Cardiology
ATTR amyloidosis with cardiomyopathy (ATTR-CM): the approved drugs compared for prescribers
Amvuttra, Attruby, Vyndamax side by side on what each first fill waits on, what the label requires you to monitor and what an insurer asks to see, with FDA decisions, label changes and open trials for ATTR amyloidosis with cardiomyopathy (ATTR-CM).
When to suspect ATTR amyloidosis with cardiomyopathy (ATTR-CM) and what to test →The 3 ATTR amyloidosis with cardiomyopathy (ATTR-CM) prescribing guides
One page per drug with the dispensing gate, prior authorization documentation, dosing, monitoring and interactions, each line sourced.
The drugs side by side
Each cell is a summary of that drug's prescribing guide, which carries the full detail and a source on every line. Insurer thresholds are one public policy shown as an example; plans differ.
| Amvuttravutrisiran | Attrubyacoramidis | Vyndamaxtafamidis | |
|---|---|---|---|
| Label dated | November 6, 2025 | June 29, 2026 | May 12, 2026 |
| Starting dose | 25mg (0.5mL) by subcutaneous injection, administered by a healthcare professional. Single-dose prefilled syringe, 29-gauge needle with a needle shield. | 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. | Vyndamax 61mg orally once daily, one capsule, swallowed whole, not crushed or cut. No titration. No dosage adjustment for patients 65 or older, and no clinically significant pharmacokinetic differences with renal or mild hepatic impairment. |
| Dispensing gate | No REMS. A Start Form to Alnylam Assist signed by patient and prescriber, which also carries the prescription; prior authorization; a site of care, from office or infusion center to home nursing where coverage allows; administration by a healthcare professional | 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 | No REMS; prior authorization where the plan requires it, a specialty pharmacy in the plan's network, and shipment to the patient's home once approved |
| Required monitoring | No labs required by the label; vitamin A supplementation at the RDA, not titrated to serum levels; ophthalmology referral for ocular symptoms suggestive of deficiency, such as night blindness | 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 | No required monitoring in the label; total thyroxine may fall without a TSH change, and BCRP substrate toxicity is watched when co-prescribed |
| Example PA threshold | Cigna example: age 18 or older, diagnosis by technetium pyrophosphate scintigraphy, TTR-typed biopsy or pathogenic TTR variant, cardiac involvement on imaging, heart failure short of NYHA class IV, cardiologist or amyloidosis specialist, no concurrent tafamidis, Attruby or silencer | 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 | Cigna example: age 18 or older, PYP scintigraphy, biopsy with TTR typing or a TTR pathogenic variant, imaging showing cardiac involvement, heart failure without NYHA class IV, cardiologist or amyloidosis specialist, no concurrent acoramidis or TTR silencer |
| Support line | Alnylam Assist, 1-833-256-2748, Monday to Friday, 8 AM to 6 PM; a Case Manager within 2 business days of the Start Form, a commercial copay program with an annual cap, one Quick Start dose when a new patient's PA is denied or pending 7 days, a Bridge Program for coverage changes, and a PAP mainly for the uninsured | 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 | VynAssist, 1-888-863-1177, Access Care Manager, copay as little as $0 a month (maximum $10,000 to $60,000 a year) for commercial plans, though the posted terms still say the offer expires 12/31/25, the Pfizer Patient Assistance Program through VyndaLink (1-888-222-8475) for uninsured or government-insured patients |
- Label dated
- November 6, 2025
- Starting dose
- 25mg (0.5mL) by subcutaneous injection, administered by a healthcare professional. Single-dose prefilled syringe, 29-gauge needle with a needle shield.
- Dispensing gate
- No REMS. A Start Form to Alnylam Assist signed by patient and prescriber, which also carries the prescription; prior authorization; a site of care, from office or infusion center to home nursing where coverage allows; administration by a healthcare professional
- Required monitoring
- No labs required by the label; vitamin A supplementation at the RDA, not titrated to serum levels; ophthalmology referral for ocular symptoms suggestive of deficiency, such as night blindness
- Example PA threshold
- Cigna example: age 18 or older, diagnosis by technetium pyrophosphate scintigraphy, TTR-typed biopsy or pathogenic TTR variant, cardiac involvement on imaging, heart failure short of NYHA class IV, cardiologist or amyloidosis specialist, no concurrent tafamidis, Attruby or silencer
- Support line
- Alnylam Assist, 1-833-256-2748, Monday to Friday, 8 AM to 6 PM; a Case Manager within 2 business days of the Start Form, a commercial copay program with an annual cap, one Quick Start dose when a new patient's PA is denied or pending 7 days, a Bridge Program for coverage changes, and a PAP mainly for the uninsured
- Label dated
- June 29, 2026
- Starting dose
- 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.
- 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
- Required 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
- 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
- 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
- Label dated
- May 12, 2026
- Starting dose
- Vyndamax 61mg orally once daily, one capsule, swallowed whole, not crushed or cut. No titration. No dosage adjustment for patients 65 or older, and no clinically significant pharmacokinetic differences with renal or mild hepatic impairment.
- Dispensing gate
- No REMS; prior authorization where the plan requires it, a specialty pharmacy in the plan's network, and shipment to the patient's home once approved
- Required monitoring
- No required monitoring in the label; total thyroxine may fall without a TSH change, and BCRP substrate toxicity is watched when co-prescribed
- Example PA threshold
- Cigna example: age 18 or older, PYP scintigraphy, biopsy with TTR typing or a TTR pathogenic variant, imaging showing cardiac involvement, heart failure without NYHA class IV, cardiologist or amyloidosis specialist, no concurrent acoramidis or TTR silencer
- Support line
- VynAssist, 1-888-863-1177, Access Care Manager, copay as little as $0 a month (maximum $10,000 to $60,000 a year) for commercial plans, though the posted terms still say the offer expires 12/31/25, the Pfizer Patient Assistance Program through VyndaLink (1-888-222-8475) for uninsured or government-insured patients
FDA decisions for ATTR amyloidosis with cardiomyopathy (ATTR-CM)
From the Trial Friend FDA decision calendar, which records each date from the sponsor's or the FDA's own announcement.
No pending or recent decisions on the calendar.
Recent label changes
What changed in each label revision, from the FDA's approval letters and the labels' own revision lists.
- June 2026Attruby. The current label, revised in June 2026, lists a bottle of 120 tablets alongside the 112-tablet carton. The label approved in November 2024 listed only the carton. DailyMed's December 2025 version did not list the bottle either, and the FDA has posted no supplement letter for it. FDA label
- November 2025Amvuttra. DailyMed carries a new version of the label dated November 6th. Its text still reads Revised 3/2025, and the FDA's approval letters stop at March 2025, so the changes below are the approved ones. FDA label
- March 2025Amvuttra. Results of a 2-year cancer study in mice were added on March 11th. The label reports no increase in tumors. FDA letter
- March 2025Amvuttra. The heart use was added on March 20th, for adults with wild-type or hereditary ATTR cardiomyopathy, to reduce heart deaths, heart hospital stays and urgent heart failure visits. The HELIOS-B trial results and its vitamin A figures were added with it. The dose did not change. FDA letter
- November 2024Attruby. The FDA approved Attruby on November 22nd for adults with ATTR cardiomyopathy, wild-type or variant, to reduce heart-related deaths and hospital stays. The approval requires a pregnancy and breastfeeding study, a liver impairment study and 2 drug interaction studies. FDA letter
- October 2023Vyndamax. The FDA approved removing the patient counseling text about the THAOS registry, an outcomes survey for people with transthyretin amyloidosis. The dose and safety text did not change. FDA letter
- February 2023Amvuttra. Updated safety data from the HELIOS-A nerve trial and a 2-year cancer study in rats were added to the label. FDA letter
- June 2022Amvuttra. First approval, on June 13th, for the nerve damage of hereditary ATTR amyloidosis in adults. That use continues alongside the heart use and is not the subject of this page. FDA letter
Open trials
Questions prescribers ask about ATTR amyloidosis with cardiomyopathy (ATTR-CM)
Which ATTR amyloidosis with cardiomyopathy (ATTR-CM) drugs require a REMS?
None of the 3 ATTR amyloidosis with cardiomyopathy (ATTR-CM) drugs on this page has a REMS: Amvuttra, Attruby and Vyndamax. Each prescribing guide lists what does gate the first fill.
What monitoring do ATTR amyloidosis with cardiomyopathy (ATTR-CM) drugs require?
Amvuttra: No labs required by the label; vitamin A supplementation at the RDA, not titrated to serum levels; ophthalmology referral for ocular symptoms suggestive of deficiency, such as night blindness. Attruby: 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. Vyndamax: No required monitoring in the label; total thyroxine may fall without a TSH change, and BCRP substrate toxicity is watched when co-prescribed.
What do insurers require before covering Amvuttra, Attruby and Vyndamax?
Each answer below is one public insurer policy, an example rather than every plan. Amvuttra: Cigna example: age 18 or older, diagnosis by technetium pyrophosphate scintigraphy, TTR-typed biopsy or pathogenic TTR variant, cardiac involvement on imaging, heart failure short of NYHA class IV, cardiologist or amyloidosis specialist, no concurrent tafamidis, Attruby or silencer. Attruby: 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. Vyndamax: Cigna example: age 18 or older, PYP scintigraphy, biopsy with TTR typing or a TTR pathogenic variant, imaging showing cardiac involvement, heart failure without NYHA class IV, cardiologist or amyloidosis specialist, no concurrent acoramidis or TTR silencer.
Which support programs start ATTR amyloidosis with cardiomyopathy (ATTR-CM) patients on therapy?
Amvuttra: Alnylam Assist, 1-833-256-2748, Monday to Friday, 8 AM to 6 PM; a Case Manager within 2 business days of the Start Form, a commercial copay program with an annual cap, one Quick Start dose when a new patient's PA is denied or pending 7 days, a Bridge Program for coverage changes, and a PAP mainly for the uninsured. Attruby: 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. Vyndamax: VynAssist, 1-888-863-1177, Access Care Manager, copay as little as $0 a month (maximum $10,000 to $60,000 a year) for commercial plans, though the posted terms still say the offer expires 12/31/25, the Pfizer Patient Assistance Program through VyndaLink (1-888-222-8475) for uninsured or government-insured patients.
A reference for licensed professionals, checked on November 7, 2026. Labels and plan policies change; the label on DailyMed and the plan's current policy govern. Not medical advice. For patients: the ATTR amyloidosis with cardiomyopathy (ATTR-CM) page and the first 90 days pages for Amvuttra, Attruby, Vyndamax.