From the Guidelines
Vutrisiran should be administered as a subcutaneous injection of 25 mg every 3 months, with no dose adjustments required for patients with mild to moderate renal or hepatic impairment, as recommended in the 2023 ACC expert consensus decision pathway on comprehensive multidisciplinary care for the patient with cardiac amyloidosis 1. The dosing regimen for Vutrisiran is straightforward, with a fixed dose of 25 mg administered subcutaneously every 3 months. This is in contrast to other treatments for hereditary transthyretin-mediated amyloidosis (hATTR), which may require more frequent administration. Key considerations for Vutrisiran administration include:
- Injection site rotation to minimize local reactions
- No requirement for dose adjustments in patients with mild to moderate renal or hepatic impairment
- Monitoring for infusion-related reactions, although these are uncommon
- Laboratory monitoring of vitamin A levels, with supplementation typically recommended due to the potential for decreased vitamin A levels resulting from TTR reduction. The mechanism of action of Vutrisiran, which involves silencing the production of transthyretin (TTR) protein through RNA interference, helps to reduce the accumulation of amyloid deposits in tissues, thereby slowing disease progression and potentially improving neurological and cardiac manifestations of hATTR amyloidosis, as noted in the context of comprehensive care for cardiac amyloidosis 1.
From the FDA Drug Label
The mean fraction of unchanged vutrisiran eliminated in urine was approximately 19. 4% at the recommended dose of 25 mg. Patients were randomized 3:1 to receive 25 mg of AMVUTTRA subcutaneously once every 3 months (N=122)
The recommended dosing of vutrisiran is 25 mg administered subcutaneously once every 3 months 2.
From the Research
Vutrisiran Dosing
- Vutrisiran is administered subcutaneously at a dose of 25 mg every 3 months 3, 4
- This dosing regimen has been shown to be effective in reducing neuropathy impairment and improving quality of life in patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy 3, 4
- The same dosing regimen has also been used in studies evaluating the efficacy and safety of vutrisiran in patients with transthyretin amyloidosis with cardiomyopathy, with results showing a lower risk of death from any cause and cardiovascular events compared to placebo 5
- Additionally, vutrisiran has been shown to have a beneficial effect on exploratory cardiac parameters, including NT-proBNP and echocardiographic parameters, in patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy 6
Key Findings
- Vutrisiran 25 mg every 3 months has been consistently used as the dosing regimen in clinical trials 3, 4, 5, 6
- This dosing regimen has been shown to be effective and well-tolerated in patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy and transthyretin amyloidosis with cardiomyopathy 3, 4, 5, 6
- The efficacy and safety of vutrisiran have been evaluated in several clinical trials, with results supporting its use as a treatment option for these conditions 3, 4, 5, 6