Dawnzera (Donidalorsen) for HAE

Dawnzera (donidalorsen) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to help prevent hereditary angioedema (HAE) attacks in adults and children 12 years of age and older.

How Dawnzera Works and How It’s Taken

Dawnzera is a type of medicine called an antisense oligonucleotide. It lowers the amount of prekallikrein made by the body. Prekallikrein helps produce bradykinin, a substance that can cause swelling and pain during HAE attacks. By lowering prekallikrein, Dawnzera helps prevent HAE attacks.

Doctors prescribe Dawnzera to prevent HAE attacks in adults and children 12 years of age and older.

Dawnzera is injected under the skin. It may be given by the person or a caregiver after proper training.

For self-injection, use the abdomen or the front of the thigh. Stay at least 2 inches away from the belly button. A caregiver or healthcare provider may also give the injection in the back of the upper arm.

Change the injection site each time. Do not inject into scars or into skin that is bruised, tender, red or discolored, hard, or damaged.

Typical Dosing for HAE

The recommended dose of Dawnzera for HAE is 80 milligrams injected under the skin every four weeks.

A dose of 80 milligrams every eight weeks may also be considered.

This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Dawnzera Side Effects

In clinical studies, the most common side effects of Dawnzera occurred in about 7 percent to 24 percent of people. These include:

Injection site reactions (such as redness or skin discoloration, pain, itching, swelling, bruising, or hives where the shot was given)
Upper respiratory tract infection (such as a cold)
Urinary tract infection
Abdominal discomfort

Serious Side Effects and Warnings

Dawnzera can cause serious side effects that may require immediate medical attention. These include:

Hypersensitivity (allergic) reactions — These can include anaphylaxis, a severe allergic reaction that can cause rash, trouble breathing, chest pain, or swelling around the mouth.

Get medical help right away if you think you are having a serious reaction.

How To Save on Dawnzera

Ionis Pharmaceuticals, the manufacturer of Dawnzera, offers the Ionis Every Step support program. Eligible people with commercial insurance may pay as little as $0 out-of-pocket for each prescription.

The Ionis Every Step support program also offers personal support from a dedicated patient education manager, plus help with insurance coverage and the appeals process if coverage is denied.

To learn more, visit the Ionis Every Step website or call 844-444-4305.

What To Know Before Taking Dawnzera

Tell your doctor if you have any allergies to donidalorsen or any ingredients in Dawnzera.

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Do not take Dawnzera if you have had a serious allergic reaction, including anaphylaxis, to donidalorsen or any of its ingredients.

If you miss a dose, inject it as soon as possible. Then restart your regular schedule, either every four weeks or every eight weeks, based on the date of your most recent dose.

If you are pregnant, planning to become pregnant, or breastfeeding while taking Dawnzera, talk with your doctor about the risks and benefits.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Dawnzera for HAE?

In a 24-week study of people 12 years of age and older with hereditary angioedema, people who received Dawnzera every four weeks had an average of 0.44 HAE attacks every four weeks. People who received placebo had an average of 2.26 attacks every four weeks.

This was an 81 percent reduction in the attack rate compared with placebo. Dawnzera given every eight weeks reduced the attack rate by 55 percent compared with placebo.

From week 4 through week 24, 53 percent of people who received Dawnzera every four weeks had no attacks. This compared with 9 percent of people who received placebo.

How long does Dawnzera take to work for HAE?

Plasma prekallikrein levels decreased by the first assessment at week 4 after treatment started.

The main study measured HAE attack rates from week 0 through week 24. The prescribing information does not report an earlier time point for reduced HAE attacks.

Can I self-administer Dawnzera for HAE?

Yes. Dawnzera is intended for self-administration after you have been trained to prepare and inject it correctly. Follow the instructions for use that come with the autoinjector.

Inject Dawnzera under the skin in the abdomen or front of the thigh. The back of the upper arm should only be used when a caregiver or healthcare provider gives the injection.