Cablivi (caplacizumab)
An approved treatment for Thrombotic Thrombocytopenic Purpura.
The same compound appears under different names depending on the context. Here is how to identify Caplacizumab wherever you encounter it, plus the key facts at a glance.
- Generic name
- Caplacizumab
- Brand name
- Cablivi
- Drug class
- Anti-von Willebrand factor nanobody
- Manufacturer
- Sanofi
- How it's taken
- On the first day, 11 mg by vein at least 15 minutes before plasma exchange, then 11 mg under the skin afterward.
A daily injection, approved February 6, 2019, for adults and children 12 and older with acquired TTP, given together with plasma exchange and immune-calming medicines.
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Where Caplacizumab fits
Added to plasma exchange and immune treatment in the hospital for acquired (immune) TTP.
How Caplacizumab works
In TTP, long strands of von Willebrand factor catch platelets and form tiny clots. Caplacizumab binds von Willebrand factor so platelets cannot stick to it, which stops new clots forming while plasma exchange and immune treatment deal with the antibodies against ADAMTS13. It does not fix the missing enzyme itself.
Mechanism: Nanobody that blocks von Willebrand factor from grabbing platelets
Side effects and safety
Cablivi has no boxed warning; its main risk is bleeding, which occurred in about 58% on Cablivi against 43% on placebo, and it is stopped 7 days before planned surgery. The most common side effects were nosebleeds (29% against 6%), headache (21% against 14%), gum bleeding (16% against 3%), tiredness (15% against 9%) and hives (14% against 6%).
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Caplacizumab
On the first day, 11 mg by vein at least 15 minutes before plasma exchange, then 11 mg under the skin afterward. After that, 11 mg under the skin once a day during plasma exchange and for 30 days after the last exchange, with up to 28 more days if ADAMTS13 stays low.
Availability and cost
Only available as the brand-name product.
Help paying for Cablivi
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Eligible patients with commercial insurance may pay as little as $0, with up to $25,000 a year in support and no income limit.
For: private insurance · source - Free medicine program
A Patient Assistance Program for eligible uninsured or underinsured patients, and a Bridge Program if coverage is lost.
For: no insurance, underinsured · source - Insurance and case manager help
Clinical educators and case managers help with coverage and getting the medicine after a hospital stay.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Access and eligibility
Approved for adults and children 12 and older with acquired TTP, together with plasma exchange and immune-calming treatment.
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
In HERCULES (NCT02553317), 145 patients with acquired TTP received Cablivi or placebo on top of standard care. TTP-related death, a return of TTP or a major clot occurred in 12.7% on Cablivi against 49.3% on placebo, and TTP came back during treatment in 4.2% against 38.4%.
Development history
Developed by Ablynx, now part of Sanofi, and approved by the FDA on February 6, 2019.
Explore Thrombotic Thrombocytopenic Purpura trials
Other Thrombotic Thrombocytopenic Purpura treatments
Common questions about Caplacizumab
▸What is Caplacizumab (Cablivi)?
A daily injection, approved February 6, 2019, for adults and children 12 and older with acquired TTP, given together with plasma exchange and immune-calming medicines.
▸How does Caplacizumab work?
In TTP, long strands of von Willebrand factor catch platelets and form tiny clots. Caplacizumab binds von Willebrand factor so platelets cannot stick to it, which stops new clots forming while plasma exchange and immune treatment deal with the antibodies against ADAMTS13. It does not fix the missing enzyme itself.
▸What are the side effects of Caplacizumab?
Cablivi has no boxed warning; its main risk is bleeding, which occurred in about 58% on Cablivi against 43% on placebo, and it is stopped 7 days before planned surgery. The most common side effects were nosebleeds (29% against 6%), headache (21% against 14%), gum bleeding (16% against 3%), tiredness (15% against 9%) and hives (14% against 6%).
▸How is Caplacizumab taken?
On the first day, 11 mg by vein at least 15 minutes before plasma exchange, then 11 mg under the skin afterward. After that, 11 mg under the skin once a day during plasma exchange and for 30 days after the last exchange, with up to 28 more days if ADAMTS13 stays low.
▸Is Caplacizumab FDA approved?
Yes, Caplacizumab (Cablivi) is FDA approved (2019) for the treatment of Thrombotic Thrombocytopenic Purpura.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed · 2026-04. CABLIVI (caplacizumab-yhdp): prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2348f06e-8004-4040-832e-e9e86a39f905
- ClinicalTrials.gov. HERCULES: caplacizumab in acquired TTP. https://clinicaltrials.gov/study/NCT02553317