Rivfloza

— THERAPEUTIC CATEGORIES —
  • Inborn errors of metabolism
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Rivfloza Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Nedosiran 160mg/mL; soln for SC inj; preservative-free.

    Pharmacological Class

    LDHA-directed small interfering RNA.

    How Supplied

    Single-dose vial (0.5mL)—1, Single-dose prefilled syringe (0.8mL, 1mL)—1

    Storage

    Store refrigerated at 2°C to 8°C (36°F to 46°F). Rivfloza can be stored, if needed, at 15°C to 30°C (59°F to 86°F) for a maximum of 28 days (4 weeks). Do not freeze. Store in original carton, away from direct heat and light.

    Manufacturer

    Novo Nordisk

    Generic Availability

    NO

    Mechanism of Action

    Nedosiran is a double-stranded siRNA, conjugated to GalNAc aminosugar residues. The GalNAc-conjugated sugars bind to asialoglycoprotein receptors (ASGPR) to deliver nedosiran to hepatocytes.

    Nedosiran reduces levels of hepatic lactate dehydrogenase (LDH) via the degradation of LDHA messenger ribonucleic acid (mRNA) in hepatocytes through RNA interference. The hepatic LDH reduction by nedosiran reduces the production of oxalate by the liver, thereby decreasing subsequent oxalate burden.

    Rivfloza Indications

    Indications

    To lower urinary oxalate levels in patients with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function (eg, eGFR ≥30mL/min/1.73m2).

    Rivfloza Dosage and Administration

    Adults and Children

    <9yrs: not established. Give as SC inj to the abdomen or upper thigh. Do not inj into vein or scarred/bruised skin. 9–11yrs (<50kg): 3.3mg/kg once monthly; max 128mg; (≥50kg): 160mg once monthly. ≥12yrs (<50kg): 128mg once monthly; (≥50kg): 160mg once monthly. 

    Rivfloza Contraindications

    Not Applicable

    Rivfloza Boxed Warnings

    Not Applicable

    Rivfloza Warnings/Precautions

    Warnings/Precautions

    Moderate or severe hepatic impairment: not studied. Severe renal impairment: not studied. Pregnancy. Nursing mothers. 

    Rivfloza Pharmacokinetics

    Absorption

    Time to maximum concentration (Tmax):  6 hours.

    Distribution

    Apparent volume of distribution: 126 L. Plasma protein bound: 85.6%.

    Metabolism

    Endo- and exonucleases to shorter oligonucleotides.

    Elimination

    Renal. Half-life: 15 hours. Estimated apparent clearance: 5.7 L/hr.

    Rivfloza Interactions

    Not Applicable

    Rivfloza Adverse Reactions

    Adverse Reactions

    Inj site reactions (erythema, pain, bruising, rash).

    Rivfloza Clinical Trials

    Clinical Trials

    The approval was based on data from the double-blind, phase 2 PHYOX 2 trial (ClinicalTrials.gov Identifier: NCT03847909), which evaluated the efficacy and safety of nedosiran in patients 6 years of age and older with PH1 or PH2 and an eGFR of at least 30mL/min/1.73m2. Study participants were randomly assigned to receive either nedosiran (n=23) or placebo (n=12) subcutaneously once monthly.

    Results showed that treatment with nedosiran met the primary endpoint demonstrating a statistically significant reduction in 24-hour urinary oxalate excretion between day 90 and 180 from baseline compared with placebo (least-squares mean difference of AUC24-hour Uox: 4976 [95% CI, 2803-7149]; P <.0001).  

    After 6 months, patients were eligible to enroll in an ongoing single-arm extension study (PHYOX3; ClinicalTrials.gov Identifier: NCT04042402). Reductions in 24-hour urinary oxalate excretion were maintained in the 13 patients with PH1 who received an additional 6 months of treatment.

    Rivfloza Note

    Not Applicable

    Rivfloza Patient Counseling

    Cost Savings Program

    Rivfloza Savings and Support

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