Administrative & Office Resources
Download the EKTERLY® (sebetralstat) onboarding checklist, sample administrative letters, and benefits investigation support.
Administrative & Office Resources
Download the EKTERLY® (sebetralstat) onboarding checklist, sample administrative letters, and benefits investigation support.
This page provides tools to help your office manage access-related tasks efficiently and reduce administrative burden when prescribing EKTERLY.
EKTERLY Onboarding
Information to support EKTERLY treatment initiation
A checklist to help ensure smooth access to EKTERLY
Download In-Office EKTERLY Onboarding Checklist
A tool for learning about your patients’ experience with HAE and starting a conversation about EKTERLY.
Download Patient Discussion Guide
Sample Administrative Letters
Use these resources to help prepare and submit prior authorization requests and respond to payer follow-up, as applicable.
Benefits Investigation Support
Our dedicated Regional Access Managers can:
- Look into patients’ insurance benefits and coverage
- Review coverage with you and your patients
- Provide prior authorization support and status monitoring
- Help you understand the appeals process
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.
