Platinum-based Drug

Cisplatin

Approved 16 May 2000InjectionInjectable

The FDA lists this product in 12 strengths and forms.

Indications

Cisplatin Injection is a platinum-based drug indicated for the treatment of: Advanced testicular cancer ( 1.1 ) Advanced ovarian cancer ( 1.2 ) Advanced bladder cancer ( 1.3 )

1.1Advanced Testicular Cancer Cisplatin

Injection is indicated for the treatment of advanced testicular cancer.

1.2Advanced Ovarian Cancer Cisplatin

Injection is indicated for the treatment of advanced ovarian cancer.

1.3Advanced Bladder Cancer Cisplatin

Injection is indicated for the treatment of advanced bladder cancer.

Contraindications

Cisplatin Injection is contraindicated in patients with severe hypersensitivity to cisplatin [see Warnings and Precautions ( 5.4 )] . Severe hypersensitivity to cisplatin ( 4 )

Warnings and precautions

Hypersensitivity reactions: Anaphylaxis and death may occur; monitor for and treat accordingly ( 5.5 ) Ototoxicity: Cumulative toxicity may be severe particularly in pediatric patients; consider audiometric and vestibular function monitoring ( 5.6 , 8.4 ) Ocular toxicity: Optic neuritis, papilledema, and cortical blindness may occur ( 5.7 ) Secondary leukemia: Secondary acute leukemia may occur ( 5.8 ) Embryo-fetal toxicity: Can cause fetal harm.

Advise of potential risk to a fetus and use of effective contraception. ( 5.9 , 8.1 , 8.3 )

5.1Nephrotoxicity Cisplatin

Injection can cause dose-related nephrotoxicity, including acute renal failure that becomes more prolonged and severe with repeated courses of the drug. Renal toxicity typically begins during the second week after a dose of Cisplatin Injection. Patients with baseline renal impairment, geriatric patients, patients who are taking other nephrotoxic drugs, or patients who are not well hydrated may be more susceptible to nephrotoxicity [see Use in Specific Populations ( 8.5 , 8.6 )] .

Indications

Cisplatin Injection is a platinum-based drug indicated for the treatment of: Advanced testicular cancer ( 1.1 ) Advanced ovarian cancer ( 1.2 ) Advanced bladder cancer ( 1.3 )

1.1Advanced Testicular Cancer Cisplatin

Injection is indicated for the treatment of advanced testicular cancer.

1.2Advanced Ovarian Cancer Cisplatin

Injection is indicated for the treatment of advanced ovarian cancer.

1.3Advanced Bladder Cancer Cisplatin

Injection is indicated for the treatment of advanced bladder cancer.

Warnings and precautions

Advise of potential risk to a fetus and use of effective contraception. ( 5.9 , 8.1 , 8.3 )

5.1Nephrotoxicity Cisplatin

Adverse reactions

The following adverse reactions are described in greater detail, in other sections: Nephrotoxicity [see Warnings and Precautions ( 5.1 )] Peripheral Neuropathy [see Warnings and Precautions ( 5.2 )] Nausea and vomiting [see Warnings and Precautions ( 5.3 )] Myelosuppression [see Warnings and Precautions ( 5.4 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.5 )] Ototoxicity [see Warnings and Precautions ( 5.6 ] Ocular toxicity [see Warnings and Precautions ( 5.7 )] Secondary malignancies [see Warnings and Precautions ( 5.8 )] Injection site reactions [see Warnings and Precautions ( 5.10 )] Common adverse reactions are nephrotoxicity, peripheral neuropathy, nausea and vomiting myelosuppression, and ototoxicity.

The following adverse reactions have been identified from clinical trials or post-marketing surveillance. 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 Skin and subcutaneous tissue disorders: Alopecia, rash Common adverse reactions are nephrotoxicity, peripheral neuropathy, nausea and vomiting, myelosuppression, and ototoxicity.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Cisplatin

Indications

1.1Advanced Testicular Cancer Cisplatin

1.2Advanced Ovarian Cancer Cisplatin

1.3Advanced Bladder Cancer Cisplatin

Contraindications

Warnings and precautions

5.1Nephrotoxicity Cisplatin

Two medicines in one question?

Cisplatin

Indications

1.1Advanced Testicular Cancer Cisplatin

1.2Advanced Ovarian Cancer Cisplatin

1.3Advanced Bladder Cancer Cisplatin

Contraindications

Warnings and precautions

5.1Nephrotoxicity Cisplatin

Two medicines in one question?

5.2Peripheral Neuropathy Cisplatin

5.3Nausea and Vomiting Cisplatin

5.4Myelosuppression

5.5Hypersensitivity Reactions Cisplatin

5.6Ototoxicity Cisplatin

5.7Ocular Toxicity

5.8Secondary Malignancies

5.9Embryo-Fetal Toxicity Based

Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Based

Adverse reactions

Composition

Strengths and forms

Official product information

At a glance