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Cisplatin

Author: Joann M. Gold Editor: Preeti Patel Updated: 6/19/2026 3:32:29 AM

Indications

FDA-Approved Indications

Cisplatin is an antineoplastic agent that was introduced in the late 1970s. Although highly toxic, cisplatin remains one of the most heavily used chemotherapeutic agents for some hematologic and solid tumor malignant neoplasms. Cisplatin may be given as monotherapy or in combination therapy for induction and neoadjuvant therapy. Cisplatin is approved by the Food and Drug Administration (FDA) for the treatment of advanced ovarian cancer, testicular cancer, and bladder carcinoma.[1][2][3] However, clinicians frequently use cisplatin off-label for several other malignant neoplasms, as detailed below, when the benefits may outweigh the risks of adverse drug effects.

Cancers that predominate in women, such as breast cancer, cervical carcinoma, endometrial carcinoma, and gestational trophoblastic neoplasia, sometimes receive treatment with cisplatin in combination with other medications, such as taxane derivatives, fluorouracil (5-FU), and doxorubicin.[4][5][6] Although hormone-sensitive and human epidermal growth factor receptor 2–positive tumors may respond well to targeted therapy, cisplatin is also useful in treating triple-negative breast cancer as single-agent neoadjuvant therapy and in combination with drugs such as veliparib.[4][7] 

Off-Label Indications

Additionally, gastrointestinal tract malignant neoplasms, such as esophageal, gastric, and advanced hepatobiliary tract cancers, have also been treated off-label with this medication and radiation.[8][9][10] Lung cancer, including small cell and non–small cell lung cancer, can be treated off-label using etoposide and cisplatin combination therapy.[11][12] Other off-label uses include treatment of metastatic, advanced, and refractory cancers, including Hodgkin lymphoma, non–Hodgkin lymphoma, penile cancer, thymoma, head and neck cancers, osteosarcoma, multiple myeloma, and mesothelioma.[13][14][15] The role of cisplatin in combination with immunotherapy is evolving.[16]

Mechanism of Action

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Mechanism of Action

Cisplatin acts via cell cycle–nonspecific cytotoxicity, which is achieved through the covalent binding of platinum complexes to the N7 positions of the purine bases guanine and adenine. Covalent binding causes intrastrand and interstrand crosslinks, with subsequent DNA strand breaks. Although DNA repair mechanisms attempt to reverse this damage, cells often undergo apoptotic or nonapoptotic cell death due to residual damaged DNA, RNA, and proteins.[17] Cisplatin chemotherapy is particularly effective at targeting rapidly dividing cells in rapidly growing malignant tumors.[18] Theoretically, cisplatin may not be as useful for slow-growing tumors. Cisplatin demonstrates greater activity against rapidly proliferating cells, which contributes to its effectiveness in many aggressive malignant neoplasms. Regarding synergy with other therapies, cisplatin-induced DNA damage activates the cyclic guanosine monophosphate–adenosine monophosphate synthase–stimulator of interferon genes (cGAS-STING) pathway and enhances immunogenicity.[16] Emerging nonclassic mechanisms include RNA targeting, mitochondrial effects, and ferroptosis induction.[19]

Pharmacokinetics 

Cisplatin is eliminated predominantly by renal excretion, with approximately 10% excreted via the biliary tract. The drug demonstrates biphasic elimination kinetics, with an initial half-life of approximately 25 to 49 min and a terminal postdistribution half-life of approximately 58 to 73 h for total platinum. Protein-bound platinum, particularly albumin-bound platinum, undergoes slow elimination and may persist in the body for several days following administration.[20]

Administration

Available Dosage Forms

Cisplatin injection, United States Pharmacopeia, is a multiple-dose vial containing 50 mg/50 mL and 100 mg/100 mL.

Available Strengths

Cisplatin is also supplied as a preservative-free intravenous solution in several vial strengths, including 50 mg/50 mL, 100 mg/100 mL, and 200 mg/200 mL preparations. The drug is also available as a preservative-free powder for reconstitution as an intravenous formulation containing 50 mg per vial. Cisplatin can be administered intravenously or intraarterially.[21] Cisplatin can also be administered intraperitoneally, as used in the treatment of carcinomatosis and primary peritoneal carcinoma. However, intraperitoneal administration is not FDA-approved and is considered off-label.[22]

Before administration, the patient must be adequately hydrated and maintain hydration and urinary output for at least 24 h after administration. A hydration protocol should be followed. Antiemetic agents can be used prophylactically to prevent nausea and vomiting and subsequent dehydration.[23] The FDA label can be reviewed for the latest dosing recommendations, which vary by cancer site. National Comprehensive Cancer Network guidelines provide updated key insights into dosing regimens, such as split-dose regimens, to reduce toxicity. 

Adult Dosage

  • Advanced ovarian cancer: Cisplatin is commonly administered intravenously at doses ranging from 75 to 100 mg/m², typically repeated at intervals of every 3 to 4 weeks.
  • Advanced testicular cancer: For advanced testicular cancer, cisplatin is often given intravenously at a dose of 20 mg/m² daily for 5 consecutive days in repeated 3-week cycles, usually in combination with bleomycin and etoposide.[24]
  • Advanced bladder cancer: Intravenous cisplatin dosing for advanced bladder carcinoma generally ranges between 50 to 70 mg/m² every 3 to 4 weeks, while patients who have undergone extensive prior treatment may receive lower dosing schedules, such as 50 mg/m² every 4 weeks.

Specific Patient Populations

Pediatric considerations: Cisplatin has no FDA-approved indications for pediatric use. However, clinicians use cisplatin off-label for the treatment of several aggressive childhood malignant neoplasms.[24][25] Cisplatin has been reported for use in the treatment of germ cell tumors, hepatoblastoma, medulloblastoma, neuroblastoma, and osteosarcoma, although universal guidelines on dosing and duration are unavailable.[26][27][28][29] The reported prevalence of cisplatin-associated hearing loss in pediatric populations is high, with estimates ranging from 40% to 60%. Early identification of hearing impairment is clinically important because prompt recognition and intervention may help reduce the long-term effects of hearing loss on social and cognitive development in children.

Renal impairment: Renal function should be carefully evaluated prior to initiation of cisplatin therapy and monitored periodically during treatment. The International Anticancer Drug Dosing in Kidney Dysfunction guidelines provide updates on contemporary dose adjustments that stratify by dose, treatment intent, performance status, and chronic kidney disease category rather than by creatinine clearance alone.[30] For patients with preexisting renal impairment or those who develop clinically significant declines in renal function during therapy, dose reduction or consideration of alternative treatment strategies may be warranted in accordance with established clinical guidelines.

Pregnancy and breastfeeding considerations: Cisplatin may cause fetal harm if administered during pregnancy. Women of reproductive potential should therefore be advised to use effective contraception throughout treatment and for 14 months following the final cisplatin dose. Men should be counseled to use effective contraceptive measures during cisplatin therapy and for 11 months after completion of treatment. Breastfeeding is generally not recommended during cisplatin therapy because of the potential risk of serious adverse effects in the nursing infant.[31]

Infertility considerations: Cisplatin therapy has been associated with cumulative, dose-dependent gonadal toxicity and impaired fertility in both sexes. Reported reproductive effects in women include ovarian failure, premature menopause, and reduced fertility, particularly with increasing cumulative exposure. In men, cisplatin may impair spermatogenesis and has been associated with oligospermia, azoospermia, and reduced fertility, which may occasionally be irreversible.

Adverse Effects

Common adverse effects associated with cisplatin therapy include nephrotoxicity, peripheral neuropathy, nausea and vomiting, myelosuppression, and ototoxicity. Cisplatin-associated toxicities are often dose-related and may become cumulative with repeated treatment cycles. If extravasation is suspected, the infusion should be stopped immediately. Any obvious fluid collection should be aspirated when feasible, and the affected extremity should be elevated. The antidote, sodium thiosulfate, should be administered in accordance with institutional extravasation protocols.[32] Cisplatin has been associated with delayed secondary malignant neoplasms, predominantly leukemias, which may occur several years after treatment completion.[33][34]

  • Nausea and vomiting are common adverse effects of cisplatin because the drug has high emetogenic potential, which can be mitigated with prophylaxis. Guidelines support antiemetic regimens with a 4-drug combination that includes olanzapine, a neurokinin-1 receptor antagonist, a 5-hydroxytryptamine type 3 receptor antagonist, and dexamethasone.[35]
  • Ototoxicity can be mitigated with sodium thiosulfate, which is FDA-approved for the prevention of cisplatin-induced hearing loss in pediatric populations.[36] 
  • Otoprotective interventions remain limited in adult populations.[37]
  • Interventions to prevent nephrotoxicity include hydration and magnesium supplementation.[38][39]
  • Painful chemotherapy-induced peripheral neuropathy may be treated with duloxetine, which remains the pharmacologic option with the strongest supporting evidence; nonpharmacologic approaches, including exercise and neuromuscular training, are under investigation.[40]
  • Tumor lysis syndrome can occur after treatment with many chemotherapeutic agents and manifest with hyperuricemia, hemodynamic alterations, hyperkalemia, and azotemia. Uric acid–reducing treatments may be necessary.[33][41] 

Other Common Adverse Effects

  • Diarrhea
  • Temporary alopecia
  • Ageusia
  • Hiccups
  • Xerostomia
  • Dark urine
  • Anhidrosis
  • Xerosis
  • Dehydration [41]

Drug-Drug Interactions

Caution is necessary when administering cisplatin with any of the following medications. Most drug interactions result in cumulative, dose-dependent hematologic, renal, and neurotoxic effects. Particular caution is warranted with concomitant use of nephrotoxic agents, neurotoxic medications, myelosuppressive therapies, and immunomodulatory drugs. Because of the risk of enhanced myelosuppression, cisplatin used concurrently with immunosuppressive medications and live vaccines may require careful monitoring or avoidance.[42][43] 

  • α-Lipoic acid
  • Aminoglycosides
  • Baricitinib
  • Bacillus Calmette-Guérin therapy
  • Chloramphenicol
  • Clozapine
  • Deferiprone
  • Denosumab
  • Dipyrone
  • Echinacea
  • Fosphenytoin
  • Leflunomide
  • Lenogristim
  • Lipefilgrastim
  • Natalizumab
  • Nivolumab
  • Ocrelizumab
  • Palifermin
  • Pidotimod
  • Pimecrolimus
  • Promazine
  • Roflumilast
  • Siponimod
  • Sipuleleucel-T
  • Tacrolimus
  • Taxane derivatives
  • Topotecan
  • Trastuzumab
  • Vaccinations
  • Vinorelbine

Contraindications

Boxed Warnings

With cisplatin therapy, boxed warnings include nephrotoxicity, peripheral neuropathy, nausea and vomiting, and myelosuppression. Few absolute contraindications exist to the use of cisplatin in the treatment of malignant neoplasms. Severe hypersensitivity to cisplatin or platinum compounds precludes administration; cisplatin is contraindicated in patients with severe hypersensitivity reactions, and rechallenge is not recommended.

Warnings and Precautions

Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis and fatal outcomes, have been reported with cisplatin therapy. Patients should be closely monitored during administration, and appropriate emergency management should be readily available if a reaction occurs.[44]

Ototoxicity: Cisplatin-associated ototoxicity is cumulative and may become severe, particularly in pediatric populations. Audiometric and vestibular function assessment should be considered before and during treatment.

Ocular toxicity: Visual complications, including papilledema, optic neuritis, and cortical blindness, may develop.

Secondary malignant neoplasms: Treatment with cisplatin may result in the development of secondary acute leukemia.

Embryo-fetal toxicity: Cisplatin has been shown to cross the placenta and may cause fetal harm.[45][46] Women of reproductive age should use reliable contraception during treatment and for up to 1 year after the final dose. Cisplatin is also present in the breast milk of lactating women receiving a cisplatin regimen. Breastfeeding is not recommended during treatment.[31]

Monitoring

A pregnancy test is necessary to determine pregnancy status in women before administering cisplatin.[45]

Hematologic

The platelet and leukocyte nadirs can be anticipated on days 18 to 23 after administration and typically recover by day 39. The clinician should order, at a minimum, a complete blood count before initiating treatment and before each subsequent treatment course.[33] Monitoring frequency should be increased if grade 3 or 4 cytopenias occur or if additional risk factors are present. Anemia is cumulative and related to erythropoietin deficiency due to renal tubular damage, and anemia may persist.[47]

Renal Function

Serum creatinine, blood urea nitrogen, creatinine clearance, estimated glomerular filtration rate (eGFR), and electrolytes should be assessed before treatment administration.[38][48] Results from emerging studies suggest that urinary biomarker monitoring may enable early detection of acute kidney injury.[49] One biomarker, neutrophil gelatinase–associated lipocalin, was approved by the FDA for predicting severe acute kidney injury in children.[50] 

Hearing and Vestibular Monitoring

Audiometric testing should be ordered in pediatric patients to establish baseline function and should be performed before each administration. Clinicians should use age-appropriate testing methods. After therapy is discontinued, audiometric testing should continue for several years.[33][48][51]

Infusion-Related Monitoring

The infusion site should be assessed before, during, and after drug administration to assess for infection and extravasation. The patient should be monitored clinically for complications related to the administration.[32][52][53]

Clinical Monitoring

Patients should be monitored for neuropathy, ocular changes, and signs of systemic infection using validated screening tools.

Toxicity

Cisplatin has several boxed warnings, including nephrotoxicity, peripheral neuropathy, severe nausea and vomiting, and myelosuppression.

Gastrointestinal Toxicity

Nausea and vomiting are dose-related adverse effects that can be severe and lead to metabolic derangements; nausea and vomiting can persist for up to 1 week after administration. Guidelines strongly recommend prophylactic treatment with antiemetic agents.[54][33]

Myelosuppression

The chief concern with myelosuppression secondary to cisplatin use is the morbidity and mortality associated with infection. Clinicians should monitor the complete blood count and frequently assess for signs of infection. High clinical suspicion for infection warrants a full workup.[33] Hematologic toxicity may require total treatment interruption. Often, hematologic toxicity will require dose modification if treatment is to continue.[33]

Neurotoxicity

Cisplatin is a dose-dependent neurotoxic medication.[55] Dose-related neurotoxicity most commonly manifests as peripheral neuropathy. Cisplatin-associated neuropathy may progress after discontinuation and, in some cases, might be irreversible.[33][56] Although dosage may need to be adjusted when neuropathy develops, high-grade peripheral neuropathy may require discontinuation of treatment.

Nephrotoxicity

Severe renal toxicity, including acute renal failure, may occur with cisplatin administration. Nephrotoxic effects are cumulative and dose-related. Pretreatment hydration plays a significant role in preventing renal toxicity.[33][38][48] The dose of cisplatin may need to be adjusted based on renal function, with close monitoring of the glomerular filtration rate.[44]

Ocular Toxicity and Retinopathy

Ocular adverse effects can manifest in a variety of ways, from loss of color discrimination to cortical blindness. Improvement usually occurs after discontinuing cisplatin, and in some cases, complete recovery may be possible.[33][57]

Ototoxicity

Monitoring for ototoxicity includes assessing the patient for tinnitus, high-frequency hearing loss, and decreased ability to follow conversations. Deafness has been reported, but it is not a common effect of cisplatin use. Loss of hearing acuity can be detrimental to language development in pediatric populations.[33][48]

Gonadotoxicity and Infertility

Cisplatin is toxic to the gonads; the drug can cause impairment of spermatogenesis and dose-dependent ovarian failure leading to premature menopause.[33] Fertility preservation should be discussed before treatment.[58][59] Posttreatment monitoring is important, and data support that patients should avoid conception for at least 12 months after completion of therapy.[60]

Cardiovascular Toxicity

A history of cisplatin-based treatment is a long-term cardiac risk factor. Long-term MRI data revealed attenuated biventricular systolic function and myocardial tissue alterations in asymptomatic patients after treatment for cancer with cumulative cisplatin doses of at least 200 mg/m².[61] The American Heart Association provides a calculator to determine the risk of cardiovascular disease after testicular cancer. Echocardiography and an electrocardiogram can be considered based on risk.[62]

Enhancing Healthcare Team Outcomes

Interprofessional collaboration and coordinated interdisciplinary care are essential for optimizing outcomes in patients receiving cisplatin therapy. Effective coordination among clinicians, particularly oncology specialists, advanced practice clinicians, nurses, pharmacists, and other healthcare professionals, contributes to improved treatment safety, earlier recognition of toxicities, and enhanced overall patient care.[63] Because cisplatin is associated with significant dose-related toxicities, a team-based approach is particularly important during treatment administration and posttreatment monitoring.[64] Collaborative monitoring for adverse effects and treatment-related complications may facilitate earlier intervention and potentially reduce morbidity associated with cisplatin therapy.[65]

Clear communication across clinical disciplines is also critical. For example, cisplatin doses exceeding 100 mg/m² per treatment course generally require verification before administration. Oncology-trained pharmacists play an important role in evaluating potential drug-drug interactions, reviewing dosing appropriateness, and promptly communicating clinically significant concerns to the treating team.

Nursing staff should recognize the importance of maintaining adequate hydration protocols and carefully monitoring intravenous infusion sites for signs of extravasation or local tissue injury. In addition, all members of the healthcare team should remain vigilant for evidence of infection, renal dysfunction, electrolyte abnormalities, tumor lysis syndrome, and cumulative toxicities during therapy. Consistent interprofessional communication and coordinated patient monitoring are essential for minimizing adverse effects while maximizing the therapeutic benefits of cisplatin treatment, ultimately improving patient outcomes.

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