Nedosiran
Nedosiran is an RNA interference therapeutic designed to reduce hepatic oxalate production in patients with primary hyperoxaluria. It is a GalNAc-conjugated small interfering RNA (siRNA) that specifically targets lactate dehydrogenase (LDH) in liver cells to decrease oxalate synthesis.
Nedosiran is an siRNA therapy that reduces liver oxalate production for treating primary hyperoxaluria.
Key facts at a glance
- ATC
- A16AX25
- RxNorm
- 2675287
- Generic
- Nedosiran
- Class
- atc-a16
- Brands
- Rivfloza
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection, prefilled syringe
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 160mg once monthly
- Maximum
- consult physician
- Frequency
- once monthly
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- based on weight
- Maximum
- consult physician
- Frequency
- once monthly
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 160mg once monthly
- Maximum
- consult physician
- Frequency
- once monthly
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteravoid if possible
use only if benefits outweigh potential risks to fetus
regular fetal monitoring recommended
Use with caution and monitor for adverse effects.
pregnancy
second trimesteravoid if possible
use only if benefits outweigh potential risks
regular fetal monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesteravoid if possible
consider discontinuing if pregnancy detected
fetal monitoring and assessment of drug continuation
Use with caution and monitor for adverse effects.
lactation
breastfeedingdiscontinue or do not breastfeed
unknown if nedosiran is excreted in human milk; decision should be made considering infant exposure and breastfeeding benefits
monitor infant for adverse effects
pediatric_age
under 18 yearsnot established
safety and efficacy not established in pediatric patients; use only in clinical trials or as directed by pediatric specialist
close clinical monitoring if used off-label
geriatric
over 65 yearsno specific adjustment
no specific dosage adjustment required; monitor renal and hepatic function
regular monitoring of renal and hepatic function
Use with caution and monitor for adverse effects.
renal_impairment
mild to moderateno specific adjustment
use with caution; no formal dosing recommendations established
monitor renal function regularly
Use with caution and monitor for adverse effects.
hepatic_impairment
mildno specific adjustment
use with caution; drug targets hepatic LDHA expression
monitor liver function tests
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
FDA approval date for Nedosiran (Rivfloza)
Drug class
RNA interference therapeutic classification
Target indication
Approved therapeutic indication
Mechanism of action
Primary hyperoxaluria type 1 treatment via LDHA inhibition
Nedosiran is indicated for the treatment of primary hyperoxaluria (PH1) in adults and children aged 4 years and older. Primary hyperoxaluria is a rare genetic disorder characterized by excessive oxalate production by the liver, which can lead to kidney stones, kidney damage, and systemic oxalosis.
Nedosiran is a double-stranded siRNA conjugated to GalNAc aminosugar residues. After subcutaneous administration, GalNAc-conjugated sugars bind to asialoglycoprotein receptors (ASGPR) on hepatocytes, facilitating delivery into liver cells. Once inside hepatocytes, nedosiran silences the LDHA gene, reducing lactate dehydrogenase enzyme activity and subsequently decreasing hepatic oxalate production.
Nedosiran is administered via subcutaneous injection. Common adverse reactions may include injection site reactions. Patients should be monitored for reduction in plasma oxalate levels and urinary oxalate excretion. The medication should be used under the supervision of physicians experienced in managing primary hyperoxaluria. Safety and efficacy in children under 4 years of age have not been established.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy