Your first 90 days
Your first 90 days on Orladeyo 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.
Orladeyo has no safety program forms, no shots and no lab tests standing between the prescription and the first box. The first fill waits on 3 things instead. A Start Form goes to Empower Patient Services, the plan approves it, and a pharmacist holds a counseling call. After that, the days are about one dose with a meal, keeping a rescue medicine close and watching the stomach in the early weeks. This page lays out those weeks from the FDA label, BioCryst's own Orladeyo pages and one insurer's written rules.
What has to happen before the first bottle ships
Orladeyo has no REMS, so the first fill waits on a Start Form, an insurance approval and a pharmacist's counseling call. These are the 6 things in the way, in order.
A Start Form to Empower Patient Services
The allergist's office sends a Start Form and supporting records to Empower Patient Services by fax, email or a digital form.
- Orladeyo is dispensed only through CareMed Specialty Pharmacy as part of Empower Patient Services.Orladeyo Start Form
A counseling call before the first box ships
BioCryst's Start Form says the patient must finish a counseling conversation with an Empower pharmacist before Orladeyo can be shipped.
- Saving the Empower number, 1-866-536-7693, helps that call get answered the first time.Orladeyo Start Form
The insurance approval
Plans such as Cigna require prior authorization for Orladeyo.
- Cigna asks for blood tests showing HAE type I or type II and a specialist in HAE.
- The C1 inhibitor and C4 results are documents the policy requires.Cigna policy
A plan for any current prevention medicine
The Start Form asks for the prescriber's directions for moving off any prior HAE therapy.
- Its checklist also asks for current and past HAE medicines, with start and stop dates and the response.Orladeyo Start Form
A full medicine list
The Patient Information asks people to share every medicine, vitamin and herbal supplement, including other HAE medicines.
- Orladeyo can raise the levels of some medicines, and some medicines can lower Orladeyo's levels.FDA label
A current weight, for children
Children 2 to under 12 take pellets dosed by weight.
- BioCryst's Start Form asks for a weight recorded within 3 to 6 weeks of the prescription.Orladeyo Start Form
The days that matter
Counted from the first dose, with the 28-day cartons, early stomach effects and the check-in BioCryst suggests at 1 to 2 months. 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 Empower
The office faxes, emails or digitally submits the Start Form, with both sides of the insurance cards and supporting records.
- The patient can sign a separate consent form for extra Empower support.
Insurance approval, or Quick Start
Empower works with the office on the prior authorization.
- BioCryst's Quick Start program may send Orladeyo to eligible insured patients while the approval is pending.
Counseling call, then shipment
An Empower pharmacist holds a counseling conversation with the patient before the first shipment.
- BioCryst's Start Form says Orladeyo cannot ship until that call happens.
First dose, once a day with food
One capsule or one packet of pellets, with a meal, at about the same time each day.
- Pellets are taken with a meal just before or just after the dose.
Levels settle
The label says berotralstat builds up to a steady level in the blood in about 6 to 12 days.
- In the main trial, attacks were fewer from the first month.
First refill, then every 28 days
Each carton holds a 28-day supply in 4 weekly cards or wallets, so the first carton runs out after day 28.
- Each refill after that covers another 28 days.
Check-in with the prescriber
BioCryst suggests a follow-up visit about 1 to 2 months after starting, to talk about attacks and side effects.
- The prescriber decides what changes, if any, make sense.
First refill, number 2
First refill, number 3
Three months in
Stomach side effects in the trial usually came early, became less frequent with time and often went away on their own.
- In the 24-week trial, attacks stayed lower than on placebo throughout.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Orladeyo 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 October 23, 2026, read from the FDA's label database today. FDA label
- October 2026
On October 16, 2026, the FDA aligned the capsule label with newly approved pellet labeling. BioCryst announced on October 21, 2026 that this adds a 150mg pellet packet for people 12 and older.FDA letter
- December 2025
Orladeyo pellets were approved for children 2 to under 12, dosed by weight, under a separate application. Later that month the capsule label was aligned with the new pellet label.FDA letter
- October 2024
Nausea was added to the side effects as a reaction reported after approval.FDA letter
- November 2023
The advice to lower the dose to 110mg with P-gp or BCRP blocking medicines was removed. Information on higher desogestrel levels with Orladeyo was added.FDA letter
- December 2020
Orladeyo capsules were first approved on December 3, 2020, for preventing HAE attacks in people 12 and older.Drugs@FDA record
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.
- Once a day, with food
The label dose is one capsule or one packet a day, taken with food.
- In a label study, food delayed the peak level by about 3 hours without changing the total amount absorbed.FDA label
- Never an extra dose for an attack
The label says Orladeyo should not be used to treat an attack, and extra or higher doses are not recommended.
- Doses above 150mg a day raised the QTc interval in adults, a heart rhythm measure.FDA label
- A rescue medicine stays in the plan
The label tells prescribers to advise patients to keep using their usual rescue medicine for an acute attack.
- Orladeyo is for preventing attacks only, not for stopping one.FDA label
- If you miss a dose
BioCryst's patient site says to take a missed dose as soon as you remember.
- If the next dose is close, do not double up, and never take more than 1 dose a day.Orladeyo patient FAQs
- Capsules, from age 12
The capsule comes in 150mg and 110mg strengths.
- The label sets 150mg once a day, and 110mg for moderate or severe liver impairment.
- The prescriber may also consider 110mg if stomach side effects persist.FDA label
- Pellets, by weight for children
Children 2 to under 12 take one packet a day by weight.
- The dose is 72mg from 12kg (about 26 pounds) and 96mg from 24kg (about 53 pounds).
- It is 108mg from 32kg (about 71 pounds) and 132mg from 40kg (about 88 pounds).FDA label
- Pellets, from age 12 too
Since October 2026, a 150mg packet of pellets is approved for people 12 and older.
- BioCryst says it suits people who have trouble swallowing or prefer not to take capsules.
- It also suits children who want to stay on pellets after turning 12.BioCryst press release
- How to take the pellets
Pour the whole packet into the mouth and swallow right away with water or milk.
- Another option is sprinkling it over 1 tablespoon of soft food such as pudding or mashed potatoes.
- Chewing or crushing the pellets breaks the coating that hides a bitter taste.FDA label
- Foods to avoid with the pellets
Acidic foods such as yogurt and applesauce can dissolve the coating.
- Food should be at or below room temperature.
- Pellets left on food more than 10 minutes are thrown away.FDA label
- Medicines that interact
The label says to avoid medicines that speed up the P-gp pump, because they can lower Orladeyo's levels.
- Orladeyo can raise levels of some medicines broken down by CYP2D6 or CYP3A4.
- The pharmacist needs to hear about every new medicine.FDA label
- Birth control with desogestrel
In a label study, Orladeyo raised the level of desogestrel's active form 2.6 times.
- The label asks prescribers to weigh benefits and risks when the two are used together.FDA label
- Liver and kidney conditions
The label lowers the capsule dose to 110mg for moderate or severe liver impairment from age 12.
- It says to avoid Orladeyo in children under 12 with that liver impairment or severe kidney impairment.
- It is not recommended with end-stage kidney disease or dialysis.FDA label
- Pregnancy and breastfeeding
The label says there are not enough data in pregnancy to know the drug's risks.
- It is not known whether berotralstat passes into breast milk, and the Patient Information asks people to talk with the prescriber about feeding.FDA label
- Storage
Room temperature, 68 to 77 degrees Fahrenheit, with short swings between 59 and 86 degrees allowed.
- Do not use a carton whose tamper-evident seal is broken or missing.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.
More than 1 dose in a day
The Patient Information says taking more than 1 dose a day may cause a heart rhythm problem called QTc interval prolongation.
- That condition can cause an abnormal heartbeat, the Patient Information says.
- The label gives no steps for an extra dose taken by mistake.FDA label
Swelling of the throat or tongue
MedlinePlus says swelling in the airway can restrict breathing and become a life-threatening blockage.
- Orladeyo does not treat an attack, so the usual rescue plan and emergency care apply.MedlinePlus Genetics
Stomach pain, vomiting or diarrhea
At 150mg, abdominal pain affected 23% against 10% on placebo, and vomiting 15% against 3%.
- Diarrhea affected 15% on 150mg against none of the people on placebo.
- These usually came early and eased over time, and persistent effects are worth raising with the prescriber.FDA label
Back pain and heartburn
Back pain affected 10% on 150mg against 3% on placebo.
- Heartburn, or reflux, was also among the most common side effects in the label.FDA label
Liver test changes
The Patient Information lists increases in liver function tests as a less common side effect.
- In the trial, one person on 150mg stopped for a large rise in liver enzymes without symptoms.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, so the office sends the reports.Cigna policy
- HAE with normal C1 inhibitorCigna's policy says HAE with normal C1 inhibitor, sometimes called type III, does not meet its criteria. BioCryst's Start Form notes most insurers want extra records for this diagnosis, such as how other causes were ruled out. The allergist's office decides what records to send with the request.Cigna policy
- Orladeyo with another prevention medicineCigna lists Orladeyo taken alongside another HAE prevention therapy, such as Takhzyro, Haegarda or Cinryze, as not medically necessary. The same policy allows other medicines for on-demand treatment and short-term procedure prophylaxis.Cigna policy
- The first box has not shippedBioCryst's Start Form says Orladeyo cannot ship until the patient finishes a counseling call with an Empower pharmacist. Calling Empower back at 1-866-536-7693 is usually the fix.Orladeyo Start Form
- A copay you cannot payWith commercial insurance, BioCryst's copay program can bring the cost to as little as $0. It is not valid for prescriptions paid in whole or in part by federal or state programs, such as Medicare or Medicaid. Our help paying page lists charity funds that may cover costs.Empower Patient Services
Cigna prior authorization policy, March 1, 2026
- Age 2 or older, with hereditary angioedema due to C1 inhibitor deficiency
- HAE type I or type II, shown by functional C1 inhibitor below 50% of normal at baseline, with documentation
- A lower than normal 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
- Not used together with another HAE prevention therapy, such as Takhzyro, Haegarda or Cinryze
Approval length. Approved a year at a time. Renewal needs a documented HAE type I or II diagnosis, a specialist and a favorable response the prescriber reports, such as fewer, milder or shorter attacks.
This version took effect March 1, 2026, when Cigna added the pellets and lowered the age to 2. It cites the December 2025 label, before the October 2026 label added 150mg pellets from age 12. 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 specialty pharmacy and support team in one, with a dedicated patient support manager reachable by phone, text or email
- Copay Assistance Program, as little as $0 for treatment, not valid for prescriptions paid in whole or in part by federal or state programs
- Help with the insurance process, plus refill reminders and shipments coordinated by time and place
- On average, a first shipment in less than a week after Empower Patient Services receives the prescription
- An online portal for monthly refills, medication reminders and progress tracking
- Quick Start program, for insured US patients 2 or older with a confirmed HAE diagnosis, subject to its terms, while the approval is pending Orladeyo Start Form
- Appeal specialists for insurance appeals, and pharmacists available 24/7 for clinical questions Empower, prescriber site
Details as the drugmaker publishes them. Empower Patient Services
Five questions for the pharmacist or the support line
- Is this prescription for capsules or pellets, and is the strength right for my age, weight and liver health?
- I take these medicines. Do any of them lower Orladeyo's levels or get raised by it?
- Does my birth control contain desogestrel?
- Which rescue medicine should I keep with me, since Orladeyo does not treat an attack?
- When will my next carton ship, and will you call me before each refill?
Questions people ask in the first weeks
How do I take Orladeyo?
Once a day with food, as one capsule or one packet of pellets. From age 12 the label dose is 150mg. Children 2 to under 12 take pellets by weight, from 72mg to 132mg.
Can I take an extra Orladeyo during an attack?
No, the label says Orladeyo should not be used to treat an attack, and extra doses are not recommended. Doses above 150mg a day lengthened the QTc interval in adults. The label points people to their usual rescue medicine for attacks.
Can adults take the Orladeyo pellets?
Yes, since October 2026 a 150mg packet of pellets is approved for people 12 and older. BioCryst says the FDA based this on manufacturing data and safety and tolerability data compared with the capsules.
What if I miss a dose of Orladeyo?
BioCryst's patient site says to take it as soon as you remember. If the next dose is close, do not double up, and never take more than 1 dose in a day.
Do I need blood tests on Orladeyo?
The label does not set any required blood tests for Orladeyo. It does list rises in liver tests as a less common side effect. Insurers ask for C1 inhibitor and C4 results to confirm the diagnosis before approval.
How well does Orladeyo prevent attacks?
In the 24-week trial in people 12 and older, attacks averaged 1.31 every 28 days on 150mg against 2.35 on placebo. That is a 44.2% reduction, and the drop began in the first month.
Who fills Orladeyo?
Orladeyo is dispensed only through CareMed Specialty Pharmacy as part of Empower Patient Services. Empower answers at 1-866-536-7693 and must reach the patient for a counseling call before the first shipment.
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Sources
- ORLADEYO- berotralstat hydrochloride capsule; ORLADEYO- berotralstat hydrochloride pellet: prescribing information, revised 10/2026, and Patient Information, issued 10/2026, BioCryst Pharmaceuticals Inc., via DailyMed, October 23, 2026.
- Empower Patient Services | ORLADEYO (berotralstat) Patient Support, BioCryst Pharmaceuticals, Inc., November 10, 2026.
- Hereditary Angioedema (HAE) FAQs | ORLADEYO (berotralstat), BioCryst Pharmaceuticals, Inc., November 10, 2026.
- Empower Patient Services | ORLADEYO (berotralstat), BioCryst Pharmaceuticals, Inc., November 10, 2026.
- Prescribing ORLADEYO (berotralstat) | HAE Prophylactic Therapy, BioCryst Pharmaceuticals, Inc., November 10, 2026.
- Getting started with ORLADEYO, Start Form and Documentation Checklist (US.ORL.03422 07/26), BioCryst Pharmaceuticals, Inc., July 1, 2026.
- ORLADEYO (berotralstat) FAQs | HAE Oral Treatment, BioCryst Pharmaceuticals, Inc., November 10, 2026.
- BioCryst Announces U.S. FDA Approval of ORLADEYO 150 mg Oral Pellets for Adults and Adolescents with HAE, BioCryst Pharmaceuticals, Inc., via GlobeNewswire, October 21, 2026.
- Drug Coverage Policy IP0096, Hereditary Angioedema, Orladeyo, Cigna, March 1, 2026.
- Hereditary angioedema: MedlinePlus Genetics, U.S. National Library of Medicine, March 11, 2024.
- NDA 214094/S-006 supplement approval letter, alignment with the oral pellet labeling approved under NDA 219776/S-003, FDA, October 16, 2026.
- NDA 219776 approval letter, Orladeyo (berotralstat) oral pellets for pediatric patients 2 to less than 12 years, FDA, December 11, 2025.
- NDA 214094/S-005 supplement approval letter, alignment with the NDA 219776 oral pellet labeling, FDA, December 23, 2025.
- NDA 214094/S-003 supplement approval letter, nausea added as a postmarketing adverse reaction, FDA, October 21, 2024.
- NDA 214094/S-002 supplement approval letter, P-gp and BCRP inhibitor dose advice removed and desogestrel interaction added, FDA, November 21, 2023.
- Drugs@FDA records for NDA 214094 (Orladeyo capsules) and NDA 219776 (Orladeyo oral pellets), via openFDA, FDA, November 10, 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.