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New FDA Drug Approvals - November 2022


vutrisiran

Amvuttra

Pharmaceutical company: Alnylam Pharmaceuticals

Pharmacologic classification:Anti-transthyretin small interfering RNA agent

Therapeutic classification:Protein inhibitor

AVAILABLE FORMS

Injection: 25 mg/0.5 mL prefilled syringe

INDICATIONS AND DOSAGES

Polyneuropathy of hereditary transthyretin-mediated amyloidosis

Adults: 25 mg subcut every three months.

CONTRAINDICATIONS AND CAUTIONS

  • This drug hasn’t been studied in those with severe renal impairment, end-stage renal disease, or moderate to severe hepatic impairment.
  • Safety and effectiveness in children haven’t been established.
  • Dialyzable drug: Unknown.

PREGNANCY-LACTATION-REPRODUCTION

  • There are no available data on use during pregnancy. Use in pregnancy only if the benefit clearly outweighs the fetal risk.
  • There is no information regarding the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production. Use cautiously during breastfeeding.

INTERACTIONS

None reported.

ADVERSE REACTIONS

CV: AV block.

Metabolic: decreased vitamin A.

Musculoskeletal: arthralgia.

Respiratory: dyspnea.

Skin: injection site reactions (bruising, erythema, pain, pruritus, warmth).

Other: anti-drug antibody development.

Reactions in bold italics are life-threatening.

Released: November 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer

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