Cablivi

Cablivi is used to treat acquired thrombotic thrombocytopenic purpura (aTTP) in adults and children who are 12 years old and older. This medicine is given along with immunosuppressant medication and plasma exchange (transfusion).

Cablivi may also be used for other reasons that are not mentioned in this medication guide.

Cablivi can make you more likely to bleed. Call your doctor if you notice unusual bruising or bleeding, or any bleeding that does not stop.

You must not use Cablivi if you are allergic to it.

Inform your doctor if you have ever had a bleeding or blood clotting disorder, such as hemophilia.

Follow your doctor's guidance on using Cablivi if you are pregnant. Cablivi may raise the risk of bleeding for both the mother and the baby. However, the benefit of treating aTTP in the mother during pregnancy may be more important than these risks. Tell your doctor immediately if you become pregnant.

It may not be safe to breastfeed while using this medicine. Speak to your doctor about any risks.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Cablivi may cause serious side effects. Call your doctor at once if you have:

• easy bruising or bleeding (nosebleeds, bleeding gums);
• unusual vaginal bleeding;
• any bleeding that will not stop; or
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects of Cablivi may include:

• nosebleeds, bleeding gums; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Cablivi is injected under the skin, or given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Cablivi and plasma exchange are usually started on the same day. This medicine is then continued for 30 days or longer after your last daily plasma exchange.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Cablivi must be mixed with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

If you need surgery, dental work, or a medical procedure, you may need to stop using Cablivi for at least 7 days ahead. Tell any doctor or dentist who treats you that you currently use this medicine.

Store Cablivi in its original carton in the refrigerator. Protect from light and do not freeze.

You may store an unopened Cablivi carton at room temperature for up to 2 months. Keep track of when you took the carton out of the refrigerator, and do not return it to the refrigerator once the medicine has reached room temperature.

If you cannot use the mixed medicine right away, store it in the refrigerator and use it within 4 hours.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

If you miss a dose while getting daily plasma exchanges: Take the medicine as soon as you remember, but skip the missed dose if it is almost time for your next dose. Do not take two doses at once.

If you miss a dose and are no longer getting plasma exchanges: Take the medicine as soon as you remember, but skip the missed dose if you are more than 12 hours late. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause excessive bleeding.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Tell your doctor about all your other medicines, especially:

• a blood thinner--warfarin, Coumadin, Jantoven; or
• any medicine used to treat or prevent blood clots.

This list is not complete. Other drugs may affect Cablivi, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.