Cablivi

Cablivi is a prescription medicine used for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy. 

aTTP happens when your immune system blocks the natural function of a protein in the blood called ADAMTS13. With this protein missing, blood clots can easily form throughout your body. These clots decrease the number of platelets in your body. This is called thrombocytopenia and can lead to uncontrolled bleeding.

Cablivi belongs to a group of drugs called anti-von Willebrand factor (vWF) humanized immunoglobulin medications. Cablivi has an active ingredient called caplacizumab-yhdp. It is a small protein that helps prevent your body from forming dangerous blood clots during an aTTP episode.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional. The first dose of Cablivi will be given through intravenous (IV) infusion before you start plasma exchange. Everyday, after plasma exchange, Cablivi will be given as an injection into the skin of your stomach. You will continue to inject Cablivi at home every day for at least 30 days.

Common side effects of Cablivi include bleeding in the nosebleed, headache, and bleeding gums.

Cablivi is a prescription medicine used for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Cablivi. See the “Cablivi Precautions” section.

Common side effects of Cablivi include the following:

• nosebleeds
• headaches
• bleeding gums

This is not a complete list of Cablivi side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• anticoagulant (blood thinner) medications such as warfarin (Coumadin, Jantoven), heparin, enoxaparin (Lovenox), fondaparinux (Arixtra), rivaroxaban (Xarelto), and apixaban (Eliquis)

This is not a complete list of Cablivi drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Cablivi including the following:

• bleeding. Cablivi can increase the risk of bleeding. This included bleeding of the nose, gums, upper stomach, or uterus. Patients with abnormal bleeding patterns or who are on blood thinners can have higher risk. If significant bleeding occurs, this medication should be stopped. This medication should also be stopped 7 days before any major surgeries, dental procedures, or other invasive interventions. Signs of bleeding should be checked after the risk of surgical bleeding resolves.

Do not take Cablivi if you:

• are allergic to Cablivi or to any of its ingredients

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Cablivi, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Cablivi, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Cablivi or to any of its ingredients

• have or have a history of blood clots or bleeding disorders

• are currently on any blood thinner

• are pregnant or plan to become pregnant

• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with Cablivi. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication. There can be an increased risk of bleeding in the fetus and neonate with this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Cablivi crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Cablivi.

Take Cablivi exactly as prescribed.

Cablivi treatment starts in the hospital with plasma exchange. Your first dose of Cablivi will be given through intravenous (IV) infusion before you start plasma exchange.

Everyday, after plasma exchange, Cablivi will be given as an injection into the skin of your stomach. Your doctor may decide that you, your family, or your caregiver should give yourself Cablivi at home. If you agree, you, your family, or your caregiver should receive training from your doctor or nurse until you or they feel confident administering Cablivi. If you or your caregiver are not comfortable doing this, or if you have any additional questions, please let your doctor or nurse know.

When your doctor decides you can go home, you will continue to inject Cablivi at home every day for at least 30 days. Cablivi treatment continues at home for 30 days after plasma exchange.

Continue taking Cablivi until your doctor tells you to stop.

Your doctor may decide you need to take Cablivi for more than 30 days. This additional period may last up to 28 days

Your doctor may order additional blood tests, including a test to measure your ADAMTS13 levels, an important marker of aTTP. This test will help your doctor decide when you no longer need Cablivi.

Taking Cablivi daily is key for successful treatment. However, if you miss a dose, do the following:

• During your plasma exchange sessions: take Cablivi as soon as possible.

• After you’re no longer on plasma exchange: take Cablivi within 12 hours of your scheduled time. After 12 hours, skip and take the next scheduled dose.

You should inject only one (1) vial of Cablivi at a time, as recommended by your doctor. If you have accidentally used more than this, don’t inject any more and consult your doctor right away. 

Talk to your doctor before you stop treatment with Cablivi. Do not stop treatment, even if you start to feel better, as stopping treatment too early could cause you to have another aTTP episode. Speak to your doctor before making any decisions about your treatment.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose/dose range of Cablivi is 11 mg, or the contents of one vial. It is given twice on the first day of treatment. Cablivi is typically given with other medication. 

• First day of treatment: 11 mg bolus intravenous injection at least 15 minutes prior to plasma exchange followed by an 11 mg subcutaneous injection after completion of plasma exchange on day 1.
• Subsequent days of treatment during daily plasma exchange: 11 mg subcutaneous injection once daily following plasma exchange.
• Treatment after plasma exchange period: 11 mg subcutaneous injection once daily continuing for 30 days following the last daily plasma exchange. If after initial treatment course, sign(s) of persistent underlying disease such as suppressed ADAMTS13 activity levels remain present, treatment may be extended for a maximum of 28 days.

If you take too much Cablivi, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Cablivi is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Cablivi in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Use the mixed Cablivi solution immediately. The mixed Cablivi solution can be stored for up to 4 hours in the refrigerator at 36°F to 46°F (2°C to 8°C).
• If needed, unopened Cablivi vials may be stored at room temperature (up to 30°C or 86°F) in the original carton for a single period of up to two months. Write the date removed from the refrigerator in the space provided on the carton.
• Do not return Cablivi to the refrigerator after it has been stored at room temperature.
• Do not freeze Cablivi.
• Keep Cablivi in the carton that it came in to protect it from light.
• Keep Cablivi and all medicines out of the reach of children.