Amvuttra
(Vutrisiran)Dosage & Administration
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Amvuttra Prescribing Information
Indication and Usage (AMVUTTRA is a transthyretin-directed small interfering RNA indicated for the treatment of:
AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults. AMVUTTRA is indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits. | 3/2025 |
AMVUTTRA is a transthyretin-directed small interfering RNA indicated for the treatment of:
- the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults ()
1.1 Polyneuropathy of Hereditary Transthyretin-mediated AmyloidosisAMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
- the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits ()
1.2 Cardiomyopathy of Wild-type or Hereditary Transthyretin-mediated AmyloidosisAMVUTTRA is indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits.
- The recommended dosage of AMVUTTRA is 25 mg administered by subcutaneous injection once every 3 months. ()
2.1 Recommended DosageThe recommended dosage of AMVUTTRA is 25 mg administered by subcutaneous injection once every 3 months
[see Dosage and Administration (2.2)].Missed DoseIf a dose is missed, administer AMVUTTRA as soon as possible. Resume dosing every 3 months from the most recently administered dose.
- AMVUTTRA is for subcutaneous use only and should be administered by a healthcare professional. ()
2.2 Administration InstructionsAMVUTTRA is for subcutaneous use only and should be administered by a healthcare professional.
Syringe Appearance Before and After UseBefore UseAfter UseImageImagePreparation and Administration1.000000000000000e+00 Prepare the syringe
If stored cold, allow the syringe to warm to room temperature for 30 minutes prior to use.
Remove the syringe from the packaging by gripping the syringe body.- Do nottouch the plunger rod until ready to inject.
Do notuse if it contains particulate matter or if it is cloudy or discolored.
Check the following:- Syringe is not damaged, such as cracked or leaking
- Needle cap is attached to the syringe
- Expiration date on syringe label
- Do notuse the syringe if any issues are found while checking the syringe.
2.000000000000000e+00 Choose and prepare the injection site
Choose an injection site from the following areas: the abdomen, thighs, or upper arms.
Avoid the following:- 5-cm area around the navel
- Scar tissue or areas that are reddened, inflamed, or swollen
3.000000000000000e+00 Prepare the syringe for injection
Hold the syringe body with one hand. Pull the needle cap straight off with other hand and dispose of needle cap immediately. It is normal to see a drop of liquid at the tip of the needle.- Do nottouch the needle or let it touch any surface.
- Do notrecap the syringe.
- Do notuse the syringe if it is dropped.
4.000000000000000e+00 Perform the injection
Pinch the cleaned skin.
Fully insert the needle into the pinched skin at a 45°-90° angle.
Inject all of the medication. - Push the plunger rod as far as it will goto administer the dose and activate the needle shield.
Release the plunger rod to allow the needle shield to cover the needle. - Do notblock plunger rod movement.
5.000000000000000e+00 Dispose of the syringeImmediately disposeof the used syringe into a sharps container.
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Injection: 25 mg/0.5 mL of vutrisiran as a clear, colorless-to-yellow solution in a single-dose prefilled syringe.
There are no available data on AMVUTTRA use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. AMVUTTRA treatment leads to a decrease in serum vitamin A levels, and vitamin A supplementation is advised for patients taking AMVUTTRA. Vitamin A is essential for normal embryofetal development; however, excessive levels of vitamin A are associated with adverse developmental effects. The effects on the fetus of a reduction in maternal serum TTR caused by AMVUTTRA and of vitamin A supplementation are unknown
AMVUTTRA treatment leads to a decrease in serum vitamin A levels
Supplementation at the recommended daily allowance of vitamin A is advised for patients taking AMVUTTRA. Higher doses than the recommended daily allowance of vitamin A should not be given to try to achieve normal serum vitamin A levels during treatment with AMVUTTRA, as serum vitamin A levels do not reflect the total vitamin A in the body.
Patients should be referred to an ophthalmologist if they develop ocular symptoms suggestive of vitamin A deficiency (e.g., night blindness).
The pharmacodynamic effects of AMVUTTRA were evaluated in patients with hATTR-PN and ATTR-CM, treated with 25 mg AMVUTTRA administered by subcutaneous injection once every 3 months.
In HELIOS-A
Vutrisiran also reduced the mean steady state serum vitamin A by 62% over 9 months
In HELIOS-B, the mean serum TTR reduction profile was similar with that observed in HELIOS-A, and consistent across the subgroups studied (age, sex, race, body weight, anti-drug antibody [ADA] status, ATTR disease type (wtATTR versus hATTR), NYHA class, and baseline tafamidis use).
Vutrisiran reduced the mean steady state serum vitamin A by 65% over 36 months.
Biomarkers associated with heart failure (NT-proBNP and Troponin I) favored AMVUTTRA over placebo.
At a dose 12 times the recommended dosage of 25 mg once every three months, AMVUTTRA does not prolong the QT interval to any clinically relevant extent.
In animal studies, subcutaneous administration of vutrisiran to pregnant rats resulted in developmental toxicity (reduced fetal body weight and embryofetal mortality) at doses associated with maternal toxicity
Subcutaneous administration of vutrisiran (0, 3, 10, or 30 mg/kg/day) to pregnant rats during the period of organogenesis resulted in embryofetal mortality at the high dose and reduced fetal body weight at the mid and high doses, which were associated with maternal toxicity.
Subcutaneous administration of vutrisiran (0, 3, 10, or 30 mg/kg/day) to pregnant rabbits resulted in no adverse effects on embryofetal development.
Subcutaneous administration of vutrisiran (0, 5, 10, or 20 mg/kg) to pregnant rats every 6 days throughout pregnancy and lactation resulted in no adverse developmental effects on the offspring.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.
None.