Garadacimab

Garadacimab is used to stop attacks of hereditary angioedema (HAE) in adults and children who are at least 12 years old.

Garadacimab may also be used for reasons that are not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Garadacimab is injected under the skin. A healthcare provider may give you this injection or may teach you 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.

Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before using.

Do not inject within 1 inch of your navel (belly button), or areas where the skin is hard, tender, bruised, or has scars. Do not inject into the same place two times in a row.

Do not reuse a needle or syringe. 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.

Store the medicine in the original carton in a refrigerator away from light. Do not shake the medication. Do not freeze.

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

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

It is not known if garadacimab will harm an unborn baby. Tell your doctor if you are pregnant or planning to become pregnant.

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

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

Common side effects of garadacimab may include:

• pain, bruising, swelling, or irritation at the injection site;
• watery eyes;
• stomach pain; or
• sneezing, runny or stuffy nose.

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

Usual Adult Dose for Hereditary Angioedema:

Initial loading dose: 400 mg subcutaneously on day 1Maintenance dose: 200 mg subcutaneously once a month Use: For prophylaxis to prevent attacks of hereditary angioedema (HAE)

Usual Pediatric Dose for Hereditary Angioedema:

12 years and older:Initial loading dose: 400 mg subcutaneously on day 1Maintenance dose: 200 mg subcutaneously once a month Use: For prophylaxis to prevent attacks of HAE

Use the missed dose as soon as you remember it. Do not use two doses in one day.

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

Follow your doctor's instructions about any limits on food, drinks, or activities.

Do not share garadacimab with anyone else, even if they have the same symptoms you have.

Other drugs may affect garadacimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.