caplacizumab-yhdp 11 mg solution for injection

Generic name:
Caplacizumab - injection

Pronunciation
(KAP-la-SIZ-ue-mab)

Brand name(s)
Cablivi

This medication is used to treat a certain blood disorder (acquired thrombotic thrombocytopenic purpura-aTTP). It is used in combination with certain other treatments for this disorder (plasma exchange, immune suppressing medication). In aTTP, blood clots form in small blood vessels throughout the body. These clots can cause serious medical problems if they block vessels and limit or stop blood flow to organs such as the brain, kidneys, and heart. This disorder can also cause red blood cells to break apart faster than the body can replace them, which results in anemia. Caplacizumab works by causing your body to make fewer/smaller blood clots.

Read the Instructions for Use if available from your pharmacist before you start using caplacizumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

The first dose of this medication is given by injection into a vein by a health care professional as directed by your doctor, usually at least 15 minutes before a certain blood procedure (plasma exchange). After the first plasma exchange procedure, you should receive another dose given by injection under the skin.

After the first day, this medication is given by injection under the skin as directed by your doctor, usually once daily. The injection is given in the abdomen (except for a 2-inch area around your belly button). On the days that you are having a plasma exchange procedure, give this medication after the procedure. The length of treatment is based on your medical condition and response to treatment.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. If the carton was not stored at room temperature, allow the vial and the syringe to reach room temperature by holding them in your hands for 10 seconds. Do not warm up this medication any other way (for example, do not heat it in the microwave or place it in hot water). Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Tell your doctor if your condition does not get better or if it gets worse.

Headache, muscle ache, or tiredness may occur. You may bruise or bleed more easily. Nosebleed and bleeding gums may occur. It may take longer than usual to stop bleeding. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any signs of serious bleeding, including:

• unusual pain/swelling/discomfort
• unusually heavy/prolonged menstrual flow
• red/dark urine
• bloody/black/tarry stools
• severe headache
• dizziness/fainting
• unusual weakness

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using caplacizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• other bleeding/blood problems (such as hemophilia)
• liver problems

Before having surgery or a dental procedure, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication should be temporarily stopped for at least 7 days before having scheduled surgery, dental procedure, or any procedure with increased risk of bleeding.

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/dabigatran)

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, blood clotting tests) should be done while you are using this medication. Keep all medical and lab appointments.

If you miss a dose, use it as soon as you remember. If it is more than 12 hours after the missed dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store in the refrigerator. Do not freeze. Keep the medication in the original carton to protect from light. This medication may also be stored at room temperature if needed. If the medication is stored at room temperature, do not put it back in the refrigerator and discard after 2 months. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.