Amvuttra Side Effects Center

Last updated on RxList: 6/24/2022
Amvuttra Side Effects Center

What Is Amvuttra?

Amvuttra (vutrisiran) is a transthyretin-directed small interfering RNA indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

What Are Side Effects of Amvuttra?

Side effects of Amvuttra include:

Call your doctor at once if you have the following serious side effects:

  • blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
  • low levels of sodium in the body with severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady; or
  • severe nervous system reaction with very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out.

Dosage for Amvuttra

The recommended dosage of Amvuttra is 25 mg administered by subcutaneous injection once every 3 months.

Amvuttra In Children

Safety and effectiveness of Amvuttra in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Amvuttra?

Amvuttra may interact with other medicines.

Tell your doctor all medications and supplements you use.

Amvuttra During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using; it is unknown how it could affect a fetus. Amvuttra treatment leads to a decrease in serum vitamin A levels, and vitamin A supplementation is advised for patients taking Amvuttra. Vitamin A is essential for normal embryofetal development; however, excessive levels of vitamin A are associated with adverse developmental effects. It is unknown if Amvuttra passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Amvuttra (vutrisiran) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Amvuttra Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

  • Reduced Serum Vitamin A Levels and Recommended Supplementation [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of AMVUTTRA cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In Study 1 [see Clinical Studies], a total of 122 patients with polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) received AMVUTTRA. Of these, 118 patients received at least 9 months of treatment and 34 patients received at least 15 months of treatment. The mean duration of treatment was 12.9 months (range: 1.7 to 19.3 months). The median patient age at baseline was 60 years and 65% of the patients were male. Seventy percent of AMVUTTRA-treated patients were Caucasian, 17% were Asian, 3% were Black, and 9% were reported as Other. Forty-four percent of patients had the Val30Met mutation in the transthyretin gene; the remaining patients had one of 21 other mutations. At baseline, 70% of patients were in Stage 1 of the disease and 30% were in Stage 2.

The most common adverse reactions (at least 5%) were arthralgia, dyspnea, and vitamin A decreased (see Table 1). In Study 1, patients were instructed to take the recommended daily allowance of vitamin A [see WARNINGS AND PRECAUTIONS]. Seventy-four percent of patients treated with AMVUTTRA had normal vitamin A levels at baseline, and 98% of those with a normal baseline developed low vitamin A levels. In some cases, the decreased vitamin A level was reported as an adverse reaction (see Table 1).

Table 1: Adverse Reactions Reported in at least 5% of Patients Treated with AMVUTTRA (Study 1)

Adverse Reaction AMVUTTRA
N=122 %
Arthralgia* 11
Dyspnea* 7
Vitamin A decreased† 7
*Comprised of several similar terms
†Percentage only reflects those reported as an adverse reaction

Two serious adverse reactions of atrioventricular (AV) heart block (1.6%) occurred in patients treated with AMVUTTRA, including one case of complete AV block.

Injection site reactions were reported in 5 (4%) patients treated with AMVUTTRA. Reported symptoms included bruising, erythema, pain, pruritus, and warmth. Injection site reactions were mild and transient.

Immunogenicity

As with all oligonucleotides, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

In Study 1, 3 (2.5%) patients treated with AMVUTTRA developed anti-drug antibodies. Although anti-drug antibody development was not found to affect the pharmacokinetics, safety, or efficacy of AMVUTTRA in these patients, the available data are too limited to make definitive conclusions.

DRUG INTERACTIONS

No Information provided

Read the entire FDA prescribing information for Amvuttra (Vutrisiran Injection)

© Amvuttra Patient Information is supplied by Cerner Multum, Inc. and Amvuttra Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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