cisplatin (Rx)

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Dosing & Uses

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Dosage Forms & Strengths

injectable solution

  • 1mg/mL

Metastatic Testicular Tumors

Usual dose in combination with other approved chemotherapeutic agents is 20 mg/m²/day IV for 5 days repeated every 3 weeks (in combination with bleomycin and etoposide)  

Advanced Bladder Cancer

50-70 mg/m² IV cycle q3-4Weeks, depending on prior radiation therapy or chemotherapy; for heavily pretreated patients, give 50 mg/m²/cycle initially; repeat q4Weeks  

Metastatic Ovarian Carcinoma

75-100 mg/m² IV per cycle q4Weeks with cyclophosphamide (600 mg/m² IV q4Weeks); administer sequentially  

Off-label: 90-270 mg/m² intraperitoneal; retain for 4 hr before draining; repeat q3Weeks (may coadminister systemic Na thiosulfate)

Cancers (Off-label)

Cancer of cervix, endometrium, prostate, esophagus, kidney; non-small cell lung cancer; head & neck squamous cell cancer; osteogenic sarcomas; bone marrow transplants

75-100 mg/m² IV q4Weeks when used with cyclophosphamide  

100 mg/m² IV q4Weeks as single agent

Dosing Considerations

Pretreatment hydration: 1-2 L fluid infused for 8-12 hr before dose

May use concomitant amifostine to decrease nephrotoxicity

Do not repeat course until SCr <1.5 mg/dL [<133 micromoles/L] or BUN <25 mg/dL [<8.93 mmol/L] or WBC >4000/mm³ AND platelets >100 k/mm³

Renal Impairment

CrCl 10-50 mL/min: Decrease dose by 25%

CrCl <10 mL/min: Administer 50% of dose

Hemodialysis

  • Partially cleared by hemodialysis
  • Posthemodialysis: Administer 50% of dose
  • Continuous ambulatory peritoneal dialysis: Administer 50% of dose
  • Continuous renal replacement therapy (CRRT): Administer 75% of dose

Metastatic Osteogenic Sarcoma (Orphan)

Liposomal cisplatin for inhalation: Treatment of osteogenic sarcoma metastatic to the lung

Orphan indication sponsor

  • Transave, Inc; 11 Deer Park Drive, Suite 117; Monmouth Junction, NJ 08852-1923

Ovarian Cancer (Orphan)

Liposomal ciplatin: Treatment of ovarian cancer

Orphan indication sponsor

  • Transave, Inc; 11 Deer Park Drive, Suite 117; Monmouth Junction, NJ 08852-1923

Squamous Cell Carcinoma (Orphan)

Cisplatin with epinephrine: Treatment of squamous cell carcinoma of the head and neck

Orphan indication sponsor

  • Matrix Pharmaceutical, Inc; 34700 Campus Drive; Fremont, CA 94555-3612

Malignant Melanoma (Orphan)

Cisplatin with epinephrine: Treatment of metastatic malignant melanoma

Orphan indication sponsor

  • Matrix Pharmaceutical, Inc; 34700 Campus Drive; Fremont, CA 94555-3612

Oral Cancers (Orphan)

ChemoThin wafer: Orphan designation for treatment of anatomically accessible oral cancers (lip, tongue, gum, floor of mouth, salivary gland, and other oral cavity)

Sponsor

  • Privo Technologies; 13 Bristol Street, Unit #1; Cambridge, Massachusetts 02141

Anal Cancer (Orphan)

Orphan designation for treatment of anal cancer

Sponsor

  • Privo Technologies; 13 Bristol Street Unit #1; Cambridge, Massachusetts 02141

Monitor

CBC; audiometric testing before each dose

Dosage Forms & Strengths

injectable solution

  • 1mg/mL

Osteogenic Sarcoma/Neuroblastoma (Off-label)

90 mg/m² IV q3Weeks OR 30 mg/m² IV qWeek  

Brain Tumors, Recurrent (Off-label)

60 mg/m² IV qDay for 2 consecutive days q3-4Weeks  

Dosing Considerations

Verify any cisplatin dose exceeding 100 mg/m² per regimen

Pretreatment hydration: 1-2 L fluid infused for 8-12 hr before dose

May use concomitant amifostine to decrease nephrotoxicity

Do not repeat course until SCr <1.5 mg/dL [<133 micromoles/L] or BUN <25 mg/dL [<8.93 mmol/L] or WBC >4000/mm³ AND platelets >100 k/mm³

Monitor therapy closely; elderly maybe more susceptible to nephrotoxicity and peripheral neuropathy

Metastatic Testicular Tumors

Usual dose in combination with other approved chemotherapeutic agents is 20 mg/m²/day IV for 5 days/cycle  

Advanced Bladder Cancer

50 -70 mg/m² IV cycle q3-4Weeks, depending on prior radiation therapy or chemotherapy; for heavily pretreated patients, give 50 mg/m²/cycle initially; repeat q4Weeks  

Metastatic Ovarian Carcinoma

75-100 mg/m² IV per cycle q3-4Weeks on Day 1 with cyclophosphamide (600 mg/m² IV q4Weeks); administer sequentially  

Unlabeled: 90-270 mg/m² intraperitoneal; retain for 4 hr before draining; repeat q3Weeks (may coadminister systemic Na thiosulfate)

Dosing considerations

Pretreatment hydration: 1-2 L fluid infused for 8-12 hr before dose

May use concomitant amifostine to decrease nephrotoxicity

Do not repeat course until SCr <1.5 mg/dL [<133 micromoles/L] or BUN <25 mg/dL [<8.93 mmol/L] or WBC >4000/mm³ AND platelets >100 k/mm³

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Interactions

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            Adverse Effects

            >10%

            Nausea (76-100%)

            Vomiting (76-100%)

            Nephrotoxicity (28-36%)

            Ototoxicity, especially in children (31%)

            Myelosuppression (25-30%)

            Anaphylaxis (1-20%)

            Alopecia

            Frequency Not Defined

            Cerebral herniation

            Encephalopathy

            Leukoencephalopathy and reversible posterior leukoencephalopathy syndrome

            Seizure

            Peripheral neuropathy (dose and duration dependent)

            Diarrhea

            Electrolyte changes

            Hyperuricemia

            Hepatotoxicity

            Local tissue irritation

            Blood and lymphatic system disorders: Coombs-positive hemolytic anemia. hemolytic uremic syndrome, thrombotic thrombocytopenic purpura

            Cardiovascular disorders: Venous thromboembolism, arterial thromboembolism, myocardial infarction, cerebrovascular accident, thrombotic microangiopathy, cerebral arteritis, pericardial effusion, cardiac failure, ventricular dysfunction, Raynaud’s phenomenon

            Eye disorders: Optic neuritis, papilledema, cortical blindness, blurred vision, color blindness, retinal pigmentation

            Gastrointestinal disorders: Nausea, vomiting, anorexia, diarrhea, stomatitis, gastrointestinal perforation, pancreatitis, hiccups

            General disorders: Asthenia, malaise

            Hepatobiliary disorders: Elevations of aminotransferases, lactate dehydrogenase, and bilirubin; hepatic failure

            Hypersensitivity: Anaphylaxis, facial edema, wheezing, tachycardia, and hypotension

            Local Site Reactions: Tissue cellulitis, fibrosis, necrosis, pain, edema, and erythema

            Metabolism and nutrition disorders: Hypomagnesemia, often requiring magnesium supplementation; hyperuricemia, other electrolyte abnormalities (hypocalcemia, hyponatremia, hypokalemia, and hypophosphatemia), Syndrome of Inappropriate Antidiuretic Hormone Excretion (SIADH), dehydration, tumor lysis syndrome, increased serum amylase

            Musculoskeletal disorders: Muscle cramps (localized, painful, involuntary skeletal muscle contractions of sudden onset and short duration)

            Nervous system disorders: Peripheral neuropathy, encephalopathy, loss of motor function, loss of taste, leukoencephalopathy, reversible posterior leukoencephalopathy syndrome, progressive multifocal leukoencephalopathy, seizures, Lhermitte’s sign, dorsal column myelopathy, autonomic neuropathy, seizures, involuntary skeletal muscle contractions, tetany (with hypocalcemia and hypomagnesemia)

            Ototoxicity: Tinnitus, hearing loss, deafness, vestibular toxicity

            Renal and urinary disorders: Nephrotoxicity including renal failure, renal electrolyte wasting, azotemia, decreased creatinine clearance

            Respiratory disorders: Pneumonitis/interstitial lung disease, pulmonary embolism

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            Warnings

            Black Box Warnings

            The drug should be administered under the supervision of an experienced cancer chemotherapy physician

            Severe nephrotoxicity, myelosuppression, and nausea and vomiting are dose related

            Significant ototoxicity, manifested by tinnitus and occasionally deafness, reported in children

            Anaphylactic-like reactions have occurred. Facial edema, bronchoconstriction, tachycardia, and hypotension may occur within minutes of cisplatin administration

            Failure to differentiate daily doses from total dose per treatment cycle may result in cisplatin overdose

            Contraindications

            Hypersensitivity to cisplatin, other platinum compounds

            Severe myelosuppression, renal impairment, hearing impairment

            Pregnancy, lactation

            Cautions

            Irritant; injection site reactions may occur during administration; local soft tissue toxicity reported following extravasation of cisplatin for injection; severity of local tissue toxicity appears to be related to concentration of drug; closely monitor infusion site during drug administration

            Avoid aluminum needles/equipment

            Pediatric patients, hearing impairment, neuropathy, neuromuscular disease, with neurotoxic agents, with ototoxic agents, elderly

            Risk of cumulative nephrotoxicity (exacerbated by aminoglycoside antibiotics); renal toxicity becomes more prolonged and severe with repeated courses; renal function must return to normal before administering another dose

            Myelosuppression occurs in 25-30%; nadirs in circulating platelets and leukocytes occur between days 18-23 (range 7.5-45) with most patients recovering by day 39; elderly may be more susceptible to myelosuppression

            Development of acute leukemia secondary to therapy reported; in these reports, cisplatin for injection was generally given in combination with other leukemogenic agents

            Optic neuritis, papilledema, and cortical blindness reported in patients receiving standard recommended doses; blurred vision and altered color perception reported after use of regimens with higher doses and dose frequencies; the altered color perception manifests as a loss of color discrimination, particularly in the blue-yellow axis and irregular retinal pigmentation of macular area on fundoscopic exam; improvement and/or total recovery usually occurs after discontinuing cisplatin for injection but can be delayed

            Cardiac abnormalities, hiccups, elevated serum amylase, rash, alopecia, malaise, asthenia, and dehydration have been reported

            Avoid pregnancy

            Renal toxicity

            • Ensure adequate hydration before, during, and after administration; measure serum creatinine, blood urea nitrogen, creatinine clearance, and serum electrolytes including magnesium prior to initiating therapy, and as clinically indicated; consider magnesium supplementation as clinically needed
            • Consider alternative treatments or reduce dose for patients with baseline renal impairment or who develop significant reductions in creatinine clearance during treatment

            Peripheral neuropathy

            • Drug can cause dose-related peripheral neuropathy that becomes more severe with repeated courses of drug; neurologic symptoms have been reported to occur after a single dose
            • Neuropathy can also have a delayed onset from 3-8 weeks after last dose of cisplatin for injection; manifestations include paresthesias in a stocking-glove distribution, areflexia, and loss of proprioception and vibratory sensation
            • Neuropathy may progress further even after stopping treatment; peripheral neuropathy may be irreversible in some patients
            • Perform a neurological examination before initiating therapy, at appropriate intervals during therapy, and after completion of therapy; consider discontinuation of cisplatin for injection for patients who develop symptomatic peripheral neuropathy; geriatric patients may be more susceptible to peripheral neuropathy

            Nausea and vomiting

            • Cisplatin for injection is a highly emetogenic antineoplastic agent; premedicate with anti-emetic agents; without antiemetic therapy, marked nausea and vomiting occur in almost all patients treated with cisplatin for injection and may be so severe that drug must be discontinued; nausea and vomiting may begin within 1 to 4 hr after treatment and last up to 72 hr; maximal intensity occurs 48 to 72 hours after administration
            • Various degrees of vomiting, nausea, and/or anorexia may persist for up to 1 week after treatment; delayed nausea and vomiting (begins or persists 24 hours or more after chemotherapy) has occurred in patients attaining complete emetic control on day of injection therapy; consider use of additional anti-emetics following infusion

            Myelosuppression

            • Potential fatalities due to infection (secondary to myelosuppression) reported
            • Perform standard hematologic tests before initiating therapy, before each subsequent course, and as clinically indicated; closely monitor patients for development of signs and symptoms of infection during and after treatment with cisplatin for injection; for patients who develop severe myelosuppression, consider dose modifications and manage according to clinical treatment guidelines

            Hypersensitivity

            • Therapy can cause severe hypersensitivity reactions, including anaphylaxis and death; manifestations have included facial edema, wheezing, tachycardia, hypotension; hypersensitivity reactions have occurred within minutes of administration to patients with prior exposure to cisplatin
            • Severe hypersensitivity reactions require immediate discontinuation of cisplatin for injection and aggressive therapy; patients with a history of severe hypersensitivity reactions should not be rechallenged with cisplatin for injection
            • Cross-reactivity between platinum-based antineoplastic agents reported; cases of severe hypersensitivity reactions have recurred after rechallenging patients with a different platinum agent

            Ototoxicity

            • Cisplatin for injection can cause ototoxicity, which is cumulative and may be severe; consider audiometric and vestibular function monitoring
            • Ototoxic effects may be more severe and detrimental in pediatric patients receiving cisplatin for injection, particularly in patients less than 5 years of age; consider audiometric and vestibular function monitoring in all patients receiving cisplatin for injection; the prevalence of hearing loss in pediatric patients is particularly high and is estimated to be 40% to 60%
            • Earlier detection of hearing loss can limit potential impact of hearing impairment on a pediatric patient’s cognitive and social development
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            Pregnancy & Lactation

            Pregnancy

            Based on human data from published literature, cisplatin can cause fetal harm when administered to pregnant women; data demonstrates transplacental transfer of cisplatin

            Exposure associated with oligohydramnios, intrauterine growth restriction, and preterm birth; cases of neonatal acute respiratory distress syndrome, cytopenias, and hearing loss reported

            Verify the pregnancy status of females of reproductive potential before initiating prior to initiation of cisplatin for injection

            Contraception

            • Females: Advise females of reproductive potential to use effective contraception during treatment and for 14 months following the last dose
            • Males: Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 11 months after the last dose

            Infertility

            • Females: Use associated with cumulative dose-dependent ovarian failure, premature menopause, and reduced fertility
            • Males: Use associated with a cumulative dose-dependent impairment of spermatogenesis (oligospermia, azoospermia; possibly irreversible) and reduced fertility

            Animal data

            • Cisplatin for injection administration to animals during and after organogenesis resulted in teratogenicity; a published study in mice showed placental transfer of cisplatin increased with placenta maturation

            Lactation

            Limited data from published literature report the presence of drug in human milk; because of potential for serious adverse reactions in a breastfed child and because of potential for tumorigenicity, advise lactating women not to breastfeed during treatment

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Platinum coordination compound that inhibits DNA synthesis; cross-links and denatures strands of DNA; disrupts DNA function by covalently binding to DNA bases; can also produce DNA intrastrand cross-linking and breakage

            Not a true alkylating agent

            Pharmacokinetics

            Half-life elimination (terminal): 24hr to 47 days

            Protein bound: >90%

            Excretion: Urine (90%); feces (10%)

            Clearance: 15 L/hr/m²

            Vd: 11 L/m²

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            Administration

            IV Incompatibilities

            Solution: Na-bicarb 5%, D5W(?)

            Additive: fluorouracil, mesna, paclitaxel(?), thiotepa

            Y-site: amifostine, amphotericin B cholesteryl-SO4, cefepime, piperacillin/tazobactam, thiotepa

            IV Compatibilities

            Solution: dextrose-saline, NS, 1/2NS, other saline concentrations

            Additive: carboplatin, cyclophosphamide w/ etoposide, etoposide, floxuridine, floxuridine w/ leucovorin, hydroxyzine, ifosfamide, leucovorin, MgSO4, mannitol, ondansetron

            Syringe: bleomycin, cyclophosphamide, doxapram, doxorubicin, droperidol, fluorouracil, furosemide, heparin, leucovorin, methotrexate, metoclopramide, mitomycin, vinblastine, vincristine

            Y-site (partial list): allopurinol, aztreonam, bleomycin, chlorpromazine, cladribine, cyclophophamide, dexamethasone Na-succinate, diphenhydramine, doxorubicin, doxorubicin liposomal, etoposide phosphate, filgrastim, fludarabine, fluorouracil, furosemide, gemcitabine, granisetron, heparin, leucovorin, linezolid, lorazepam, melphalan, methotrexate, methylprednisolone Na-succinate, metoclopramide, mitomycin, morphine, ondansetron, paclitaxel, prochlorperazine edisylate, propofol, sargramostim, vinblastine, vincristine, vinorelbine

            IV Preparation

            Further dilution stability is dependent on chloride ion concentration & should be mixed in solutions of NS (at least 0.3% NaCl)

            Further dilution in NS, D5/½NS or D5/NS to a concentration of 0.05-2 mg/mL are stable for 72 hr at 4-25°C in combination with mannitol

            May administer 12.5-50 g mannitol/L

            Standard dilution: dose/250-1000 mL NS, D5W/NS or D5/½NS

            IV Administration

            Perform pretreatment hydration

            Do not use aluminum-containing needles or IV administration sets that may come in contact with carboplatin (aluminum can react causing precipitate formation & loss of potency)

            Administration rate has varied from a 15-120 min infusion, 1 mg/min infusion, 6-8 hr infusion, 24 hr infusion, or per protocol

            Maximum rate of infusion: 1 mg/min in patients with CHF

            When administered as sequential infusions, taxane derivatives (docetaxel, paclitaxel) should be administered before platinum derivatives to limit myelosuppression & to enhance efficacy

            Extravasation Management

            Large extravasations (>20 mL) of concentrated solutions (>0.5 mg/mL) produce tissue necrosis

            Tx is not recommended unless a large amount of highly concentrated solution is extravasated

            Mix 4 mL of 10% sodium thiosulfate with 6 mL SWI; inject 1-4 mL through existing IV line cannula; administer 1 mL for each mL extravasated; inject SC if needle is removed

            Storage

            Store intact vials at 15-25°C (59-77°F)

            Protect from light

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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