Brand Name
Rivfloza
Generic Name
Nedosiran
View Brand Information FDA approval date: February 19, 2024
Form: Injection
What is Rivfloza (Nedosiran)?
RIVFLOZA is indicated to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 and relatively preserved kidney function, e.g., eGFR ≥30 mL/min.
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Brand Information
RIVFLOZA (nedosiran)
1INDICATIONS AND USAGE
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
2DOSAGE 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
3CONTRAINDICATIONS
None.
4DESCRIPTION
RIVFLOZA injection contains nedosiran, a double-stranded small interfering RNA (siRNA) with four covalently attached
The structural formula of the nedosiran sodium drug substance is presented below:
The molecular formula of nedosiran sodium is C
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.
5PATIENT COUNSELING INFORMATION
- 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:
Novo Nordisk Inc.
Manufactured by
6PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – Pre-filled Syringe 128 mg/0.8 mL
NDC: 0169-5307-08
List 530708
rivfloza
(nedosiran) injection
128 mg/0.8 mL
For subcutaneous injection only
1 x 0.8 mL Sterile Single-dose Pre-filled Syringe
Do not use the Pre-filled Syringe if the carton is damaged or if the tamper proof seal is not intact.
Rx Only
Dicerna™
a Novo Nordisk company
7PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – Pre-filled Syringe 160 mg/mL
NDC: 0169-5306-10
List 530610
rivfloza
(nedosiran) injection
160 mg/mL
For subcutaneous injection only
1 x 1 mL Sterile Single-dose Pre-filled Syringe
Do not use the Pre-filled Syringe if the carton is damaged or if the tamper proof seal is not intact.
Rx Only
Dicerna™
a Novo Nordisk company
8PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – Vial 80 mg/0.5 mL
NDC: 0169-5308-01
List 530801
rivfloza
(nedosiran) injection
80 mg/0.5 mL
For subcutaneous injection only
1 x 0.5 mL Sterile Single-dose Vial – Discard Unused Portion
Do not use the vial if the carton is damaged or if the tamper proof seal is not intact.
Rx Only
Dicerna™
a Novo Nordisk company
