Mediclarum
Medicine guide

Rivfloza

80 mg/.5mL · Injection, Solution

  • Prescription only
Active substance
Nedosiran
Made by
Novo Nordisk

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-03-03

Used for
  • RIVFLOZA is indicated to lower urinary oxalate levels in
The label’s usual adult dose

Adults and Pediatric Patients (2 years of age and older) Body weight Less than 39 kg 39 kg to less than 50 kg 50 kg and above Age 2 to less than 12 years 3.3 mg/kg 128 mg 160 mg Age 12 years and older 128 mg 160 mg Missed Dose If a planned dose is missed, administer RIVFLOZA as soon as possible.

Full directions ↓
Do not take it if

None. None. ( 4 )

All warnings ↓
Good to know
  • Prescription only
  • Mediclarum could not reach the FDA to check for recalls just now. This is not a result.
  • Mediclarum could not reach the FDA to check for shortages just now.
2other products contain Nedosiran — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • RIVFLOZA is indicated to lower urinary oxalate levels in
  • children 2 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 m 2 [see Clinical Pharmacology (‎ 12.3 )], Clinical Studies (‎ 14.1 )].
  • RIVFLOZA is an LDHA -directed small interfering RNA indicated to lower urinary oxalate levels in
  • children 2 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 m 2 .
  • (‎ 1 )

From the official label · 2025-03-03 · DailyMed

How it works

From this product’s own US prescribing label.

Nedosiran is a double-stranded siRNA, conjugated to GalNAc aminosugar residues.

After subcutaneous administration, the GalNAc-conjugated sugars bind to asialoglycoprotein receptors (ASGPR) to deliver nedosiran to hepatocytes.

How the body breaks it down

T max [Median (Range)] 6 (2 to 12) hours Distribution a Estimated Vz/F 126 L Protein Binding 85.6% Elimination Half-Life (Mean (%CV)]) 15 (68) hours Estimated CL/F 5.7 L/hr Metabolism Primary Pathway Nedosiran is metabolized by endo- and exonucleases to shorter oligonucleotides.

How it leaves the body

Primary Pathway Approximately 27% of the administered nedosiran dose is excreted unchanged into the urine within 24 hours of dosing. a Nedosiran distributes primarily to the liver after subcutaneous administration.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-03-03

Do not take it if

None. None. ( 4 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • The recommended dosage is shown below and is administered subcutaneously once monthly.
  • (‎ 2.1 ) Body weight Less than 39 kg 39 kg to less than 50 kg 50 kg and above Age 2 to less than 12 years 3.3 mg/kg 128 mg 160 mg Age 12 years and older 128 mg 160 mg See full Prescribing Information for important administration instructions.
  • (‎ 2.2 )
  • 2.1 Recommended Dosage RIVFLOZA is administered subcutaneously once monthly at the recommended doses shown in Table 1 .
  • Dosing is based on actual body weight.
  • Table 1:
  • RIVFLOZA Dose Regimen in
  • Adults and Pediatric Patients (2 years of age and older) Body weight Less than 39 kg 39 kg to less than 50 kg 50 kg and above Age 2 to less than 12 years 3.3 mg/kg 128 mg 160 mg Age 12 years and older 128 mg 160 mg Missed Dose If a planned dose is missed, administer RIVFLOZA as soon as possible.
  • If the planned dose is missed by more than 7 days, administer RIVFLOZA as soon as possible and resume monthly dosing from the most recently administered dose.
  • 2.2 Administration Instructions Pre-filled syringe:
  • A healthcare provider, caregiver, or patient 12 years of age and older may inject RIVFLOZA using the pre-filled syringe.
  • In pediatric patients 2 to less than 12 years of age who weigh ≥39 kg, a healthcare provider or caregiver may inject RIVFLOZA using the pre-filled syringe.
  • Vials:
  • RIVFLOZA vials are intended for use under the guidance and supervision of a healthcare provider.
  • Adult patients or caregivers may administer RIVFLOZA after proper training in preparing RIVFLOZA vials for administration, if a healthcare provider determines that it is appropriate, and with medical follow-up as necessary.
  • Administer RIVFLOZA by subcutaneous injection to the abdomen (at least 2 inches from the navel) or the upper thigh.
  • Do not inject into a vein or into scarred or bruised skin.
  • Inspect visually for particulate matter and discoloration prior to injection.
  • RIVFLOZA should be colorless-to-yellow and particle free.
  • If the solution is cloudy or contains particulate matter, do not use.
  • Instructions for delivering the dosage are provided in the Instructions for Use leaflets enclosed with the RIVFLOZA Pre-filled Syringe and single-dose vial.
  • Discard the unused portion of the drug.

Quoted from the official label, section “Dosage & Administration”.

Pregnancy and breastfeeding

  • Risk Summary Available data from reports of pregnancy in clinical trials with RIVFLOZA are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
  • In animal reproduction studies, no adverse developmental effects were observed when nedosiran was administered to pregnant mice at doses up to approximately 58 times the maximum recommended human dose (MRHD) of 160 mg nedosiran (equivalent to 170 mg nedosiran sodium) per dose, based on body surface area (BSA) or upon administration of a mouse-specific (pharmacologically active) analog.
  • Subcutaneous administration of nedosiran to pregnant rabbits during the period of organogenesis at doses approximating the MRHD resulted in increased fetal loss in the presence of maternal toxicity.
  • Adverse developmental outcomes (fetal cardiovascular and skeletal malformations) were observed at a dose approximately 2 times the MRHD (see Data).
  • Nedosiran is not pharmacologically active in rabbits or mice.
  • The cause for the embryo-fetal toxicities observed in rabbits remains unclear.
  • The estimated background risk of major birth defects and miscarriage in the indicated population is unknown.
  • All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
  • Data Animal Data In mice, subcutaneous administration of nedosiran at doses up to 2000 mg/kg/dose (approximately 58 times the MRHD based on BSA) or a mouse-specific (pharmacologically active) analog (10 mg/kg/dose) during organogenesis (dosing on gestation days 6, 8, 10, 12, and 14 for nedosiran; gestation days 3 and 10 for the analog) did not have adverse effects on embryo-fetal development.
  • Subcutaneous administration of nedosiran (0, 2, 6 or 20 mg/kg/dose) to pregnant rabbits during organogenesis (dosing on gestation days 7, 9, 11, 13, 15, 17, and 19) resulted in maternal toxicity on the basis of body weight loss of up to 6.5% following the first dose in the 6 and 20 mg/kg/dose groups.
  • Higher post-implantation loss and lower numbers of live fetuses occurred at ≥6 mg/kg/dose (exposures equivalent to the MRHD based on BSA), and fetal cardiovascular and skeletal malformations occurred at the 20 mg/kg/dose (2 times the MRHD based on BSA).
  • At the 2 mg/kg/dose, which is below the MRHD, no adverse findings were seen.
  • In a pre- and postnatal study in mice, subcutaneous administration of nedosiran (0, 250, 500, or 1000 mg/kg/dose) or a mouse-specific (pharmacologically active) analog (10 mg/kg/dose) from implantation (dosing on gestational days 6, 8, 10, 12, 14, 16) to weaning (dosing on lactation days 1, 8, 15, 20) did not have adverse effects on the growth, viability, development and reproductive performance of the offspring .
  • IN SPECIFIC POPULATIONS
  • 8.1 Pregnancy Risk Summary Available data from reports of pregnancy in clinical trials with RIVFLOZA are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
  • In animal reproduction studies, no adverse developmental effects were observed when nedosiran was administered to pregnant mice at doses up to approximately 58 times the maximum recommended human dose (MRHD) of 160 mg nedosiran (equivalent to 170 mg nedosiran sodium) per dose, based on body surface area (BSA) or upon administration of a mouse-specific (pharmacologically active) analog.
  • Subcutaneous administration of nedosiran to pregnant rabbits during the period of organogenesis at doses approximating the MRHD resulted in increased fetal loss in the presence of maternal toxicity.
  • Adverse developmental outcomes (fetal cardiovascular and skeletal malformations) were observed at a dose approximately 2 times the MRHD (see Data).
  • Nedosiran is not pharmacologically active in rabbits or mice.
  • The cause for the embryo-fetal toxicities observed in rabbits remains unclear.
  • The estimated background risk of major birth defects and miscarriage in the indicated population is unknown.
  • All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
  • Data Animal Data In mice, subcutaneous administration of nedosiran at doses up to 2000 mg/kg/dose (approximately 58 times the MRHD based on BSA) or a mouse-specific (pharmacologically active) analog (10 mg/kg/dose) during organogenesis (dosing on gestation days 6, 8, 10, 12, and 14 for nedosiran; gestation days 3 and 10 for the analog) did not have adverse effects on embryo-fetal development.
  • Subcutaneous administration of nedosiran (0, 2, 6 or 20 mg/kg/dose) to pregnant rabbits during organogenesis (dosing on gestation days 7, 9, 11, 13, 15, 17, and 19) resulted in maternal toxicity on the basis of body weight loss of up to 6.5% following the first dose in the 6 and 20 mg/kg/dose groups.
  • Higher post-implantation loss and lower numbers of live fetuses occurred at ≥6 mg/kg/dose (exposures equivalent to the MRHD based on BSA), and fetal cardiovascular and skeletal malformations occurred at the 20 mg/kg/dose (2 times the MRHD based on BSA).
  • At the 2 mg/kg/dose, which is below the MRHD, no adverse findings were seen.
  • In a pre- and postnatal study in mice, subcutaneous administration of nedosiran (0, 250, 500, or 1000 mg/kg/dose) or a mouse-specific (pharmacologically active) analog (10 mg/kg/dose) from implantation (dosing on gestational days 6, 8, 10, 12, 14, 16) to weaning (dosing on lactation days 1, 8, 15, 20) did not have adverse effects on the growth, viability, development and reproductive performance of the offspring .
  • 8.2 Lactation Risk Summary There are no data on the presence of RIVFLOZA in human or animal milk, the effects on the breastfed child, or the effects on milk production.
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RIVFLOZA and any potential adverse effects on the breastfed infant from RIVFLOZA or from the underlying maternal condition.
  • 8.4 Pediatric Use The safety and effectiveness of RIVFLOZA have been established in pediatric patients aged 2 years and older.
  • Use of RIVFLOZA in these age groups is supported by evidence from an adequate and well-controlled trial in adult and pediatric patients 9 years of age and older (PHYOX2), and a single-arm study in pediatric patients 2 to less than 12 years of age (PHYOX8) [see Clinical Studies ( ‎ 14 )] .
  • The safety and effectiveness of RIVFLOZA in patients younger than 2 years of age have not been established.
  • 8.5 Geriatric Use Clinical studies of RIVFLOZA did not include patients aged 65 and over to determine whether they respond differently from younger patients.
  • No dose adjustment is recommended in patients ≥65 years old [see Clinical Pharmacology (‎ 12.3 )].
  • 8.6 Hepatic Impairment No dose adjustment of RIVFLOZA is recommended for patients with mild hepatic impairment (total bilirubin ≤ upper limit of normal [ULN] and aspartate aminotransferase [AST] > ULN or total bilirubin >1 to 1.5 times ULN and any AST).
  • RIVFLOZA has not been studied in patients with moderate or severe hepatic impairment (total bilirubin >1.5 ULN with any AST) [see Clinical Pharmacology ( ‎ 12.3 )] .
  • 8.7 Renal Impairment No dose adjustment is recommended in patients with an estimated glomerular filtration rate (eGFR) of ≥30 mL/min/1.73 m 2 [see Clinical Pharmacology (‎ 12.3 )] .
  • RIVFLOZA has not been studied in PH1 patients with severe renal impairment (eGFR <30 mL/min/1.73 m 2 ).

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

  • The safety and effectiveness of RIVFLOZA have been established in pediatric patients aged 2 years and older.
  • Use of RIVFLOZA in these age groups is supported by evidence from an adequate and well-controlled trial in adult and pediatric patients 9 years of age and older (PHYOX2), and a single-arm study in pediatric patients 2 to less than 12 years of age (PHYOX8) [see Clinical Studies ( ‎ 14 )] .
  • The safety and effectiveness of RIVFLOZA in patients younger than 2 years of age have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Clinical studies of RIVFLOZA did not include patients aged 65 and over to determine whether they respond differently from younger patients. No dose adjustment is recommended in patients ≥65 years old [see Clinical Pharmacology (‎ 12.3 )].

Quoted from the official label, section “Geriatric Use”.

Side effects

  • Most common adverse reactions (reported in ≥20% of patients) are injection site reactions.
  • (‎ 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-844-906-5099 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • The safety of RIVFLOZA has been evaluated in one placebo-controlled clinical trial (PHYOX2) and one open-label extension study (PHYOX3).
  • Across these studies, 29 adults and 12 children with PH1 have been treated with RIVFLOZA.
  • Patients with PH1 in these studies ranged in age from 9 to 46 years at first dose.
  • The median duration of exposure was approximately 15 months (range 1-29 months).
  • Overall, 38 patients with PH1 were treated for at least 6 months, 24 patients for at least 12 months, and 16 patients for at least 18 months.
  • In the randomized, placebo-controlled, double-blind PHYOX2 trial in pediatric and adult patients 9 to 46 years of age, 18 patients with PH1 received RIVFLOZA and 11 patients received placebo.
  • Of the 18 patients treated with RIVFLOZA, 17 patients received ≥5 months of active treatment.
  • The most common adverse reactions were injection site reactions, which were reported in 7 patients with PH1 (39%) on RIVFLOZA as compared to no patients on placebo.
  • Injection site reactions included erythema, pain, bruising, and rash and were generally mild and did not lead to discontinuation of treatment.
  • In the single-arm extension study (PHYOX3) that included 40 patients with PH1, additional injection site reactions included atrophy in 1 patient (3%).
  • The safety of RIVFLOZA has additionally been evaluated in one single-arm clinical study (PHYOX8) in 15 pediatric patients 2 to less than 12 years of age with PH1 and an eGFR > 30 mL/min/1.73 m 2 .
  • Injection site reactions were reported in 2 patients (13%).
  • Overall, the RIVFLOZA safety profile was similar to that seen in PHYOX2.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Instruct patients/caregivers on the appropriate dose of RIVFLOZA to use, the timing of the dose, how and where to inject subcutaneously, and what to do if a dose is missed. For more information contact:
  • Dicerna Pharmaceuticals, Inc. A Novo Nordisk company Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, NJ 08536 1-844-906-5099 Manufactured by Pyramid Laboratories 3598 Cadillac Ave Costa Mesa, CA 92626

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

  • FORMS AND STRENGTHS RIVFLOZA Injection 160 mg/mL (present as 170 mg nedosiran sodium) is a clear, colorless-to-yellow solution available as follows:
  • 80 mg/0.5 mL single-dose vial
  • 128 mg/0.8 mL single-dose Pre-filled Syringe
  • 160 mg/ mL single-dose Pre-filled Syringe RIVFLOZA Injection 160 mg/mL is a clear, colorless-to-yellow solution available as follows:
  • 80 mg/0.5 mL single-dose vial
  • 128 mg/0.8 mL single-dose Pre-filled Syringe
  • 160 mg/ mL single-dose Pre-filled Syringe (‎ 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • 16.1 How Supplied RIVFLOZA is a clear, sterile, preservative-free, colorless-to-yellow solution available in single-dose pre-filled syringes and single-dose vials in cartons containing one unit each.
  • Table 3:
  • RIVFLOZA Presentations RIVFLOZA Presentation Total Volume Total amount available in presentation Concentration NDC number Single-dose vial 0.5 mL 80 mg 160 mg/mL NDC 0169-5308-01 Single-dose Pre-filled Syringe 0.8 mL 128 mg 160 mg/mL NDC 0169-5307-08 Single-dose Pre-filled Syringe 1 mL 160 mg 160 mg/mL NDC 0169-5306-10
  • 16.2 Storage and Handling 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.
  • Table 4:
  • Storage Conditions for RIVFLOZA Refrigerated 2°C to 8°C (36°F to 46°F) Room Temperature at 15°C to 30°C (59°F to 86°F) RIVFLOZA Until expiration date Maximum 28 days (4 weeks)

Quoted from the official label, section “How Supplied”.

What is in it

  • RIVFLOZA injection contains nedosiran, a double-stranded small interfering RNA (siRNA) with four covalently attached N -acetyl-D-galactosamine (GalNAc) residues.
  • Nedosiran targets lactate dehydrogenase A (LDHA) in hepatocytes via GalNAc-mediated delivery.
  • The structural formula of the nedosiran sodium drug substance is presented below:
  • The molecular formula of nedosiran sodium is C 662 H 808 F 19 N 231 O 413 P 57 S 6 Na 57 with a molecular weight of 22,238 Da.
  • Nedosiran sodium is freely soluble in water.
  • RIVFLOZA Pre-filled Syringe is supplied as a clear, sterile, preservative-free, colorless‑to‑yellow solution for subcutaneous injection containing either the equivalent of 160 mg (present as 170 mg nedosiran sodium salt) nedosiran in 1 mL or the equivalent of 128 mg (present as 136 mg nedosiran sodium salt) nedosiran in 0.8 mL of water for injection and sodium hydroxide and/or hydrochloric acid to adjust the pH to ~7.2.
  • RIVFLOZA vial is supplied as a clear, sterile, preservative-free, colorless-to-yellow solution for subcutaneous injection containing the equivalent of 80 mg (present as 85 mg nedosiran sodium salt) nedosiran in 0.5 mL of water for injection and sodium hydroxide and/or hydrochloric acid to adjust the pH to ~7.2. structural_formula

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Details

Made byNovo Nordisk
Active substanceNedosiran
Strength80 mg/.5mL
FormInjection, Solution
RouteSubcutaneous
Packs1 VIAL in 1 CARTON / .5 mL in 1 VIAL
NDC0169-5308

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Rivfloza160 mg/mLPrescription onlyInjection, Solution Novo Nordisk · NedosiranRivfloza128 mg/.8mLPrescription onlyInjection, Solution Novo Nordisk · Nedosiran

See every product with Nedosiran