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Ekterly (Sebetralstat): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
300 mg
Active ingredient:

Patient information: uses, side effects, how to take - Ekterly

What is EKTERLY?

  • EKTERLY is a prescription medicine used to treat sudden (acute) attacks of hereditary angioedema (HAE) in adults and children aged 12 years of age and older.
  • It is not known if EKTERLY is safe and effective in children under 12 years of age.

Before you take EKTERLY, tell your healthcare provider about all of your medical conditions, including if you:

  • are pregnant or planning to become pregnant. It is not known if EKTERLY can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if EKTERLY passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking EKTERLY.

  • have liver problems.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

  • Taking EKTERLY with certain other medicines can cause side effects or affect how well EKTERLY or the other medicines work.

Especially tell your healthcare provider if you take any of the following, as their use with EKTERLY is not recommended:

  • itraconazole
  • phenytoin
  • efavirenz

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take EKTERLY?

  • Take EKTERLY exactly as your healthcare provider tells you to take it.
  • Take 2 tablets, by mouth, at the earliest sign of an acute attack of hereditary angioedema. If you do not feel better or if your symptoms worsen or come back, take another dose (2 tablets) at least 3 hours after the first dose.
  • Your healthcare provider may change how much EKTERLY you receive if you take certain medicines or if you have liver problems:

    • Take 1 tablet, by mouth, at the earliest sign of an acute attack of hereditary angioedema. If you do not feel better or if your symptoms worsen or come back take another dose (1 tablet) at least 3 hours after the first dose.
  • If you take too much EKTERLY, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What are the possible side effects of EKTERLY?

The most common side effects of EKTERLY include:

  • headache

For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store EKTERLY?

  • Store EKTERLY in the blister package that it comes in.
  • Store EKTERLY at room temperature between 68°F to 77°F (20°C to 25°C).

Keep EKTERLY and all medicines out of the reach of children.

General information about the safe and effective use of EKTERLY

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EKTERLY for a condition for which it was not prescribed. Do not give EKTERLY to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about EKTERLY that is written for health professionals.

What are the ingredients in EKTERLY?

Active ingredient: sebetralstat

Inactive ingredients: croscarmellose sodium, glycerol mono and dicaprylocaprate, guar gum/guar galactomannan, hypromellose, iron oxide black, iron oxide yellow, macrogol polyvinyl alcohol graft copolymer, magnesium stearate, maltodextrin, medium chain triglycerides, microcrystalline cellulose, polyvinyl alcohol, povidone, talc and titanium dioxide.

Distributed by KalVista Pharmaceuticals, Inc. 200 Crossing Boulevard, Framingham, MA 01702

EKTERLY is a registered trademark of KalVista Pharmaceuticals Limited

©2025 KalVista Pharmaceuticals, Inc. All rights reserved.

For more information, visit www.EKTERLY.com or call 1-855-258-4782.

This Patient Information has been approved by the U.S. Food and Drug Administration Issued: 04/2026

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 219301 · View the label on DailyMed

Revision date stated in the text: April 2026

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Ekterly

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Plasma Kallikrein Inhibitor
Active ingredient Sebetralstat 300 mg
Dosage form Tablet
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) KALVISTA
FDA approval NDA 219301New Drug Application (NDA) Approved July 3, 2025
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
300 mg – 1 in 1 blister pack / 4 in 1 carton NDC 82928-300-01
300 mg – 2 in 1 blister pack / 2 in 1 carton NDC 82928-300-02

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.