al function.
Other
Alopecia occurred in approximately 83% of the patients treated with IFEX as a single agent. In combination, this incidence may be as high as 100%, depending on the other agents included in the chemotherapy regimen. Increases in liver enzymes and/or bilirubin were noted in 3% of the patients. Other less frequent side effects included phlebitis, pulmonary symptoms, fever of unknown origin, allergic reactions, stomatitis, cardiotoxicity, and polyneuropathy.
OVERDOSAGE
No specific antidote for IFEX is known. Management of overdosage would include general supportive measures to sustain the patient through any period of toxicity that might occur.
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, USP) is available in single-dose vials as follows:
IFEX (ifosfamide for injection).
NDC 0338-3991-01 1-gram Single-Dose Vial
NDC 0338-3993-01 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 soluti |
