Source: FDA, National Drug Code (US) Revision Year: 2023
RIVFLOZA is indicated to lower urinary oxalate levels in children 9 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 m² [see Clinical Pharmacology (12.3)], Clinical Studies (14.1)].
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 (9 years of age and older):
| Age | Body Weight | Dosing Regimen |
|---|---|---|
| Adults and adolescents 12 years and older | Greater than or equal to 50 kg | 160 mg once monthly (Pre-filled Syringe, 1 mL) |
| Less than 50 kg | 128 mg once monthly (Pre-filled Syringe, 0.8 mL) | |
| Children 9 to 11 years | Greater than or equal to 50 kg | 160 mg once monthly (Pre-filled Syringe, 1 mL) |
| Less than 50 kg | 3.3 mg/kg once monthly, not to exceed 128 mg (Vial, dose volume rounded to nearest 0.1 mL) |
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.
Pre-filled syringe: A healthcare professional, caregiver, or patient 12 years of age and older may inject RIVFLOZA using the pre-filled syringe. In pediatric patients 9 to 11 years of age who weigh ≥50 kg, a healthcare professional 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 professional. A caregiver may administer RIVFLOZA to pediatric patients after proper training in preparing RIVFLOZA vials for administration, if a healthcare professional 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.
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) |
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