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Medical Information | Non-US Health Care Professionals
Important Safety Information
Prescribing Information
Rivfloza® (nedosiran) injection 80 mg, 128 mg, or 160 mg logo

Rivfloza® is indicated to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, eg, eGFR ≥30 mL/min/1.73 m2.

Prescribing Information
Important Safety Information

Rivfloza® delivered rapid and durable control of 24-hour UOx1

Patients treated with Rivfloza® (nedosiran) injection experienced an improvement from baseline in 24-hour UOx from Day 90 to Day 180.1

See below for efficacy and safety data.

UOx=urinary oxalate.

Rivfloza® delivered rapid and durable control of 24-hour UOx1

Patients treated with Rivfloza® (nedosiran) injection experienced an improvement from baseline in 24-hour UOx from Day 90 to Day 180.1

See below for efficacy and safety data.

UOx=urinary oxalate.

In a 180-day, randomized, double-blind trial, Rivfloza® was compared with placebo in patients aged 6 years or older with primary hyperoxaluria type 1 (PH1) or primary hyperoxaluria type 2 (PH2). Patients received monthly doses of Rivfloza® (n=23) or placebo (n=12).1
Too few patients with PH2 were enrolled to evaluate efficacy in the PH2 population. Therefore, Rivfloza® is only indicated in patients with PH1.1

The efficacy of Rivfloza® was evaluated in the PHYOXTM2 pivotal study1

PHYOX™2 was a randomized, double-blind, placebo-controlled study of 35 patients aged ≥6 years with PH1 (n=29) or PH2 (n=6) and eGFR ≥30 mL/min/1.73m2.1

Randomization chart
Randomization chart

Primary endpoint1:
Percent change from baseline in 24-hour UOxa excretion from Day 90 to Day 180 (LS mean assessed by area under the curve 24-hour UOx [AUC24-hour UOx]).

Baseline characteristics were as follows:

Baseline characteristics chart

a24-hour UOx values were adjusted by 1.73 m2 BSA in patients aged <18 years.1

BSA=body surface area; eGFR=estimated glomerular filtration rate; LS=least squares; SD=standard deviation.

Efficacy results from PHYOXTM2

Primary endpoint1: percent change from baseline in 24-hour UOxa excretion from Day 90 to Day 180 (LS mean assessed by area under the curve 24-hour UOx [AUC24-hour UOx]).

In patients with PH1 or PH2, the LS mean AUC24-hour UOx in the Rivfloza® arm (n=23) was -3486 vs 1490 in the placebo arm (n=12), resulting in an LS mean difference of 4976 (95% CI: 2803, 7149; P<0.0001).

Change from baseline in 24-hour UOx in patients with PH13

Primary endpoint graph

Results are plotted as mean (95% CI) percent change from baseline.3 Visits are shown slightly offset for visibility.
a24-hour UOx values were adjusted by 1.73 m2 BSA in patients aged <18 years.1
AUC=area under the curve; BSA=body surface area; CI=confidence interval; LS=least squares.

56% with down arrow

Difference in LS mean percent change in UOx from baseline compared to placebo, measured monthly from Day 90 to Day 180 in patients with PH1 (95% CI: 33%, 80%).3

Molecule with down arrow icon

The reduction in UOx was maintained in all 13 patients with PH1 who received an additional 6 months of treatment with Rivfloza® in PHYOX™3, an ongoing single-arm extension study.1

Rivfloza® reduced UOx to normal or near-normal levels in the majority of patients with PH13

Key secondary endpoint: patients who achieved normalization or near normalization of 24-hour UOx on ≥2 consecutive visits between Day 90 and Day 180 in patients with PH13

Secondary endpoint bar graph
Secondary endpoint bar graph

Patients who received placebo had higher mean baseline UOx levels.2

24-hour urine samples were collected and evaluated every 30 days to ensure UOx levels remained normalized (<0.46 mmol/24 hours) or near normalized (≥0.46 mmol/24 hours to <0.60 mmol/24 hours) between ≥2 consecutive visits.2,3

Near normal (or normal) UOx excretion was defined as <1.3 x ULN.2

ULN=upper limit of normal.

76% pie chart

of PH1 patients treated with Rivfloza® (n=17)a had normal or near-normal 24-hour UOx at Day 180.3

aPercentage is based on the number of participants in the ITT PH1 population with 24-hour UOx meeting completeness criteria.3

ITT=intent to treat.

Patients who received placebo had higher mean baseline UOx levels.2

24-hour urine samples were collected and evaluated every 30 days to ensure UOx levels remained normalized (<0.46 mmol/24 hours) or near normalized (≥0.46 mmol/24 hours to <0.60 mmol/24 hours) between ≥2 consecutive visits.2,3

Near normal (or normal) UOx excretion was defined as <1.3 x ULN.2

ULN=upper limit of normal.

Additional endpoints: stone assessment in patients with PH1 treated with Rivfloza®

Prespecified secondary endpoint: In a post-hoc analysis, summed kidney stone surface area was measured at Day 180 via kidney ultrasound.2

Median percent change in summed kidney stone surface area (mm2) from baseline to Day 180 in patients with PH12

Summed kidney stone surface area chart

Exploratory endpoint: In a post-hoc analysis, the annualized stone event rate was studied.3

Annualized kidney stone event rate in patients with PH13

Annualized kidney stone event rate chart
Annualized kidney stone event rate chart

Limitations: These subanalyses were included in the study as exploratory endpoints and not adjusted for multiplicity or powered to determine statistical significance.

There was no prespecified statistical analysis for controlling for false positive rate when conducting multiple analyses, and alpha was not allocated. No efficacy conclusions can be drawn from these analyses.

Rivfloza® was safe and well-tolerated

No serious treatment-related adverse events in patients with PH1 who received Rivfloza® in the pivotal trial1

Most common adverse reactions reported in ≥20% of patients with PH1 studied in PHYOX™2.1

Common adverse reaction chart
Common adverse reaction chart
  • Injection site reactions included erythema, pain, bruising, and rash and were generally mild and did not lead to discontinuation of treatment.1
  • Across all clinical studies, Rivfloza® did not induce or boost ADAs. Among 59 patients tested with an ADA assay, none developed treatment-emergent ADAs.1

ADA=antidrug antibody.

Dad putting on his daughter's helmet
  • Injection site reactions included erythema, pain, bruising, and rash and were generally mild and did not lead to discontinuation of treatment.1
  • Across all clinical studies, Rivfloza® did not induce or boost ADAs. Among 59 patients tested with an ADA assay, none developed treatment-emergent ADAs.1

ADA=antidrug antibody.

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Once-monthly at-home administration1

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Important Safety Information for Rivfloza®

Adverse Reactions

  • Most common adverse reaction (reported in 39% of patients) are injection site reactions, which include erythema, pain, bruising, and rash.

Indications and Usage

Rivfloza® (nedosiran) injection 80 mg, 128 mg, or 160 mg is indicated to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, eg, eGFR ≥30 mL/min/1.73 m2.

Please click here for Rivfloza® Prescribing Information.

Important Safety Information for Rivfloza®

Adverse Reactions

  • Most common adverse reaction (reported in 39% of patients) are injection site reactions, which include erythema, pain, bruising, and rash.

Indications and Usage

Rivfloza® (nedosiran) injection 80 mg, 128 mg, or 160 mg is indicated to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, eg, eGFR ≥30 mL/min/1.73 m2.

Please click here for Rivfloza® Prescribing Information.

References:

  1. Rivfloza® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
  2. Baum MA, Langman C, Cochat P, et al. PHYOX2 study investigators. PHYOX2: a pivotal randomized study of nedosiran in primary hyperoxaluria type 1 or 2. Kidney Int. 2023;103(1):207-217. doi:10.1016/j.kint.2022.07.025
  3. Data on file. Novo Nordisk Inc; Plainsboro, NJ.