Ifex (Ifosfamide / Mesna) - Indications and Dosage

INDICATION AND USAGE

IFEX, used in combination with certain other approved antineoplastic agents, is indicated for third line chemotherapy of germ cell testicular cancer. It should ordinarily be used in combination with a prophylactic agent for hemorrhagic cystitis, such as mesna.

DOSAGE AND ADMINISTRATION

IFEX should be administered intravenously at a dose of 1.2 g/m² per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity (Platelets ≥100,000/µL, WBC ≥4,000/µL). In order to prevent bladder toxicity, IFEX should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day. A protector, such as mesna, should also be used to prevent hemorrhagic cystitis. IFEX should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Although IFEX has been administered to a small number of patients with compromised hepatic and/or renal function, studies to establish optimal dose schedules of IFEX in such patients have not been conducted.

Preparation for Intravenous Administration/Stability

Injections are prepared for parenteral use by adding Sterile Water for Injection, USP, or Sterile Bacteriostatic Water for Injection, USP (benzyl alcohol or parabens preserved), to the vial and shaking to dissolve. Use the quantity of diluent shown below to constitute the product:

Dosage Strength	Quantity of Diluent	Final Concentration
1 gram	20 mL	50 mg/mL
3 grams	60 mL	50 mg/mL

Solutions of ifosfamide may be diluted further to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:

     5% Dextrose Injection, USP
     0.9% Sodium Chloride Injection, USP
     Lactated Ringer’s Injection, USP
     Sterile Water for Injection, USP

Because essentially identical stability results were obtained for Sterile Water admixtures as for the other admixtures (5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer’s Injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB^™ bags that contain intermediate concentrations or mixtures of excipients (eg, 2.5% Dextrose Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose and 0.9% Sodium Chloride Injection) is also acceptable.

Constituted or constituted and further diluted solutions of IFEX should be refrigerated and used within 24 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

HOW SUPPLIED

IFEX^® (ifosfamide for injection) is available in combination packages with the uroprotective agent Mesnex^® (mesna) injection or as single-dose vials as follows:

IFEX (ifosfamide for injection)/Mesnex (mesna) injection.

NDC 0015-3556-26	5 × 1-gram Single-Dose Vial of Ifex/3 × 1-gram Multidose Vial of Mesnex
NDC 0015-3554-27	10 × 1-gram Single-Dose Vial of Ifex/10 × 1-gram Multidose Vial of Mesnex
NDC 0015-3564-15	2 × 3-gram Single-Dose Vial of Ifex/6 × 1-gram Multidose Vial of Mesnex

IFEX (ifosfamide for injection).

NDC 0015-0556-05	1-gram Single-Dose Vial
NDC 0015-0557-41	3-gram Single-Dose Vial

Store at controlled room temperature 20° C to 25° C (68° F to 77° F).

Protect from temperatures above 30° C (86° F).

Procedures for proper handling and disposal of anticancer drugs should be considered. Skin reactions associated with accidental exposure to IFEX may occur. The use of gloves is recommended. If IFEX solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water. Several guidelines on this subject have been published.^1-7 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.