Cisplatin

Pronunciation

Class: Antineoplastic Agents
VA Class: AN900
Chemical Name: (SP-4-2)-Diamminedichloroplatinum
Molecular Formula: Cl2H6N2Pt
CAS Number: 15663-27-1
Brands: Platinol-AQ

Warning(s)

  • Experience of Supervising Clinician
  • Use under supervision of a qualified clinician experienced in therapy with antineoplastic agents.1 Use only when adequate treatment facilities for appropriate management of therapy and complications are available.1

  • Dose-Related Toxicities
  • Risk of dose-related toxicities, including myelosuppression, nausea, vomiting, and cumulative, severe renal toxicity.1 Dosages >100 mg/m2/cycle once every 3–4 weeks rarely used.1

  • Ototoxicity
  • Risk of ototoxicity; more pronounced in children.1 Manifestations include tinnitus, loss of high frequency hearing, decreased hearing acuity, and, occasionally, deafness.1 276 287 288 289 290 291 292 358

  • Anaphylaxis
  • Risk of anaphylactoid reactions (e.g., facial edema, bronchoconstriction, wheezing, tachycardia, hypotension); may occur within minutes following administration.1 (See Anaphylactoid Reactions under Cautions.) IV epinephrine, corticosteroids, and antihistamines have been effectively employed to alleviate symptoms.1

  • Potential Medication Errors
  • Avoid accidental, potentially fatal, overdosage due to confusion with carboplatin (Paraplatin)1 419 420 421 422 or due to failure to differentiate daily dosages from total dosage per cycle.1 Cisplatin dosages >100 mg/m2/cycle once every 3–4 weeks rarely used.1

Introduction

Antineoplastic agent; platinum-containing compound.1 7 13

Uses for Cisplatin

Testicular Cancer

Adjunct to other antineoplastic agents for the treatment of metastatic testicular tumors (including nonseminomatous testicular carcinoma, seminoma testis, and extragonadal germ-cell tumors) in patients who have already received appropriate surgery and/or radiation therapy.1 63 403

For induction of remissions, a regimen of cisplatin, bleomycin, and vinblastine (with or without other antineoplastic agents) has been used.64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 403

For treatment of disseminated disease, a regimen of cisplatin, bleomycin, and etoposide has been used.63 335 403 406 407 408 409 410 411 412

Regimen consisting of cisplatin, ifosfamide with mesna, and either vinblastine or etoposide considered standard initial salvage (i.e., second-line) regimen in patients with recurrent disease.63 403 507

Ovarian Cancer

Used alone or in combination therapy for the treatment of ovarian cancer.1 509

Platinum-based therapy has been used for adjuvant treatment following surgery in early-stage ovarian epithelial cancer.509

For initial (first-line) treatment of advanced ovarian epithelial cancer, combination chemotherapy with a platinum-containing agent (e.g., cisplatin, carboplatin) and paclitaxel currently is preferred regimen.63 509 Carboplatin is as effective as but less toxic than cisplatin when used in combination with either paclitaxel757 758 or cyclophosphamide; 521 522 therefore, carboplatin in combination with paclitaxel currently is a preferred regimen for initial treatment of advanced ovarian epithelial cancer.63 509 Regimen consisting of cisplatin and paclitaxel is superior to regimen consisting of cisplatin and cyclophosphamide.509 517 641

Second-line therapy for the treatment of advanced epithelial ovarian cancer when retreatment is indicated in patients with platinum-sensitive disease who relapse.1 489 509 However, carboplatin monotherapy preferred to cisplatin monotherapy by some clinicians due to its more favorable toxicity profile.489 509 Nonplatinum-based monotherapy regimens (e.g., paclitaxel) generally preferred for retreatment of platinum-resistant disease.489 509 512 514

Slideshow: Flashback: FDA Drug Approvals 2013

For the adjuvant therapy of ovarian germ-cell tumors, combination chemotherapy with cisplatin, bleomycin, and etoposide currently is regimen of choice.63 415 582

Bladder Cancer

Used alone or in combination therapy for the treatment of muscle-invasive and advanced bladder cancer that is no longer amenable to surgery and/or radiation therapy.1 584 585 587 591 605 606

For adjuvant treatment of muscle-invasive bladder cancer, regimens consisting of cisplatin, methotrexate, and vinblastine with or without doxorubicin (abbreviated as M-VAC or CMV, respectively) currently is used.591 605 606

For palliative treatment of advanced or metastatic bladder cancer, M-VAC, CMV, or, alternatively, a regimen consisting of cisplatin and gemcitabine currently is used.63 134 556 584 585 626

Head and Neck Cancer

Used in combination with docetaxel and fluorouracil as induction therapy prior to radiotherapy or chemoradiotherapy in the treatment of locally advanced squamous cell carcinoma of the head and neck.765 766

Adjunct to fluorouracil or paclitaxel for the palliative treatment of recurrent or metastatic head and neck cancer.63 527 673 674 Regimen consisting of cisplatin, methotrexate, bleomycin, and vincristine also has been used.675

Cervical Cancer

Used alone63 685 687 or in combination therapy63 684 686 687 688 as an adjunct to radiation therapy for the treatment of invasive cervical cancer (FIGO stages IB2 through IVA684 685 687 688 or FIGO stage IA2, IB, or IIA with poor prognostic factors).683 684 685 686 687 688 690 697

Component of various combination chemotherapeutic regimens (e.g., bleomycin, cisplatin, and ifosfamide [BIP]; bleomycin, cisplatin, mitomycin, and vincristine [BOMP]) for the treatment of metastatic or recurrent cervical cancer.63 177 179 180 181

Non-small Cell Lung Cancer

Component of various chemotherapeutic regimens for advanced non-small cell lung cancer.63 529 665

Currently preferred regimens include the combination of cisplatin with another agent, such as paclitaxel,63 187 529 665 666 vinorelbine,63 529 665 667 gemcitabine,63 187 529 669 670 or docetaxel.187 529

Small Cell Lung Cancer

Adjunct to other antineoplastic agents for the treatment of small cell lung cancer.63 533

Regimens consisting of cisplatin and etoposide or irinotecan currently considered preferred regimens.63 515 533

Malignant Pleural Mesothelioma

Used in combination with pemetrexed for the treatment of malignant pleural mesothelioma in patients not eligible for surgery.63 679

Monotherapy202 203 679 680 or as adjunct to other antineoplastic agents (e.g., doxorubicin, gemcitabine, mitomycin)63 204 681 for the palliative treatment of advanced malignant pleural mesothelioma.202 203 204 679 680 681

Esophageal Cancer

Monotherapy569 576 644 or as adjunct to other antineoplastic agents63 568 569 570 576 644 for the treatment of localized or advanced esophageal cancer.

For treatment of localized, resectable esophageal cancer, some experts recommend combined modality treatment with combination chemotherapy (e.g., cisplatin and fluorouracil) and concurrent radiation therapy with or without surgery.361 568 572

For palliative treatment of metastatic (local or distant) disease or recurrent or locally advanced disease not amenable to surgery or radiation therapy,63 568 570 576 644 combination therapy with cisplatin and fluorouracil is considered regimen of choice.63 568 644

Biliary Tract Cancer

Use in combination with gemcitabine is recommended (accepted) for the treatment of unresectable locally advanced or metastatic biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or ampullary cancer), including unresectable recurrent disease following surgical resection, in patients with good performance status (ECOG performance status of 0 or 1).761 763 764

Brain Tumors

Adjunct for the treatment of astrocytic tumors, such as anaplastic astrocytoma and glioblastoma multiforme.63

Used in combination with lomustine and vincristine as adjuvant therapy following surgical resection and radiation therapy for the treatment of medulloblastoma.63 546

Monotherapy or in combination chemotherapy regimens (e.g., cisplatin and etoposide) as salvage therapy for recurrent oligodendroglioma.63 213

Adjunct to etoposide for the treatment of intracranial germ cell tumors.63 214 545

Neuroblastoma

Component of combination therapy for high-risk neuroblastoma.63 541

In patients with intermediate-risk tumors or some patients with low-risk tumors, combination chemotherapy with moderate doses of carboplatin, cyclophosphamide, doxorubicin, and etoposide is used in conjunction with surgery (with or without radiation therapy).541 In patients with high-risk tumors, aggressive chemotherapy using higher doses of these drugs and additional drugs (e.g., ifosfamide, high-dose cisplatin, vincristine) is used.541

Cisplatin Dosage and Administration

General

Hydration

  • Hydrate with 1–2 L IV fluid 8–12 hours prior to administration.1 67 245 252 344 Maintain adequate hydration and urinary output during and for 24 hours after administration to minimize nephrotoxicity.1 243 245 251 256 343 344

  • In adults, IV fluids usually administered alone or with mannitol and/or furosemide to achieve a diuresis of 150–400 mL/hour (during and for at least 4–6 hours after administration of cisplatin)245 251 252 256 343 344 or ≥100–200 mL/hour (for the next 18–24 hours65 251 252 343 344 or until vomiting stops and oral fluids are tolerated).343

  • Potassium chloride (e.g., 10–20 mEq/L) often added to IV fluids to replace losses and prevent deficiencies.245 259 344

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion.1

Aluminum displaces platinum from cisplatin molecule,10 11 12 causing formation of a black precipitate1 10 11 12 and loss of potency;1 12 do not use needles or IV administration sets that contain aluminum parts for preparation or administration.1

Handle cautiously (e.g., use gloves); avoid exposure during handling and preparation of IV solution.1 If skin or mucosal contact occurs, immediately and thoroughly wash skin with soap and water and flush mucosa with water.1

Dilution

Dilute preservative-free solution with 2 L of 5% dextrose and 0.33 or 0.45% sodium chloride injection containing 18.75 g of mannitol/L (i.e., 37.5 g in 2 L).1 Do not dilute with 5% dextrose injection.1

If not used within 6 hours, protect from light.1

Rate of Administration

Manufacturer recommends administering dose by IV infusion over 6–8 hours.1

Has been administered over 15 minutes to 2 hours with minimal adverse renal effects.65 243 247 252 256 257 258 261 Continuous 24-hour38 or 5-day263 264 265 IV infusions also have been used.

Rapid IV injection (e.g., over 1–5 minutes)25 27 259 290 associated with increased risk of nephrotoxicity243 or ototoxicity.290

Dosage

Contact prescriber if prescribed dose >100 mg/m2/cycle.1 (Cisplatin dosages exceeding 100 mg/m2/cycle once every 3–4 weeks are rarely used.)1 Inadvertent substitution of cisplatin for carboplatin can result in potentially fatal overdosage.419 420 421 422 (See Boxed Warning.)

Do not administer repeat course until Scr <1.5 mg/dL and/or BUN <25 mg/dL, platelet count ≥100,000/mm3, and leukocyte count ≥4000/mm3, and unless auditory acuity is within normal limits.1

Consult published protocols for dosages of other chemotherapeutic agents and alternative cisplatin dosages, the method and sequence of administration, and duration of therapy.

Adults

Testicular Cancer
IV

20 mg/m2 daily for 5 consecutive days every 3 weeks for 3 or 4 courses of therapy.1 64 65 66 67 68 69 70 71 72 73 335 408 3 cycles of therapy are sufficient for favorable-prognosis germ cell tumors.85 86

Ovarian Cancer
IV

Combination chemotherapy with paclitaxel: 75 mg/m2 once every 3 weeks.361 517

Combination chemotherapy with cyclophosphamide: 50–100 mg/m2 once every 3–4 weeks.1 361 Administer cisplatin and cyclophosphamide sequentially.1

Monotherapy: Manufacturer recommends 100 mg/m2 once every 4 weeks.1 Some experts recommend 50–100 mg/m2 once every 3 weeks;361 dosages of 30–120 mg/m2 once every 3–4 weeks have been used.97 98 101 102 103 104 105 383

Bladder Cancer
IV

50–70 mg/m2 once every 3–4 weeks, depending on extent of prior radiation therapy and/or chemotherapy.1

In extensively pretreated patients, 50 mg/m2 once every 4 weeks.1

Head and Neck Cancer
IV

Monotherapy: 80–120 mg/m2 once every 3 weeks38 143 144 147 149 or 50 mg/m2 on the first and eighth days of every 4 weeks.143 148

Combination chemotherapy: 50–120 mg/m2; frequency of administration depends on the specific regimen employed (consult specialized references).144 146 149 150 151 152 154 155 157 158 160 161 162 163 164 165 166 167 168 169 170

Induction therapy (in combination with docetaxel and fluorouracil): 75–100 mg/m2 once every 3 weeks.765 766

Cervical Cancer
Invasive Cervical Cancer
IV

Monotherapy: 40 mg/m2 once weekly has been administered concurrently with radiation therapy up to a maximum of 6 doses.685 687

Combination chemotherapy (e.g., with fluorouracil): 50–75 mg/m2 has been administered concurrently with radiation therapy according to various dosage schedules.684 686 687

Metastatic or Recurrent Cervical Cancer
IV

50 mg/m2 once every 3 weeks up to a maximum of 6 courses.175 178 180 181 Higher dosages (e.g., 100 mg/m2 once every 3 weeks) produce higher response rates but also increased toxicity.175

Non-small Cell Lung Cancer
IV

75–100 mg/m2 once every 3–4 weeks.666 667 669 670

Esophageal Cancer
IV

Monotherapy: 50–120 mg/m2 once every 3–4 weeks.576

Combination chemotherapy: 75–100 mg/m2 once every 3–4 weeks.361 570 572 576

Biliary Tract Cancer
IV

Combination chemotherapy with gemcitabine: Cisplatin 25 mg/m2 (as 1-hour infusion) has been given on days 1 and 8 of each 21-day cycle; administered in combination with gemcitabine (1 g/m2 as 30-minute infusion on days 1 and 8 after cisplatin).761 763 Treatment continued for 24 weeks (8 cycles) in the absence of disease progression or unacceptable toxicity.761 763

Prescribing Limits

Adults

Do not administer cycle more frequently than once every 3–4 weeks.1

Contact prescriber if prescribed dose >100 mg/m2/cycle.1 (Cisplatin dosages exceeding 100 mg/m2/per cycle once every 3–4 weeks are rarely used.)1

Consider that renal toxicity becomes more severe with repeated courses of cisplatin.1

Cervical Cancer

Invasive cervical cancer: Maximum 6 doses.685 687

Metastatic or recurrent cervical cancer: Maximum 6 courses.175 178 180 181

Special Populations

Geriatric Patients

Careful dosage selection and monitoring of renal function recommended due to possible age-related decrease in renal function.1 756

Cautions for Cisplatin

Contraindications

  • Patients with preexisting renal impairment, myelosuppression, or hearing impairment.1

  • Known hypersensitivity to cisplatin or other platinum-containing compounds or any ingredient in the formulation.1

Warnings/Precautions

Warnings

Renal Effects

Risk of dose-related (cumulative), severe nephrotoxicity1 243 244 245 246 (manifested as increased Scr, BUN, serum uric acid concentrations, and/or decreased Clcr 1 243 244 245 246 and GFR);247 339 nephrotoxicity more common and severe than with carboplatin.440 493 521 522 542 549 566

Nephrotoxicity generally occurs during second week following initiation of therapy;1 246 may occur within several days following administration of high-dose regimens.246 (See Clinical/Laboratory Monitoring under Cautions.)

High13 243 244 245 or repeated doses1 13 390 can increase severity1 13 244 390 and duration1 244 of renal impairment. Recovery generally occurs within 2–4 weeks after administration of cisplatin,244 246 256 but renal insufficiency may be irreversible (sometimes fatal).13 243 244 245

Maintain adequate hydration and urinary output during and for 24 hours after administration of cisplatin to minimize nephrotoxicity.1 243 245 251 256 343 344 (See Hydration under Dosage and Administration.)

Nervous System Effects

Risk of neurotoxicity, usually characterized by severe neuropathy (e.g., paresthesia, areflexia, loss of proprioception and vibratory sensation)1 101 276 297 298 299 300 301 302 303 304 444 in patients receiving higher single or cumulative doses, prolonged therapy (4–7 months),1 276 297 298 299 300 301 302 303 304 486 488 or greater dose frequency than recommended.1 Neurotoxicity more severe and occurs more frequently than with carboplatin.440 493 521 522

Perform neurologic examination regularly.1 If manifestations of neuropathy occur, discontinue cisplatin immediately; neuropathy may worsen even after discontinuance.1 297 488 Peripheral neuropathy may be irreversible in some patients.1 297

Possible motor (especially gait) difficulties,101 276 297 299 300 302 472 reduced or absent deep-tendon reflexes,101 297 298 300 304 leg weakness,300 301 or loss of motor function.1 Muscle cramps reported, particularly in patients receiving high cumulative dose and at advanced symptomatic stage of peripheral neuropathy.1

Loss of taste, seizures, Lhermitte’s sign, dorsal column myelopathy, and autonomic neuropathy reported.1

Otic Effects

Risk of dose-related, cumulative ototoxicity.1 (See Boxed Warning.) Hearing loss can be unilateral or bilateral and becomes more frequent and severe with repeated doses;1 may occasionally require dosage reduction or discontinuance of therapy.276 290 358 (See Clinical/Laboratory Monitoring under Cautions.)

Risk of vestibular ototoxicity1 295 296 (manifested as vertigo295 ) or vestibular dysfunction.296

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; teratogenicity and embryolethality demonstrated in animals.1 347 360 367 368 Avoid pregnancy during therapy.1 If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.1 347 360

Carcinogenic Effects

Malignancies (e.g., leukemia, renal fibrosarcoma) reported in rats.1 Bladder cancer reported in at least 1 patient, but causal relationship not established.330 331 Acute leukemia rarely reported in humans; in such cases, cisplatin generally was given in combination with other leukemogenic agents and/or radiation.1 331 478 479 480 481

Sensitivity Reactions

Anaphylactoid Reactions

Anaphylactoid reactions reported.1 (See Boxed Warning.) Anaphylactoid reactions usually have occurred only after multiple cycles (e.g., at least 5 doses),245 312 313 440 but also can occur after the initial dose.440 Observe patients carefully; supportive equipment and medication should be available for immediate use.1

Major Toxicities

Hematologic Effects

Risk of cumulative myelosuppression (manifested as leukopenia, thrombocytopenia, and anemia).1 13 276 Leukopenia and thrombocytopenia are dose-related.1 276 Anemia not clearly dose-related but may be severe, possibly requiring transfusions.97 245 393

Myelosuppression may be more severe in patients previously treated with other antineoplastic agents or radiation therapy.245 276 Myelosuppression less pronounced than with carboplatin.440 495 496 521 522 551

Nadir in circulating platelets, leukocytes, and hemoglobin occurs 18–23 days (range: 7.2–45 days) following single dose; levels return to pretreatment values in most patients within 39 days (range: 13–62 days).1 440 (See Clinical/Laboratory Monitoring under Cautions.)

Fever and infection reported in patients with neutropenia.1

Hemolytic anemia reported.1 Repeat course may result in increased hemolysis; carefully weigh benefit of therapy versus risk.1

GI Effects

Marked nausea and vomiting reported in virtually all patients;1 276 440 441 442 445 446 447 448 449 450 462 468 469 470 occasionally may require discontinuance of therapy.1 276 468

Increased incidence and severity in females, in young patients, following administration of high doses or by rapid infusion, and/or following concomitant administration with other emetogenic drugs (e.g., doxorubicin); patients with history of chronic heavy alcohol use may experience less frequent and severe emetogenic effects.440 450 462 468

Nausea and vomiting generally begin within 1–6 (usually 2–3) hours after administration of cisplatin; persist for up to 24 hours or longer.1 101 276 440 441 462 Average of 10–12 vomiting episodes reported within first 24 hours after initial dose.440 462 468 Various degrees of nausea, vomiting, and anorexia may persist for up to 5–10 days.1 101 259 276

Delayed nausea and vomiting (beginning or persisting ≥24 hours following chemotherapy) has occurred in patients who had attained complete emetic control on the day of cisplatin therapy.1 440 441 445 449 450 451 458 459 462 468

Cardiovascular and Cerebrovascular Effects

Bradycardia,316 left bundle-branch block,276 ST-T-wave changes with CHF,276 postural hypotension,276 MI, cerebrovascular accident, thrombotic microangiopathy, or cerebral arteritis reported rarely.1

Electrolyte Disturbances

Hypomagnesemia,1 251 268 269 270 271 272 273 342 390 hypocalcemia,1 268 269 271 342 390 hypokalemia,1 271 hypophosphatemia,1 271 and hyponatremia1 274 342 reported. SIADH reported.1

Manifestations of hypomagnesemia and/or hypocalcemia include muscle irritability268 or cramps,270 clonus,271 tremor,270 carpopedal spasm,269 271 and/or tetany.1 269 271

Electrolyte disturbances may occur within several days after administration of initial dose;268 269 342 hypomagnesemia usually develops within 3–4 weeks268 269 270 273 and appears to increase in severity with progressive courses of treatment.390 (See Clinical/Laboratory Monitoring under Cautions.)

Normal serum electrolyte concentrations generally restored by administration (usually parenteral)268 269 270 271 390 of appropriate supplemental electrolytes and drug discontinuance.1 268 269 270 271

Metabolic Effects

Hyperuricemia (resulting from drug-induced nephrotoxicity256 ) reported;1 126 256 more pronounced with doses >50 mg/m2.1 Peak uric acid concentrations generally occur 3–5 days after administration of drug.1

Allopurinol effectively reduces uric acid concentrations.1 256

Ocular Effects

Optic neuritis1 298 304 314 (principally retrobulbar),298 314 papilledema,1 314 and cerebral (cortical) blindness1 48 315 471 reported infrequently. Corticosteroids, with or without mannitol, have been used; however, efficacy of such treatment not established.1

Blurred vision and altered color perception reported following administration of higher dosages or greater dosing frequencies.1

Hepatic Effects

Mild and transient elevations of serum AST (SGOT),1 276 ALT (SGPT),276 and bilirubin1 reported. (See Clinical/Laboratory Monitoring under Cautions.)

Local Effects

Soft tissue toxicity (e.g., severe cellulitis with residual fibrosis,322 482 and full-thickness skin necrosis323 482 ) reported following extravasation of drug.1 482

Infusion of solutions with concentration >0.5 mg/mL may result in tissue cellulitis, fibrosis, and necrosis.1

General Precautions

Clinical/Laboratory Monitoring

Monitor Scr, BUN, Clcr, and serum magnesium, sodium, potassium, and calcium concentrations prior to initiating therapy and prior to each subsequent course.1 Do not administer repeat dose until Scr <1.5 mg/dL and/or BUN <25 mg/dL.1 (See Dosage under Dosage and Administration.)

Monitor peripheral blood counts weekly.1

Perform neurologic examination regularly.1

Monitor liver function periodically.1

Perform audiometric testing prior to initiating therapy and prior to each subsequent dose.1 Do not administer repeat doses unless auditory acuity is within normal limits.1

Specific Populations

Pregnancy

Category D.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Distributed into milk.1 Discontinue nursing.1 347 360 361

Pediatric Use

Safety and efficacy not established.1 34 205 206 207 208

More severe ototoxic effects.1 289 Increased risk of hypomagnesemia.269

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.756

Possible increased risk for myelosuppression, infectious complications, peripheral neuropathy, and nephrotoxicity.1 756

Careful dosage selection and monitoring of renal function recommended due to possible age-related decrease in renal function.1 756

Common Adverse Effects

Nausea, vomiting, nephrotoxicity, ototoxicity, myelosuppression.1 (See Warnings under Cautions.)

Interactions for Cisplatin

No evidence to date that cisplatin undergoes enzymatic biotransformation.7 14

Renally Excreted Drugs

Potentially altered elimination of renally excreted drugs,347 361 possibly as a result of cisplatin-induced nephrotoxicity.337

Specific Drugs

Drug

Interaction

Comments

Aminoglycosides

Increased risk of nephrotoxicity.1 245 248 253 254 255

Increased risk of ototoxicity.1

Avoid concomitant use; if must be used concomitantly (during or shortly after cisplatin therapy), exercise extreme caution.245 248 251 253 254 Some clinicians recommend avoiding aminoglycoside for at least 2 weeks after cisplatin to minimize risk.245

Monitor carefully for ototoxicity.276 294

Amphotericin B

Increased risk of nephrotoxicity.251 253 254

Avoid concomitant use.251 253 254

Anticonvulsants (e.g., phenytoin)

Possible decreased phenytoin concentrations (due to decreased absorption and/or increased metabolism).414

Monitor serum phenytoin concentrations; adjust dosage accordingly.414

Bleomycin

Possible altered renal elimination of bleomycin.337

Possible synergistic antineoplastic effects.362

Diuretics, loop (e.g., ethacrynic acid, furosemide)

Increased risk of ototoxicity.1

Monitor carefully for ototoxicity.276 294

Etoposide

Possible decreased etoposide elimination.378

Possible synergistic antineoplastic effects.80 94 193 154 355 363 364 366

Methotrexate

Possible altered renal elimination of methotrexate.338

Possible synergistic antineoplastic effects.362

Pyridoxine

Response duration adversely affected when used concomitantly with cisplatin and altretamine (hexamethylmelamine).1

Cisplatin Pharmacokinetics

Absorption

Following rapid IV injection over 1–5 minutes25 27 or rapid IV infusion over 15 minutes30 31 386 or 1 hour,26 36 peak plasma drug27 and platinum25 26 27 30 31 36 386 concentrations occur immediately.

Distribution

Extent

After cisplatin administration, platinum is widely distributed into body fluids and tissues,44 45 with highest platinum concentrations in the kidneys,1 44 59 liver,1 44 45 59 and prostate;1 44 somewhat lower concentrations in the bladder,1 44 muscle,1 44 59 testes,1 44 59 pancreas,1 44 59 and spleen;1 44 59 and lowest concentrations in the small and large intestines,1 44 45 59 adrenals,1 44 59 heart,1 44 59 lungs,1 44 59 lymph nodes,59 thyroid,59 gallbladder,59 thymus,59 cerebrum,1 44 49 cerebellum,1 44 49 ovaries,44 and uterus.44 Distributed minimally into leukocytes25 and erythrocytes.60 371 386

Platinum present in tissues for as long as 180 days after administration of last dose.1

Possible accumulation of platinum compound when administered on a daily basis.1

Crosses the placenta44 and is distributed into milk.1

Plasma Protein Binding

Platinum from cisplatin is 90% irreversibly bound51 (mainly to albumin, transferrin, and γ-globulin).1 36 51 Only nonprotein-bound platinum is cytotoxic.26 50

Special Populations

Increased plasma concentrations of nonprotein-bound platinum in patients with renal impairment.31

Elimination

Metabolism

No evidence to date that cisplatin undergoes enzymatic biotransformation.7 14 Chloride ligands of the cisplatin complex believed to be displaced by water, forming positively charged platinum complexes that react with nucleophilic sites.7 14

Elimination Route

Excreted principally in urine (predominantly via glomerular filtration26 54 141 391 ) as intact cisplatin25 53 55 and platinum-containing product(s);1 25 26 28 29 30 31 36 52 55 approximately 10–50% of dose excreted within 24–48 hours.1 25 26 28 29 30 37 391

Fecal elimination1 29 45 appears to be insignificant.1

May undergo enterohepatic circulation.36 39 40 371

Minimally removed by hemodialysis.57 58

Half-life

Intact cisplatin: 20–30 minutes (initial phase) following rapid IV injection or infusion.1 27

Total platinum: 8.1–49 minutes (initial phase)25 26 29 36 46 371 386 and 30.5–107 hours25 26 29 36 46 or possibly longer386 (terminal phase) following rapid IV injection or infusion.25 26 29 36 46 386 Following 6-hour IV infusion, terminal elimination half-life is 73–290 hours.28 29 37

Nonprotein-bound platinum: 2.7–30 minutes (initial phase)26 31 371 386 and 32–53.5 minutes (terminal phase) following rapid IV injection or infusion.26 30 31 371 386

Special Populations

Impaired elimination38 58 and prolonged terminal half-life in renal impairment.58

Stability

Storage

Parenteral

Injection

15–25°C; do not refrigerate (since precipitation may occur).1 4 5 402 Protect from light.1 3 402

Following initial entry of vial, cisplatin is stable for 28 days (protected from light) or 7 days (under fluorescent room light).1

Protect diluted solution from light if not used within 6 hours.1

Cisplatin Stability in Various IV Solutions and Admixtures

IV Solution

Cisplatin Concentration (mg/ml)

Duration of Stability (time and temperature)

5% Dextrose and 0.45 or 0.9% Sodium Chloride

0.05, 0.5

at least 24 h at room temperatureHID

5% Dextrose and 0.33% Sodium Chloride with 1.875% Mannitol (with or without 0.15% Potassium Chloride)

0.05, 0.1, 0.2

at least 72 h at 4 or 25°C5

5% Dextrose and 0.45% Sodium Chloride with 1.875% Mannitol

0.05, 0.1, 0.2

at least 72 h at 4 or 25°C5

0.2% Sodium Chloride

0.2

at least 24 h at room temperature4

0.225% Sodium Chloride

0.05, 0.1, 0.2

at least 72 h at 4 or 25°C5

0.3% Sodium Chloride

0.05, 0.1, 0.2

at least 72 h at 4 or 25°C5

0.45% Sodium Chloride

0.2

at least 24 h at room temperature4

 

0.05, 0.5

at least 24 h at 25°C6

0.9% Sodium Chloride

0.2

at least 24 h at room temperature4

 

0.05, 0.5

at least 24 h at 25°C6

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Aluminum displaces platinum from cisplatin molecule,10 11 12 causing formation of a black precipitate1 10 11 12 and loss of potency;1 12 do not use needles or IV administration sets that contain aluminum parts for preparation or administration.1

Parenteral

Solution CompatibilityHID

Compatible

Dextrose 5% in sodium chloride 0.225, 0.45, or 0.9%

Dextrose 5% in sodium chloride 0.33 or 0.45% with mannitol 1.875%

Dextrose 5% in sodium chloride 0.33% with potassium chloride 20 mEq/L and mannitol 1.875%

Sodium chloride 0.225, 0.3, 0.45, or 0.9%

Incompatible

Sodium bicarbonate 5%

Variable

Dextrose 5% in water

Drug Compatibility
Admixture CompatibilityHID

Compatible

Carboplatin

Cyclophosphamide with etoposide

Etoposide

Etoposide with floxuridine

Floxuridine

Floxuridine with leucovorin calcium

Hydroxyzine HCl

Ifosfamide

Ifosfamide with etoposide

Leucovorin calcium

Magnesium sulfate

Mannitol

Ondansetron HCl

Incompatible

Etoposide with mannitol and potassium chloride

Fluorouracil

Mesna

Thiotepa

Variable

Paclitaxel

Y-Site CompatibilityHID

Compatible

Allopurinol sodium

Anidulafungin

Aztreonam

Bleomycin sulfate

Caspofungin acetate

Cladribine

Cyclophosphamide

Doripenem

Doxorubicin HCl

Doxorubicin HCl liposome injection

Droperidol

Etoposide phosphate

Filgrastim

Fludarabine phosphate

Fluorouracil

Furosemide

Gemcitabine HCl

Granisetron HCl

Heparin sodium

Leucovorin calcium

Linezolid

Melphalan HCl

Methotrexate sodium

Metoclopramide HCl

Mitomycin

Ondansetron HCl

Paclitaxel

Palonosetron HCI

Pemetrexed disodium

Propofol

Sargramostim

Teniposide

Topotecan HCl

Vinblastine sulfate

Vincristine sulfate

Vinorelbine tartrate

Incompatible

Amifostine

Amphotericin B cholesteryl sulfate complex

Gallium nitrate

Piperacillin sodium–tazobactam sodium

Thiotepa

Actions

  • Heavy metal complex containing a platinum atom surrounded by 2 chloride atoms and 2 ammonia molecules.1 7 13 16

  • Chloride ligands of the cisplatin complex are displaced by water (aquation), forming positively charged platinum complexes.7 14 489 490 491 492 493 These toxic platinum complexes bind to specific DNA base sequences,15 489 490 493 494 producing intrastrand and interstrand DNA cross-links,14 15 17 20 125 which are thought to inhibit DNA replication, transcription, and ultimately cell division.489 490 493

  • Cycle-phase nonspecific.21 125

  • Exhibits immunosuppressive,13 radiosensitizing,23 24 49 and antimicrobial properties.13

  • Possible cross-resistance with carboplatin.493 495 496

Advice to Patients

  • Risk of nausea, vomiting, nephrotoxicity, myelosuppression, and ototoxicity.1

  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.1

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 Necessity for clinicians to advise women to avoid pregnancy during therapy; advise pregnant women of risk to the fetus.1

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Platinol (cisplatin for injection, USP) lyophilized powder is no longer commercially available. Requests for this preparation of the drug for patients for whom Platinol-AQ (cisplatin injection), a preservative-free aqueous solution of the drug, is not a medically acceptable substitute, may be made by contacting the Medical Services Department at Bristol-Myers Squibb Company by phone (800-437-0994). For additional information, the Medical Department at Bristol-Myers Squibb may be contacted by phone (800-426-7644).

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Cisplatin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IV infusion

1 mg/mL (50 or 100 mg)*

Cisplatin Injection

Platinol-AQ

Bristol-Myers Squibb

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions June 19, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Bristol-Myers Squibb. Platinol-AQ (cisplatin injection) prescribing information. Princeton, NJ; 2002 Nov.

HID2. Trissel LA. Handbook on injectable drugs. 3rd ed. Bethesda, MD: American Society of Health-System Pharmacists, Inc.; 1983:126-8.

3. United States Pharmacopeia Dispensing Information, 1984. Vol 1. Rockville, MD: The United States Pharmacopeial Convention, Inc.; 1983:349.

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5. Mariana EP, Southard BJ, Woolever JT et al. Physical compatibility and chemical stability of cisplatin in various diluents and in large volume parenterals. In: Prestayko AW, Crooke ST, Carter SK, eds. Cisplatin: current status and new developments. New York: Academic Press, Inc., 1980:305-16.

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108. Wallach RC, Cohen C, Bruckner H et al. Chemotherapy of recurrent ovarian carcinoma with cis-dichlorodiammine platinum II and adriamycin. Obstet Gynecol. 1980; 55:371-2. [IDIS 112182] [PubMed 7189048]

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110. Wernz JC, Speyer JL, Noumoff J et al. Cisplatin (DDP)/cytoxan: a high dose DDP regimen for advanced stage ovarian carcinoma. Proc Am Soc Clin Oncol. 1982; 1:112.

111. Ehrlich CE, Einhorn L, Williams SE et al. Chemotherapy for Stage III-IV epithelial ovarian cancer with cis-dichlorodiammineplatinum (II), adriamycin, and cyclophosphamide: a preliminary report. Cancer Treat Rep. 1979; 63:281-8. [IDIS 121091] [PubMed 376134]

112. Bruckner HW, Ratner LH, Cohen CJ et al. Combination chemotherapy for ovarian carcinoma with cyclophosphamide, adriamycin, and cis-dichlorodiammineplatinum(II) after failure of initial chemotherapy. Cancer Treat Rep. 1978; 62:1021-3. [IDIS 98894] [PubMed 688244]

113. Williams CJ, Stevenson KE, Buchanan RB et al. Advanced ovarian carcinoma: a pilot study of cis-dichlorodiammineplatinum (II) in combination with adriamycin and cyclophosphamide in previously untreated patients and as a single agent in previously treated patients. Cancer Treat Rep. 1979; 63:1745-53. [IDIS 110512] [PubMed 393378]

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115. Omura GA, Ehrlich CE, Blessing JA. A randomized trial of cyclophosphamide (C) plus adriamycin (A) with or without cis-platinum (P) in ovarian carcinoma. Proc Am Soc Clin Oncol. 1982; 1:104.

116. Budd GT, Livingston RB, Webster K et al. Treatment of advanced ovarian cancer with cis-platin, adriamycin and cytoxan (PAC). Proc Am Soc Clin Oncol. 1982; 1:117.

117. Vogl SE, Pagano M, Kaplan BH et al. Cis-platin based combination chemotherapy for advanced ovarian cancer: high overall response rate with curative potential only in women with small tumor burdens. Cancer. 1983; 51:2024-30. [IDIS 170835] [PubMed 6404547]

118. Greco FA, Julian CG, Richardson RL et al. Advanced ovarian cancer: brief intensive combination chemotherapy and second-look operation. Obstet Gynecol. 1981; 58:199-205. [IDIS 136701] [PubMed 6789265]

119. Kane R, Harvey H, Andrews T et al. Phase II trial of cyclophosphamide, hexamethylmelamine, adriamycin, and cis-dichlorodiammineplatinum(II) combination chemotherapy in advanced ovarian carcinoma. Cancer Treat Rep. 1979; 63:307-9. [IDIS 121095] [PubMed 109201]

120. Vogl SE, Berenzweig M, Kaplan BH et al. The CHAD and HAD regimens in advanced ovarian cancer: combination chemotherapy including cyclophosphamide, hexamethylmelamine, adriamycin, and cis-dichlorodiammineplatinum(II). Cancer Treat Rep. 1979; 63:311-9. [IDIS 121096] [PubMed 109202]

121. Vogl SE, Pagano M, Kaplan BH et al. Combination chemotherapy of advanced ovarian cancer with hexamethylmelamine, cis-platinum, and doxorubicin after failure of prior therapy. Obstet Gynecol. 1980; 56:635-40. [IDIS 123995] [PubMed 6776457]

122. Bradof JE, Hakes TB, Ochoa M et al. Germ cell malignancies of the ovary: treatment with vinblastine, actinomycin D, bleomycin and cisplatin containing chemotherapy combinations. Cancer. 1982; 50:1070-5. [IDIS 157672] [PubMed 6179591]

123. Julian CG, Barrett JM, Richardson RL et al. Bleomycin, vinblastine, and cis-platinum in the treatment of advanced endodermal sinus tumor. Obstet Gynecol. 1980; 56:396-401. [IDIS 123244] [PubMed 6158721]

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