CABLIVI was tested in a clinical study of adults with aTTP. It included 145 people with aTTP, of whom 72 received CABLIVI with plasma exchange and immunosuppressive therapy. The other 73 people received placebo (an injection without active medicine) with plasma exchange and immunosuppressive therapy.
Both groups received either treatment with CABLIVI or placebo during daily plasma exchange therapy and for 30 days after. Some people received treatment for an additional 28 days based on their doctor’s decision. After treatment was stopped, everyone was followed by their doctor for 28 more days.
CABLIVI helped return platelet counts to normal significantly faster when added to PEX and immunosuppressive therapy
Significantly fewer people had another episode of aTTP that required starting plasma exchange again within the full study period (while taking CABLIVI and 28 day after stopping CABLIVI) in the CABLIVI group vs the placebo group. 13% receiving CABLIVI (9 people) vs 38% receiving placebo (28 people).
CABLIVI is the first and only FDA-approved therapy for adults with aTTP in combination with plasma exchange and immunosuppressive therapy
Do not take CABLIVI if you’ve had an allergic reaction to caplacizumab-yhdp or to any of the ingredients in CABLIVI.
Tell your doctor if you have a medical condition including if you have a bleeding disorder. Tell your doctor about any medicines you take.
Talk to your doctor before scheduling any surgery, medical or dental procedure.
CABLIVI can cause severe bleeding. In clinical studies, severe bleeding adverse reactions of nosebleed, bleeding from the gums, bleeding in the stomach or intestines, and bleeding from the uterus were each reported in 1% of subjects.
Contact your doctor immediately if excessive bleeding or bruising occur.
You may have a higher risk of bleeding if you have a bleeding disorder (i.e. hemophilia) or if you take other medicines that increase your risk of bleeding such as anti-coagulants. CABLIVI should be stopped for 7 days before surgery or any medical or dental procedure. Talk to your doctor before you stop taking CABLIVI.
The most common side effects include nosebleed, headache and bleeding gums.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CABLIVI. Call your doctor for medical advice about side effects.
CABLIVI (caplacizumab-yhdp) is a prescription medicine used for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
Click here to learn more about Sanofi’s commitment to fighting counterfeit drugs.TTP=thrombotic thrombocytopenic purpura.