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Ekterly (sebetralstat) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat acute attacks of hereditary angioedema (HAE) in adults and children ages 12 and older.
Ekterly is a plasma kallikrein inhibitor. Plasma kallikrein is a protein involved in swelling. Ekterly blocks this protein and lowers the production of bradykinin.
Bradykinin can make blood vessels leak fluid and cause swelling. In HAE, this helps reduce swelling during sudden attacks.
Doctors prescribe Ekterly when adults and children ages 12 and older need treatment for sudden HAE attacks.
Ekterly comes as tablets taken by mouth.
The recommended dose is 600 milligrams, or 2 tablets, at the earliest sign of an acute HAE attack.
A second dose of 600 milligrams may be taken at least three hours after the first dose if the first dose does not work well enough, or if symptoms worsen or return.
Do not take more than 1,200 milligrams, or 4 tablets, in any 24-hour period.
People taking a moderate CYP3A4 inhibitor should take 300 milligrams, or 1 tablet. A second dose of 300 milligrams may be taken at least three hours later if the first dose does not work well enough, or if symptoms worsen or return.
People with moderate liver impairment (Child-Pugh Class B) should also take 300 milligrams per dose.
Do not use Ekterly with strong CYP3A4 inhibitors or strong or moderate CYP3A4 inducers. People with severe liver impairment (Child-Pugh Class C) should also avoid Ekterly.
CYP3A4 inhibitors are medicines that slow the breakdown of certain drugs in the body.
Take Ekterly exactly as your healthcare provider tells you.
This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
In a clinical study, headache was the most common side effect of Ekterly and occurred in about 3 percent of people.
None are listed in the prescribing information.
Get medical help right away if you think you are having a serious reaction.
KalVista Pharmaceuticals, the manufacturer of Ekterly, offers the KalVista Cares Co-Pay Assistance Program. Eligible people with commercial insurance may pay as little as $0 for their Ekterly prescription.
The program also offers support from dedicated Care Managers, including help understanding insurance coverage, exploring financial assistance options, coordinating with your specialty pharmacy, and connecting you with educational resources and HAE advocacy organizations.
To learn more, visit the KalVista Cares Patient Support Program or call 844-432-3322.
Tell your doctor if you have any allergies to sebetralstat or any ingredients in Ekterly.
Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.
Be sure to tell your doctor if you take:
Before taking Ekterly, tell your doctor if you have liver problems.
If you are pregnant, planning to become pregnant, or breastfeeding while taking Ekterly, talk with your doctor about the risks and benefits.
These answers are fact-checked by our editorial staff.
How effective is Ekterly for HAE?
In a study of 110 people ages 12 and older with HAE, 76 percent of people who received Ekterly 600 milligrams began to feel symptom relief within 12 hours. This was compared with 49 percent of people who received a placebo (an inactive treatment).
The median time to the beginning of symptom relief was 2.0 hours with Ekterly 600 milligrams. Within 24 hours, 49 percent of people who received Ekterly 600 milligrams had complete attack resolution, compared with 27 percent of people who received a placebo.
How long does Ekterly take to work for HAE?
In the main study, the median time to the beginning of symptom relief was 2.0 hours after taking Ekterly 600 milligrams. In a separate study of healthy people, Ekterly reduced plasma kallikrein activity starting 30 minutes after a 600-milligram dose.
This laboratory finding does not mean that every person will feel relief within 30 minutes.
What should I do if I miss a dose of Ekterly for HAE?
Ekterly is not taken on a regular daily schedule. Take it at the earliest sign of an acute HAE attack.
If the first dose does not work well enough, or if symptoms worsen or return, you may take a second dose at least three hours later. Do not take more than 1,200 milligrams, or 4 tablets, in any 24-hour period.
On myHAEteam, people share their experiences with HAE, get advice, and find support from others who understand.
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