Safety

AMVUTTRA® safety and tolerability profile

Adverse reactions reported in at least 5% of patients treated with AMVUTTRA1
Adverse
Reaction		 AMVUTTRA
N=122
(%)
Pain in extremitya 15
Arthralgiaa 11
Dyspneaa 7
Vitamin A decreasedb 7

aComprised of several similar terms.

bPercentage only reflects those reported as an adverse reaction.

aExternal placebo group from APOLLO. Mean duration of exposure was 15 months (range: 1.3-18.8 months).

bIncludes dyspnea, dyspnea exertional, and dyspnea paroxysmal nocturnal.

 
Adverse reactions reported in at least 5% of patients treated with AMVUTTRA1
Adverse
Reaction		 AMVUTTRA
N=122
(%)
Pain in extremitya 15
Arthralgiaa 11
Dyspneaa 7
Vitamin A decreasedb 7

aComprised of several similar terms.

bPercentage only reflects those reported as an adverse reaction.

  • The safety profile of AMVUTTRA was generally consistent across all subgroups2,c
  • There were no drug-related discontinuations or deaths in patients treated with AMVUTTRA3
  • Injection site reactions occurred in 4% of patients and were mild and transient1,3
  • There are no contraindications for AMVUTTRA1

cSubgroups included age, sex, V30M variant status, previous TTR stabilizer use, and disease stage.2

TTR=transthyretin.

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Important Safety Information and Indication

Important Safety Information

Reduced Serum Vitamin A Levels and Recommended Supplementation

AMVUTTRA® (vutrisiran) 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

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%).

Indication

AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

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

References

  1. AMVUTTRA Prescribing Information. Cambridge, MA: Alnylam Pharmaceuticals, Inc.
  2. Data on file. Alnylam Pharmaceuticals, Inc.
  3. Adams D, Tournev IL, Taylor MS, et al. Amyloid. 2022. Published online July 23, 2022. doi.org/10.1080/13506129.2022.2091985.