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nedosiran (Rivfloza)

Indications: - FDA-approved to lower urinary oxalate levels in children >= 9 years of age & adults with primary hyperoxaluria type 1 with relatively preserved renal function Contraindications: - pregnancy insufficient data to recommend Dosage: - once monthly SQ injection into the abdomen or upper thigh - 160 mg adults & children or adolecents >= 50 kg - 3.3 mg/kg children < 50 kg, not toexceed 128 mg (Vial, dose volume rounded to nearest 0.1 mL) * single-dose vial or Pre-filled Syringe - 80 mg (0.5 mL) single-dose vial - 128 mg (0.8 mL) single-dose Pre-filled Syringe - 160 mg (1 mL) single-dose Pre-filled Syringe Adverse effects: - > 20% - injection site reactions Mechanism of action: - small inhibitory RNA (siRNAP reduces levels of hepatic lactate dehydrogenase (LDH) the enzyme responsible for the conversion of glyoxylate to oxalate

General

short interfering double-stranded RNA; antisense oligonucleotide (siRNA, microRNA, miRNA)

References

  1. Goldfarb DS, Lieske JC, Groothoff J et al Nedosiran in primary hyperoxaluria subtype 3: results from a phase I, single-dose study (PHYOX4). Urolithiasis. 2023 Apr 28;51(1):80. PMID: 37118061 PMCID: PMC10147791 Free PMC article. Clinical Trial.
  2. Hoppe B, Koch A, Cochat P et al Safety, pharmacodynamics, and exposure-response modeling results from a first-in-human phase 1 study of nedosiran (PHYOX1) in primary hyperoxaluria. Kidney Int. 2022 Mar;101(3):626-634. Epub 2021 Sep 2. PMID: 34481803 Free article. Clinical Trial.
  3. HIGHLIGHTS OF PRESCRIBING INFORMATION RIVFLOZA (nedosiran) injection, for subcutaneous use https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215842s000lbl.pdf