"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
DOSAGE AND ADMINISTRATION
IFEX (ifosfamide) 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 (ifosfamide) 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 reduce the incidence of hemorrhagic cystitis. IFEX (ifosfamide) should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Although IFEX (ifosfamide) has been administered to a small number of patients with compromised hepatic and/or renal function, studies to establish optimal dose schedules of IFEX (ifosfamide) 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 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 (ifosfamide) should be refrigerated and used within 24 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
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).
Caution should be excersied when handling IFEX (ifosfamide) . Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-4 Skin reactions associated with accidental exposure to IFEX (ifosfamide) may occur. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and solutions containing IFEX (ifosfamide) . If IFEX (ifosfamide) solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water.
1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Pulication No. 2004-165.
2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling occupational exposure to hazardous drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006;63:1172-1193.
4. Polovich M, White JM, Kelleher LO, eds. 2005. Chemotherapy and biotherapy guidelines and recommendations for practice. 2nd ed. Pittsburgh, PA: Oncology Nursing Society.
Manufactured by: Baxter Healthcare Corporation Deerfield, IL 60015 USA. For Product Inquiry 1800 ANA DRUG (1-800-262-3784).
Last reviewed on RxList: 5/12/2011
This monograph has been modified to include the generic and brand name in many instances.
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