pharmacopeia
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/api/v1/drug/cisplatin

Boxed warning

Cisplatin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available. Cumulative renal toxicity associated with cisplatin is severe. Other major dose-related toxicities are myelosuppression, nausea, and vomiting. Ototoxicity, which may be more pronounced in children, and is manifested by tinnitus, and/or loss of high frequency hearing and occasionally deafness, is significant. Anaphylactic-like reactions to cisplatin have been reported. Facial edema, bronchoconstriction, tachycardia, and hypotension may occur within minutes of cisplatin administration. Epinephrine, corticosteroids, and antihistamines have been effectively employed to alleviate symptoms (see WARNINGS and ADVERSE REACTIONS ). Exercise caution to prevent inadvertent cisplatin overdose . Doses greater than 100 mg/m 2 /cycle once every 3 to 4 weeks are rarely used. Care must be taken to avoid inadvertent cisplatin overdose due to confusion with carboplatin or prescribing practices that fail to differentiate daily doses from total dose per cycle.

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Nucleic Acid Synthesis Inhibitors.

Nucleic Acid Synthesis

Indications

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  • Cisplatin 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 radio therapeutic 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.

Contraindications

Sourced from openFDA
  • Cisplatin is contraindicated in patients with pre-existing renal impairment. Cisplatin should not be employed in myelosuppressed patients, or in patients with hearing impairment.contraindicated

Dosage & administration

Sourced from openFDA

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/m 2 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/m 2 IV per cycle once every 4 weeks (DAY 1). The dose of cyclophosphamide when used in combination with cisplatin is 600 mg/m 2 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/m 2 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/m 2 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/m 2 per cycle repeated every 4 weeks is recommended.

Warnings & precautions

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Cisplatin 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 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 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 have been reported. These reactions have occurred within minutes of administration to patients with prior exposure to cisplatin, and have been alleviated by administration of epinephrine, corticosteroids, and antihistamines. Cisplatin 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 ).

Adverse reactions

Sourced from openFDA

Nephrotoxicity Dose-related and cumulative renal insufficiency, including acute renal failure, is the major dose-limiting toxicity of cisplatin. Renal toxicity has been noted in 28% to 36% of patients treated with a single dose of 50 mg/m 2 . It is first noted during the second week after a dose and is manifested by elevations in BUN and creatinine, serum uric acid and/or a decrease in creatinine clearance. Renal toxicity becomes more prolonged and severe with repeated courses of the drug. Renal function must return to normal before another dose of cisplatin can be given. Elderly patients may be more susceptible to nephrotoxicity (see PRECAUTIONS, Geriatric Use ). Impairment of renal function has been associated with renal tubular damage. The administration of cisplatin using a 6 hour to 8 hour infusion with intravenous hydration, and mannitol has been used to reduce nephrotoxicity. However, renal toxicity still can occur after utilization of these procedures. Ototoxicity Ototoxicity has been observed in up to 31% of patients treated with a single dose of cisplatin 50 mg/m 2 , and is manifested by tinnitus and/or hearing loss in the high frequency range (4,000 to 8,000 Hz). The prevalence of hearing loss in children is particularly high and is estimated to be 40 to 60%. Decreased ability to hear normal conversational tones may occur. Deafness after the initial dose of cisplatin has been reported. Ototoxic effects may be more severe in children receiving cisplatin.

Use in specific populations

Sourced from openFDA

Pregnancy Pregnancy Category D (See WARNINGS ).

Overdosage

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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.

Approval history

Sourced from openFDA
  • Dec 19, 1978NDANDA018057Hq Spclt Pharma
  • Jul 16, 1999ANDAANDA074735Fresenius Kabi Usa
  • May 16, 2000ANDAANDA074656Pharmachemie Bv
  • Nov 7, 2000ANDAANDA075036Hikma
  • Aug 18, 2015ANDAANDA206774Accord Hlthcare
  • Mar 17, 2017ANDAANDA207323Gland
  • May 10, 2024ANDAANDA218868Qilu

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
76,216 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use5,7217.5%
  2. 2Nausea5,3757.1%
  3. 3Neutropenia4,7906.3%
  4. 4Disease Progression4,5906.0%
  5. 5Vomiting4,5225.9%
  6. 6Febrile Neutropenia4,4985.9%
  7. 7Anaemia3,9665.2%
  8. 8Diarrhoea3,7224.9%
  9. 9Thrombocytopenia3,7104.9%
  10. 10Pyrexia3,3544.4%
  11. 11Drug Ineffective3,2484.3%
  12. 12Malignant Neoplasm Progression3,1624.1%
  13. 13Death2,6953.5%
  14. 14Myelosuppression2,4863.3%
  15. 15Fatigue2,4783.3%

Literature

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Recent PubMed references pinned to Cisplatin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 5,174 ClinicalTrials.gov registrations naming Cisplatin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Cisplatin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • ACYP2CPIC D (provisional)ClinPGx 3
  • ERCC1CPIC D (provisional)ClinPGx 3
  • GSTM1CPIC D (provisional)ClinPGx 3
  • NQO1CPIC D (provisional)
  • XPCCPIC D (provisional)ClinPGx 3

Frequently asked questions

How does Cisplatin work?
Mechanism-of-action class: Nucleic Acid Synthesis Inhibitors.
What is Cisplatin used for?
According to FDA labeling, Cisplatin carries indications including: Cisplatin 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 radio therapeutic 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Cisplatin?
Cisplatin is classified as Platinum compounds, Platinum-based Drug, Nucleic Acid Synthesis Inhibitors, Decreased DNA Integrity.
What are the contraindications for Cisplatin?
Cisplatin labeling lists contraindications including: Cisplatin is contraindicated in patients with pre-existing renal impairment. Cisplatin should not be employed in myelosuppressed patients, or in patients with hearing impairment.. Always consult the full prescribing information and a clinician.
Note. Data for cisplatin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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