Carboplatin (3 brand names, 2 dosage forms, 2 routes)
Available dosage forms: INJECTABLE, SOLUTION.
Routes of administration: INJECTION, INTRAVENOUS.
Brand Names
- CARBOPLATIN
- KYXATA
- PARAPLATIN
Boxed Warning
Carboplatin injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate treatment facilities are readily available. Bone marrow suppression is dose related and may be severe, resulting in infection and/or bleeding. Anemia may be cumulative and may require transfusion support. Vomiting is another frequent drug related side effect. Anaphylactic-like reactions to carboplatin have been reported and may occur within minutes of carboplatin injection administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms.
Indications and Usage
Initial Treatment of Advanced Ovarian Carcinoma Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES ). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup. Secondary Treatment of Advanced Ovarian Carcinoma Carboplatin injection is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin. Within the group of patients previously treated with cisplatin, those who have developed progressive disease while receiving cisplatin therapy may have a decreased response rate.
Dosage and Administration
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 2IV on day 1 every 4 weeks (alternatively see Formula Dosing). In general, however, single intermittent courses of carboplatin 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 - 300 mg/m 2IV on day 1 every 4 weeks for 6 cycles (alternatively see Formula Dosing). Cyclophosphamide - 600 mg/m 2IV 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 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 Recommendations Pretreatment platelet count and performance status are important prognostic factors for severity of myelosuppression in previously treated patients. The suggested dose adjustments for single agent or combination therapy shown in the table below are modified from controlled trials in previously treated and untreated patients with ovarian carcinoma. Blood counts were done weekly, and the recommendations are based on the lowest post-treatment platelet or neutrophil value. Platelets Neutrophils Adjusted Dose* (From Prior Course) > 100,000 > 2,000 125% 50 to 100,000 500 to 2,000 No adjustment < 50,000 < 500 75% * Percentages apply to carbopl
Contraindications
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.
Adverse Reactions
To report SUSPECTED ADVERSE REACTIONS, contact BPI Labs, LLC at (727) 471-0850 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/mm3 <50,000/mm3 66 33 62 35 Neutropenia <2,000 cells/mm3 <1,000 cells/mm3 96 82 67 21 Leucopenia <4,000 cells/mm3 <2,000 cells/mm3 97 71 85 26 Anemia <11 g/dL < 8 g/dL 90 14 90 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 Cyclophosphamide for Initial Treatment of Ovarian Cancer:Data are based on the experience of 393 patients with ovarian cancer (regardless of baseline status) who received initial combination therapy with carboplatin and cyclophosphamide in two randomized controlled studies conducted by SWOG and NCIC (see CLINICAL STUDIES ). Combination with cyclophosphamide as well as duration of treatment may be responsible for the differences that can be noted in the adverse experience table. ** Single Agent Use for the Secondary Treatment of Ovarian Cancer:Data are based on the experience of 553 patients with previously treated ovarian carcinoma (regardless of bas
Drug Interactions
The renal effects of nephrotoxic compounds may be potentiated by carboplatin.
Overdosage
There is no known antidote for carboplatin injection overdosage. The anticipated complications of overdosage would be secondary to bone marrow suppression and/or hepatic toxicity.