Safety profile-ATTR-CM

Safety

AMVUTTRA® has an established safety and tolerability profile in adults1

The safety and tolerability of AMVUTTRA were established in a study of adult patients with hATTR-PN (HELIOS-A).1

Safety in HELIOS-A (hATTR-PN)1

Chart showing the safety and tolerability profile during the HELIOS A clinical trialChart showing the safety and tolerability profile during the HELIOS A clinical trial

Adverse reactions reported in at least 5% of patients treated with AMVUTTRA.1

Safety in HELIOS-B (ATTR-CM)2

Chart showing the safety and tolerability profile during the HELIOS B clinical trialChart showing the safety and tolerability profile during the HELIOS B clinical trial

*Comprised of several similar terms.1

†Percentage only reflects those reported as an adverse reaction.1

No new safety issues were identified in HELIOS-B1

  • In HELIOS-B, the frequency of pain in extremity, arthralgia, and dyspnea were similar to placebo.2

*Comprised of several similar terms.1

†Percentage only reflects those reported as an adverse reaction.1

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Important Safety Information

Reduced Serum Vitamin A Levels and Recommended Supplementation

AMVUTTRA treatment leads to a decrease in serum vitamin A levels.

Supplementation at the recommended daily allowance (RDA) of vitamin A is advised for patients taking AMVUTTRA. Higher doses than the RDA 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).

Adverse Reactions

In a study of patients with hATTR-PN, the most common adverse reactions that occurred in patients treated with AMVUTTRA were pain in extremity (15%), arthralgia (11%), dyspnea (7%), and vitamin A decreased (7%).

In a study of patients with ATTR-CM, no new safety issues were identified.

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

Indications

AMVUTTRA® (vutrisiran) 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.
  • polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.

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