RIVFLOZA 80 mg/.5mL
nedosiran · INJECTION, SOLUTION · Novo Nordisk
RIVFLOZA is a injection, solution containing nedosiran at 80 mg/.5mL, taken subcutaneous. Manufactured by Novo Nordisk.
Key Facts
- Brand Name
- RIVFLOZA
- Generic Name
- nedosiran
- NDC Code (Product)
0169-5308- Manufacturer
- Novo Nordisk
- Strength
- 80 mg/.5mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA215842
- Marketing Start
- 02/19/2024
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS 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 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 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 pediatri…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS 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, …
Frequently Asked Questions
What is RIVFLOZA used for?
RIVFLOZA contains nedosiran. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is RIVFLOZA a controlled substance?
RIVFLOZA is not classified as a controlled substance by the DEA.
What is the generic name for RIVFLOZA?
The generic name for RIVFLOZA is nedosiran. There are no other listed brand versions of nedosiran.
What is the NDC code for RIVFLOZA 80 mg/.5mL?
The NDC (National Drug Code) for RIVFLOZA 80 mg/.5mL is 0169-5308, listed by Novo Nordisk.
Other RIVFLOZA Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)