CISPLATIN (Page 3 of 3)

OVERDOSAGE

Caution should be exercised to prevent inadvertent overdosage with cisplatin. Acute overdosage with this drug may result in kidney failure, liver failure, deafness, ocular toxicity (including detachment of the retina), significant myelosuppression, intractable nausea and vomiting and/or neuritis. In addition, death can occur following overdosage.
No proven antidotes have been established for cisplatin overdosage. Hemodialysis, even when initiated four hours after the overdosage, appears to have little effect on removing platinum from the body because of cisplatin’s rapid and high degree of protein binding. Management of overdosage should include general supportive measures to sustain the patient through any period of toxicity that may occur.

DOSAGE & ADMINISTRATION

Cisplatin is administered by slow intravenous infusion. CISPLATIN SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION.

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

The usual cisplatin 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 dose for the treatment of metastatic ovarian tumors in combination with cyclophosphamide is 75 to 100 mg/m2 IV per cycle once every 4 weeks (DAY 1).

The dose of cyclophosphamide when used in combination with cisplatin is 600 mg/m2 IV once every 4 weeks (DAY 1).

For directions for the administration of cyclophosphamide, refer to the cyclophosphamide package insert.
In combination therapy, cisplatin and cyclophosphamide are administered sequentially.
As a single agent, cisplatin should be administered at a dose of 100 mg/m2 IV per cycle once every 4 weeks.
Advanced Bladder Cancer

Cisplatin 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 4 weeks is recommended.
All Patients

Pretreatment hydration with 1 to 2 liters of fluid infused for 8 to 12 hours prior to a cisplatin 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 hour to 8 hour period. If diluted solution is not to be used within 6 hours, protect solution from light. Do not dilute cisplatin in just 5% Dextrose Injection. Adequate hydration and urinary output must be maintained during the following 24 hours.

A repeat course of cisplatin 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 ≥ 4,000/mm3). Subsequent doses of cisplatin 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 cisplatin.

Skin reactions associated with accidental exposure to cisplatin may occur. The use of gloves is recommended. If cisplatin 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 hour 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 cisplatin 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

Cisplatin is a sterile, multiple dose vial without preservatives.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. 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

CISplatin Injection (1 mg/mL) is supplied as follows:

NDC No. Strength Package
68083-162-01 50 mg/50 mL vial One Multiple dose vial in one carton
68083-163-01 100 mg/100 mL vial One Multiple dose vial in one carton

The above products are multiple dose vials packaged individually.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not refrigerate. Protect from light.
This container closure is not made with natural rubber latex.

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL — PRINCIPAL DISPLAY — CISplatin 50 mL Multiple Dose Vial Label

NDC 68063-162-01 Rx only
CISplatin Injection
50 mg/50 mL (1 mg/mL)
Cytotoxic Agent
For Intravenous Use
50 mL Multiple Dose Vial
CISplatin doses greater than 100 mg/m2 once every 3 to 4 weeks are rarely used. See Package Insert.

Cisplatin-50mL-vial
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY — CISplatin 100 mL Multiple Dose Vial Label
NDC 68063-163-01 Rx only
CISplatin Injection
100 mg/100 mL (1 mg/mL)
Cytotoxic Agent
For Intravenous Use
100 mL Multiple Dose Vial
Cisplatin doses greater than 100 mg/m2 once every 3 to 4 weeks are rarely used. See Package Insert.
Cisplatin-100mL-vial-label
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY — CISplatin 50 mL Multiple Dose Vial Carton Label
NDC 68063-162-01 Rx only
STOP! Verify Drug Name & Dose!
CISplatin Injection
50 mg/50 mL (1 mg/mL)
Cytotoxic Agent
For Intravenous Use
50 mL Multiple Dose Vial
Cisplatin doses greater than 100 mg/m2 once every 3 to 4 weeks are rarely used. See Package Insert.
Cisplatin-50mL-carton-label
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY — CISplatin 100 mL Multiple Dopse Vial Carton Label
NDC 68063-163-01 Rx only
STOP! Verify Drug Name & Dose!
CISplatin Injection
100 mg/100 mL (1 mg/mL)
Cytotoxic Agent
For Intravenous Use
100 mL Multiple Dose Vial
Cisplatin doses greater than 100 mg/m2 once every 3 to 4 weeks are rarely used. See Package Insert.
Cisplatin-100mL-carton-label
(click image for full-size original)

CISPLATIN cisplatin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-162
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CISPLATIN (CISPLATIN) CISPLATIN 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 9 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68083-162-01 1 VIAL in 1 CARTON contains a VIAL
1 50 mL in 1 VIAL This package is contained within the CARTON (68083-162-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207323 04/03/2017
CISPLATIN cisplatin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-163
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CISPLATIN (CISPLATIN) CISPLATIN 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 9 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68083-163-01 1 VIAL in 1 CARTON contains a VIAL
1 100 mL in 1 VIAL This package is contained within the CARTON (68083-163-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207323 04/03/2017
Labeler — Gland Pharma Limited (918601238)
Establishment
Name Address ID/FEI Operations
Gland Pharma Limited 650540227 ANALYSIS (68083-162), ANALYSIS (68083-163), MANUFACTURE (68083-162), MANUFACTURE (68083-163), PACK (68083-162), PACK (68083-163)

Revised: 03/2017 Gland Pharma Limited

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