Concizumab

Concizumab is used in adults and children who are at least 12 years old with certain types of hemophilia to help prevent bleeding episodes or reduce how often they happen.

Your doctor will ensure that you can be treated with concizumab.

Concizumab may also be used for reasons not mentioned in this medication guide.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

You should not use concizumab if you are allergic to it.

Tell your doctor if you have or have ever had:

• a planned surgery;
• blood clots or any other blood clotting disorder; or
• conditions that increase the risk of blood clots such as coronary artery disease (clogged arteries), cancer, crush injury, or sepsis (a severe reaction to an infection).

It is not known if concizumab will harm an unborn baby. You may need a pregnancy test to ensure you are not pregnant. Use effective birth control while using concizumab and for at least 7 weeks after your last dose. Tell your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while using concizumab.

Get emergency medical help if you notice signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Concizumab can lead to unwanted blood clots, especially if you are also taking other medicines for bleeding episodes or if you have certain other medical conditions. Contact your doctor immediately if you experience:

• sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, confusion;
• issues with vision or balance, eye pain or swelling;
• severe chest pain, sudden cough or shortness of breath, or coughing up blood;
• sudden stomach or back pain; or
• swelling or warmth in one leg.

Common side effects of concizumab may include:

• pain, bruising, swelling, or irritation at the injection site; or
• hives.

This is not a complete list of side effects and others may occur. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Concizumab is injected under the skin in the stomach or thigh, usually once a day. A healthcare provider may give you this injection or may teach you or your caregiver how to properly use this medicine by yourself.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Do not inject within 2 inches of your navel, or areas where the skin is tender, hard, scaly, bruised, or has scars. Do not inject into the same place two times in a row.

Do not reuse a needle. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand how to use an injection.

Your blood may need to be tested often. Your doctor will need to check your progress on a regular basis.

Doses are based on weight. Your dose may change if you gain or lose weight.

Your doctor may tell you to use concizumab together with another medicine to help with bleeding episodes. Follow your doctor's dosing instructions very carefully.

Your condition may get worse if you stop using concizumab suddenly. Ask your doctor before stopping the medicine.

This medicine can affect the results of certain blood tests. Tell any doctor who treats you that you are using concizumab.

Tell your doctor if you have a planned surgery.

Store this medicine in the original carton in the refrigerator. Protect from light and do not freeze.

You may store a used prefilled pen in the refrigerator or at room temperature for up to 28 days. Throw the medicine away if not used within 28 days, even if there is still medicine left inside.

Call your doctor for instructions if you forget to take a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Using concizumab with other medicines that treat your bleeding episodes may raise your risk of blood clots. Inform your doctor about any other medications you take, especially factor VIIa (rFVIIa) or activated prothrombin complex concentrate (aPCC).

Other medications may influence how concizumab works, including both prescription and over-the-counter drugs, vitamins, and herbal products. Not all possible drug interactions are mentioned here.