Your first 90 days
Your first 90 days on Onpattro 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.
Onpattro is not a pill and not a pharmacy pickup. It is an infusion into a vein that a nurse or doctor gives every 3 weeks. Each visit starts with premedicines, followed by a drip that runs for about 80 minutes. This page lays out the first 90 days from the FDA label, Alnylam's own support program and one insurer's written rules.
What has to happen before the first bottle ships
Onpattro has no boxed warning and no REMS, but it is a specialty drug given by infusion. The first dose waits on a Start Form, an insurance approval and a place to give it. These are the 5 things in the way, in order.
A Start Form signed by you and your neurologist
The Alnylam Assist Start Form enrolls you in Alnylam's support program and carries the dosing details.
- Those include your weight in kg, the dose in mg and the number of vials.
- Both signatures are required, and the office faxes it or submits it online.Start Form
Contact from an Alnylam Case Manager
Within 2 business days of the Start Form, a Case Manager sends you and your doctor a summary of your insurance benefits.
- The same person keeps you updated on the prior authorization and any appeal.Alnylam Assist
The insurance approval
Cigna's policy, the example further down this page, requires prior authorization for Onpattro.
- Its criteria include a genetic test and documented nerve symptoms.
- Approval under that policy lasts 1 year at a time.Cigna policy
Choosing where the infusion is given
Infusions are given at a treatment site or, for some patients, at home.
- Alnylam's guide for clinicians says the home decision follows the treating doctor's evaluation and recommendation.
- It adds that not every insurance plan covers home infusion.Dosing and Preparation Guide
A plan for vitamin A
The label advises a vitamin A supplement at the recommended daily allowance for everyone on Onpattro.
- It warns against taking more to push the blood level back to normal.
- Ask your neurologist which product to use and when to begin.FDA label
The days that matter
Counted from the first infusion, with the premedicines, the vitamin A start and an infusion every 3 weeks after that. 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.Start Form signed and sent
You and your neurologist sign the Start Form, which carries your weight and the dose.
- The office faxes it to Alnylam Assist or submits it online.
A Case Manager makes contact
An Alnylam Case Manager contacts you and your doctor with a summary of your benefits.
- The program says this contact is where its support begins.
Prior authorization
The office sends the insurer the records it asks for, such as the genetic test and notes on your nerve symptoms.
- The Case Manager keeps you updated on the approval status.
Where the infusion is given
After the Start Form, Alnylam Assist provides a list of treatment sites based on your coverage and preferences.
- Its website also links to a treatment site locator.
Premedicines, at least 60 minutes before
The label lists 4 premedicines on infusion day: a corticosteroid, acetaminophen, an H1 blocker and an H2 blocker.
- They are given at least 60 minutes before the infusion starts, to lower the risk of a reaction.
Infusion 1, about 80 minutes
A healthcare professional gives the dose into a vein by pump.
- The label sets a slow rate for the first 15 minutes and a faster rate after that.
- It also tells staff to observe you during the whole infusion.
Daily vitamin A, at the recommended amount
The label advises a daily supplement at the recommended daily allowance for everyone taking Onpattro.
- It names no start day, so your neurologist says when to begin.
Infusion 2
The label's schedule is one infusion every 3 weeks, with the same premedicines each time.
- Of the patients who had an infusion reaction, 79% had the first one within the first 2 infusions.
Infusion 3
The label says infusion reactions became less frequent over time.
- Alnylam Case Managers schedule check-ins before and after each treatment, and they support patients through insurance coverage changes.
Infusion 4
The dose is based on your actual body weight.
- Each vial holds 10mg, and Alnylam's guide shows a dose using 1 to 4 vials depending on weight.
Infusion 5, then every 3 weeks
The fifth infusion falls inside the first 90 days.
- The label's schedule continues every 3 weeks after that, and a missed dose is given as soon as possible.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Onpattro 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 September 8, 2025, read from the FDA's label database today. FDA label
- September 2025
DailyMed carries the current version of the label, dated September 8th and marked Revised 9/2025. It lists no recent major changes, and no FDA approval letter for this revision was found. Compared with the January 2023 label, the example H2 blocker premedicine is now famotidine 20mg instead of ranitidine 50mg. The indication, dose and warnings on this page come from this version.FDA label
- January 2023
On January 13th, the FDA approved added data from a study in patients with a prior liver transplant. The change was to the label's sections on how the drug acts in the body, and the dose stayed the same.FDA letter
- October 2022
On October 3rd, the FDA approved an addition to the side effects section about lower vitamin A levels after Onpattro.FDA letter
- August 2018
First approval, on August 10th, for the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. The FDA also required a pregnancy surveillance program.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.
- Given by a healthcare professional, into a vein
Onpattro is given by intravenous infusion, which means a drip into a vein.
- Alnylam's guide for clinicians says a healthcare professional should perform the infusion in every setting, including the home.
- Some doctors choose the clinic for the first few infusions, the guide adds.Dosing and Preparation Guide
- The dose follows your weight
The label bases the dose on actual body weight.
- People under 100kg (about 220 pounds) get 0.3mg per kg every 3 weeks.
- People weighing 100kg or more get 30mg every 3 weeks.FDA label
- Four premedicines before every infusion
The label lists an intravenous corticosteroid such as dexamethasone 10mg, acetaminophen 500mg by mouth, and 2 intravenous antihistamines.
- Those are an H1 blocker such as diphenhydramine 50mg and an H2 blocker such as famotidine 20mg.
- All are given at least 60 minutes before the infusion starts.
- Equivalents by mouth are allowed when the intravenous form is unavailable or not tolerated.FDA label
- How the infusion runs
The infusion takes about 80 minutes through a pump and a filtered line.
- The rate is about 1mL a minute for the first 15 minutes, then about 3mL a minute.
- The label says the infusion may be slowed, paused or lengthened if a reaction occurs.FDA label
- If a dose is missed
The label says to give the missed dose as soon as possible.
- If that happens within 3 days, the original schedule continues.
- If it is more than 3 days late, dosing continues every 3 weeks from the late dose.FDA label
- Vitamin A every day, at the recommended amount and no more
Onpattro lowers the level of vitamin A in the blood.
- In the main trial, 99% of patients with a normal level at the start developed a low level.
- The label says to supplement at the recommended daily allowance and not to take more to chase a normal blood level.
- The blood level does not reflect the body's total vitamin A.FDA label
- Your eyes
The label says to contact your healthcare provider about eye symptoms that suggest vitamin A deficiency, such as night blindness.
- It says patients with these symptoms should be referred to an ophthalmologist, a medical eye doctor.FDA label
- Other medicines and who should not take it
The contraindications section of the label, which names who must not take a drug, says none.
- It says no formal drug interaction studies were done and that Onpattro is not expected to cause drug interactions.
- Tell the neurologist about every multivitamin, because it may already contain vitamin A.FDA label
- Pregnancy and breastfeeding
The label says to tell your healthcare provider if you are pregnant or plan to be.
- Vitamin A matters for a baby's development, but too much can harm it, and the effects of Onpattro on a pregnancy are unknown.
- In animal studies, doses that were toxic to pregnant rabbits also caused fetal deaths and lower fetal weight.
- The label tells doctors to advise women who could become pregnant about the potential risk to the fetus.
- The label lists a pregnancy registry that patients can call at 1-877-256-9526.
- Whether Onpattro passes into human breast milk is also unknown.FDA label
- Storage is handled by the clinic or pharmacy
Vials are kept in a refrigerator at 36 to 46 degrees Fahrenheit (2 to 8 Celsius) and never frozen.
- The label allows room temperature up to 77 degrees Fahrenheit (25 Celsius) for up to 14 days when no refrigerator is available.
- A healthcare professional filters and dilutes the medicine before each infusion.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.
Signs of an infusion reaction
The label names flushing, shortness of breath, chest pain, fainting, a rash, a faster heartbeat and swelling of the face.
- It says to contact your healthcare provider immediately if you have these signs.
- The label also tells staff to monitor for these signs during every infusion.FDA label
What else a reaction can feel like
Across the trials, the most common reaction symptoms were flushing, back pain, nausea, belly pain, shortness of breath and headache.
- Severe low blood pressure, fainting and itching have also been reported.FDA label
What the staff do about a reaction
The label tells staff to consider slowing or pausing the infusion and treating the symptoms.
- A paused infusion may resume at a slower rate once symptoms have resolved.
- After a serious or life-threatening reaction, the infusion is stopped and not resumed.FDA label
Night blindness or other vision changes
The label ties trouble seeing in dim light to low vitamin A and says to contact your healthcare provider.
- In the main trial, dry eye, blurred vision and floaters were each reported in 5% of patients or fewer.FDA label
Pain, swelling or redness where the IV goes in
Medicine leaked outside the vein in fewer than 0.5% of infusions in the trials.
- Signs included swelling, redness, a burning feeling or pain at the site, and some cases were serious.
- The label tells staff to watch the infusion site during the infusion.FDA label
The most common side effects
In the main trial, 29% of patients on Onpattro had upper respiratory tract infections, compared with 21% on placebo.
- Infusion reactions occurred in 19%, compared with 9% on placebo.
- Indigestion, shortness of breath and muscle spasms each occurred in 8%.
- The label also reports 4 serious cases of atrioventricular heart block, a heart rhythm problem, in that trial.
- Those cases were 2.7% of patients on Onpattro, and 3 of them were complete heart block.
- No serious cases were reported on placebo, and the label gives no monitoring instruction for it.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 deniedThe Case Manager keeps you updated on prior authorizations and appeals and tells you about any step you need to take. Your doctor's office and treatment site can contact Alnylam Assist for support.Alnylam Assist
- The plan wants more recordsPlans such as Cigna ask for the genetic test result and documentation of symptomatic polyneuropathy. Cigna's policy gives a clinical exam, electromyography and nerve conduction testing as examples. The neurologist's office sends these records to the plan.Cigna policy
- The plan will not pay alongside another TTR medicineCigna's policy does not cover Onpattro used with Amvuttra, Attruby, Tegsedi, Wainua or a tafamidis product. The neurologist's office decides whether to appeal or change the plan of treatment.Cigna policy
- A liver transplant in your historyCigna's policy, since March 2026, requires that the patient has no history of liver transplantation. The label reports similar TTR lowering in people with a prior liver transplant, and the neurologist's office decides whether to appeal.Cigna policy
- The place of the infusion is not coveredAlnylam's guide for clinicians says home infusion may not be covered by all insurance plans. It says Alnylam Assist can help answer questions about home administration.Dosing and Preparation Guide
- Your insurance changed partway throughThe Alnylam Assist Bridge Program provides medicine to eligible Onpattro patients who have a change or delay in coverage. A Case Manager checks eligibility once a Start Form is on file.Alnylam Assist HCP
- A cost you cannot payCommercial insurance: the Alnylam Assist Copay Program, which covers certain out-of-pocket costs. People on Medicare, Medicaid or other government insurance cannot use it. The Alnylam Assist Patient Assistance Program gives treatment at no cost to eligible people, mainly the uninsured.Onpattro financial assistance
Cigna prior authorization policy, March 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
- A dose of up to 0.3mg per kg, to a maximum of 30mg, no more often than once every 3 weeks
- Not combined with Amvuttra, Attruby, Tegsedi, Wainua or a tafamidis product
Approval length. Approval lasts a year at a time, and the policy lists no separate renewal criteria.
This policy took effect on March 1, 2026, and cites the January 2023 version of the label. The current label is dated September 2025, with the same indication and dose. The ban on combining TTR medicines and the liver transplant rule are the plan's rules, not the label's. 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.
- The Alnylam Assist Copay Program, which covers certain out-of-pocket costs for eligible people with commercial insurance, not for Medicare, Medicaid or other government insurance
- Programs that may help during a delay or change in insurance coverage, with eligibility set by a Case Manager after a Start Form
- The Alnylam Assist Patient Assistance Program, which provides treatment at no cost to eligible people, mainly the uninsured
- A link to independent foundations that may offer financial help to people who are uninsured or underinsured
- Alnylam Case Managers who verify your benefits, check whether you qualify for financial help and schedule check-ins before and after each treatment, once your doctor sends a Start Form Alnylam Assist teams
- Patient Education Liaisons, Alnylam employees with nursing backgrounds who teach about the disease and answer treatment questions but do not give medical care or advice Alnylam Assist teams
- The copay program has an annual cap, and its terms require a patient to be 18 or older with a valid prescription Copay terms
Details as the drugmaker publishes them. Onpattro financial assistance
Five questions for the pharmacist or the support line
- Where will my infusions be given, and does my plan cover that place?
- Which premedicines will I get before each infusion, and will they be by vein or by mouth?
- Which vitamin A supplement and amount should I take, and does my multivitamin already count toward it?
- Is my plan paying for Onpattro under my medical benefit or my pharmacy benefit, and what will I owe each infusion?
- Are my next infusions already on the calendar, and who calls me if one needs to move?
Questions people ask in the first weeks
How is Onpattro given?
As an infusion into a vein every 3 weeks, by a healthcare professional, over about 80 minutes. The dose is 0.3mg per kg of body weight, or 30mg for people weighing 100kg (about 220 pounds) or more.
What premedicines are given before Onpattro?
The label lists 4, given at least 60 minutes before each infusion. Two are an intravenous corticosteroid such as dexamethasone 10mg and acetaminophen 500mg by mouth. The other 2 are antihistamines, an H1 blocker such as diphenhydramine 50mg and an H2 blocker such as famotidine 20mg. They lower the risk of an infusion reaction.
What does an Onpattro infusion reaction look like?
The label names flushing, shortness of breath, chest pain, fainting, a rash, a faster heartbeat and swelling of the face. It says to contact your healthcare provider immediately. In the main trial, 19% of patients had a reaction, and most first reactions came within the first 2 infusions.
Do I need a vitamin A supplement on Onpattro?
Yes, the label advises a daily supplement at the recommended daily allowance. It also says not to take more than that to raise the blood level, which does not reflect the body's total vitamin A. Your neurologist names the product and the start date.
What eye symptoms should I watch for on Onpattro?
Trouble seeing at night or in dim light, which the label links to low vitamin A. The label says to contact your healthcare provider, and that patients with these symptoms should be referred to an ophthalmologist.
What if I miss an Onpattro infusion?
The label says the missed dose is given as soon as possible. If it is given within 3 days, the original schedule continues. If it is later than that, the next doses follow every 3 weeks from the late one.
Can Onpattro be given at home?
The label does not address home infusion, but Alnylam's guide for clinicians does. It says home infusion may be an option for some patients after the treating doctor's evaluation. Not all insurance plans cover it, the guide adds. A healthcare professional gives the infusion in every setting.
Why was Onpattro denied by my insurance?
Plans such as Cigna ask for a genetic test showing a TTR variant and documentation of nerve symptoms. Cigna also excludes people with a liver transplant and will not pay alongside another TTR medicine. The Case Manager can track the appeal with your neurologist's office.
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Sources
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- ONPATTRO® (patisiran) Dosing and Preparation Guide (TTR02-USA-00054-052018-V12), Alnylam Pharmaceuticals, November 12, 2026.
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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.