How CABLIVI works

Acquired thrombotic thrombocytopenic purpura, called aTTP, is a very rare, potentially life-threatening blood clotting disorder. It’s unknown why anyone develops aTTP, and everyone’s experience with aTTP is different. For many, aTTP is a lifelong condition. In fact, in one study of 21 patients with aTTP over 30 years, 90% of these patients who had one aTTP event had another, called a recurrence. It’s important to note that every aTTP event is considered a medical emergency that can result in serious complications, including death.

Treatment for adults with aTTP can include a procedure called plasma exchange and a type of medication called immunosuppressants. During an aTTP event, patients may experience a variety of symptoms, including bleeding from the gums or nose, dark bruises or dots on the skin, blood in urine, stomach pain, chest pain, seizures, headaches, confusion, and tiredness.

aTTP occurs when your immune system blocks the natural function of a protein in the blood called ADAMTS13. Normally, ADAMTS13 cuts another protein, called von Willebrand factor, or vWF, into smaller pieces. vWF sticks to an important component of blood, called platelets, to form clots when bleeding occurs. In aTTP patients, there are more long pieces of vWF in circulation than normal because ADAMTS13 isn’t working correctly. As a result, these longer pieces of vWF attract more platelets than normal, causing blood clots to form easily throughout the body. These clots decrease the number of platelets in the body, a condition called thrombocytopenia, and can lead to uncontrolled bleeding.

CABLIVI can help adults in the fight against aTTP when used in combination with plasma exchange and immunosuppressive therapy. Plasma exchange helps filter your blood by removing things you have too much of that can cause clotting, like vWF, and adding things you have too little of, like ADAMTS13. Immunosuppressants help decrease the activity of your immune system, which is overactive during an event of aTTP.

CABLIVI was specifically developed to reduce platelet binding to vWF in aTTP. CABLIVI sticks to vWF, making it harder for platelets to attach. This helps stop the uncontrolled formation of dangerous blood clots during an aTTP event.

INDICATION AND IMPORTANT SAFETY INFORMATION
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.

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, including medicines that increase your risk of bleeding such as anti-coagulants and anti-platelet agents.

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. In the post-marketing setting, cases of life-threatening and fatal bleeding were reported in patients receiving CABLIVI. Contact your doctor immediately if symptoms of excessive bruising, excessive bleeding, or major bleeding occur. Signs and symptoms of bleeding include: pain, swelling or discomfort, prolonged bleeding from cuts, increased menstrual flow or vaginal bleeding, nosebleeds, bleeding of gums from brushing, unusual bleeding or bruising, red or dark brown urine, red or tar black stools, headache, dizziness, or weakness.

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 and anti-platelet agents.

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.

Please see accompanying full Prescribing Information.