Donidalorsen

Donidalorsen is a prescription medication indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.

• Donidalorsen is available under the following different brand names: Dawnzera

Common side effects of Donidalorsen include:

• injection site reactions 
• upper respiratory tract infection 
• urinary tract infection 
• abdominal discomfort

Serious side effects of Donidalorsen include:

• symptoms of serious allergic reaction may include rash, trouble breathing, fainting, dizziness, feeling lightheaded (low blood pressure), swelling of the face, lips, or tongue, chest pain, or itching

Rare side effects of Donidalorsen include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, SC solution

• 80 mg/0.8 mL single-dose autoinjector

Hereditary Angioedema (HAE)

Adult and pediatric dosage

• Recommended dose: 80 mg SC every 4 weeks
• May consider administering every 8 weeks

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Visit the RxList Drug Interaction Checker for any drug interactions. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of serious hypersensitivity reactions, including anaphylaxis, to donidalorsen or product excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Donidalorsen?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Donidalorsen?”

Cautions

• Hypersensitivity
• Hypersensitivity reactions, including anaphylaxis, reported

Discontinue and institute appropriate therapy if signs and symptoms of serious hypersensitivity reactions occur

Pregnancy and Lactation

• Data are not available regarding use during pregnancy to evaluate drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Lactation
  • Data are unavailable for drug presence in human milk, its effects on breast-fed infants, or on milk production
  • Donidalorsen was excreted into the milk of lactating mice; however, due to species-specific differences in lactation physiology, animal lactation data may not reliably predict levels in human milk