Amvuttra (Vutrisiran) Injection [Alnylam Pharmaceuticals, Inc.]

AMVUTTRA is a transthyretin-directed small interfering RNA indicated for the treatment of:the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults (1.1)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)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.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.

Reduced serum vitamin A levels and recommended supplementation: Supplement with the recommended daily allowance of vitamin A. Refer to an ophthalmologist if ocular symptoms suggestive of vitamin A deficiency occur. (5.1)5.1 Reduced Serum Vitamin A Levels and Recommended SupplementationAMVUTTRA treatment leads to a decrease in serum vitamin A levels [see Adverse Reactions (6.1) and Clinical Pharmacology (12.2)].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 recommended dosage of AMVUTTRA is 25 mg administered by subcutaneous injection once every 3 months. (2.1)AMVUTTRA is for subcutaneous use only and should be administered by a healthcare professional. (2.2)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.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.Prepare the syringeIf 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 not touch the plunger rod until ready to inject.Visually inspect the drug solution for discoloration and particulate matter prior to administration. AMVUTTRA is a sterile, preservative-free, clear, colorless-to-yellow solution. Do not use if it contains particulate matter or if it is cloudy or discolored.Check the following:Syringe is not damaged, such as cracked or leakingNeedle cap is attached to the syringeExpiration date on syringe label Do not use the syringe if any issues are found while checking the syringe. 2.Choose and prepare the injection siteChoose an injection site from the following areas: the abdomen, thighs, or upper arms.Avoid the following:5-cm area around the navelScar tissue or areas that are reddened, inflamed, or swollenClean the chosen injection site.3.Prepare the syringe for injectionHold 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 not touch the needle or let it touch any surface. Do not recap the syringe. Do not use the syringe if it is dropped.4.Perform the injectionPinch 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 go to administer the dose and activate the needle shield. Release the plunger rod to allow the needle shield to cover the needle. Do not block plunger rod movement. 5.Dispose of the syringe Immediately dispose of the used syringe into a sharps container.ImageImageImageImageImage

The recommended dosage of AMVUTTRA is 25 mg administered by subcutaneous injection once every 3 months [see Dosage and Administration (2.2)].

Injection: 25 mg/0.5 mL of vutrisiran as a clear, colorless-to-yellow solution in a single-dose prefilled syringe.