CARBOPLATIN 10 mg/mL
Carboplatin · INJECTION, SOLUTION · Gland Pharma Limited
Carboplatin is a platinum-based chemotherapy drug given as an injection into the vein to treat various cancers, including ovarian, lung, and breast cancers. It works by damaging cancer cell DNA to slow or stop cancer growth.
Key Facts
- Brand Name
- CARBOPLATIN
- Generic Name
- Carboplatin
- NDC Code (Product)
68083-192- Manufacturer
- Gland Pharma Limited
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA207324
- Drug Class
- Platinum-based Drug [EPC]
- Marketing Start
- 02/20/2017
Recall History
Mylan Institutional LLC
Presence of Particulate Matter
Hospira Inc.
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Teva Pharmaceuticals USA, Inc.
Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
Hospira Inc.
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Hospira Inc.
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Hospira Inc.
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Infusion Options, Inc.
Lack of Assurance of Sterility
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged between 01/05/12 through 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 ). 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 trea…
Dosage & Administration
DOSAGE AND ADMINISTRATION NOTE: Aluminium reacts with carboplatin causing precipitate formation and loss of potency, therefore, needles or intravenous sets containing aluminium 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. Combination Therapy with Cyclophosphamide In the chemotherapy of advanced ovarian cancer, an effective combination for previously untreated patients consists of: Carboplatin - 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 carb…
Warnings
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. Marrow suppression is also increased in patients with impaired kidney function. Initial carboplatin injection dosages in these patients should be appropriately reduced (see DOSAGE AND ADMINISTRATION ) and blood counts should be carefully monitored between courses. The use of carboplatin in combination with other bone marrow suppressing therapies must be carefully managed with respect to dosage and timing in order to minimize…
Contraindications
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
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS Contact Apotex Corp.at 1-800-706-5575 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 * 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 baseline status) who received single agent carboplatin. First Line Combination Therapy * Percent Second Line Sing…
Frequently Asked Questions
What is CARBOPLATIN used for?
Carboplatin is a platinum-based chemotherapy drug given as an injection into the vein to treat various cancers, including ovarian, lung, and breast cancers. It works by damaging cancer cell DNA to slow or stop cancer growth.
Is CARBOPLATIN a controlled substance?
CARBOPLATIN is not classified as a controlled substance by the DEA.
What is the generic name for CARBOPLATIN?
The generic name for CARBOPLATIN is Carboplatin. There are 4 other brand versions of Carboplatin.
What is the NDC code for CARBOPLATIN 10 mg/mL?
The NDC (National Drug Code) for CARBOPLATIN 10 mg/mL is 68083-192, listed by Gland Pharma Limited.