What is EKTERLY used for?

1 INDICATIONS AND USAGE EKTERLY® is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. EKTERLY ® is a plasma kallikrein inhibitor indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ( 1 )

How does EKTERLY work?

11 DESCRIPTION The active ingredient of EKTERLY is sebetralstat, a plasma kallikrein inhibitor.

What pharmaceutical form is EKTERLY available in?

EKTERLY: Tabletki powlekane 300 mg (doustna)

What are the side effects of EKTERLY?

6 ADVERSE REACTIONS The most common adverse reaction (incidence ≥2%) is headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact KalVista Pharmaceuticals, Inc. at 1-855-258-4782 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and

Who should NOT take EKTERLY?

4 CONTRAINDICATIONS None. None ( 4 )

Does EKTERLY interact with other medications?

7 DRUG INTERACTIONS Strong and Moderate CYP3A4 Inhibitors : Avoid use with strong CYP3A4 inhibitors. In patients taking moderate CYP3A4 inhibitors, take one dose of 300 mg. A second dose of 300 mg may be taken at least 3 hours after the first dose if response is inadequate, or if symptoms worsen or recur. ( 2.2 , 7.1 , 12.3 ) CYP3A4 Inducers : Avoid use with moderate or strong CYP3A4 inducers. ( 2.2 , 7.1 , 12.3 ) 7.1 Effect of Other Drugs on EKTERLY Strong CYP3A4 Inhibitors Av

Can EKTERLY be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS Hepatic Impairment : Avoid use of EKTERLY in patients with severe hepatic impairment (Child-Pugh Class C). In patients with moderate hepatic impairment (Child-Pugh Class B) take one dose of 300 mg. A second dose of 300 mg may be taken at least 3 hours after the first dose if response is inadequate, or if symptoms worsen or recur. ( 2.3 , 8.6 , 12.3 ) 8.1 Pregnancy Risk Summary There are no available data on EKTERLY in pregnant women to evaluate for

What precautions should be taken with EKTERLY?

No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Who manufactures EKTERLY?

KalVista Pharmaceuticals (Ireland) Ltd. (Wielka Brytania)

What ATC class does EKTERLY belong to?

EKTERLY: ATC B06AC. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

OTC

EKTERLY

300 mg, Tabletki powlekane

INN: Sebetralstat

Data updated: 2026-04-13

Available in:

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Form

Tabletki powlekane

Dosage

300 mg

Route

doustna

Storage

—

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