Concizumab-mtci Injection

WHY is this medicine prescribed?

Concizumab-mtci is used to reduce or prevent bleeding episodes in patients with certain types of hemophilia. Concizumab-mtci is in a class of medications called monoclonal antibodies. It works by improving the body's ability to allow blood to clot.

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?

Concizumab-mtci injection comes as a solution (liquid) in a prefilled dosing pen to inject subcutaneously (just under the skin). It is given once a day. Use at the same time every day.

Use concizumab-mtci injection exactly as directed. Ask your doctor or pharmacist to explain any part you do notunderstand. Do not use more or less of it or use it more often than prescribed by your doctor.

Concizumab-mtci injection helps to control bleeding episodes, but it is not a cure. Continue to use concizumab-mtci injection even if you feel well. Do not stop using concizumab-mtci injection without talking to your doctor.

Your first dose will be a bigger dose and then you will be given a smaller dose daily for 4 weeks. After 4 weeks of treatment, your doctor will check your labs and then adjust your dose as needed. Your dose after this will be considered your maintenance dose.

Your doctor will show you or your caregiver how to use concizumab-mtci injection. Also carefully read the manufacturer's instructions for use that come with the medication. Be sure to ask your pharmacist or doctor if you have any questions about how to inject this medication.

Always look at the solution before you inject it. It should be clear and colorless (or slightly yellow), but may have some clear or white particles. Do not use concizumab-mtci if it is discolored or if the expiration date on the pen has passed.

Never reuse needles and never share needles or pens. Always remove the needle right after you inject your dose. Dispose of needles in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture resistant container.

You can inject concizumab-mtci in your thigh or stomach area (at least 2 inches away from your belly button). Change the injection site for each injection every day. Do not inject into skin that is tender, bruised, red or hard, or areas where thereare moles, scars, or stretch marks.

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

What SPECIAL PRECAUTIONS should I follow?

Before using concizumab-mtci,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

• 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 a serious injury or infection or have or have ever had cancer or blood vessel disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You may be required to have a pregnancy test prior to starting concizumab-mtci. You should use birth control during and for 7 weeks after ending treatment with concizumab-mtci. Talk to your doctor about what birth control is right for you. If you become pregnant while using concizumab-mtci, call your doctor.

• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using concizumab-mtci injection.

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?

If you miss a dose in the first 4 weeks of treatment contact your doctor. They will tell you how much concizumab-mtci to use.

If you miss a maintenance dose, then follow these instructions.

• If you miss one dose, continue your regular dosing schedule.
• If you miss 2–6 doses, use 2 doses as soon as you remember and then continue your usual dose and schedule beginning the next day.
• If you miss 7 or more maintence doses, contact your doctor right away for instructions about your next doses.

What SIDE EFFECTS can this medicine cause?

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

• redness, bruising, or bleeding at the site of injection

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

• itching, redness, rash, hives on the skin; tightness of the chest; wheezing
• swelling of the face, lips, tongue, or hands; difficulty swallowing or breathing; fast heartbeat; dizziness
• swelling, warmth, pain, or redness of the skin; shortness of breath or chest pain
• headache, confusion, difficulty with speech ormovement, numbness of the face, eye pain or swelling, or vision problems
• sudden pain in the stomach or back area

Concizumab-mtci may cause other side effects. Call your doctor if you have any unusual problems while using 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 and out of reach of children.

Store unused concizumab-mtci pens in the refrigerator (36°F to 46°F [2°C to 8°C]). Store it in the refrigerator in the original carton to protect from light. Do not freeze or allow it to be close to a refrigerator cooling element.

Once a concizumab-mtci pen is in use you can store it at room temperature (below 86°F [30°C]) or in the refrigerator. Make a note of the date you first use a concizumab-mtci pen, and dispose of the pen after 28 days, even if there is some solution left in the pen. Always store the pens with the cap on and in the original container to protect from light. Do not use the pen if frozen or stored above 86°F [30°C].

Keep all medication out of sight and reach of children as many containers are not child resistant.Always lock safety caps. Place the medication in a safe location – one that is up andaway and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot takethem. Do not flush this medication down the toilet. Use a medicine take-back program. Talk toyour pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal ofMedicines (https://goo.gl/c4Rm4p) for more information.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to concizumab-mtci.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using concizumab-mtci.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicinesvitamins, minerals, and dietary supplements you are taking. Bring this list with you each timeyou visit a doctor or if you are admitted to the hospital. You should carry the list with you incase of emergencies.