Your first 90 days
Your first 90 days with Ekterly for hereditary angioedema (HAE)
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Ekterly is not taken on a schedule, so its first 90 days look different from most medicines. The first job is getting tablets in hand before an attack comes. The second is knowing what the label says to do when one starts. That means the first dose, the 3-hour wait, the daily limit and the medicines that change the dose. This page lays those out from the FDA label, KalVista's own Ekterly pages and one insurer's written rules.
What has to happen before the first bottle ships
Ekterly's label sets no tests or safety program, and KalVista's path to the first carton runs through a Start Form, an insurance check and a specialty pharmacy. These are the 7 things in the way, in order.
A Start Form to KalVista Cares
The allergist's office completes the Start Form online or faxes it to KalVista Cares.
- The form carries the prescription, written as 4-count blister packs with a number of refills.Ekterly Start Form
A call from a Care Manager
KalVista says a dedicated Care Manager contacts the patient within 1 business day once eligibility is confirmed.
- The KalVista Cares number is 1-844-432-3322, answered Monday to Friday, 8:30 am to 8 pm ET.KalVista Cares
The insurance approval
Plans such as Cigna require prior authorization for Ekterly.
- Cigna asks for blood tests showing HAE type I or type II.
- It also asks for an allergist, immunologist or a physician who specializes in HAE.Cigna policy
For adults, a question about icatibant
Cigna's policy asks whether an adult has tried generic icatibant, another medicine for HAE attacks.
- That step does not apply to people 12 to 17, or to anyone who has already treated an attack with Ekterly.Cigna policy
A full medicine list
The Patient Information asks people to share every medicine, vitamin and herbal supplement.
- It names itraconazole, phenytoin and efavirenz as medicines not recommended with Ekterly.
- The label lowers the dose to 1 tablet with some other medicines.FDA label
Any liver problems
The Patient Information asks people to tell the prescriber about liver problems.
- The label sets 1 tablet per dose for moderate liver impairment and says to avoid Ekterly in severe impairment.FDA label
QuickStart, if the approval is slow
KalVista's Start Form says Quick Start may be available for eligible newly prescribed patients when coverage authorization is delayed.
- Those prescriptions are filled only at a designated non-commercial pharmacy, the form says.Ekterly Start Form
The days that matter
Counted from the day the first carton arrives, because Ekterly is taken only when an attack starts. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.Start Form to KalVista Cares
The office enrolls the patient online or by fax, with the insurance details and the signed prescription.
- The patient signs the form's authorization so KalVista Cares can work with the plan and pharmacy.
A Care Manager calls
KalVista Cares confirms eligibility, then a dedicated Care Manager contacts the patient within 1 business day to discuss next steps.
Insurance approval, or QuickStart
A Care Manager helps with insurance coverage.
- KalVista Cares may help eligible new patients with temporary treatment options while they await a coverage determination.
First carton in hand
Each carton holds four 300mg tablets in child-resistant blister cards.
- That is enough for 2 full 600mg doses.
- The label lists 2 carton layouts, with 1 tablet or 2 tablets on each card.
At an attack
First dose, at the earliest sign
The label dose is 2 tablets by mouth at the earliest recognition of an attack.
- In the main trial, people took Ekterly a median of 41 minutes after an attack began, KalVista says.
At least 3 hours later
A second dose, if needed
The label allows 2 more tablets at least 3 hours after the first dose.
- It applies if symptoms do not ease, get worse or come back.
- The limit is 4 tablets in any 24 hours.
After any use
Refills follow your attacks
Ekterly has no fixed refill date, because it is taken only when an attack starts.
- As one example, Cigna covers up to 16 tablets per 28 days at retail, which it counts as enough for 4 attacks.
In one plan
A home delivery limit
Cigna's home delivery limit is 48 tablets per 84 days.
- Its policy allows a one-time override of 16 more tablets for a further attack, once every 30 days.
Three months in
Ekterly may sit unused between attacks.
- The FDA's approval letter sets its shelf life at 36 months from the date of manufacture, when stored at room temperature.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Ekterly label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Current label dated April 1, 2026, read from the FDA's label database today. FDA label
- April 2026
The prescribing information is marked revised April 2026, and the Patient Information is marked issued April 2026. Drugs@FDA lists no labeling supplement for it, and the approved use is still ages 12 and older.Drugs@FDA record
- July 2025
Ekterly tablets were first approved on July 3, 2025, for treating acute HAE attacks in adults and children 12 and older.FDA letter
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- At the earliest sign of an attack
The label dose is 600mg, taken as 2 tablets by mouth at the earliest recognition of an attack.
- In the main trial, the median time to the start of symptom relief was 2.0 hours.FDA label
- A second dose, after at least 3 hours
The label allows a second 600mg dose at least 3 hours after the first.
- It applies if the response is not enough, or if symptoms worsen or return.
- In the trial, 38% of people on 600mg took a second dose within 12 hours.FDA label
- No more than 4 tablets in 24 hours
The maximum recommended dosage is 1,200mg, which is 4 tablets, in any 24-hour period.
- After taking too much, the Patient Information says to call the prescriber or Poison Help at 1-800-222-1222.
- Its other option is going to the nearest hospital emergency room right away.FDA label
- With or without food
KalVista's patient site says Ekterly can be taken with or without food.
- It needs no preparation, setup or refrigeration, the site says.Taking Ekterly, patient site
- For attacks, alongside any preventive medicine
KalVista's patient site says people on preventive treatment should always have an on-demand treatment with them.
- Ekterly is an on-demand treatment, used to treat attacks as they happen.Managing HAE attacks, patient site
- One tablet per dose with some medicines
With a moderate CYP3A4 inhibitor, the label lowers each dose to 300mg, which is 1 tablet.
- A second 300mg dose may follow at least 3 hours later.
- Verapamil is the moderate inhibitor the label studied, and it doubled the body's exposure to sebetralstat.FDA label
- Medicines the label says to avoid
The label says to avoid Ekterly with strong CYP3A4 inhibitors, such as itraconazole.
- It also says to avoid strong or moderate CYP3A4 inducers, such as phenytoin and efavirenz.
- In label studies, those 2 inducers lowered exposure to sebetralstat by 83% and 79%.FDA label
- Liver conditions
For moderate liver impairment, the label sets 300mg per dose, with a second 300mg dose allowed after at least 3 hours.
- It says to avoid Ekterly in severe liver impairment.
- Mild impairment needs no dose change.FDA label
- Ages 12 and older
Ekterly is approved for adults and children 12 and older, and the label says its safety and effectiveness under 12 are not established.
- KalVista announced interim results on March 30, 2026 from KONFIDENT-KID, its trial in children aged 2 to 11.KalVista press release
- Pregnancy and breastfeeding
The label says there are no data on Ekterly in pregnant women to judge its risks.
- It is not known whether Ekterly passes into breast milk.
- The Patient Information asks people to talk with the prescriber about feeding.FDA label
- Storage
The Patient Information says to store Ekterly in the blister package it comes in, at 68°F to 77°F (20°C to 25°C).
- The prescribing information permits excursions between 59°F and 86°F (15°C and 30°C).
- It also says not to use a carton whose tamper-evident seal is broken or missing.FDA label
- Not for sharing
The Patient Information says not to give Ekterly to other people, even if they have the same symptoms.
- It may harm them, the leaflet says.FDA label
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
Swelling in the throat
The label says severe laryngeal attacks, meaning attacks in the throat, were not treated in the main trial.
- Of the 264 attacks treated with Ekterly or placebo, 8 had mild to moderate throat symptoms.
- The label gives no separate instructions for a throat attack.FDA label
Trouble breathing
MedlinePlus says swelling of the airway is a life-threatening emergency.
- It says to seek immediate medical attention for difficulty breathing due to swelling.MedlinePlus
An attack that does not ease
The label allows a second dose at least 3 hours after the first if symptoms do not ease, get worse or come back.
- The label does not say what to do if symptoms continue after the 24-hour maximum is reached.FDA label
Too many tablets
After taking too much Ekterly, the Patient Information says to call the prescriber or Poison Help at 1-800-222-1222.
- The other option it gives is going to the nearest hospital emergency room right away.FDA label
Headache
Headache was the most common side effect, in 3.2% of people on 600mg against 1.2% on placebo.
- The Patient Information says to call the doctor for medical advice about side effects.FDA label
A new medicine
Taking Ekterly with certain medicines can cause side effects or change how well either one works, the Patient Information says.
- It asks people to keep a medicine list to show the prescriber or pharmacist with each new medicine.FDA label
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- 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.Cigna policy
- 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.Cigna policy
- 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.Cigna policy
- 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.Cigna quantity policy
- 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
Cigna prior authorization policy, August 15, 2026
- Age 12 or older, with hereditary angioedema due to C1 inhibitor deficiency, for treating acute attacks
- HAE type I or type II, shown by functional C1 inhibitor below 50% of normal at baseline, with documentation
- A lower than normal serum C4 level at baseline, with documentation
- HAE with normal C1 inhibitor, also called type III, does not meet the criteria
- Prescribed by or in consultation with an allergist, immunologist or a physician who specializes in HAE
- Age 12 to 17, or a past attack treated with Ekterly, or a trial of generic icatibant (generic icatibant or Sajazir on individual and family plans)
- Not covered for preventing attacks
Approval length. 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. Cigna policy
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- 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
Details as the drugmaker publishes them. KalVista Cares
Five questions for the pharmacist or the support line
- Do any of my medicines mean 1 tablet per dose instead of 2, or that I should not take Ekterly?
- How many cartons come in each fill, and how many attacks does that cover?
- How soon can I refill after I treat an attack, and does my plan limit tablets per month?
- What is the expiry date on this carton?
- Does my plan cover Ekterly at a retail pharmacy, by home delivery, or both?
Questions people ask in the first weeks
How do I take Ekterly?
The label dose is 2 tablets, 600mg, by mouth at the earliest sign of an HAE attack. KalVista's patient site says it can be taken with or without food. The prescriber may set 1 tablet per dose with certain medicines or liver problems.
When can I take a second dose of Ekterly?
The label allows a second dose at least 3 hours after the first. It applies if the response is not enough, or if symptoms worsen or return. In the main trial, 38% of people on 600mg took a second dose within 12 hours.
What is the most Ekterly I can take in a day?
The label's maximum is 1,200mg, which is 4 tablets, in any 24-hour period. After taking too much, the Patient Information says to call the prescriber or Poison Help at 1-800-222-1222, or go to the nearest emergency room.
Does Ekterly work for throat attacks?
The label says severe laryngeal attacks were not treated in the main trial. Of the 264 attacks treated in the trial with Ekterly or placebo, 8 had mild to moderate throat symptoms. MedlinePlus calls airway swelling a life-threatening emergency and says to seek immediate medical attention for difficulty breathing.
Can children under 12 take Ekterly?
Not under the current label, which covers people 12 and older. KalVista announced interim results on March 30, 2026 from KONFIDENT-KID, its trial in children aged 2 to 11. The April 2026 label still says safety and effectiveness under 12 have not been established.
Do I need blood tests on Ekterly?
The label does not set any required blood tests for Ekterly. Insurers such as Cigna ask for C1 inhibitor and C4 results to confirm the diagnosis before approval.
How many Ekterly tablets come in a carton?
Each carton holds four 300mg tablets in child-resistant blister cards. That is 2 full 600mg doses, which is also the label's 24-hour maximum. As one example, Cigna covers up to 16 tablets per 28 days at retail.
Who helps me get Ekterly?
KalVista Cares assigns a Care Manager who works with the insurance plan and the specialty pharmacy. The team answers at 1-844-432-3322, Monday to Friday, 8:30 am to 8 pm ET.
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Sources
- EKTERLY- sebetralstat tablet: prescribing information, revised 4/2026, and Patient Information, issued 04/2026, KalVista Pharmaceuticals Ltd, via DailyMed, April 1, 2026.
- KalVista Cares™ Patient Support Program | EKTERLY® (sebetralstat), KalVista Pharmaceuticals, Inc., November 11, 2026.
- How to Take EKTERLY® (sebetralstat) for HAE Attacks, KalVista Pharmaceuticals, Inc., November 11, 2026.
- Managing HAE Attacks | EKTERLY® (sebetralstat), KalVista Pharmaceuticals, Inc., November 11, 2026.
- KalVista Cares™ Patient Support | EKTERLY® (sebetralstat), KalVista Pharmaceuticals, Inc., November 11, 2026.
- EKTERLY Patient Start Form, KalVista Cares Patient Support Program (US-SEB-00039v3 07/25), KalVista Pharmaceuticals, Inc., July 1, 2025.
- Drug Coverage Policy IP0756, Hereditary Angioedema, Ekterly, Cigna, August 15, 2026.
- Drug Coverage Policy DQM010, Hereditary Angioedema, Ekterly Drug Quantity Management Policy, Per Days, Cigna, September 15, 2026.
- Hereditary angioedema: MedlinePlus Medical Encyclopedia, U.S. National Library of Medicine, January 20, 2026.
- 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., March 30, 2026.
- NDA 219301 approval letter, Ekterly (sebetralstat) film-coated tablet for acute attacks of hereditary angioedema in adults and pediatric patients 12 and older, FDA, July 3, 2025.
- Drugs@FDA: FDA-Approved Drugs, New Drug Application (NDA) 219301, EKTERLY, FDA, November 11, 2026.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing allergist or immunologist. Found an error? Use the report link in the footer and it will be checked against the source.