Sebetralstat

Sebetralstat is a prescription medication indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.

• Sebetralstat is available under the following different brand names: Ekterly

Common side effects of Sebetralstat include:

• headache

Serious side effects of Sebetralstat include:

• none

Rare side effects of Sebetralstat include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

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

Tablet

• 300 mg

Hereditary Angioedema

Adult and pediatric dosage

• 600 mg orally at the earliest recognition of acute HAE
• If inadequate response or symptoms worsen or recur, may administer a second 600-mg dose no sooner than 3 hours after the first dose
• Not to exceed 1200 mg/24 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

Drug interaction overview

• Sebetralstat is a sensitive 3A4 substrate
• Strong CYP3A4 inhibitors H5
  • Avoid coadministration
  • Coadministration increases Sebetralstat AUC by approximately 5.2-fold, which may increase adverse effects
• Moderate CYP3A4 inhibitors
  • Modify the Sebetralstat dose
  • Decrease the Sebetralstat acute dose and optional second dose
  • See Dosage Modifications
• Strong and moderate CYP3A4 inducers
  • Avoid coadministration
  • Sebetralstat systemic exposure is reduced, which may decrease efficacy

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• None

Pregnancy and Lactation

• Data are unavailable for use during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Lactation
  • There are no data on the presence of sebetralstat or its metabolites in human milk, effects on breastfed infants, or effects on milk production