RIVFLOZA Solution for injection Ref.[107412] Active ingredients: Nedosiran

Source: FDA, National Drug Code (US) Revision Year: 2023

Product description

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 C₆₆₂H₈₀₈F₁₉N₂₃₁O₄₁₃P₅₇S₆Na₅₇ 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.

Dosage Forms and Strengths
RIVFLOZA Injection 160 mg/mL (present as 170 mg nedosiran sodium salt) 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 (1 mL) single-dose Pre-filled Syringe

How Supplied

RIVFLOZA is a clear, sterile, preservative-free, colorless-to-yellow solution available in singledose 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

Manufactured by: Pyramid Laboratories, 3598 Cadillac Ave, Costa Mesa, CA 92626

Drugs

Drug	Countries
RIVFLOZA	United States

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