Prescribing guide
Ekterly (sebetralstat)On-demand dosing, CYP3A4 and hepatic dose changes, quantity limits and prior authorization criteria for hereditary angioedema attacksFor prescribers and their offices treating hereditary angioedema (HAE): what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
No REMS, no boxed warning, no contraindications and no baseline labs in the label; KalVista's enrollment path is the KalVista Cares Start Form, benefits investigation and prior authorization, then a specialty pharmacy.
Example PA threshold
Cigna example: age 12 or older, HAE type I or II with functional C1-INH below 50% of normal and low C4, both documented, an HAE specialist, and for adults a trial of generic icatibant or a prior attack treated with Ekterly.
Monitoring
No laboratory monitoring in the label; the dose depends on CYP3A4 co-medication and Child-Pugh class, and severe laryngeal attacks were not treated in KONFIDENT.
Support line
KalVista Cares, 1-844-432-3322, Monday to Friday 8:30 am to 8 pm ET; Start Form online or by fax to 1-844-432-9525; co-pay as little as $0 for commercial plans; QuickStart.
Give your patient their plan
A one-page handout for starting Ekterly, in plain language: what the first fill waits on, the first dates, who will call and the symptoms to report, with blank lines for the start date and your office's number. The link opens the patient's full first 90 days page, where their dates become calendar entries.
trialfriend.com/p/ekterlyBefore the first fill: REMS, labs and enrollment
The steps that the pharmacy, the REMS or the drugmaker's program will wait on, in the order they usually need to happen. A first fill of a specialty drug most often stalls on one of these rather than on the plan.
| Step | What it requires | Source |
|---|---|---|
| Enroll with the Start Form | Complete the EKTERLY Patient Start Form online at kalvistacaresenroll.com or fax it to 1-844-432-9525. The form carries the prescription and needs the prescriber's signature and the patient's signed authorization. | Ekterly Start Form |
| Write the prescription in cartons | The Start Form prescription reads 600mg, two 300mg tablets, at the earliest recognition of an HAE attack, with additional doses if needed up to 1,200mg per day. Quantity is written in 4-count blister packs, with a number of refills. The form pre-prints ICD-10 D84.1 and the 600mg dose only. | Ekterly Start Form |
| Check CYP3A4 co-medication and liver function | Moderate CYP3A4 inhibitors and Child-Pugh B both set 300mg per dose. The label says to avoid use with strong CYP3A4 inhibitors, with strong or moderate inducers and in Child-Pugh C. | FDA label |
| Prior authorization | KalVista Cares Care Managers run the benefits investigation and assist with prior authorization requests, reauthorizations and appeals. | KalVista Cares, prescriber site |
| QuickStart | In the event of a delay in coverage authorization, Quick Start may be available for eligible newly prescribed patients. Quick Start prescriptions are filled only at the designated non-commercial pharmacy. | Ekterly Start Form |
| Pharmacy routing | KalVista Cares works with the patient's specialty pharmacy to help ensure the patient receives treatment. A Care Manager contacts the patient within 1 business day once eligibility is confirmed. | KalVista Cares |
| Counsel on dosing at an attack | The label's counseling section covers not using Ekterly with strong CYP3A4 inhibitors, the 300mg dose with moderate inhibitors or moderate hepatic impairment, and avoiding use in severe hepatic impairment. | FDA label |
Prior authorization criteria and what to document
One public policy as the example: Cigna, August 15, 2026. Approval approved for 1 year. Renewal needs a documented HAE type I or II diagnosis, a specialist and a favorable response the prescriber reports, such as shorter attacks or quick symptom relief. This version took effect August 15, 2026, after a July 2026 review that made no criteria changes. It cites the July 2025 label, before the April 2026 label revision. Other plans set their own criteria and approval lengths. It is here as an example of what a plan asks for, not as a rule.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Diagnosis | HAE due to C1-INH deficiency, type I or type II; HAE with normal C1-INH (type III) does not meet the criteria | Diagnosis in the chart note | Cigna policy |
| Functional C1-INH | Below 50% of normal at baseline, by the laboratory's reference values, documentation required | Lab report with date and reference range | Cigna policy |
| Serum C4 | Lower than normal at baseline, by the laboratory's reference values, documentation required | Lab report with date and reference range | Cigna policy |
| Age | 12 years or older | Date of birth on the request | Cigna policy |
| Prescriber | Prescribed by or in consultation with an allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders | Specialty on the request, or the consult note | Cigna policy |
| Preferred product step | One of: age 12 to under 18; a previous acute HAE attack treated with Ekterly; or a trial of generic icatibant (generic icatibant or Sajazir on individual and family plans). A trial of any icatibant product counts. | Medication history with dates, or the prior Ekterly-treated attack | Cigna policy |
| Renewal | Documented HAE type I or II, the same prescriber requirement, and a favorable clinical response per the prescriber, such as shorter attacks, quick onset of symptom relief, complete resolution, or fewer or milder attacks | Attack and treatment notes since the last approval | Cigna policy |
| Not for prophylaxis | Ekterly for HAE prophylaxis is listed as not medically necessary; it is not indicated for prophylaxis | Indication on the request: treatment of acute attacks | Cigna policy |
| Quantity | 16 tablets per 28 days at retail or 48 per 84 days by home delivery; a one-time override of 16 additional tablets for a subsequent attack, once every 30 days | Tablets dispensed in the past 28 or 84 days and the attack that needs more | Cigna quantity policy |
Ekterly dosing and titration
| When | Label | Source |
|---|---|---|
| At the earliest recognition of an attack | 600mg (two 300mg tablets) orally, for adults and pediatric patients 12 and older. | FDA label |
| At least 3 hours later, if needed | A second 600mg dose if response is inadequate, or if symptoms worsen or recur. In KONFIDENT, 38% of patients in the 600mg group took a second dose within 12 hours. | FDA label |
| Any 24-hour period | Maximum 1,200mg (four tablets). | FDA label |
| Moderate CYP3A4 inhibitor | 300mg (one tablet) at the earliest recognition of an attack; a second 300mg dose at least 3 hours later if needed. | FDA label |
| Moderate hepatic impairment (Child-Pugh B) | 300mg (one tablet) at the earliest recognition of an attack; a second 300mg dose at least 3 hours later if needed. Cmax rose 63% and AUC 100% after a single 600mg dose. | FDA label |
| Severe hepatic impairment (Child-Pugh C) | Avoid use; the pharmacokinetics are unknown. | FDA label |
| Food | No clinically relevant difference in pharmacokinetics with a high-fat meal. Median time to peak concentration is about 1 hour after a single 600mg dose. | FDA label |
| Under 12 | Safety and effectiveness not established in the April 2026 label. KalVista announced interim KONFIDENT-KID data in children aged 2 to 11 on March 30, 2026. | KalVista press release |
| Supply | 300mg film-coated tablets in cartons of 4: four blister cards of 1 tablet (NDC 82928-300-04) or two cards of 2 tablets (NDC 82928-300-05). Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C. | FDA label |
Monitoring the Ekterly label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Baseline and ongoing | No laboratory monitoring is specified | The label has no boxed warning, no contraindications and no Warnings and Precautions section | FDA label |
| Dose selection | Hepatic impairment, by Child-Pugh class | Usual dose in class A, 300mg per dose in class B, avoid in class C | FDA label |
| Each new medicine | CYP3A4 inhibitors and inducers | Reassess the dose against Table 1; the Patient Information names itraconazole, phenytoin and efavirenz as not recommended | FDA label |
| Each attack | Response at 3 hours or later | A second dose if response is inadequate or symptoms worsen or recur; no more than 1,200mg in 24 hours | FDA label |
| Laryngeal attacks | Severe laryngeal attacks were not treated in KONFIDENT; 8 of 264 treated attacks (3%) had mild to moderate laryngeal symptoms | The label gives no separate instruction | FDA label |
| Adverse reactions | Headache, 3.2% on 600mg vs 1.2% on placebo | The only adverse reaction at 2% or more and above placebo in KONFIDENT | FDA label |
| Overdose | Label section 10 names no specific treatment | Consider contacting the poison control help line (1-800-222-1222) or a medical toxicologist | FDA label |
| Postmarketing requirement | PMR 4814-1, a 2-year carcinogenicity study in rats | Required in the July 3, 2025 approval letter, with a final report date of October 2025 | FDA letter |
Ekterly drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Strong CYP3A4 inhibitors | Avoid. Itraconazole 200mg daily raised sebetralstat Cmax 2.4-fold and AUC 5.2-fold. | FDA label |
| Moderate CYP3A4 inhibitors | Reduce to 300mg per dose. Verapamil 240mg daily raised Cmax 1.8-fold and AUC 2-fold. | FDA label |
| Weak CYP3A4 inhibitors | No dose modification. Cimetidine, evaluated as a weak inhibitor, made no clinically significant difference. | FDA label |
| Strong or moderate CYP3A4 inducers | Avoid; efficacy may fall. Phenytoin lowered Cmax 66% and AUC 83%; efavirenz lowered Cmax 63% and AUC 79%. | FDA label |
| Weak CYP3A4 inducers | No dose modification. Modafinil made no clinically significant difference. | FDA label |
| P-gp and BCRP inhibitors | No clinically significant difference with quinidine (P-gp) or eltrombopag (BCRP). | FDA label |
| Acid-reducing agents | Estimated Cmax decrease of up to 56% and AUC decrease of up to 30% at pH 6 relative to pH 0.5; the label sets no dose change. | FDA label |
| Background HAE prophylaxis | 22% of KONFIDENT patients were on background HAE prophylaxis. Section 7 lists no interaction other than CYP3A4 inhibitors and inducers. | FDA label |
Why a first fill stalls, and the fix
- Prior authorization pending or deniedCigna asks for HAE type I or type II with functional C1 inhibitor below 50% of normal and a low C4 level, both documented. It also wants an allergist, immunologist or HAE specialist. The policy marks both lab results as required documents.
- Asked to try icatibant firstCigna's employer plan criteria ask adults to have tried generic icatibant. People 12 to 17 are exempt, and so is anyone who has already treated an attack with Ekterly. A previous trial of any icatibant product counts, the policy says.
- HAE with normal C1 inhibitorCigna's policy says HAE with normal C1 inhibitor, sometimes called type III, does not meet its criteria. Cigna treats any use outside its listed criteria as not medically necessary.
- Refill refused as over the quantity limitCigna limits Ekterly to 16 tablets per 28 days at retail and 48 per 84 days by home delivery. Its policy allows a one-time override of 16 more tablets to treat a further attack, once every 30 days.
- A copay you cannot payWith commercial insurance, KalVista's copay program may bring the cost to as little as $0. People with Medicare, Medicaid, TRICARE or other government insurance are not eligible. Our help paying page lists charity funds that may cover costs.
KalVista Cares Patient Support Program (KalVista)
- A dedicated Care Manager who helps with insurance coverage and works with the specialty pharmacy
- Co-Pay Assistance Program, as little as $0 for eligible commercially insured patients, up to a program maximum; not for Medicare, Medicaid, TRICARE or other government insurance
- QuickStart Program, which may help eligible new patients with temporary treatment options while a coverage decision is pending
- A check of eligibility for financial support programs that may help cover the cost
- Connections to educational resources and HAE advocacy groups
- Help for the office with prior authorization requests, reauthorizations and appeals KalVista Cares, prescriber site
- Enrollment online or by fax, with QuickStart prescriptions filled only at a designated non-commercial pharmacy Ekterly Start Form
Questions prescribers' offices ask about Ekterly
What is the Ekterly dose for an HAE attack?
600mg (two 300mg tablets) orally at the earliest recognition of an acute attack, for patients 12 and older, per the April 2026 label. A second 600mg dose may be taken at least 3 hours after the first if response is inadequate or symptoms worsen or recur. The maximum is 1,200mg (four tablets) in any 24-hour period.
How do CYP3A4 inhibitors and inducers change the Ekterly dose?
300mg (one tablet) per dose with moderate CYP3A4 inhibitors, with a second 300mg dose allowed at least 3 hours later, per the April 2026 label (sections 2.2 and 7.1). Avoid strong CYP3A4 inhibitors and strong or moderate CYP3A4 inducers. Weak inhibitors and weak inducers need no change.
What is the Ekterly dose in hepatic impairment?
300mg (one tablet) per dose in moderate hepatic impairment (Child-Pugh B), with a second 300mg dose allowed at least 3 hours later, per the April 2026 label (sections 2.3 and 8.6). Avoid use in severe impairment (Child-Pugh C). Mild impairment (Child-Pugh A) takes the usual dose.
What does the Ekterly label say about laryngeal attacks?
8 of the 264 attacks treated in KONFIDENT (3%) had mild to moderate laryngeal symptoms, and severe laryngeal attacks were not treated in the trial, per the April 2026 label (section 14). The label has no Warnings and Precautions section and gives no separate instruction for laryngeal attacks.
What do insurers ask for to approve Ekterly, and how much do they cover?
1 year of approval under Cigna policy IP0756, effective August 15, 2026, for patients 12 and older with HAE type I or II shown by functional C1-INH below 50% of normal and low C4, both documented, prescribed by or with an allergist, immunologist or HAE specialist. Adults must have tried generic icatibant unless they have already treated an attack with Ekterly. Cigna's quantity policy DQM010 covers 16 tablets per 28 days at retail.
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Sources
- EKTERLY- sebetralstat tablet: prescribing information, revised 4/2026, and Patient Information, issued 04/2026, KalVista Pharmaceuticals Ltd, via DailyMed, 2026-04-01.
- KalVista Cares™ Patient Support Program | EKTERLY® (sebetralstat), KalVista Pharmaceuticals, Inc., 2026-11-11.
- How to Take EKTERLY® (sebetralstat) for HAE Attacks, KalVista Pharmaceuticals, Inc., 2026-11-11.
- Managing HAE Attacks | EKTERLY® (sebetralstat), KalVista Pharmaceuticals, Inc., 2026-11-11.
- KalVista Cares™ Patient Support | EKTERLY® (sebetralstat), KalVista Pharmaceuticals, Inc., 2026-11-11.
- EKTERLY Patient Start Form, KalVista Cares Patient Support Program (US-SEB-00039v3 07/25), KalVista Pharmaceuticals, Inc., 2025-07.
- Drug Coverage Policy IP0756, Hereditary Angioedema, Ekterly, Cigna, 2026-08-15.
- Drug Coverage Policy DQM010, Hereditary Angioedema, Ekterly Drug Quantity Management Policy, Per Days, Cigna, 2026-09-15.
- Hereditary angioedema: MedlinePlus Medical Encyclopedia, U.S. National Library of Medicine, 2026-01-20.
- KalVista Pharmaceuticals Announces Positive Interim Phase 3 Data From KONFIDENT-KID Trial of EKTERLY® (sebetralstat) for Children Aged 2-11 Years at the 2026 Global Angioedema Leadership Conference, KalVista Pharmaceuticals, Inc., 2026-03-30.
- NDA 219301 approval letter, Ekterly (sebetralstat) film-coated tablet for acute attacks of hereditary angioedema in adults and pediatric patients 12 and older, FDA, 2025-07-03.
- Drugs@FDA: FDA-Approved Drugs, New Drug Application (NDA) 219301, EKTERLY, FDA, 2026-11-11.
A reference drawn from the April 1, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 11, 2026. Labels and policies change; the label on DailyMed and the plan's current policy govern. Trial Friend is not a medical provider. It reports what these documents say and does not judge whether a drug is safe or right for any patient; that is the prescriber's decision. Not a substitute for the prescribing information.