Concizumab Injection

What is this medication?

CONCIZUMAB (kon SIZ ue mab) prevents bleeding episodes in people with hemophilia, a condition caused by low levels of blood clotting factors. It works by helping your body make a protein that helps your blood clot. This lowers the risk of bleeding. It is a monoclonal antibody.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Alhemo

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Cancer
• Conditions that cause blood clots
• Having surgery
• Heart or blood vessel conditions
• Infection
• Injury
• An unusual or allergic reaction to concizumab, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is injected under the skin. It can be given by your care team in a hospital or clinic setting. It may also be given at home.

If you get this medication at home, you will be taught how to prepare and give it. Take it as directed on the prescription label. Keep taking it unless your care team tells you to stop.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Talk to your care team about what to do if you miss a dose.

What may interact with this medication?

• Factor eight inhibitor bypassing activity (FEIBA)
• Factor VIIa

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 7 weeks after the last dose. You will need a negative pregnancy test before taking this medication. Contraception is recommended while taking this medication and for 7 weeks after the last dose. Your care team can help find the option that works for you.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Pain, redness, or irritation at injection site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Keep this medication in the original packaging until you are ready to take it. Protect from light. Do not freeze. Get rid of any unused medication after the expiration date.

Before first use: Store in the refrigerator.

After first use: Store in the refrigerator or at room temperature below 30 degrees C (86 degrees F). Get rid of any unused medication after 28 days.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.