Marstacimab-hncq injection

WHY is this medicine prescribed?

Marstacimab-hncq injection is used to prevent or reduce the frequency of bleeding in adults and children 12 years of age and older with certain types of hemophilia A (condition in which the blood does not clot normally because of a missing or faulty blood clotting factor VII) or hemophilia B (condition in which the blood does not clot normally because of a missing or faulty blood clotting factor IX). Marstacimab-hncq is in a class of medications called hemostatic antibodies. It works by decreasing the activity of a naturally occurring substance in the body that prevents blood clotting.

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?

Marstacimab-hncq injection comes as a solution (liquid) to be injected subcutaneously (under the skin). It is usually given as two injections for the first dose, followedby one injection once a week. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use marstacimab-hncq injection exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may allow you or a caregiver to perform the injections at home. Your healthcare provider will teach you or a caregiver how to perform the injections at home. Before you use marstacimab-hncq 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. Be sure to ask your doctor or pharmacist if you have any questions about how to inject the medication.

Marstacimab-hncq injection comes in prefilled syringes and prefilled pens. Use each syringeand pen only once and inject all the solution in the syringe or pen. Do not reuse marstacimab-hncqpre-filled syringes and do not recap the syringes after use. Dispose of used syringes andpens in a puncture-resistant container. Talk to your doctor or pharmacist about how todispose of the puncture-resistant container.

If you are using a prefilled syringe or prefilled pen that has been refrigerated, place the syringeor pen on a flat surface without removing the needle cap and allow it warm to roomtemperature for 15 to 30 minutes before you are ready to inject the medication. Do not try to warmthe medication by heating it in a microwave, placing it in hot water, or through any othermethod.

Do not shake a syringe or pen that contains marstacimab-lbkz injection.

Always look at marstacimab-lbkz solution before injecting it. Check that the expiration date has not passed and that the liquid is clear and colorless or pale yellow. The liquid should not contain visible particles. Do not use a syringe or dosing pen if it is cracked or broken, if it is expired, or if the liquid is cloudy or contains large or colored particles.

You can inject marstacimab-lbkz injection on the front of your thighs (upper leg) or abdomen (stomach) except yournavel (belly button) and the area 2 inches (5 centimeters) around it. If someone else is givingyou the injection, the back of the upper arm or buttocks may also be used. To reduce the chances ofsoreness or redness, use a different injection site for each injection. Do not inject themedication into an area where the skin is tender, bruised, red, or hard or where you have scars or stretch marks.

Marstacimab-lbkz controls bleeding in people with hemophilia but does not cure it. Continue to use marstacimab-lbkz injection even if you feel well. Do not stop using marstacimab-lbkz injection without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using marstacimab-hncq injection,

• tell your doctor and pharmacist if you are allergic to marstacimab-hncq, any other medications, or any of the ingredients in marstacimab-hncq 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.

• tell your doctor if you have or have ever had blood clots in your arm, legs, lungs, or head. Also, tell your doctor if you get sick, develop an infection or fever, or are injured.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant while you are using marstacimab-hncq injection. You will need to have a pregnancy test before you start treatment and you should use birth control to prevent pregnancy during your treatment and for at least 2 months after your final dose. Talk to your doctor about birth control methods that will work for you. Marstacimab-hncq may harm your unborn baby. If you become pregnant while using marstacimab-hncq injection, call your doctor immediately.

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?

Inject the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one. If you are not sure when to inject marstacimab-hncq injection, call your doctor.

What SIDE EFFECTS can this medicine cause?

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

• pain, redness, swelling, warmth, burning, bruising, hardness, or itching at the injection site

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

• swelling, pain, or redness in arms or legs
• shortess of breath
• coughing up blood
• sudden headache, eye pain or swelling, or trouble seeing
• numbness in your face
• chest or back pain
• fast, pounding, or irregular heartbeat
• hives, rash, itching; swelling of the face, eyes, mouth, throat, tongue, or lips; difficulty breathing or swallowing; dizziness or fainting; or sweating

Marstacimab-hncq 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 (https://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 marstacimab-hncq injection in the refrigerator but do not freeze. Keep the prefilled syringes and dosing pens in their original cartons to protect them from light. If needed, marstacimab-hncq injection may be stored at room temperature for up to 7 days, but should not be returned to the refrigerator. Dispose of any unused medication that has been stored at room temperature for more than 7 days.

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. https://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 (https://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.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using marstacimab-hncq injection.

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.