Carboplatin is a platinum-based drug sold in the U.S. under 2 brand and generic names, for urinary bladder neoplasms, bone marrow diseases 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 Carboplatin (application ANDA077139). Other carboplatin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
NOTE: Aluminum reacts with carboplatin causing precipitate formation and loss of potency, therefore, needles or intravenous sets containing aluminum parts that may come in contact with the drug must not be used for the preparation or administration of Carboplatin Injection. Single-Agent Therapy Carboplatin Injection, as a single agent, has been shown to be effective in patients with recurrent ovarian carcinoma at a dosage of 360 mg/m 2 IV on day 1 every 4 weeks (alternatively see Formula Dosing ). In general, however, single intermittent courses of Carboplatin Injection should not be repeated until the neutrophil count is at least 2,000 and the platelet count is at least 100,000. Combination Therapy with Cyclophosphamide In the chemotherapy of advanced ovarian cancer, an effective combination for previously untreated patients consists of: Carboplatin Injection–300 mg/m 2 IV on day 1 every 4 weeks for 6 cycles (alternatively see Formula Dosing ). Cyclophosphamide–600 mg/m 2 IV on day 1 every 4 weeks for 6 cycles. For directions regarding the use and administration of cyclophosphamide please refer to its package insert (see CLINICAL STUDIES ). Intermittent courses of Carboplatin Injection in combination with cyclophosphamide should not be repeated until the neutrophil count is at least 2,000 and the platelet count is at least 100,000. Dose Adjustment…
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For a comparison of toxicities when carboplatin or cisplatin was given in combination with cyclophosphamide, see CLINICAL STUDIES , Use with Cyclophosphamide for Initial Treatment of Ovarian Cancer, Comparative Toxicity. ADVERSE EXPERIENCES IN PATIENTS WITH OVARIAN CANCER First Line Combination Therapy * Percent Second Line Single Agent Therapy ** Percent Bone Marrow Thrombocytopenia < 100,000/mm 3 66 62 < 50,000/mm 3 33 35 Neutropenia < 2,000 cells/mm 3 96 67 < 1,000 cells/mm 3 82 21 Leukopenia < 4,000 cells/mm 3 97 85 < 2,000 cells/mm 3 71 26 Anemia < 11/g/dL 90 90 < 8 g/dL 14 21 Infections 16 5 Bleeding 8 5 Transfusions 35 44 Gastrointestinal Nausea and vomiting 93 92 Vomiting 83 81 Other GI side effects 46 21 Neurologic Peripheral neuropathies 15 6 Ototoxicity 12 1 Other sensory side effects 5 1 Central neurotoxicity 26 5 Renal Serum creatinine elevations 6 10 Blood urea elevations 17 22 Hepatic Bilirubin elevations 5 5 SGOT elevations 20 19 Alkaline phosphatase elevations 29 37 Electrolytes loss Sodium 10 47 Potassium 16 28 Calcium 16 31 Magnesium 61 43 Other side effects Pain 44 23 Asthenia 41 11 Cardiovascular 19 6 Respiratory 10 6 Allergic 11 2 Genitourinary 10 2 Alopecia 49 2 Mucositis 8 1 *Use with…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
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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.
Carboplatin Injection is contraindicated in patients with a history of severe allergic reactions to cisplatin or other platinum-containing compounds. Carboplatin Injection should not be employed in patients with severe bone marrow depression or significant bleeding.
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