Caplacizumab-yhdp Injection

WHY is this medicine prescribed?

Caplacizumab-yhdp injection is used to treat acquired thrombotic thrombocytopenic purpura (aTTP; a disorder in which the body attacks itself and causes clots, low amounts of platelets and red blood cells, and could cause other serious complications) in combination with plasma exchange therapy and immunosuppressant medications. Caplacizumab-yhdp is in a class of medications called antithrombotic agents. It works by blocking the action of a certain substance in the body that causes the symptoms of aTTP.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Caplacizumab-yhdp comes as a powder to be dissolved in liquid and given by intravenous (into the vein) or subcutaneous (under the skin) injection. It is usually given on the first day of treatment as an intravenous injection at least 15 minutes before plasma exchange, and then again as a subcutaneous injection after plasma exchange is finished. After the first day of treatment it is usually given as a once daily subcutaneous injection following plasma exchange for as long as you receive plasma exchange therapy, and then once daily for an additional 30 to 58 days after stopping plasma exchange therapy. Use caplacizumab-yhdp at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use caplacizumab-yhdp exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Your doctor may allow you or a caregiver to perform the injections at home. Ask your doctor or pharmacist to show you or the person who will be performing the injections how to prepare and inject caplacizumab-yhdp. Before you use caplacizumab-yhdp injection yourself for the first time, read the written instructions that come with it. Ask your pharmacist or doctor for a copy of the manufacturer's instructions for use information for the patient.

You should inject caplacizumab-yhdp injection subcutaneously in the abdominal (stomach) area but avoid your navel and the area 2 inches (5 centimeters) around it. Do not inject in the same spot two days in a row.

Dispose of used needles, syringes, and vials in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

What SPECIAL PRECAUTIONS should I follow?

Before receiving caplacizumab-yhdp,

• tell your doctor and pharmacist if you are allergic to caplacizumab-yhdp, any other medications, or any of the ingredients in caplacizumab-yhdp injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: apixaban (Eliquis), clopidogrel (Plavix), dabigatran (Pradaxa), dipyrimadole (Persantine, in Aggrenox), edoxaban (Savaysa), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, prasugrel (Effient), rivaroxaban (Xarelto), ticagrelor (Brilinta), or warfarin (Coumadin, Jantoven). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had hemophilia (a genetic disorder in which the body can't stop bleeding properly) or other bleeding problems, or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving caplacizumab-yhdp, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Use the missed dose as soon as you remember it. However, if you are no longer receiving plasma exchange therapy, and more than 12 hours have passed since the missed dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Caplacizumab-yhdp may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• extreme tiredness
• back pain
• muscle pain
• tingling, prickling, or numb feeling on the skin
• itching near the spot the medication was injected
• shortness of breath
• fever

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:

• hives
• heavy bleeding that won't stop including bleeding from rectum, vagina, nose, gums or place where the medication was injected
• vomiting blood
• red, or black, tarry stools
• blood in urine
• sudden severe headache, nausea, vomiting
• sudden, sharp abdominal pain, nausea, vomiting
• frequent, painful, or urgent urination

Caplacizumab-yhdp injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator, and away from light. Do not freeze. Caplacizumab-yhdp injection may be kept at room temperature for up to 2 months but should be kept on the original carton to protect from light. Caplacizumab-yhdp should not be put back into the refrigerator after it has been stored at room temperature.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• bleeding

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check if treatment with caplacizumab-yhdp should be continued.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.