nedosiran (Rivfloza)
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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
* 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
More general terms
References
- ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/37118061 PMCID: PMC10147791 Free PMC article. Clinical Trial.
- ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/34481803 Free article. Clinical Trial.
- ↑ HIGHLIGHTS OF PRESCRIBING INFORMATION RIVFLOZA<TM> (nedosiran) injection, for subcutaneous use https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215842s000lbl.pdf