Version May 2024
Note: Provide vitamin A supplementation at the recommended daily allowance during therapy. If patients develop ocular symptoms consistent with vitamin A deficiency (eg, night blindness), refer to an ophthalmologist.
Polyneuropathy associated with hereditary transthyretin-mediated amyloidosis:
SUBQ: 25 mg once every 3 months.
Missed dose: Administer as soon as possible after missed dose, then continue dosing every 3 months thereafter.
eGFR ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.
eGFR <30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Mild impairment (total bilirubin ≤1 times the ULN and AST >1 times ULN, or total bilirubin >1 to 1.5 times ULN and any AST): No dosage adjustment necessary.
Moderate to severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%: Neuromuscular & skeletal: Arthralgia (11%), limb pain (15%)
1% to 10%:
Cardiovascular: Atrioventricular block (2%; including complete atrioventricular block)
Endocrine & metabolic: Vitamin A deficiency (7%)
Immunologic: Antibody development (3%)
Local: Injection-site reaction (≤4%; including bruising at injection site, erythema at injection site, injection-site pruritus, pain at injection site, warm sensation at injection site)
Respiratory: Dyspnea (7%)
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Vitamin A: May cause decreased serum vitamin A.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous, as sodium [preservative free]:
Amvuttra: 25 mg/0.5 mL (0.5 mL) [latex free]
No
Solution Prefilled Syringe (Amvuttra Subcutaneous)
25 mg/0.5 mL (per 0.5 mL): $143,221.20
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
SUBQ: Administer by a health care professional. If stored cold, allow syringe to warm to room temperature for 30 minutes prior to use. Inject into abdomen, thighs, or upper arms; do not inject into the 5 cm area around the navel or areas where skin is red, scarred, inflamed, or swollen. Clean planned injection site and uncap needle; a drop of liquid at the tip of the needle is normal. Inject at a 45° to 90° angle into pinched skin. Push plunger rod as far as it will go to inject the full dose and activate plunger needle shield.
Polyneuropathy associated with hereditary transthyretin-mediated amyloidosis: Treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
None known.
There are no known significant interactions.
Vutrisiran decreases serum concentrations of vitamin A, which is required for normal fetal development. The effects to the fetus of maternal vitamin A supplementation during therapy, or the effects to the fetus of reducing maternal serum transthyretin, are not known.
It is not known if vutrisiran is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Ocular symptoms suggestive of vitamin A deficiency (eg, night blindness).
Vutrisiran is a double-stranded small interfering ribonucleic acid (siRNA)-N-acetylgalactosamine (GalNAc) conjugate that causes degradation of mutant and wild-type transthyretin (TTR) messenger RNA (mRNA) through RNA interference, which results in a reduction of serum TTR protein and TTR protein deposits in tissues.
Distribution: Vd: ~10.1 L.
Protein binding: 80%.
Metabolism: Via endo- and exonucleases; forms short nucleotide fragments of varying sizes within the liver.
Half-life elimination: ~5.2 hours.
Time to peak: ~4 hours.
Excretion: Urine (~19.4% as unchanged drug).
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