Your first 90 days
Your first 90 days on Wainua for hereditary ATTR amyloidosis with polyneuropathy
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.
Wainua is a monthly injection that patients or caregivers can give with an autoinjector, once a healthcare provider has trained them. The label also asks for a daily vitamin A supplement and attention to your eyes. This page lays out the first 90 days from the FDA label, AstraZeneca's own support program and one insurer's written rules.
What has to happen before the first bottle ships
Wainua has no REMS, and the label requires no blood test before a dose. The first dose waits on an enrollment form, an insurance approval, a specialty pharmacy delivery and training on the autoinjector. These are the 12 things in the way, in order.
An enrollment form from your neurologist's office
The Wainua Enrollment Form goes by fax to AstraZeneca Access 360, the drugmaker's access program.
- It starts a benefits check, prior authorization follow-up and the transfer of your prescription to a specialty pharmacy.
- Your signature on its Patient Authorization is needed for the prior authorization follow-up.Enrollment Form
The insurance approval
Cigna's policy, one example, requires prior authorization and approves Wainua for 1 year at a time.
- It asks for a genetic test result and records of nerve symptoms, and its full list is further down this page.Cigna policy
A free limited supply if the approval is slow
The enrollment form has an optional request for a Free Limited Supply.
- AstraZeneca says it is for eligible patients who face a delay in approval by their insurance company.
- The form calls it temporary and does not print how many doses it covers.Enrollment Form
A specialty pharmacy, or a clinic for the syringe
AstraZeneca says the autoinjector is delivered to your home by a specialty pharmacy.
- The prefilled syringe is given at a healthcare provider's office or an injection center instead.How to take Wainua
A Patient Education Manager, if you want one
WAINUA WAY offers a Patient Education Manager as a dedicated point of contact throughout treatment.
- AstraZeneca lists information about Wainua, updates during the insurance approval and resources on how to take it.
- You can reach one by calling 1-844-292-4682 or by returning a signed authorization form.WAINUA WAY
No REMS and no required blood test
Wainua is not on the FDA's list of approved REMS programs, so no safety program enrollment stands before the first dose.
- The label requires no blood test before a dose either.FDA REMS list
Knowing which form you were prescribed
Wainua comes as a single-dose autoinjector and as a single-dose prefilled syringe.
- The autoinjector is meant for you or a caregiver to use.
- The label says only a healthcare provider may inject the prefilled syringe.FDA label
Training on the autoinjector
The Patient Information says your healthcare provider will show you or your caregiver how to inject the first time.
- The label tells prescribers to train patients or caregivers before the autoinjector is started.FDA label
A plan for vitamin A
The label advises a vitamin A supplement at the recommended daily allowance for people taking Wainua.
- It warns against higher doses meant to bring the blood level back to normal.
- Your neurologist names the amount and the start date.FDA label
A full list of what you take
The Patient Information says to tell your healthcare provider about every medicine, vitamin and herbal supplement.
- It singles out vitamin A and beta-carotene supplements.FDA label
Pregnancy and breastfeeding
The Patient Information says to tell your healthcare provider if you are pregnant, plan to become pregnant, are breastfeeding or plan to breastfeed.
- It asks for this before Wainua is started.FDA label
A place in the refrigerator
Wainua is stored in the refrigerator, between 36 and 46 degrees Fahrenheit (2 to 8 Celsius), in its original carton.
- The label says it should never be frozen at any point.FDA label
The days that matter
Counted from the first injection, with the vitamin A supplement, the monthly doses and one carton for each dose. The label sets the monthly rhythm, and your neurologist sets the actual dates. Days before the first dose are estimates, because paperwork and insurance set the pace. 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.Enrollment form faxed
Your neurologist's office completes the Wainua Enrollment Form and faxes it to AstraZeneca Access 360.
- When Orsini Specialty Pharmacy will dispense, the form also carries the prescription.
Benefits check and prior authorization
The enrollment form starts a benefits investigation and prior authorization follow-up by Access 360.
- A Free Limited Supply can be requested on the same form if the insurer's approval is delayed.
The specialty pharmacy calls
The pharmacy calls to schedule your delivery and can set up text alerts.
- AstraZeneca says most people receive Wainua within 2 weeks of their prescription, from Orsini shipment data as of June 2024.
The carton arrives cold
AstraZeneca says the autoinjector arrives in a cooler and should be stored in a refrigerator.
- A sharps container is mailed by the specialty pharmacy as well.
Dose 1, one 45mg injection
One autoinjector or one prefilled syringe holds the full 45mg dose.
- Your healthcare provider shows you or your caregiver how to use the autoinjector the first time.
Daily vitamin A, at the recommended amount
The label advises a supplement at the recommended daily allowance for people taking Wainua.
- It names no start day, so your neurologist says when to begin.
The injection site
In the main trial, 7% of patients had a reaction where the shot went in.
- The label lists redness, pain and itching as the reactions it counted.
Next carton, one dose in each
Each carton holds one single-dose autoinjector or one single-dose prefilled syringe.
- The label does not say how many cartons a pharmacy sends at once.
Dose 2, then once a month
The Patient Information says to inject Wainua once, on the same day of each month.
- On that schedule, doses 3 and 4 fall near days 61 and 91.
Next carton, number 2
Dose 2, number 2
Next carton, number 3
Dose 2, number 3
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Wainua 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 15, 2026, read from the FDA's label database today. FDA label
- April 2026
A single-dose prefilled syringe was added on April 15th, alongside the autoinjector. The label says the syringe must be given by a healthcare provider. The label's list of recent major changes names only its dosage and administration sections.FDA letter
- December 2025
The FDA approved a quick reference guide on the carton and changes to the autoinjector's Instructions for Use booklet on December 17th. The autoinjector instructions in the current label are dated December 2025.FDA letter
- April 2025
The label's description section was updated on April 18th to list the amount of each inactive ingredient. It now says each dose contains less than 5mg of sodium and less than 5mg of phosphorus.FDA letter
- September 2024
Results of a 26-week cancer study in mice were added on September 25th, and the label reports no increase in tumors.FDA letter
- December 2023
First approval, on December 21st, for the polyneuropathy of hereditary ATTR amyloidosis in adults. The FDA addressed its approval letter to Ionis Pharmaceuticals, and its record now lists the application under AstraZeneca.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.
- Who gives the injection, and where
With the autoinjector, you or a caregiver can inject into the belly or the front of the thigh.
- The back of the upper arm is for a caregiver or healthcare provider only.
- The label says only a healthcare provider may inject the prefilled syringe.FDA label
- Choosing the spot
The Instructions for Use say each injection goes at least 1 inch (3cm) from the last one.
- They rule out the 2 inches (5cm) around the belly button and skin that is red, warm, tender, bruised, scaly or hard.
- Scars, damaged, discolored or tattooed skin and injecting through clothing are also ruled out.FDA label
- Before the injection
The autoinjector stays in its carton at room temperature for 30 minutes first.
- The instructions say not to warm it any other way, such as in a microwave or hot water.
- The liquid should be clear and colorless to slightly yellow, and small air bubbles are normal.FDA label
- When not to use an autoinjector
The instructions say not to use one that was frozen, dropped or damaged, or that looks tampered with.
- The same goes for one past its expiration date, or with liquid that is cloudy, discolored or holds large particles.
- The instructions say each autoinjector holds 1 dose, can be used only 1 time and should not be shared.FDA label
- During the injection
The instructions say to press and hold the autoinjector flat against the skin for 10 seconds, until the orange plunger fills the viewing window.
- A click at the start and another at the end are normal.
- The instructions say not to remove the cap until just before the injection and not to put it back on.
- They also say not to move the autoinjector once the injection has started.
- If the orange plunger does not fill the window, the instructions say to contact your healthcare provider.FDA label
- If a dose is missed
The Patient Information says to take the missed dose as soon as possible.
- The next dose then falls 1 month after that injection, which sets the new monthly schedule.FDA label
- Vitamin A every day, at the recommended amount and no more
Wainua lowers the amount of vitamin A in the blood.
- In the main trial, every patient began with a normal level and 95% developed a low level.
- The label says to supplement at the recommended daily allowance and not to take more to reach a normal blood level.
- The blood level does not reflect the body's total vitamin A.FDA label
- Your eyes
The Patient Information says to call your healthcare provider if you develop eye problems.
- Its examples are difficulty seeing at night or in low light, and dry eyes.
- It says your healthcare provider should then send you to an eye doctor, called an ophthalmologist.FDA label
- Other medicines
The label lists no contraindications and has no drug interactions section.
- It says no clinical drug interaction studies were done, and lab studies suggest eplontersen is unlikely to interact through liver enzymes or drug transporters.
- The Patient Information still asks you to report vitamin A and beta-carotene supplements.FDA label
- Pregnancy and breastfeeding
The Patient Information says it is not known if Wainua can harm an unborn baby.
- It adds that changes in vitamin A levels and vitamin A supplements related to Wainua may harm an unborn baby.
- Whether Wainua passes into breast milk is also unknown, so it says to tell your healthcare provider.
- It also says to tell your healthcare provider if you become pregnant, or think you may be, while taking Wainua.FDA label
- Storage
In the refrigerator, between 36 and 46 degrees Fahrenheit (2 to 8 Celsius), in the original carton and protected from light.
- If needed, a carton can stay at room temperature, no higher than 86 degrees Fahrenheit (30 Celsius), for up to 6 weeks.
- The label says to throw it away if it is not used within those 6 weeks.
- It also says never to freeze Wainua or expose it to heat.
- The instructions say to keep the autoinjector and all medicines out of the sight and reach of children.
- An autoinjector kept at room temperature past 6 weeks goes into an FDA-cleared sharps disposal container.FDA label
- After the injection
The used autoinjector goes straight into an FDA-cleared sharps disposal container, not the household trash.
- The instructions say a small amount of blood or liquid at the site is normal.FDA label
- Driving and machinery
The label carries no caution about driving or using machines.
- It does list blurred vision as a side effect, seen in 6% of patients in the main trial.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.
Night blindness or dry eyes
The Patient Information calls low vitamin A a serious but common side effect of Wainua.
- It says to call your healthcare provider about difficulty seeing at night or in low light, or dry eyes.
- Your healthcare provider should then send you to an eye doctor.FDA label
The most common side effects
The Patient Information names decreased vitamin A and vomiting.
- In the main trial of 144 patients, 15% had decreased vitamin A reported as a side effect and 9% had vomiting.
- Protein in the urine occurred in 8%, blurred vision in 6% and cataract in 6%.FDA label
A reaction where the shot went in
Redness, pain or itching at the injection site occurred in 7% of patients in the main trial.
- The Patient Information says to call your doctor for medical advice about side effects.FDA label
Heart block in the trial
The label reports 3 serious cases of atrioventricular heart block among the 144 patients, which is 2%.
- One of the 3 was complete heart block.
- The label gives no monitoring instruction for it and lists no symptoms to watch for.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 delayedThe enrollment form lets the prescriber request a Free Limited Supply for eligible patients facing an insurance approval delay. The form says the patient must have an FDA-approved diagnosis, and it calls the program temporary.Enrollment Form
- The plan wants more recordsCigna asks for documentation of a disease-causing TTR variant found by genetic testing and of symptomatic polyneuropathy. Chart notes, test results and genetic test results are the kinds of records it names.Cigna policy
- The plan wants Amvuttra tried firstCigna's policy asks that Amvuttra was tried and, according to the prescriber, worked inadequately or was not tolerated. The other way to meet that rule is to have already started Wainua.Cigna policy
- The plan will not pay alongside another TTR medicineCigna treats Wainua given with Amvuttra, Attruby, Onpattro, Tegsedi or a tafamidis product as not medically necessary. That is the plan's rule, and the neurologist decides what you take.Cigna policy
- The denial needs an appealAccess 360 offers prior authorization support and support with the claims and appeal process. AstraZeneca notes that Access 360 does not file claims or appeals for patients or offices.Wainua HCP access
- A cost you cannot payCommercial insurance: the WAINUA Savings Program, with which eligible patients may pay as little as $0. People on Medicare, Medicaid, Medigap, VA, Department of Defense or TRICARE coverage cannot use it. Access 360 can explain other financial assistance programs, including for people without coverage.Wainua savings
- No insurance, or Medicare and the cost is out of reachThe enrollment form says AZ&Me may be able to help patients without coverage, or on Medicare, who cannot afford their medicine. The form lists www.azandmeapp.com and 1-800-292-6363 as the ways to reach that program.Enrollment Form
- A damaged autoinjectorAstraZeneca's patient site says not to use a damaged autoinjector and to call 1-844-292-4682 for a replacement.Wainua patient FAQ
Cigna prior authorization policy, October 1, 2026
- Age 18 or older, with the polyneuropathy of hereditary ATTR amyloidosis
- A disease-causing TTR variant confirmed by genetic testing, with documentation
- Symptomatic polyneuropathy, with documentation, such as reduced strength or coordination or impaired sensation
- No history of liver transplantation
- Prescribed by or with a neurologist, a geneticist or a physician who specializes in amyloidosis
- Amvuttra tried first with inadequate effect or significant intolerance, unless Wainua was already started
- A dose of 45mg under the skin once monthly
- Not combined with Amvuttra, Attruby, Onpattro, Tegsedi or a tafamidis product
Approval length. A year at a time. The policy lists no separate renewal criteria.
This is Cigna's Drug Coverage Policy IP0628, which took effect on October 1st. Its reference list cites the April 2025 prescribing information, not the April 2026 label, though it already covers the prefilled syringe. Trying Amvuttra first and the ban on combining TTR medicines are the plan's rules, not the label's. For the autoinjector on employer plans, the policy ties the Amvuttra rule to the Value, Advantage and Total Savings drug lists. The policy says a member's own plan document always overrides it. 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.
- AstraZeneca Access 360, which can check your insurance coverage, explain what your plan provides and tell you which financial assistance programs you may be eligible for
- The WAINUA Savings Program, with which eligible people with commercial insurance may pay as little as $0, once the plan has approved Wainua and they have enrolled
- No savings program for Medicare Part D, Medicaid, Medigap, VA, Department of Defense or TRICARE coverage, and a yearly maximum savings limit whose amount the page does not print
- For Medicare Part D, a note that out-of-pocket costs may be paid monthly or in full upfront
- A Patient Education Manager as a dedicated contact, who can meet at home or virtually to share resources on how to take Wainua How to take Wainua
- Patient Education Managers who can assist with injection training for patients and caregivers, live or virtually Wainua HCP FAQ
- A welcome kit after enrolling in WAINUA WAY, with answers to common questions and tools to get started WAINUA WAY
- A demonstration autoinjector with no needle or medicine for practice, for people prescribed Wainua and enrolled in WAINUA WAY How to take Wainua
- A Free Limited Supply, requested by the prescriber, for eligible patients facing a delay in insurance approval Enrollment Form
- AZ&Me, AstraZeneca's patient assistance program, for people without coverage or on Medicare who cannot afford the medicine (1-800-292-6363) Enrollment Form
Details as the drugmaker publishes them. Wainua savings
Five questions for the pharmacist or the support line
- Am I getting the autoinjector or the prefilled syringe, and who will give each dose?
- Who will train me or my caregiver on the autoinjector before the first dose at home?
- Which vitamin A supplement and amount should I take, and does my multivitamin already count toward it?
- How will each carton arrive, and how long was it out of the refrigerator on the way?
- Which day of the month is my dose, and what happens to the schedule if one is late?
Questions people ask in the first weeks
How is Wainua given?
As one 45mg injection under the skin once a month. The autoinjector is meant for patients or caregivers to use after training from a healthcare provider. A prefilled syringe is also available, and the label says only a healthcare provider may inject it.
Can I inject Wainua myself?
Yes, with the autoinjector, after your healthcare provider shows you how the first time. The Patient Information says you can inject into the belly or the front of the thigh. The upper arm is only for an injection given by a caregiver or healthcare provider.
Do I need a vitamin A supplement on Wainua?
The label advises a supplement at the recommended daily allowance for people taking Wainua. It also says higher doses should not be used to reach a normal blood level. The blood level does not reflect the body's total vitamin A. Your neurologist names the product and the amount.
What eye symptoms should I report on Wainua?
Difficulty seeing at night or in low light, which is called night blindness, and dry eyes. The Patient Information says to call your healthcare provider about these eye problems. It says your healthcare provider should then send you to an eye doctor.
What if I miss a dose of Wainua?
The Patient Information says to take the missed dose as soon as possible. The following dose is then due 1 month after that injection. It says to ask your healthcare provider about any question on your schedule.
How long can Wainua stay out of the refrigerator?
Up to 6 weeks in its original carton, at room temperature no higher than 86 degrees Fahrenheit (30 Celsius). The label says a carton not used within those 6 weeks should be thrown away. It also says not to freeze Wainua or expose it to heat.
Does Wainua need blood tests or a REMS?
No REMS, and the label requires no blood test before a dose. Wainua does not appear on the FDA's list of approved REMS programs, which this page checked in November 2026. AstraZeneca's site for prescribers says there are no laboratory monitoring requirements for Wainua.
How does Wainua get to me?
AstraZeneca says a specialty pharmacy mails the autoinjector and a sharps container to your home. The pharmacy may call or text to schedule the delivery, and the carton arrives in a cooler. The prefilled syringe is given at a healthcare provider's office or an injection center.
Is there help paying for Wainua?
With commercial insurance, the WAINUA Savings Program may bring the cost to as little as $0. It excludes Medicare, Medicaid, Medigap, VA, Department of Defense and TRICARE coverage. AstraZeneca Access 360, at 1-844-292-4682, explains other programs, including AZ&Me for people without coverage or on Medicare.
Why was Wainua denied by my insurance?
Plans such as Cigna ask for a genetic test result, records of nerve symptoms and a specialist prescriber. Cigna also asks that Amvuttra was tried first on the plans it lists, unless Wainua was already started. Access 360 offers appeal support, and a Free Limited Supply exists for eligible patients during a delay.
Can I take Wainua with tafamidis, Attruby or Amvuttra?
The label lists no contraindications and has no drug interactions section. Cigna's policy, one example, will not pay for Wainua alongside those medicines, Onpattro or Tegsedi. The neurologist decides what you take, and the office can appeal a denial.
Is Wainua approved for the heart form of ATTR amyloidosis?
The April 2026 label lists one use, the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Polyneuropathy is the nerve damage this disease causes in the body. The label does not list ATTR cardiomyopathy, the heart form, as an approved use. The Patient Information says it is not known if Wainua is safe and effective in children.
Free email alert
Hear when the Wainua label changes
One email the day the FDA revises the Wainua label, with what changed in plain words. No trial alerts, no newsletter.
Label changes for Wainua only, usually a few a year and some years none. Stop anytime. We never share your email. Privacy policy
Want the whole condition instead? Follow Hereditary ATTR amyloidosis with polyneuropathy for new trials, FDA decisions and label changes for every treatment.
Sources
- WAINUA (eplontersen) injection, for subcutaneous use, with Patient Information (Approved: 04/2026) and Instructions for Use, AstraZeneca Pharmaceuticals LP, via DailyMed, April 15, 2026.
- NDA 217388, WAINUA (eplontersen sodium), submissions and approval dates, FDA, via openFDA, November 12, 2026.
- Savings and Affordability | WAINUA® (eplontersen), AstraZeneca, November 12, 2026.
- WAINUA WAY Support Program for Patients | WAINUA® (eplontersen), AstraZeneca, November 12, 2026.
- How to Take 45 mg Injection for Subcutaneous Use | WAINUA® (eplontersen), AstraZeneca, November 12, 2026.
- Frequently Asked Questions | WAINUA® (eplontersen), AstraZeneca, November 12, 2026.
- WAINUA® (eplontersen) Enrollment Form, AstraZeneca Access 360 (US-104756, Last Updated 3/26), AstraZeneca, November 12, 2026.
- Access & Support | WAINUA® (eplontersen) | For HCPs, AstraZeneca, November 12, 2026.
- Frequently Asked Questions | WAINUA® (eplontersen) | For HCPs, AstraZeneca, November 12, 2026.
- Drug Coverage Policy IP0628, Wainua, Cigna, October 1, 2026.
- Approved Risk Evaluation and Mitigation Strategies (REMS), FDA, November 12, 2026.
- NDA 217388/S-005 supplement approval letter, single-dose prefilled syringe, FDA, April 15, 2026.
- NDA 217388/S-006 supplement approval letter, carton quick reference guide and autoinjector Instructions for Use, FDA, December 17, 2025.
- NDA 217388/S-004 supplement approval letter, section 11 description, FDA, April 18, 2025.
- NDA 217388/S-002 supplement approval letter, section 13.1 mouse carcinogenicity, FDA, September 25, 2024.
- NDA 217388 approval letter, FDA, December 21, 2023.
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 neurologist. Found an error? Use the report link in the footer and it will be checked against the source.