How to take CABLIVI

Dosing

Your first dose of CABLIVI will be given by bolus
intravenous (IV) Intravenous (IV): Entering the body through a vein. injection before you start plasma exchange. Then, CABLIVI is given as an injection after your first plasma exchange and through the rest of treatment. You will take CABLIVI once a day for 30 days or more after plasma exchange depending on your doctor’s direction.

Hospital

CABLIVI treatment starts in the hospital with plasma exchange

  • Your first dose of CABLIVI will given by bolus IV injection before you start
    plasma exchange Plasma exchange: A procedure that removes and replaces a person’s blood plasma. This process helps clean the body by removing things it has too much of (such as immune cells) and adding things it has too little of (such as ADAMTS13 and platelets).
  • Every day after plasma exchange, CABLIVI will be given as an injection into the skin of your stomach
Home

CABLIVI treatment continues at home for 30 days after plasma exchange

  • When your doctor decides you can go home, you will continue to inject CABLIVI at home every day for the next 30 days
Continue

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 level, an important marker of aTTP. This test may help your doctor decide when you no longer need CABLIVI

Always take CABLIVI exactly as your doctor prescribed. Ask your doctor if you have any questions during your treatment.

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. Let your doctor know if you, your family, or your caregiver are not comfortable doing this or if you have any questions.

What if I miss a dose?

Taking CABLIVI once a day 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 receiving plasma exchange: Take CABLIVI within 12 hours of your scheduled time. After 12 hours, skip the dose and take the next scheduled dose

Incorrect doses or stopping treatment early

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 call 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.

Watch how to administer CABLIVI at home

Keep watching for CABLIVI Important Safety Information at the end of this video. Talk to your doctor about any questions you have about CABLIVI. Be sure that you read, understand, and follow the Instructions For Use before you inject CABLIVI and each time you get a refill. There may be new information. Your healthcare provider should show you how to prepare and inject CABLIVI properly before your first injection. Talk to your healthcare provider if you have any questions.

When it’s time for your injection, take CABLIVI out of the refrigerator. Never freeze your vials. If needed, CABLIVI may be stored at room temperature for up to 2 months. It may be helpful to write the date it was removed from the refrigerator in the space provided on the carton. Keep CABLIVI in the carton that it came in to protect it from light. For each injection, one carton of CABLIVI is needed.

Wash your hands with soap and water and place all components of the kit on a clean, flat surface. Check to make sure the carton contains all the items needed to prepare a dose of CABLIVI. Only use the supplies that are provided in the carton to prepare your prescribed dose. Do not reuse any of the supplies. Check the expiration date on the package and vial.

If the carton was stored in the refrigerator, allow the vial and the syringe to reach room temperature by holding in your hands for 10 seconds.

Remove the green plastic flip-off cap from the vial, and clean the rubber stopper using one of the alcohol pads. Allow to dry for a few seconds.

Take the packed vial adapter and remove the paper cover leaving the vial adapter in its packaging for now.

Place the adapter over the vial, while keeping the adapter in its plastic packaging.

Press down firmly until the adapter snaps into place, with the adapter spike pushing through the vial stopper.

Leave the adapter attached to the vial, still in its outer packaging.

Holding the syringe in one hand, break off the white cap by snapping at the perforation of the cap with your other hand. Then lay the syringe on a clean flat surface.

Remove the plastic packaging from the adapter by pressing the sides of the adapter packaging, and then lifting the packaging upwards. Be sure that the adapter does not detach from the vial. Hold the adapter with the attached vial. Place the tip of the syringe on the connector part of the vial adapter. Gently lock the syringe onto the vial by turning it clockwise until it cannot twist any further.

Place the vial upright on a flat surface. Slowly push the syringe plunger down until the syringe is empty.

Gently swirl the vial with connected syringe until the powder is dissolved. Allow the vial with connected syringe to stand on the flat surface for 2 minutes to allow the solution to completely dissolve.

Use the mixed CABLIVI solution immediately. The mixed CABLIVI solution can be stored for up to 4 hours in the refrigerator. Check the solution for particles, cloudiness, or clumps. All powder must be fully dissolved, and the solution must be clear. Use a new carton or call your healthcare provider if solution is not clear. Slowly press the syringe’s plunger fully down. Turn the whole - vial, adapter and syringe - upside down. While keeping it vertical, slowly pull the plunger to transfer all the solution into the syringe.

Turn the whole - vial, adapter and syringe - right-side up and place on the flat surface. Detach the filled syringe from the adapter by gently turning the syringe counter-clockwise. Put the vial and the attached adapter into a sharps disposal container. Place the syringe on the clean flat surface.

Remove the needle from the package, and attach it to the syringe without removing the needle cap by turning clockwise until it cannot twist any further. Pull back the needle safety shield.

Use the second alcohol pad to clean the injection site on your abdomen. Avoid the 2-inch area around your belly button. Let your skin dry.

Carefully remove the needle protection cap from the needle. Hold the syringe at eye level with the needle pointing upwards to see if there are any air bubbles. Remove any air bubbles by tapping the side of the syringe with your finger until they rise towards the tip. Then, slowly push the plunger until a small amount of liquid drips out of the needle. Gently pinch the cleaned skin between your thumb and forefinger to make a fold. Hold the pinch during the entire injection. Insert the full length of the needle into the skin fold at a 45- to 90-degree angle and press the plunger down until all of the solution is gone. Pull out the needle at the same angle you inserted it.

Right after your injection, move the needle safety shield over the needle until it clicks into place. In case you are bleeding at the injection site, place a cotton ball over the skin right away. Press gently on the cotton ball until the bleeding has stopped.

Put the syringe, needle, and vial with adapter in a sharps disposal container right away after use. If you do not have an FDA-cleared sharps disposal container, you may use a household container that meets specific requirements according to your community guidelines.

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.

Please see full Prescribing Information.

CABLIVI Administration Training Guide

Information to help with the administration of CABLIVI.

Download the administration training guide >

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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