INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
EKTERLY® (sebetralstat) 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.
IMPORTANT SAFETY INFORMATION
Adverse reactions: The most commonly reported adverse reaction was
headache.
Drug interactions:
EKTERLY is a substrate of CYP3A4. Concomitant use of EKTERLY with a strong CYP3A4 inhibitor increases
sebetralstat exposure, which may increase the risk of sebetralstat adverse reactions. Avoid use of EKTERLY
with strong CYP3A4 inhibitors and reduce the dose of EKTERLY to one dose of 300 mg (one tablet) with moderate
CYP3A4 inhibitors. Concomitant use of EKTERLY with a strong or moderate CYP3A4 inducer decreases sebetralstat
exposure, which may decrease efficacy. The use of EKTERLY with strong or moderate CYP3A4 inducers is not
recommended.
Use in specific populations: Avoid use of EKTERLY in patients with
severe hepatic impairment (Child-Pugh Class C). The recommended dosage of EKTERLY is one dose of 300 mg (one
tablet) in patients with moderate hepatic impairment (Child-Pugh Class B).
There are no available data on EKTERLY in pregnant women to evaluate for a drug-associated risk of major birth
defects, miscarriage, or other adverse maternal or fetal outcomes. There are no data on the presence of
sebetralstat or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk
production.
The safety and effectiveness of EKTERLY in pediatric patients aged under 12 years of age have not been
established.
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.
Please see full Prescribing Information.