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EKTERLY® (sebetralstat) patient Cari enjoying a day fishing with family EKTERLY® (sebetralstat) patient Cari enjoying a day fishing with family

EKTERLY
Resources

Real EKTERLY patient

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  • ANYTIME, ANYWHERE

    Hear allergy/immunology specialist Dr. Michael Manning discuss
    the key attributes of EKTERLY.

  • EKTERLY EXPLAINED

    Hear about the clinical trial and data for EKTERLY from allergy/
    immunology specialist Dr. William Lumry.

Patient advocacy groups

Help your patients get information
and build community.

Hereditary Angioedema Association logo
Hereditary Angioedema Association

The US Hereditary Angioedema Association (HAEA) is a 501(c)(3) nonprofit advocacy and research organization serving people living with the rare genetic condition HAE and their families.

Visit haea.org Link
National Organization for Rare Disorders (NORD) Logo
National Organization for Rare Disorders

The National Organization for Rare Disorders (NORD) is a 501(c)(3) nonprofit dedicated to supporting individuals with rare diseases through advocacy, research, and patient assistance programs. It connects patients, caregivers, and researchers to advance treatment access and policy improvements.

Visit rarediseases.org Link

HAE=hereditary angioedema; US HAEA=US Hereditary Angioedema Association.

EKTERLY® (sebetralstat) patient Zach speaking to his healthcare professional EKTERLY® (sebetralstat) patient Zach speaking to his healthcare professional
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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 (3.2%).

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.