How CABLIVI helps

CABLIVI with plasma exchange and immunosuppressive therapy can provide better results in adults with aTTP

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.

In a clinical study, CABLIVI showed:

Clock

Faster time to normal platelet count

Patients

87% of people in the CABLIVI group were free of aTTP-related events during the treatment period

Significantly fewer people had at least 1 of the following aTTP-related events in the CABLIVI group vs the placebo group (13% receiving CABLIVI [9 people] vs 49% receiving placebo [36 people]):

  • Death (0% receiving CABLIVI [0 people] vs 4% receiving placebo [3 people])
  • Another episode of aTTP requiring plasma exchange during treatment (4% receiving CABLIVI [3 people] vs 38% receiving placebo [28 people])
  • A serious event due to a blood clot (such as a heart attack or stroke) (9% receiving CABLIVI [6 people] vs 8% receiving placebo [6 people])

Four aTTP-related deaths happened during the trial, including 1 non–treatment-related death in the CABLIVI group during the treatment-free follow-up period and 3 deaths in the placebo group during the treatment period.

Recurrence

87% of people in the CABLIVI group did not have another episode of aTTP during treatment and for 28 days after

Significantly fewer people had another episode of aTTP that required starting plasma exchange again within the full study period in the CABLIVI group vs the placebo group (13% receiving CABLIVI [9 people] vs 38% receiving placebo [28 people]).

IMPORTANT SAFETY INFORMATION

Who should not take CABLIVI?

Do not take CABLIVI if you’ve had an allergic reaction to caplacizumab-yhdp or to any of the ingredients in CABLIVI.

What should I tell my healthcare team before starting 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.

What are the possible side effects of CABLIVI?

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.

INDICATION

What is CABLIVI?

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.

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