Donidalorsen

Donidalorsen is used by adults and children who are at least 12 years old to prevent attacks of hereditary angioedema (HAE).

Donidalorsen may also be used for reasons 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.

Donidalorsen is injected under the skin, usually once every 4 or 8 weeks. A healthcare provider may give you this injection or may teach you or your caregiver how to properly use this medicine.

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

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 warm the medicine with hot water, sunlight, or a microwave.

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

You may need blood tests to check your platelets and liver function.

Throw away the Dawnzera Autoinjector after one use, even if there is still medicine left inside. Do not reuse a needle or autoinjector. 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 this medicine in the original carton in the refrigerator. Protect from light and do not freeze.

You may store this medicine at room temperature for up to 6 weeks. Throw the medicine away if not used within 6 weeks. Protect from heat.

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

You should not use donidalorsen if you are allergic to it or any of its ingredients.

Tell your doctor if you have or have ever had:

• low levels of platelets in your blood; or
• liver disease.

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

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

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

Donidalorsen may cause serious side effects. Call your doctor right away if you have:

• chest pain;
• fainting, dizziness, feeling light-headed; or
• easy bruising, unusual bleeding, purple or red spots under your skin.

Common side effects of donidalorsen may include:

• pain, bruising, swelling, or irritation where the medicine was injected;
• stomach discomfort;
• pain and burning when you urinate; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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

Usual Adult Dose for Hereditary Angioedema:

80 mg subcutaneously every 4 weeksComments:-A dose of 80 mg subcutaneously every 8 weeks may also be considered. Use: As prophylaxis to prevent attacks of hereditary angioedema

Usual Pediatric Dose for Hereditary Angioedema:

12 years and older: 80 mg subcutaneously every 4 weeksComments:-A dose of 80 mg subcutaneously every 8 weeks may also be considered. Use: As prophylaxis to prevent attacks of hereditary angioedema

Use the medicine as soon as you remember, and then return to your regular schedule. Do not use two doses at the same time.

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, drinks, or activities.

Other drugs may affect donidalorsen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.