pharmacopeia
GET
/api/v1/drug/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. 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.

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Nucleic Acid Synthesis Inhibitors.

Nucleic Acid Synthesis

Indications

Sourced from openFDA
  • 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.

Contraindications

Sourced from openFDA
  • 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.contraindicated

Dosage & administration

Sourced from openFDA

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 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.

Warnings & precautions

Sourced from openFDA

General Needles or intravenous administration sets containing aluminium parts that may come in contact with carboplatin injection should not be used for the preparation or administration of the drug. Aluminium can react with carboplatin causing precipitate formation and loss of potency. Drug Interactions The renal effects of nephrotoxic compounds may be potentiated by carboplatin. Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of carboplatin has not been studied, but compounds with similar mechanisms of action and mutagenicity profiles have been reported to be carcinogenic. Carboplatin has been shown to be mutagenic both in vitro and in vivo . It has also been shown to be embryotoxic and teratogenic in rats receiving the drug during organogenesis. Secondary malignancies have been reported in association with multi-drug therapy. Pregnancy Pregnancy Category D See WARNINGS . Nursing Mothers It is not known whether carboplatin is excreted in human milk. Because there is a possibility of toxicity in nursing infants secondary to carboplatin treatment of the mother, it is recommended that breast-feeding be discontinued if the mother is treated with carboplatin injection. Pediatric Use Safety and effectiveness in pediatric patients have not been established (see WARNINGS: "audiologic toxicity"). Geriatric Use Of the 789 patients in initial treatment combination therapy studies (NCIC and SWOG), 395 patients were treated with carboplatin in combination with cyclophosphamide. Of these, 141 were over 65 years of age and 22 were 75 years or older.

Adverse reactions

Sourced from openFDA

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.

Overdosage

Sourced from openFDA

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.

Approval history

Sourced from openFDA
  • Oct 14, 2004ANDAANDA077269Pharmachemie Bv
  • Oct 14, 2004ANDAANDA076517Hospira
  • Nov 23, 2004ANDAANDA077059Hospira
  • Feb 15, 2006ANDAANDA077266Fresenius Kabi Usa
  • Jan 18, 2007ANDAANDA077861Teyro Labs
  • Mar 28, 2016ANDAANDA205487Eugia Pharma
  • Feb 9, 2017ANDAANDA206775Accord Hlthcare
  • Aug 8, 2025NDANDA219921Avyxa Holdings

FDA shortages

View JSON

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Carboplatin, Injection, 10 mg/1 mL (NDC 0703-4239-01)Active
    Sponsor: Teva Pharmaceuticals USA, Inc. · Reason: Other
    Updated
  • Carboplatin, Injection, 10 mg/1 mL (NDC 0703-4244-01)Active
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Carboplatin, Injection, 10 mg/1 mL (NDC 0703-4246-01)Active
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Carboplatin, Injection, 10 mg/1 mL (NDC 0703-4248-01)Active
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Carboplatin, Injection, 10 mg/1 mL (NDC 16729-295-12)Active
    Sponsor: Accord Healthcare Inc. · Reason: Requirements related to complying with good manufacturing practices
    Updated
  • Carboplatin, Injection, 10 mg/1 mL (NDC 16729-295-31)Active
    Sponsor: Accord Healthcare Inc. · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Carboplatin, Injection, 10 mg/1 mL (NDC 16729-295-33)Active
    Sponsor: Accord Healthcare Inc. · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Carboplatin, Injection, 10 mg/1 mL (NDC 16729-295-34)Active
    Sponsor: Accord Healthcare Inc. · Reason: Requirements related to complying with good manufacturing practices
    Updated
  • Carboplatin, Injection, 10 mg/1 mL (NDC 63323-172-60)Active
    Sponsor: Fresenius Kabi USA, LLC · Reason: Delay in shipping of the drug
    Updated
  • Carboplatin, Injection, 150 mg/15 mL (10 mg/mL) (NDC 61703-150-05)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Demand increase for the drug
    Updated
  • Carboplatin, Injection, 150 mg/15 mL (10 mg/mL) (NDC 61703-339-22)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Demand increase for the drug
    Updated
  • Carboplatin, Injection, 150 mg/15 mL (10 mg/mL) Multiple Dose Vial (NDC 60505-6282-3)Active
    Sponsor: Teyro Labs · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Carboplatin, Injection, 150 mg/15 mL (10 mg/mL) Multiple Dose Vial (NDC 60505-6282-3)To be discontinued
    Sponsor: Teyro Labs
    Updated
  • Carboplatin, Injection, 150mg/15mL (NDC 54288-165-01)Active
    Sponsor: Gland Pharma Limited · Reason: Demand increase for the drug
    Updated
  • Carboplatin, Injection, 450 mg/45 mL (10 mg/mL) (NDC 61703-262-05)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Demand increase for the drug
    Updated
  • Carboplatin, Injection, 450 mg/45 mL (10 mg/mL) (NDC 61703-339-50)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Demand increase for the drug
    Updated
  • Carboplatin, Injection, 450 mg/45 mL (10 mg/mL) Multiple Dose Vial (NDC 60505-6282-6)Active
    Sponsor: Teyro Labs · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Carboplatin, Injection, 450 mg/45 mL (10 mg/mL) Multiple Dose Vial (NDC 60505-6282-6)To be discontinued
    Sponsor: Teyro Labs
    Updated
  • Carboplatin, Injection, 450 mg/45 mL (NDC 50742-447-45)To be discontinued
    Sponsor: Ingenus Pharmaceuticals LLC
    Updated
  • Carboplatin, Injection, 450 mg/45 mL (NDC 55150-335-01)Active
    Sponsor: Eugia US LLC · Reason: Demand increase for the drug
    Updated
  • Carboplatin, Injection, 450mg/45mL (NDC 54288-166-01)Active
    Sponsor: Gland Pharma Limited · Reason: Demand increase for the drug
    Updated
  • Carboplatin, Injection, 50 mg/5 mL (10 mg/mL) (NDC 61703-339-18)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Demand increase for the drug
    Updated
  • Carboplatin, Injection, 50 mg/5 mL (10 mg/mL) (NDC 61703-360-18)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Demand increase for the drug
    Updated
  • Carboplatin, Injection, 50 mg/5 mL (10 mg/mL) Multiple Dose Vial (NDC 60505-6282-1)Active
    Sponsor: Teyro Labs · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Carboplatin, Injection, 50 mg/5 mL (10 mg/mL) Multiple Dose Vial (NDC 60505-6282-1)To be discontinued
    Sponsor: Teyro Labs
    Updated
  • Carboplatin, Injection, 50mg/5mL (NDC 54288-164-01)Active
    Sponsor: Gland Pharma Limited · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Carboplatin, Injection, 600 mg/60 mL (10 mg/mL) (NDC 61703-339-56)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Demand increase for the drug
    Updated
  • Carboplatin, Injection, 600 mg/60 mL (10 mg/mL) (NDC 61703-600-05)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Demand increase for the drug
    Updated
  • Carboplatin, Injection, 600 mg/60 mL (10 mg/mL) Multiple Dose Vial (NDC 60505-6282-7)Active
    Sponsor: Teyro Labs · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Carboplatin, Injection, 600 mg/60 mL (10 mg/mL) Multiple Dose Vial (NDC 60505-6282-7)To be discontinued
    Sponsor: Teyro Labs
    Updated
  • Carboplatin, Injection, 600 mg/60 mL (NDC 50742-448-60)To be discontinued
    Sponsor: Ingenus Pharmaceuticals LLC
    Updated
  • Carboplatin, Injection, 600 mg/60 mL (NDC 55150-386-01)Active
    Sponsor: Eugia US LLC · Reason: Demand increase for the drug
    Updated
  • Carboplatin, Injection, 600 mg/65 mL (NDC 54288-167-01)Active
    Sponsor: Gland Pharma Limited · Reason: Demand increase for the drug
    Updated
  • Kyxata, Injection, 500 mg/50 mL (10 mg/mL) (NDC 83831-142-50)Active
    Sponsor: Avyxa Pharma, LLC
    Updated
  • Kyxata, Injection, 80 mg/8 mL (10 mg/mL) (NDC 83831-141-08)Active
    Sponsor: Avyxa Pharma, LLC
    Updated

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
122,601 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use8,3256.8%
  2. 2Neutropenia7,2825.9%
  3. 3Anaemia7,0625.8%
  4. 4Nausea6,9355.7%
  5. 5Febrile Neutropenia6,4355.2%
  6. 6Diarrhoea6,0875.0%
  7. 7Disease Progression5,9574.9%
  8. 8Malignant Neoplasm Progression5,9024.8%
  9. 9Thrombocytopenia5,7774.7%
  10. 10Dyspnoea5,3234.3%
  11. 11Vomiting5,0754.1%
  12. 12Pyrexia4,7453.9%
  13. 13Fatigue4,6353.8%
  14. 14Drug Ineffective4,2713.5%
  15. 15Death4,2333.5%

Literature

View JSON

Recent PubMed references pinned to Carboplatin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 4,213 ClinicalTrials.gov registrations naming Carboplatin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Carboplatin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • MTHFRCPIC C (provisional)ClinPGx 3

Frequently asked questions

How does Carboplatin work?
Mechanism-of-action class: Nucleic Acid Synthesis Inhibitors.
What is Carboplatin used for?
According to FDA labeling, Carboplatin carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Carboplatin?
Carboplatin is classified as Platinum compounds, Platinum-based Drug, Nucleic Acid Synthesis Inhibitors, Decreased DNA Integrity.
What are the brand names for Carboplatin?
Carboplatin is marketed under brand names including Kyxata, Paraplatin.
What are the contraindications for Carboplatin?
Carboplatin labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.
Note. Data for carboplatin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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