s, protect solution from light. Do not dilute PLATINOL-AQ in just 5% Dextrose Injection. Adequate hydration and urinary output must be maintained during the following 24 hours.
A repeat course of PLATINOL-AQ should not be given until the serum creatinine is below 1.5 mg/100 mL, and/or the BUN is below 25 mg/100 mL. A repeat course should not be given until circulating blood elements are at an acceptable level (platelets ≥100,000/mm3, WBC ≥4000/mm3). Subsequent doses of PLATINOL-AQ should not be given until an audiometric analysis indicates that auditory acuity is within normal limits.
PREPARATION OF INTRAVENOUS SOLUTIONS
Preparation Precautions
Caution should be exercised in handling the aqueous solution. Procedures for proper handling and disposal of anticancer drugs should be utilized. Several guidelines on this subject have been published.1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and IV sets containing PLATINOL-AQ.
Skin reactions associated with accidental exposure to cisplatin may occur. The use of gloves is recommended. If PLATINOL-AQ contacts the skin or mucosa, immediately and thoroughly wash the skin with soap and water and flush the mucosa with water. More information is available in the references listed below.
Instructions for Preparation
The aqueous solution should be used intravenously only and should be administered by IV infusion over a 6- to 8-hour period (see DOSAGE AND ADMINISTRATION).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
NOTE TO PHARMACIST: Exercise caution to prevent inadvertent PLATINOL-AQ overdosage. Please call prescriber if dose is greater than 100 mg/m2 per cycle. Aluminum and flip-off seal of vial have been imprinted with the following statement:
CALL DR. IF DOSE>100 MG/M2/CYCLE.
STABILITY
PLATINOL-AQ is a sterile, multidose vial without preservatives.
Store at 15° C to 25° C. Do not refrigerate. Protect unopened container from light.
The cisplatin remaining in the amber vial following initial entry is stable for 28 days protected from light or for 7 days under fluorescent room light.
HOW SUPPLIED
PLATINOL®-AQ (cisplatin injection)
NDC 61126-004-01—Each multidose vial contains 50 mg of cisplatin
NDC 61126-004-02—Each multidose vial contains 100 mg of cisplatin
References
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) Publication 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:
Corden Pharma Latina S.p.A.
Sermoneta-Latina 04013 Italy
Rev December 2011
PLATINOL-AQ
cisplatin injection, solution
Produc |
