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Rivfloza
nedosiran
Adult Dosing .
Dosage forms: INJ (pre-filled syringe): 128 mg per 0.8 mL, 160 mg per mL; INJ (vial): 80 mg per 0.5 mL
primary hyperoxaluria, type 1
- [<50 kg]
- Dose: 128 mg SC qmo
- [>50 kg]
- Dose: 160 mg SC qmo
renal dosing
- [see below]
- eGFR <30: avoid use
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.1-1.5x ULN or AST >ULN: no adjustment; bilirubin >1.5x ULN: not defined
Peds Dosing .
- Dosage forms: INJ (pre-filled syringe): 128 mg per 0.8 mL, 160 mg per mL; INJ (vial): 80 mg per 0.5 mL
primary hyperoxaluria, type 1
- [2-11 yo, <39 kg]
- Dose: 3.3 mg/kg/dose SC qmo
- [2-11 yo, 39-49 kg]
- Dose: 128 mg SC qmo
- [2-11 yo, >50 kg]
- Dose: 160 mg SC qmo
- [12 yo and older, <50 kg]
- Dose: 128 mg SC qmo
- [12 yo and older, >50 kg]
- Dose: 160 mg SC qmo
renal dosing
- [see below]
- eGFR <30: avoid use
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.1-1.5x ULN or AST >ULN: no adjustment; bilirubin >1.5x ULN: not defined
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- eGFR <30
Drug Interactions .
Overview
nedosiran
lactate dehydrogenase A-directed siRNA
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
may occur but none reported
Common Reactions
- injection site rxn
- skin atrophy (long-term use)
Safety/Monitoring .
Monitoring Parameters
eGFR at baseline
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available; risk of fetal loss based on conflicting animal data at MRHD and risk of fetal cardiovascular and skeletal malformations based on conflicting animal data at 2x MRHD
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: nucleolytic degradation; CYP450: none
Excretion: urine (27% unchanged); Half-life: 15h
Subclass: Inherited Metabolic Disorders ; Nephrolithiasis
Mechanism of Action
small interfering ribonucleic acid (siRNA) degrades lactate dehydrogenase A (LDHA) mRNA in hepatocytes, reducing LDH and oxalate production
Formulary .
No Formulary Selected
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