Possible side effects with CABLIVI*

CABLIVI can cause side effects, although not everyone will experience them. In clinical studies, the most common side effects included nosebleeds, headaches, and bleeding from gums.

Because CABLIVI works by stopping the formation of blood clots, it may affect normal blood clotting and increase the risk of 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 happens. Your doctor will decide on next steps. Tell your doctor if you have a medical condition including if you have a bleeding disorder. You may have a higher risk of bleeding if you have a bleeding disorder (such as hemophilia) or if you take other medicines that increase your risk of bleeding (such as anticoagulants).

CABLIVI should be stopped for 7 days before surgery or any medical or dental procedure. Talk to your doctor before you stop taking CABLIVI.

While taking CABLIVI, you may experience:

  • Bleeding from gums
  • Nosebleeds
  • Headache
  • Anal bleeding
  • Hemorrhoids
  • Fever
  • Tiredness
  • Muscle pain
  • Rash
  • Blood in urine
  • Unusually heavy periods
  • Vaginal bleeding
  • Shortness of breath
  • Injection site reactions such as rash, bleeding, and itching

*Please see the full list of side effects within the full Prescribing Information for CABLIVI. Talk with your doctor if you have any questions or if you have a side effect that does not go away.

Reporting side effects

If you have side effects, including ones not listed above, talk to your doctor right away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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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