Carboplatin
Generic Name: carboplatin
Brand Names:
Carboplatin
DESCRIPTION Carboplatin injection,USP is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1,1-cyclobutane dicarboxylato(2-)-0,0’]-,(SP-4-2), and carboplatin, USP has the following structural formula: C 6 H 12 N 2 O 4 Pt M.W. 371.25 Carboplatin, USP is a crystalline powder.
Overview
DESCRIPTION Carboplatin injection,USP is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1,1-cyclobutane dicarboxylato(2-)-0,0’]-,(SP-4-2), and carboplatin, USP has the following structural formula: C 6 H 12 N 2 O 4 Pt M.W. 371.25 Carboplatin, USP is a crystalline powder.
Uses
INDICATIONS 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 ).
Dosage
DOSAGE & 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 2 IV 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.
Side Effects
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.
Interactions
Drug Interactions The renal effects of nephrotoxic compounds may be potentiated by carboplatin.
Warnings
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. WARNINGS Bone marrow suppression (leukopenia, neutropenia, and thrombocytopenia) is dose-dependent and is also the dose-limiting toxicity. Peripheral blood counts should be frequently monitored during carboplatin injection treatment and, when appropriate, until recovery is achieved. Median nadir occurs at day 21 in patients receiving single agent carboplatin. In general, single intermittent courses of carboplatin should not be repeated until leukocyte, neutrophil, and platelet counts have recovered. Since anemia is cumulative, transfusions may be needed during treatment with carboplatin, particularly in patients receiving prolonged therapy. Bone marrow suppression is increased in patients who have received prior therapy, especially regimens including cisplatin. 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.
Pregnancy
Pregnancy Pregnancy Category D (See WARNINGS ).
Storage
HOW SUPPLIED Carboplatin injection,USP is available in multi-dose vials, individually cartoned: NDC Number Fill volume Package 54288-164-01 5 mL fill in 10 mL Multiple dose vial One Multiple dose vial in one carton 54288-165-01 15 mL fill in 20 mL Multiple dose vial One Multiple dose vial in one carton 54288-166-01 45 mL fill in 50 mL Multiple dose vial One Multiple dose vial in one carton 54288-1...
Frequently Asked Questions
What is Carboplatin used for?▼
INDICATIONS 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 ).
What are the side effects of Carboplatin?▼
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.
Can I take Carboplatin during pregnancy?▼
Pregnancy Pregnancy Category D (See WARNINGS ).
What are the important warnings for Carboplatin?▼
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. WARNINGS Bone marrow suppression (leukopenia, neutropenia, and thrombocytopenia) is dose-dependent and is also the dose-limiting toxicity. Peripheral blood counts should be frequently monitored during carboplatin injection treatment and, when appropriate, until recovery is achieved. Median nadir occurs at day 21 in patients receiving single agent carboplatin. In general, single intermittent courses of carboplatin should not be repeated until leukocyte, neutrophil, and platelet counts have recovered. Since anemia is cumulative, transfusions may be needed during treatment with carboplatin, particularly in patients receiving prolonged therapy. Bone marrow suppression is increased in patients who have received prior therapy, especially regimens including cisplatin. 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.