Frindovyx Dosage

Important Administration Instructions

During or immediately after the administration of FRINDOVYX, adequate amounts of fluid should be ingested or infused to force diuresis in order to reduce the risk of urinary tract toxicity. Therefore, FRINDOVYX should be administered in the morning.

Recommended Dosage for Malignant Diseases

Adults and Pediatric Patients

Intravenous

When used as the only oncolytic drug therapy, the recommended dosage for the initial course of FRINDOVYX for patients with no hematologic deficiency is 40 mg/kg to 50 mg/kg given intravenously in divided doses over a period of 2 to 5 days. Other intravenous regimens include 10 mg/kg to 15 mg/kg given every 7 to 10 days or 3 mg/kg to 5 mg/kg twice weekly.

Adjust the dosage of FRINDOVYX based on the specific regimen administered, response to treatment, myelosuppression or other adverse reactions, and patient risk factors.

Preparation, Handling and Administration

FRINDOVYX is a hazardous drug. Follow applicable special handling and disposal procedures1. Caution should be exercised when handling and preparing FRINDOVYX. To minimize the risk of dermal exposure, always wear gloves when handling vials containing FRINDOVYX.

FRINDOVYX

Intravenous Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use cyclophosphamide vials if there are signs of particulate matter.

Cyclophosphamide does not contain any antimicrobial preservative and thus care must be taken to assure the sterility of prepared solutions. Use aseptic technique.

For Direct Intravenous Injection

Withdraw the prescribed dose of FRINDOVYX from the vial with a syringe and dilute with 0.9% Sodium Chloride Injection, USP to a concentration of 20 mg/mL of cyclophosphamide.

For Intravenous Infusion

Withdraw the prescribed dose of FRINDOVYX from the vial with a syringe and dilute FRINDOVYX to a concentration of 2 mg/mL with any of the following diluents:

• 0.45% Sodium Chloride Injection, USP
• 5% Dextrose Injection, USP
• 5% Dextrose and 0.9% Sodium Chloride Injection, USP

To reduce the likelihood of adverse reactions that appear to be administration rate-dependent (e.g., facial swelling, headache, nasal congestion, scalp burning), cyclophosphamide should be injected or infused very slowly. Duration of the infusion also should be appropriate for the volume and type of carrier fluid to be infused.

Storage of Diluted Cyclophosphamide Solution:

If not used immediately, for microbiological integrity, cyclophosphamide solutions should be stored as described in Table 1.

Storage of Undiluted Cyclophosphamide Solution (Multiple-Dose Vial):

After first use, store partially used multiple-dose vial in the original carton refrigerated at 2°C to 8°C (36ºF to 46°F) for up to 28 days or at room temperature at 20°C to 25°C (68ºF to 77°F) for up to 7 days. Discard unused portion.