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Overview: Dawnzera is a medicine used to prevent attacks of hereditary angioedema (HAE). This medicine is injected under your skin. Pain, itching, swelling, or redness where the medicine goes in is the most common side effect. Consider using an app or calendar to help you remember when to use Dawnzera.

Uses

What is Dawnzera used for?

Dawnzera (donidalorsen) is commonly used to prevent attacks of hereditary angioedema (HAE).

Dawnzera may also be used for other conditions as determined by your health care provider.

How does Dawnzera work (mechanism of action)?

People with hereditary angioedema (HAE) have too much of a substance called kallikrein. When there is too much kallikrein in the body, you get too much of another substance called bradykinin. Bradykinin can cause fluid to build up where it should not. 

Dawnzera lowers the amount of a protein called PKK. Lowering PKK prevents too much bradykinin from being made. Thus, Dawnzera can help prevent HAE attacks.

How is Dawnzera supplied (dosage forms)?

Brands and other names

  • Dawnzera

Dosage forms and strengths

  • 80 mg/0.8 mL single-dose autoinjector

How should I store Dawnzera?

Store Dawnzera in the original carton to protect it from light. Keep the carton in the refrigerator between 36 F and 46 F (2 C and 8 C). Do not freeze. You may keep Dawnzera at room temperature up to 86 F (30 C) for up to 6 weeks. Throw Dawnzera away if it has been kept at room temperature for more than 6 weeks.

Side Effects

What are the most common side effects of Dawnzera?

The most common side effects of Dawnzera are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Pain, itching, swelling, or redness near the injection site
  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Kidney or bladder infection
  • Discomfort in your stomach area

There may be other side effects of Dawnzera that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Dawnzera?

While less common, the most serious side effects of Dawnzera are described below, along with what to do if they happen.

Severe Allergic Reactions. Dawnzera may cause allergic reactions, which can be serious. Stop using Dawnzera and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Warnings & Precautions

Who should not use Dawnzera?

Allergies to Ingredients. People who are allergic to any of the following should not use Dawnzera.

  • Dawnzera
  • Donidalorsen
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Dawnzera.

What should I know about Dawnzera before using it?

Do not use Dawnzera unless it has been prescribed to you by a health care provider. Use it as prescribed. Follow the “Instructions for Use” that comes with this medicine. If you have any questions, ask your health care provider.

Do not share Dawnzera with other people, even if they have the same condition as you. It may harm them.

Keep Dawnzera out of the reach of children. Since this medicine may be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.

Consider using a calendar or app to help you remember when to use Dawnzera.

Do not heat this medicine. You can let Dawnzera come to room temperature by removing the carton from the refrigerator 30 minutes before using it. To protect the medicine from light, take Dawnzera out of the carton right before use.

What should I tell my health care provider before using Dawnzera?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Dawnzera is right for you.

In particular, make sure that you discuss any of the following.

Liver or Gallbladder Problems. Dawnzera may not be a good option for you if you have liver problems or gallbladder problems. Get any bloodwork that your health care provider orders for you.

Pregnancy. It is not known if or how Dawnzera could affect pregnancy or harm an unborn baby. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should use Dawnzera while you are pregnant or trying to get pregnant.

Breastfeeding. It is not known if Dawnzera passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Dawnzera while breastfeeding.

How can I get more information about Dawnzera?

For more information about Dawnzera, you can visit the drugmaker’s website at www.dawnzera.com or call them at 833-644-6647.

Interactions

Does Dawnzera interact with foods or drinks?

There are no known interactions between Dawnzera and foods or drinks.

It is unknown if drinking alcohol will affect Dawnzera.

Does Dawnzera interact with other medicines (drug interactions)?

There are no known interactions between Dawnzera and other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Dawnzera?

If you or someone else has used too much Dawnzera, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Dawnzera?

If you miss a dose, use it as soon as you remember. Use your next dose at the recommended dosing frequency starting from the date of your last dose. Do not use double or extra doses.

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