Nedosiran

(Rivfloza®)

Nedosiran

Drug updated on 10/21/2024

Dosage FormInjection (subcutaneous; 80 mg [0.5 mL], 128 mg [0.8 mL], 160 mg [1 mL])
Drug ClassLDHA-directed small interfering RNAs
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for lowering urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR 30 mL/min/1.73 square meters.

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Summary
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  • This summary is based on the review of one randomized controlled trial(s). [1]
  • Nedosiran significantly reduced 24-hour urinary oxalate (UOX) excretion, with an area under the curve (AUC) of +3507 (SE 788) in the nedosiran group compared to -1664 (SE 1190) in the placebo group, resulting in a difference of 5172 (95% CI 2929-7414; P < 0.001).
  • In the PH1 subgroup, 64.7% achieved normal or near-normal Uox excretion on ≥2 consecutive visits starting at day 90, while 0% in the placebo group achieved this outcome (P < 0.001), indicating a favorable response to nedosiran.
  • The PH2 subgroup did not demonstrate a consistent reduction in Uox, suggesting a less favorable or variable response to nedosiran.
  • Nedosiran was generally safe and well tolerated, with injection-site reactions occurring in 9% of participants, all of which were mild and self-limiting.
  • The safety profile of nedosiran indicates manageable adverse effects, with no significant safety concerns reported beyond the mild injection-site reactions.
  • There is no population types or subgroups information available in the reviewed documents.

Product Monograph / Prescribing Information

Document TitleYearSource
Rivfloza (nedosiran) Prescribing Information.2023Novo Nordisk Inc., Plainsboro, NJ

Randomized Controlled Trials

Document TitleSex DistributionYearSource
PHYOX2: a pivotal randomized study of nedosiran in primary hyperoxaluria type 1 or 2
Data not availableSubjects
F: null%
M: null%
2023Kidney International

Sex Distribution:

No Data

Year:

2023

Source:Kidney International

Clinical Practice Guidelines