Cisplatin
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Questions & Answers
Side Effects & Adverse Reactions
Cisplatin injection produces cumulative nephrotoxicity which is potentiated by aminoglycoside antibiotics. The serum creatinine, blood urea nitrogen (BUN), creatinine clearance, and magnesium, sodium, potassium, and calcium levels should be measured prior to initiating therapy, and prior to each subsequent course. At the recommended dosage, Cisplatin injection should not be given more frequently than once every 3 to 4 weeks (see ADVERSE REACTIONS). Elderly patients may be more susceptible to nephrotoxicity (see PRECAUTIONS: Geriatric Use).
There are reports of severe neuropathies in patients in whom regimens are employed using higher doses of Cisplatin injection or greater dose frequencies than those recommended. These neuropathies may be irreversible and are seen as paresthesias in a stocking-glove distribution, areflexia, and loss of proprioception and vibratory sensation. Elderly patients may be more susceptible to peripheral neuropathy (see PRECAUTIONS: Geriatric Use).
Loss of motor function has also been reported.
Anaphylactic-like reactions to Cisplatin injection have been reported. These reactions have occurred within minutes of administration to patients with prior exposure to Cisplatin injection, and have been alleviated by administration of epinephrine, corticosteroids, and antihistamines.
Cisplatin injection can commonly cause ototoxicity which is cumulative and may be severe. Audiometric testing should be performed prior to initiating therapy and prior to each subsequent dose of drug (see ADVERSE REACTIONS).
Certain genetic variants in the thiopurine S-methyltransferase (TPMT) gene are associated with increased risk of ototoxicity in children administered conventional doses of cisplatin (see CLINICAL PHARMACOLOGY). Children who do not have one of these TPMT gene variants remain at risk for ototoxicity. All pediatric patients receiving cisplatin should have audiometric testing at baseline, prior to each subsequent dose, of drug and for several years post therapy.
Cisplatin injection can cause fetal harm when administered to a pregnant woman. Cisplatin injection is mutagenic in bacteria and produces chromosome aberrations in animal cells in tissue culture. In mice Cisplatin injection is teratogenic and embryotoxic. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients should be advised to avoid becoming pregnant.
The carcinogenic effect of Cisplatin injection was studied in BD IX rats. Cisplatin injection was administered intraperitoneally (i.p.) to 50 BD IX rats for 3 weeks, 3 X 1 mg/kg body weight per week. Four hundred and fifty-five days after the first application, 33 animals died, 13 of them related to malignancies: 12 leukemias and 1 renal fibrosarcoma.
The development of acute leukemia coincident with the use of Cisplatin injection has been reported. In these reports, Cisplatin injection was generally given in combination with other leukemogenic agents.
Injection site reactions may occur during the administration of Cisplatin injection (see ADVERSE REACTIONS). Given the possibility of extravasation, it is recommended to closely monitor the infusion site for possible infiltration during drug administration. A specific treatment for extravasation reactions is unknown at this time.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Cisplatin injection is indicated as therapy to be employed as follows:
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.
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 injection and cyclophosphamide. 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 injection therapy.
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.
History
There is currently no drug history available for this drug.
Other Information
Cisplatin injection infusion concentrate is a clear, colorless, sterile aqueous solution available in amber vials. Each 50 mL or 100 mL amber vial of infusion concentrate contains: 1 mg/mL cisplatin, 9 mg/mL sodium chloride, hydrochloric acid and/or sodium hydroxide to adjust pH, and water for injection to a final volume of 50 mL or 100 mL, respectively. The pH range of Cisplatin Injection is 3.5 to 6.5.
Cisplatin injection infusion concentrate must be further diluted prior to administration (see DOSAGE AND ADMINISTRATION: All Patients).
The active ingredient, cisplatin, is a yellow to orange crystalline powder with the molecular formula PtCl2H6N2, and a molecular weight of 300.1. Cisplatin is a heavy metal complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position. It is soluble in water or saline at 1 mg/mL and in dimethylformamide at 24 mg/mL. It has a melting point of 207° C.
Sources
Cisplatin Manufacturers
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Pfizer Laboratories Div Pfizer Inc.
![Cisplatin Injection [Pfizer Laboratories Div Pfizer Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Cisplatin | Pfizer Laboratories Div Pfizer Inc.
Cisplatin injection is administered by slow intravenous infusion. CISPLATIN INJECTION SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION.
Note: Needles or intravenous sets containing aluminum parts that may come in contact with cisplatin injection should not be used for preparation or administration. Aluminum reacts with cisplatin injection, causing precipitate formation and a loss of potency.
Metastatic Testicular TumorsThe usual 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 TumorsThe usual Cisplatin injection dose for the treatment of metastatic ovarian tumors in combination with cyclophosphamide is 75–100 mg/m2 IV per cycle once every four weeks (DAY 1).
The dose of cyclophosphamide when used in combination with Cisplatin injection 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 injection and cyclophosphamide are administered sequentially.
As a single agent, Cisplatin injection should be administered at a dose of 100 mg/m2 IV per cycle once every four weeks.
Advanced Bladder CancerCisplatin 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 4 weeks is recommended.
All PatientsPretreatment hydration with 1 to 2 liters of fluid infused for 8 to 12 hours prior to a 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 injection in just 5% Dextrose Injection. Adequate hydration and urinary output must be maintained during the following 24 hours.
A repeat course of 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, WBC ≥4,000/mm3). Subsequent doses of cisplatin injection should not be given until an audiometric analysis indicates that auditory acuity is within normal limits.
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Teva Parenteral Medicines, Inc.
Cisplatin | Teva Parenteral Medicines, Inc.
Cisplatin Injection is administered by slow intravenous infusion. CISPLATIN INJECTION SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION.
Note: Needles or intravenous sets containing aluminum parts that may come in contact with Cisplatin Injection should not be used for preparation or administration. Aluminum reacts with Cisplatin Injection, causing precipitate formation and a loss of potency.
Metastatic Testicular TumorsThe usual 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 TumorsThe usual 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 Injection 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 Injection and cyclophosphamide are administered sequentially.
As a single agent, Cisplatin Injection should be administered at a dose of 100 mg/m2 IV per cycle once every four weeks.
Advanced Bladder CancerCisplatin 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 4 weeks is recommended.
All PatientsPretreatment hydration with 1 to 2 liters of fluid infused for 8 to 12 hours prior to a Cisplatin Injection dose is recommended. The drug is then diluted in 2 liters of 5% Dextrose in ½ or ⅓ 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 Injection in just 5% Dextrose Injection. Adequate hydration and urinary output must be maintained during the following 24 hours.
A repeat course of 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, WBC ≥ 4000/mm3). Subsequent doses of Cisplatin Injection should not be given until an audiometric analysis indicates that auditory acuity is within normal limits.
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Fresenius Kabi Usa, Llc
Cisplatin | Fresenius Kabi Usa, Llc
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- 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- 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.
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- 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- 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.
-
Mylan Institutional Llc
Cisplatin | Mylan Institutional Llc
Cisplatin injection is administered by slow intravenous infusion. CISPLATIN INJECTION SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION.
Note: Needles or intravenous sets containing aluminum parts that may come in contact with cisplatin injection should not be used for preparation or administration. Aluminum reacts with cisplatin injection, causing precipitate formation and a loss of potency.
Metastatic Testicular TumorsThe usual 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 TumorsThe usual Cisplatin injection dose for the treatment of metastatic ovarian tumors in combination with cyclophosphamide is 75–100 mg/m2 IV per cycle once every four weeks (DAY 1).
The dose of cyclophosphamide when used in combination with Cisplatin injection 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 injection and cyclophosphamide are administered sequentially.
As a single agent, Cisplatin injection should be administered at a dose of 100 mg/m2 IV per cycle once every four weeks.
Advanced Bladder CancerCisplatin 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 4 weeks is recommended.
All PatientsPretreatment hydration with 1 to 2 liters of fluid infused for 8 to 12 hours prior to a 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 injection in just 5% Dextrose Injection. Adequate hydration and urinary output must be maintained during the following 24 hours.
A repeat course of 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, WBC ≥4,000/mm3). Subsequent doses of cisplatin injection should not be given until an audiometric analysis indicates that auditory acuity is within normal limits.
-
Wg Critical Care, Llc
Cisplatin | Wg Critical Care, Llc
Cisplatin Injection is administered by slow intravenous infusion. CISPLATIN INJECTION SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION.
Note: Needles or intravenous sets containing aluminum parts that may come in contact with Cisplatin Injection should not be used for preparation or administration. Aluminum reacts with Cisplatin Injection, causing precipitate formation and a loss of potency.
Metastatic Testicular TumorsThe usual 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 TumorsThe usual 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 Injection 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 Injection and cyclophosphamide are administered sequentially.
As a single agent, Cisplatin Injection should be administered at a dose of 100 mg/m2 IV per cycle once every four weeks.
Advanced Bladder CancerCisplatin 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 4 weeks is recommended.
All PatientsPretreatment hydration with 1 to 2 liters of fluid infused for 8 to 12 hours prior to a 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 Injection in just 5% Dextrose Injection. Adequate hydration and urinary output must be maintained during the following 24 hours.
A repeat course of 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, WBC ≥4000/mm3). Subsequent doses of Cisplatin Injection should not be given until an audiometric analysis indicates that auditory acuity is within normal limits.
![Cisplatin Injection, Solution [Teva Parenteral Medicines, Inc.]](https://www.recallguide.org/wp-content/themes/bootstrap/assets/img/drug-image-placeholder.jpg)
![Cisplatin Injection, Solution [Fresenius Kabi Usa, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=de6302d5-85f0-4116-a709-57826c2c84fe&name=cisplatin-injection-figure-3-100351-vial.jpg)
![Cisplatin Injection [Mylan Institutional Llc ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=64975f5d-0eca-4998-8a72-06eec98285eb&name=cisplatininjmylan-figure-02.jpg)
![Cisplatin Injection, Solution [Wg Critical Care, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2bf8d2fb-80c8-401d-8e9b-d58463f5e954&name=image-02.jpg)
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