Caplacizumab-yhdp (kap-la-SIZ-ue-mab - yhdp)

Treats acquired thrombotic thrombocytopenic purpura (aTTP).

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• A nurse or other trained health professional will give you the first dose of this medicine at least 15 minutes before starting plasma exchange treatment in a medical facility. It is given through a needle placed into one of your veins.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to. It is given as a shot under the skin of your stomach.
• Allow the vial and the syringe to reach room temperature by holding them in your hands for 10 seconds.
• Dissolve the powder in the vial using the liquid in the syringe. Then, attach the vial adapter.
• Remove the plastic cap from the syringe and attach it to the vial adapter by twisting it clockwise until it cannot twist any further.
• Slowly push the syringe plunger down until the syringe is empty. Do not remove the syringe from the vial adapter.
• Gently swirl the vial until the powder is completely dissolved. Do not shake.
• Check the solution in the vial. It should be clear and colorless. All powder must be fully dissolved. Do not use the medicine if it is cloudy, clumpy, or has particles in it.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Use a new needle and syringe each time you inject your medicine.
• Use each vial only one time. Do not save an open vial.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose of this medicine after the plasma exchange period and it is within 12 hours from your regular schedule, take the missed dose as soon as possible. If you miss a dose and it is more than 12 hours from your regular schedule, skip the missed dose and take your next dose at your usual time.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. You may also store this medicine at room temperature in its original carton for up to 2 months. Do not return it back to the refrigerator once stored at room temperature. You may keep the mixed solution in the refrigerator for up to 4 hours.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use a blood thinner or antiplatelet medicine together with this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, hemophilia, or blood clotting problems.
• This medicine may increase your risk of serious bleeding problems, which may be life-threatening. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine 7 days before having surgery, dental procedures, or other operations.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blood in the urine or stools, coughing up blood
• Excessive bleeding or bruising
• Nosebleeds or bleeding gums that take longer to stop

If you notice these less serious side effects, talk with your doctor:

• Back pain
• Headache
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Pain, itching, burning, swelling, or a lump under your skin where the needle was placed or shot given

If you notice other side effects that you think are caused by this medicine, tell your doctor

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