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Drug overview for AMVUTTRA (vutrisiran sodium):
Generic name: vutrisiran sodium (VUE-tri-SIR-an)
Drug class: Amyloidosis Agents - Transthyretin (TTR) Suppression
Therapeutic class: Endocrine
Vutrisiran, a small interfering RNA (siRNA) that targets transthyretin (TTR) messenger RNA (mRNA), is a TTR silencer.
No enhanced Uses information available for this drug.
Generic name: vutrisiran sodium (VUE-tri-SIR-an)
Drug class: Amyloidosis Agents - Transthyretin (TTR) Suppression
Therapeutic class: Endocrine
Vutrisiran, a small interfering RNA (siRNA) that targets transthyretin (TTR) messenger RNA (mRNA), is a TTR silencer.
No enhanced Uses information available for this drug.
DRUG IMAGES
AMVUTTRA 25 MG/0.5 ML SYRINGE
The following indications for AMVUTTRA (vutrisiran sodium) have been approved by the FDA:
Indications:
Transthyretin familial amyloid polyneuropathy
Transthyretin-related amyloid cardiomyopathy
Professional Synonyms:
Cardiomyopathy due to ATTR
Polyneuropathy due to ATTR
Polyneuropathy due to transthyretin amyloidosis
Transthyretin amyloid cardiomyopathy
Transthyretin amyloid polyneuropathy
TTR familial amyloid polyneuropathy
Indications:
Transthyretin familial amyloid polyneuropathy
Transthyretin-related amyloid cardiomyopathy
Professional Synonyms:
Cardiomyopathy due to ATTR
Polyneuropathy due to ATTR
Polyneuropathy due to transthyretin amyloidosis
Transthyretin amyloid cardiomyopathy
Transthyretin amyloid polyneuropathy
TTR familial amyloid polyneuropathy
The following dosing information is available for AMVUTTRA (vutrisiran sodium):
Dosage of vutrisiran sodium is expressed in terms of vutrisiran.
Vutrisiran sodium is administered by subcutaneous injection only. The injection should be administered by a clinician. Vutrisiran sodium is commercially available as a single-dose 1-mL prefilled syringe containing 25 mg vutrisiran per 0.5
mL of solution. Prior to use, store vutrisiran prefilled syringes at 2-30degreesC in their original carton; do not freeze. If stored cold, allow vutrisiran prefilled syringes to warm to room temperature for 30 minutes prior to administration.
Visually inspect vutrisiran injection prior to administration and do not use if the solution is discolored, cloudy, or contains particulate matter. Administer vutrisiran subcutaneously into the abdomen (except for the 5-cm area around the navel), thigh, or upper arm. Avoid scar tissue or areas that are red, inflamed, or swollen.
If a dose is missed, administer the dose as soon as possible. Resume dosing every 3 months from the most recently administered dose.
mL of solution. Prior to use, store vutrisiran prefilled syringes at 2-30degreesC in their original carton; do not freeze. If stored cold, allow vutrisiran prefilled syringes to warm to room temperature for 30 minutes prior to administration.
Visually inspect vutrisiran injection prior to administration and do not use if the solution is discolored, cloudy, or contains particulate matter. Administer vutrisiran subcutaneously into the abdomen (except for the 5-cm area around the navel), thigh, or upper arm. Avoid scar tissue or areas that are red, inflamed, or swollen.
If a dose is missed, administer the dose as soon as possible. Resume dosing every 3 months from the most recently administered dose.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| AMVUTTRA 25 MG/0.5 ML SYRINGE | Maintenance | Adults inject 0.5 milliliter (25 mg) by subcutaneous route every 3 months |
No generic dosing information available.
The following drug interaction information is available for AMVUTTRA (vutrisiran sodium):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for AMVUTTRA (vutrisiran sodium):
Drug contraindication overview.
*None.
*None.
There are 0 contraindications.
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Night blindness |
| Vitamin A deficiency |
There are 0 moderate contraindications.
The following adverse reaction information is available for AMVUTTRA (vutrisiran sodium):
Adverse reaction overview.
Adverse reactions occurring in >=5% of patients receiving vutrisiran include arthralgia, dyspnea, and decreased vitamin A concentrations.
Adverse reactions occurring in >=5% of patients receiving vutrisiran include arthralgia, dyspnea, and decreased vitamin A concentrations.
There are 1 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Heart block |
| Rare/Very Rare |
|---|
| None. |
There are 7 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Arthralgia Dyspnea Pain in extremities Vitamin A deficiency |
Injection site erythema Injection site pain Injection site sequelae |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for AMVUTTRA (vutrisiran sodium):
Safety and efficacy in pediatric patients have not been established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no adequate data on the developmental risks associated with the use of vutrisiran in pregnant women. In animal studies, vutrisiran produced developmental toxicity (i.e., increased embryofetal mortality, decreased fetal body weight) when given subcutaneously to pregnant rats. These effects were observed at dosages associated with maternal toxicity.
Vutrisiran causes a decrease in vitamin A concentrations, and vitamin A supplementation is advised in patients receiving the drug. Vitamin A is essential for normal embryofetal development; however, excessive vitamin A concentrations are associated with adverse developmental effects. The effects on the fetus of a reduction in maternal serum transthyretin caused by vutrisiran and of vitamin A supplementation are unknown.
Vutrisiran causes a decrease in vitamin A concentrations, and vitamin A supplementation is advised in patients receiving the drug. Vitamin A is essential for normal embryofetal development; however, excessive vitamin A concentrations are associated with adverse developmental effects. The effects on the fetus of a reduction in maternal serum transthyretin caused by vutrisiran and of vitamin A supplementation are unknown.
It is not known whether vutrisiran is distributed into milk, affects milk production, or affects the breast-fed infant. Consider the benefits of breast-feeding along with the importance of vutrisiran to the woman and any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.
In the pivotal clinical trial, 38% of patients receiving vutrisiran were >=65 years of age, and 6% of patients were >=75 years of age. No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment is required in geriatric patients.
The following prioritized warning is available for AMVUTTRA (vutrisiran sodium):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for AMVUTTRA (vutrisiran sodium)'s list of indications:
| Transthyretin familial amyloid polyneuropathy | |
| E85.1 | Neuropathic heredofamilial amyloidosis |
| G63 | Polyneuropathy in diseases classified elsewhere |
| Transthyretin-related amyloid cardiomyopathy | |
| E85.4 | Organ-limited amyloidosis |
| E85.82 | Wild-type transthyretin-related (ATTr) amyloidosis |
| I43 | Cardiomyopathy in diseases classified elsewhere |
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