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Prescription medicine

Caplacizumab Brand names: Cablivi

Caplacizumab (Cablivi) is a prescription medicine. No generic is listed in FDA's NDC Directory.

  • No generic listed

Check it at the source: the caplacizumab FDA label on DailyMed (effective April 24, 2026); every caplacizumab label on DailyMed.

Highlights of the record

FDA label of April 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications 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.

Forms and strengths

Kit.

On the market

Generic approvals
No generic approved
Labelers listed (NDC)
1 of which 0 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
Not in the survey
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
No recall recorded
FAERS reports
1,709 through July 30, 2026

What is caplacizumab used for?

From the label: indications 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. CABLIVI is a von Willebrand factor (vWF)-directed antibody fragment 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.

Source: FDA drug label (Cablivi), Genzyme Corporation, effective April 24, 2026 (SPL set 2348f06e-8004-4040-832e-e9e86a39f905), via openFDA; the full label on DailyMed

Is there a generic for caplacizumab (Cablivi)?

No generic caplacizumab is approved (Drugs@FDA, October 8, 2026).

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the caplacizumab label say about other medicines?

The caplacizumab label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Heparindrug interactionsMonitor 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.

Check caplacizumab against other medicines

Source: FDA drug label (Cablivi), Genzyme Corporation, effective April 24, 2026 (SPL set 2348f06e-8004-4040-832e-e9e86a39f905), via openFDA; the full label on DailyMed

What do FAERS reports show for caplacizumab?

The FDA Adverse Event Reporting System holds 1,709 reports that list caplacizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 105 are coded as a death and 347 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

  • Product Use In Unapproved Indication (a use or a product term, not a reaction)573
  • Off Label Use (a use or a product term, not a reaction)200
  • Adamts13 Activity Decreased156
  • Epistaxis (named in the label)129
  • Platelet Count Decreased129
  • Fatigue (named in the label)111
  • Contusion86
  • Thrombotic Thrombocytopenic Purpura (a use or a product term, not a reaction)81

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Caplacizumab side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other