pregnant/postpartum women, children, elderly patients). * Analyze the influence of new therapies (caplacizumab, rituximab, recombinant ADAMTS13) on care pathways. * Identify progno...

Retrospective Analysis of the Efficiency of Caplacizumab in the Treatment of Acquired Thrombotic Thrombocytopenic Purpura (aTTP)- REACT-2020

Enrollment Status: Recruiting

Publish Date: December 09, 2024

Intervention Type: Drug

Summary: The objective of this national, prospective, multi-centre observational study is to describe the prescription rational and practice in Germany, confirm the efficacy of caplacizumab in a real-world setting, and identify predicting factors in iTTP-patients with regard to persistent autoimmune activity, therapy guidance and risk of complications. The rational is to develop new treatment algorithms th...

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Microfluidic Shear-Based Assay for Assessing ADAMTS13 Activity Under Flow.

Journal: Methods in molecular biology (Clifton, N.J.)

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Treating Immune-Mediated Thrombotic Thrombocytopenic Purpura with Caplacizumab.

Journal: Methods in molecular biology (Clifton, N.J.)

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Thrombotic thrombocytopenic purpura in pregnancy: Lessons from a case series of three patients.

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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