KYXATA 500 mg/50mL
CARBOplatin · INJECTION · Avyxa Pharma, LLC
KYXATA is a injection containing carboplatin at 500 mg/50mL, taken intravenous. Manufactured by Avyxa Pharma, LLC.
Key Facts
- Brand Name
- KYXATA
- Generic Name
- CARBOplatin
- NDC Code (Product)
83831-142- Manufacturer
- Avyxa Pharma, LLC
- Strength
- 500 mg/50mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA219921
- Drug Class
- Platinum-based Drug [EPC]
- Marketing Start
- 09/10/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE KYXATA is a platinum-based drug indicated in adults: As part of a combination regimen, for the initial treatment of advanced ovarian carcinoma. ( 1.1 ) As a single-agent for the treatment of ovarian carcinoma recurrent after prior chemotherapy. ( 1.2 ) 1.1 Initial Treatment of Advanced Ovarian Carcinoma KYXATA, as part of a combination regimen, is indicated for the initial treatment of adults with advanced ovarian carcinoma. 1.2 Recurrent Advanced Ovarian Carcinoma KYXATA is indicated for treatment of adults with ovarian carcinoma recurrent after prior chemotherapy.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Initial Treatment of Advanced Ovarian Carcinoma: KYXATA 300 mg/m 2 -OR- AUC of 4 mg/mL∙min to 6 mg/mL∙min intravenously in combination with cyclophosphamide on Day 1 every 4 weeks for each cycle. ( 2.2 ) Administer up to six cycles or until disease progression or unacceptable toxicity occurs. ( 2.2 ) Recurrent Advanced Ovarian Carcinoma as a Single Agent: KYXATA 360 mg/m 2 - OR - AUC of 4 mg/mL∙min to 6 mg/mL∙min intravenously on Day 1 every 4 weeks for each cycle until disease progression or unacceptable toxicity occurs. ( 2.2 ) Avoid contact of carboplatin with aluminum parts. ( 2.5 ) 2.1 Premedication and Supportive Medications Administer KYXATA in a setting where cardiopulmonary resuscitation medication and equipment are available [see Warnings and Precautions (5.1) ]. Premedicate patients with antiemetics prior to each infusion of KYXATA for the prevention of nausea and vomiting. Continue antiemetics following infusion as needed [see Warnings and Precautions (5.3) ]. 2.2 Recommended Dosage Initial Treatment of Advanced Ovarian Carcinoma with Cyclophosphamide KYXATA 300 mg/m 2 -OR- AUC of 4 mg/mL∙min to 6 mg/mL∙min* intravenously in combination with …
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Aminoglycosides : Avoid concomitant use with aminoglycosides. ( 7.1 ) 7.1 Use with Aminoglycosides Avoid concomitant use of aminoglycosides with KYXATA. Concomitant use of KYXATA with aminoglycosides increased renal toxicity and ototoxicity.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Myelosuppression [see Warnings and Precautions (5.2) ] Nausea and Vomiting [see Warnings and Precautions (5.3) ] Peripheral Neuropathy [see Warnings and Precautions (5.4) ] Most common adverse reactions, including laboratory abnormalities, in patients with advanced ovarian cancer who received KYXATA in combination with cyclophosphamide (≥30%) are leukopenia, neutropenia, nausea and vomiting, anemia, thrombocytopenia, hypomagnesemia, other gastrointestinal adverse reactions, alopecia, asthenia, and pain. ( 6.1 ) Most common adverse reactions, including laboratory abnormalities, in patients with recurrent ovarian cancer who received KYXATA as a single agent (≥30%) are nausea and vomiting, anemia, neutropenia, thrombocytopenia, hyponatremia, hypomagnesemia, hyperphosphatasemia, and hypocalcemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avyxa Pharma, LLC at 1-888-520-0954 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely va…
Frequently Asked Questions
What is KYXATA used for?
KYXATA contains CARBOplatin. It is a injection taken intravenous. Consult your doctor for specific uses.
Is KYXATA a controlled substance?
KYXATA is not classified as a controlled substance by the DEA.
What is the generic name for KYXATA?
The generic name for KYXATA is CARBOplatin. There are 11 other brand versions of CARBOplatin.
What is the NDC code for KYXATA 500 mg/50mL?
The NDC (National Drug Code) for KYXATA 500 mg/50mL is 83831-142, listed by Avyxa Pharma, LLC.