Prescribing guide
Attruby (acoramidis)Dosing, interactions, specialty dispensing and prior authorization criteria for ATTR-CMFor prescribers and their offices treating ATTR amyloidosis with cardiomyopathy: 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; specialty dispensing through Orsini, PANTHERx Rare or select health system pharmacies after prior authorization; ForgingBridges Start Form and patient consent faxed to 1-877-738-0545, or eRx to RareMed Solutions.
Example PA threshold
Cigna example: age 18 or older, diagnosis by PYP scintigraphy, typed biopsy or pathogenic TTR variant, cardiac involvement on imaging, heart failure short of NYHA class IV, cardiologist or amyloidosis specialist, no concurrent tafamidis or TTR silencer.
Monitoring
No scheduled monitoring in the label; expect a creatinine rise of about 0.2mg/dL and an eGFR fall of about 8 mL/min/1.73m2 within 4 weeks that stabilizes; free T4 may fall without a TSH change.
Support line
ForgingBridges, 1-888-552-7434 (1-888-55-BRIDGE), Field Reimbursement Managers for PA and appeals, copay as low as $0 for commercial plans, a 1-month Free Trial, QuickStart up to 2 months during a coverage delay, and a Patient Assistance Program.
Give your patient their plan
A one-page handout for starting Attruby, 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/attrubyBefore 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 |
|---|---|---|
| Confirm the diagnosis in the chart | Cigna IP0728 asks for PYP scintigraphy, a tissue biopsy with TTR typing by mass spectrometry, immunoelectron microscopy or immunohistochemistry, or genetic testing showing a pathogenic TTR variant, with documentation. | Cigna policy |
| Enroll in ForgingBridges | Fax pages 2 and 3 of the Start Form to 1-877-738-0545 with demographics, a copy of the insurance card, the ICD-10-CM code, the prescription and the prescriber's signature. The patient consents on the form or by eConsent, and may sign after submission. | Start Form |
| Route the prescription | Orsini Specialty Pharmacy, (888) 331-6574, or PANTHERx Rare, (888) 471-4026; eRx can go to RareMed Solutions (NPI 1043877996). BridgeBio does not route prescriptions to health system specialty pharmacies, which order through specialty distributors. | How to get Attruby |
| Medication reconciliation | Avoid UGT inducers and strong CYP3A inducers. Note sensitive CYP2C9 substrates for closer monitoring. The Patient Information asks patients to report all prescription and over-the-counter medicines, vitamins and herbal supplements. | FDA label |
| Bridge a slow approval | Free Trial: a 1-month supply once per lifetime for new patients, prescribed as a 28-day supply with 0 refills in the Free Trial box of the Start Form; the web terms exclude DoD, VA and TRICARE. QuickStart: up to 2 months in 28-day increments for insured new patients whose coverage is delayed, ending at approval. | ForgingBridges terms |
| Tell the patient to answer | The specialty pharmacy or ForgingBridges calls the patient to collect insurance information, possibly from an unknown or 800 number. BridgeBio says orders ship within 48 hours after coverage approval. | ForgingBridges |
Prior authorization criteria and what to document
One public policy as the example: Cigna, March 1, 2026. Approval a year at a time. This policy took effect on March 1, 2026, before the June 2026 label revision, and cites the November 2024 label. The approved use has not changed between those 2 labels. Other plans set their own rules, too. The Blue Cross Blue Shield Federal Employee Program, for one, accepts only a genetic test or biopsy, not a heart scan. It also asks for a heart wall thickness of 12mm or more and an NT-proBNP of 300 or more. 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 |
|---|---|---|---|
| Age and diagnosis | 18 or older, with cardiomyopathy of wild-type or hereditary ATTR | Diagnosis note and ICD-10-CM code | Cigna policy |
| Diagnostic confirmation | One of: technetium pyrophosphate scan, tissue biopsy with TTR typing, or genetic test identifying a pathogenic TTR variant, with documentation | Scan report, pathology report or genetic result | Cigna policy |
| Cardiac involvement | Diagnostic cardiac imaging demonstrating involvement, such as increased ventricular wall or septal thickness | Echocardiogram or cardiac MRI report | Cigna policy |
| Functional class | Heart failure without NYHA class IV disease | NYHA class in the note | Cigna policy |
| Prescriber | Prescribed by or in consultation with a cardiologist or a physician who specializes in amyloidosis | Specialty on the request, or the consult note | Cigna policy |
| Preferred product | Individual and Family Plans only: Vyndamax tried with inadequate efficacy or significant intolerance, according to the prescriber | Tafamidis dose, dates and the reason it failed | Cigna policy |
| Monotherapy | No concurrent tafamidis, Amvuttra, Onpattro, Tegsedi or Wainua | Current medication list; a stop date if switching | Cigna policy |
Attruby dosing and titration
| When | Label | Source |
|---|---|---|
| Day 1 onward | 712mg orally twice daily as two 356mg tablets, with or without food; swallow whole, do not cut, crush or chew. No titration and no other strength. | FDA label |
| Supply | Carton of 112 tablets in 4 blister cards of 28 (NDC 82228-712-28), a 28-day supply; bottle of 120 tablets (NDC 82228-712-30), a 30-day supply. Store in the original blister card until use. | FDA label |
| Missed dose | The label gives no missed-dose instruction. | FDA label |
| Renal impairment | No clinically significant PK difference with renal impairment; no adjustment listed. | FDA label |
| Hepatic impairment | Effect of Child-Pugh A, B or C on PK is unknown; the approval letter requires a hepatic impairment PK study. | FDA letter |
| Older adults | No adjustment for 65 or older; 97% of trial participants were 65 or older, median age 78. | FDA label |
Monitoring the Attruby label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Weeks 1 to 4 | Serum creatinine and eGFR | Mean creatinine rise 0.2 against 0.0mg/dL and eGFR fall 8.2 against 0.7 mL/min/1.73m2 at day 28; stabilizes and reverses after discontinuation | FDA label |
| Any time | Thyroid function | Free thyroxine may fall without a TSH change, attributed to reduced thyroxine binding to TTR | FDA label |
| Any time | Diarrhea and upper abdominal pain | 11.6% against 7.6% and 5.5% against 1.4% in ATTRibute-CM; mostly mild and resolved without discontinuation; discontinuation for adverse events 9.3% against 8.5% | FDA label |
| With CYP2C9 substrates | Signs of exposure-related toxicity | Consider more frequent monitoring with sensitive CYP2C9 substrates | FDA label |
| Pharmacodynamics | Serum TTR, TTR stabilization assays | Serum TTR rose by day 28; near-complete in vitro stabilization from day 28 through month 30 | FDA label |
| Renewal | Clinical status | The Cigna policy approves 1 year at a time and lists no separate renewal criteria | Cigna policy |
Attruby drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Avoid | UGT inducers and strong CYP3A inducers; acoramidis is glucuronidated by UGT1A9, UGT1A1 and UGT2B7, and strong CYP3A inducers can also induce UGT | FDA label |
| Monitor | Sensitive CYP2C9 substrates; acoramidis is a time-dependent CYP2C9 inhibitor | FDA label |
| No meaningful effect | OAT1 substrate adefovir and OAT3 substrate oseltamivir carboxylate; concomitant diuretics do not change acoramidis levels | FDA label |
| QTc | No clinically relevant QTc prolongation at about 1.2 times steady-state Cmax | FDA label |
| Pregnancy | Data insufficient; no rat or rabbit malformations at 34 and 13 times clinical exposure; report pregnancies to BridgeBio at 1-844-550-2246 | FDA label |
| Pharmacokinetics | Effective half-life about 6 hours; steady state by 4 days; no food effect | FDA label |
Why a first fill stalls, and the fix
- Prior authorization pending or deniedThe Cigna policy below wants the diagnosis confirmed by a heart scan, biopsy or genetic test, heart imaging, and heart failure short of NYHA class IV. A ForgingBridges Field Reimbursement Manager helps the office with prior authorizations and appeals.
- The plan wants Vyndamax tried firstIn Cigna's Individual and Family Plans, Attruby is covered after Vyndamax did not work well enough or was not tolerated, according to the prescriber. Cigna relies on the prescriber's account of how the earlier drug went.
- You already take tafamidis or a TTR silencerCigna does not cover Attruby used alongside tafamidis, Amvuttra, Onpattro, Tegsedi or Wainua. The cardiologist decides which drug continues, and the request then shows a single treatment.
- The prescription went to the wrong pharmacyAttruby ships from Orsini, PANTHERx Rare or select health system pharmacies. BridgeBio says it does not route prescriptions to health system pharmacies, so the office sends it there directly.
- Coverage is taking a whileQuickStart may supply up to 2 months free, in 28-day steps, for insured patients new to Attruby. The Free Trial gives new patients one free 1-month supply, once per lifetime.
- A copay you cannot payWith commercial insurance, the copay program offers as little as $0 a month, subject to maximums. Medicare, Medicaid, TRICARE and VA patients are excluded from it by its terms. The Patient Assistance Program gives free drug to people who meet income rules, including Medicare patients.
ForgingBridges
- A Patient Access Liaison who helps you start Attruby, understand coverage, find financial help and work with the specialty pharmacy
- A copay program for commercial insurance, as little as $0 a month subject to maximum benefit amounts, not valid with Medicare, Medicaid, TRICARE, VA or other government coverage
- A Free Trial of a 1-month supply for patients new to Attruby, once per lifetime, excluding DoD, VA and TRICARE coverage
- QuickStart, up to a 2-month supply at no cost in 28-day steps while a new patient's insurance is delayed
- A Patient Assistance Program giving Attruby free to people with no or inadequate coverage who meet income rules, including Medicare patients
Questions prescribers' offices ask about Attruby
What is the Attruby dose?
The June 2026 label gives 712mg orally twice daily, taken as two 356mg tablets, with or without food, swallowed whole. There is one strength, no titration and no renal adjustment.
Does Attruby have a REMS or required monitoring?
No REMS appears on the FDA's REMS list, and the June 2026 label has no boxed warning, no contraindications and no Warnings and Precautions section. It sets no monitoring schedule, but describes a mean creatinine rise of 0.2mg/dL and an eGFR fall of 8.2 mL/min/1.73m2 at day 28 that stabilizes and reverses on discontinuation.
Which drugs interact with Attruby?
The June 2026 label says to avoid UGT inducers and strong CYP3A inducers, which can lower acoramidis exposure. Acoramidis is a time-dependent CYP2C9 inhibitor, so the label advises considering closer monitoring with sensitive CYP2C9 substrates.
Can Attruby be combined with tafamidis or a TTR silencer?
The June 2026 label does not address combination use; in ATTRibute-CM, 14.9% of the Attruby arm started open-label tafamidis after month 12. The Cigna policy on this page, effective March 1, 2026, lists concurrent use with tafamidis, vutrisiran, patisiran, inotersen or eplontersen as not medically necessary.
What do insurers ask for to approve Attruby?
The Cigna policy on this page, effective March 1, 2026, asks for age 18 or older and a diagnosis confirmed by technetium pyrophosphate scintigraphy, tissue biopsy with TTR typing, or a pathogenic TTR variant, all documented. It also asks for imaging showing cardiac involvement, heart failure short of NYHA class IV, and a cardiologist or amyloidosis specialist. Individual and Family Plans add a Vyndamax step.
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Sources
- DailyMed - ATTRUBY- acoramidis hydrochloride tablet, film coated (prescribing information and Patient Information, revised June 2026), BridgeBio Pharma, via DailyMed, 2026-06-29.
- ATTRUBY prescribing information, November 2024 (Drugs@FDA file 216540s000lbl.pdf), FDA, Drugs@FDA, 2024-11-22.
- ATTRUBY SPL version 6, effective December 16, 2025 (DailyMed archive download), BridgeBio Pharma, via DailyMed, 2025-12-16.
- Approved Risk Evaluation and Mitigation Strategies (REMS), FDA, 2026-11-07.
- Attruby Patient Support | ForgingBridges Attruby (acoramidis) Patient Site, BridgeBio Pharma, 2026-11-07.
- Financial Assistance | ForgingBridges Attruby (acoramidis) Patient Site, BridgeBio Pharma, 2026-11-07.
- Terms & Conditions | ForgingBridges Attruby (acoramidis) Patient Site, BridgeBio Pharma, 2026-11-07.
- Enroll | ForgingBridges Attruby (acoramidis) HCP Site, BridgeBio Pharma, 2026-11-07.
- ForgingBridges Support Program Start Form, BridgeBio Pharma, 2026-11-07.
- How to Get Attruby | ForgingBridges Attruby (acoramidis) HCP Site, BridgeBio Pharma, 2026-11-07.
- Insurance Coverage & Plans | ForgingBridges Attruby (acoramidis) HCP Site, BridgeBio Pharma, 2026-11-07.
- Attruby Access & Reimbursement Support | ForgingBridges Attruby (acoramidis) HCP Site, BridgeBio Pharma, 2026-11-07.
- Attruby® (acoramidis) Dosing & Packaging Information, BridgeBio Pharma, 2026-11-07.
- Amyloidosis – Attruby, Drug Coverage Policy IP0728, Cigna, 2026-03-01.
- Pharmacy Policy 5.75.046, Attruby, Blue Cross Blue Shield Federal Employee Program, 2026-04-01.
- NDA 216540 approval letter, Attruby (acoramidis) tablets, November 22, 2024, FDA, 2024-11-22.
A reference drawn from the June 29, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 7, 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.