Cisplatin is a platinum-based drug sold in the U.S. under 3 brand and generic names, for astrocytoma, urinary bladder neoplasms and breast neoplasms. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Cisplatin (application ANDA206774). Other cisplatin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer pre-treatment hydration and pre- and post-treatment antiemetics. ( 2.1 ) • Cisplatin injection has been administered intravenously at: Advanced testicular cancer: 20 mg/m2 daily for 5 days per cycle ( 2.2 ) Advanced ovarian cancer: 75 mg/m2 to 100 mg/m2 per cycle once every 3 to 4 weeks ( 2.3 ) Advanced bladder cancer: 50 mg/m2 to 70 mg/m2 intravenously per cycle once every 3 to 4 weeks ( 2.4 ) Refer to current treatment guidelines for specific dosing information. • Administer by slow intravenous infusion. Avoid contact of cisplatin injection with aluminum parts. ( 2.6 ) 2.1 Hydration and Anti-Emetic Treatment Patients treated with cisplatin injection must receive appropriate pre-treatment hydration. Maintain adequate hydration and urinary output for 24 hours after cisplatin injection administration [see Warnings and Precautions ( 5.1 )] . Administer pre-treatment and post-treatment antiemetics as appropriate [see Warnings and Precautions ( 5.7 )] . 2.2 Advanced Testicular Cancer Cisplatin injection has been administered at 20 mg/m 2 intravenously daily for 5 days per cycle. Other doses and combination regimens have been used. 2.3 Advanced Ovarian Cancer Cisplatin injection has been administered at 75 mg/m 2 to 100 mg/m 2 intravenously per cycle once every 3 to 4 weeks on Day 1. Other doses and combination regimens have been used. 2.4…
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,…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
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From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Cisplatin injection is contraindicated in patients with severe hypersensitivity to cisplatin [see Warnings and Precautions ( 5.4 )] . Severe hypersensitivity to cisplatin ( 4 )
The following drug interactions are described in other sections: Nephrotoxic drugs [see Warnings and Precautions ( 5.1 )] Ototoxic drugs [see Warnings and Precautions ( 5.6 )]
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| 3 | Not yet rated | Prescription | Injectable | — | — | View → |