How was AMVUTTRA® studied?

The safety and efficacy of AMVUTTRA were evaluated in an 18-month study of 164 adult patients with polyneuropathy caused by hATTR amyloidosis.

The clinical study of AMVUTTRA focused on changes in nerve function and quality of life.

The effects of AMVUTTRA on other aspects of the disease, including walking speed, nutritional health, and ability to perform activities of daily living, were also evaluated.

In the Study:

The efficacy of AMVUTTRA was evaluated using multiple assessments.

These assessments were performed at 9 months and again at 18 months.

Efficacy was determined by comparing results

  • Patients treated with AMVUTTRA
  • Patients from a similar study who were given a placeboa

aPlacebo: treatment without any active medication.

Up next Learn more about how AMVUTTRA may help

Important Safety Information and Indication

Important Safety Information

What are the most important things I should know about AMVUTTRA® (vutrisiran)?

AMVUTTRA can cause:

  • Low Vitamin A Levels

    Treatment with AMVUTTRA lowers the amount of vitamin A in your blood. Your doctor will tell you to take a vitamin A supplement every day. You should not take more than the amount of vitamin A recommended by your doctor.

    Low vitamin A levels can affect vision. If you have problems with your vision (e.g., night blindness) while taking AMVUTTRA, talk to your doctor. Your doctor may refer you to an eye specialist.

What are the common side effects of AMVUTTRA?

The most common side effects of AMVUTTRA are pain in the arms or legs, pain in the joints (arthralgia), shortness of breath (dyspnea), and low vitamin A levels.

These are not all the possible side effects of AMVUTTRA. Talk to your doctor about side effects that you experience. You are encouraged to report negative side effects of prescription drugs to the U.S. Food and Drug Administration (FDA). Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Indication

What is AMVUTTRA?

AMVUTTRA is a prescription medicine that treats the polyneuropathy caused by an illness called hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis). AMVUTTRA is used in adults only.

For additional information about AMVUTTRA, please see the full Prescribing Information.

For healthcare providers
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