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Cisplatin

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Cisplatin

Indications
Dosage
How Supplied

INDICATIONS

Cisplatin injection (cisplatin injection (cisplatin (cisplatin injection) injection) ) is indicated as therapy to be employed as follows:

Metastatic Testicular Tumors - In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures.

Metastatic Ovarian Tumors - In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of cisplatin (cisplatin injection) and cyclophosphamide. Cisplatin (cisplatin injection) , as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received cisplatin (cisplatin injection) therapy.

Advanced Bladder Cancer - Cisplatin (cisplatin injection) is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments such as surgery and/or radiotherapy,

DOSAGE AND ADMINISTRATION

Note: Needles or intravenous sets containing aluminum parts that may come in contact with cisplatin (cisplatin injection) should not be used for preparation or administration. Aluminum reacts with cisplatin (cisplatin injection) , causing precipitate formation and a loss of potency.

Metastatic Testicular Tumors - The usual cisplatin (cisplatin injection) dose for the treatment of testicular cancer in combination with other approved chemotherapeutic agents is 20 mg/m2 IV daily for 5 days per cycle.

Metastatic Ovarian Tumors - The usual cisplatin (cisplatin injection) dose for the treatment of metastatic ovarian tumors in combination with cyclophosphamide is 75 to 100 mg/m2 IV per cycle once every four weeks (DAY 1).

The dose of cyclophosphamide when used in combination with cisplatin (cisplatin injection) is 600 mg/m2 IV once every four weeks (DAY 1).

For directions for the administration of cyclophosphamide, refer to the cyclophosphamide package insert.

In combination therapy, cisplatin (cisplatin injection) and cyclophosphamide are administered sequentially.

As a single agent, cisplatin (cisplatin injection) should be administered at a dose of 100 mg/m2 IV per cycle once every four weeks.

Advanced Bladder Cancer -Cisplatin (cisplatin injection) should be administered as a single agent at a dose of 50 to 70 mg/m2 IV per cycle once every 3 to 4 weeks depending on the extent of prior exposure to radiation therapy and/or prior chemotherapy. For heavily pretreated patients an initial dose of 50 mg/m2 per cycle repeated every four weeks is recommended.

All Patients - Pretreatment hydration with 1 to 2 liters of fluid infused for 8 to 12 hours prior to a cisplatin (cisplatin injection) dose is recommended. The drug is then diluted in 2 liters of 5% Dextrose in 1/2 or 1/3 normal saline containing 37.5 g of mannitol, and infused over a 6- to 8- hour period. If diluted solution is not to be used within 6 hours, protect solution from light. Do not dilute cisplatin (cisplatin injection) in just 5% Dextrose Injection. Adequate hydration and urinary output must be maintained during the following 24 hours.

A repeat course of cisplatin (cisplatin injection) 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,WBC4,000/mm3).Subsequent doses of cisplatin (cisplatin injection) should not be given until an audiometric analysis indicates that auditory acuity is within normal limits.

As with other potentially toxic compounds, caution should be exercised in handling the aqueous solution. Skin reactions associated with accidental exposure to cisplatin (cisplatin injection) may occur. The use of gloves is recommended. If cisplatin (cisplatin injection) contacts the skin or mucosa, immediately and thoroughly wash the skin with soap and water and flush the mucosa with water.

The aqueous solution should be used intravenously only and should be administered by IV infusion over a 6- to 8- hour period.

NOTE TO THE PHARMACIST-Exercise caution to prevent inadvertent cisplatin (cisplatin injection) overdosage. Please call prescriber if dose greater than 100 mg/m2 per cycle. Aluminum cap and flip-off seal of vial have been imprinted with the following statement:

CALL DR. IF DOSE > 100 MG/M2/CYCLE.

Stability

Cisplatin Injection (cisplatin injection (cisplatin (cisplatin injection) injection) ) is a sterile, multidose vial without preservatives.

Store at 15° to 25°C (59° to 77°F). Do not refrigerate. Protect unopened container from light.

The cisplatin (cisplatin injection) remaining in the amber vial following initial entry is stable for 28 days protected from light or for 7 days under fluorescent room light.

Procedures for proper handling and disposal of anticancer drugs should be considered. 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.

HOW SUPPLIED

Cisplatin Injection (cisplatin injection (cisplatin (cisplatin injection) injection) ) is supplied as follows:

NDC 55390-099-01- Each amber vial contains 1 mg/mL; 200 mg/200 mL MULTIPLE DOSE vial of cisplatin (cisplatin injection) .
NDC 55390-112-99 -Each amber vial contains 1 mg/mL; 100 mg/100 mL MULTIPLE DOSE vial of cisplatin (cisplatin injection) .
NDC 55390-112-50 - Each amber vial contains 1 mg/mL; 50 mg/50 mL MULTIPLE DOSE vial of cisplatin (cisplatin injection) .

REFERENCES

1. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents. US Government Printing Office, Washington, D.C. 20402.

2. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA. 1985; 253(11): 1590-1592.

3. National Study Commission on Cytotoxic Exposure - Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, SC.D, Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.

4. Clinical Oncological Society of Australia. Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia 1983; 1:426-428.

5. Jones RB, et al: Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA - A Cancer Journal for Clinicians. 1983; (Sept/Oct) 258-263.

6. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm 1990; 47: 1033-1049.

7. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines). Am J Health-Syst Pharm 1996; 53: 1669-1685.

Manufactured By: Ben Venue Laboratories, Inc., Bedford, OH 44146. Manufactured for: Bedford Laboratories™ Bedford, OH 44146. FDA Rev date: 12/5/2002

Last reviewed on RxList: 6/13/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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