oxaliplatin 5 mg/mL
oxaliplatin · INJECTION, SOLUTION · Shandong New Time Pharmaceutical Co., Ltd.
oxaliplatin is a injection, solution containing oxaliplatin at 5 mg/mL, taken intravenous. Manufactured by Shandong New Time Pharmaceutical Co., Ltd..
Key Facts
- Brand Name
- oxaliplatin
- Generic Name
- oxaliplatin
- NDC Code (Product)
42677-337- Manufacturer
- Shandong New Time Pharmaceutical Co., Ltd.
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA219765
- Drug Class
- Platinum-based Drug [EPC]
- Marketing Start
- 01/15/2026
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Oxaliplatin Injection, in combination with infusional fluorouracil and leucovorin, is indicated for: adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. treatment of advanced colorectal cancer. Oxaliplatin Injection is a platinum-based drug used in combination with infusional fluorouracil and leucovorin, which is indicated for: adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. ( 1 ) treatment of advanced colorectal cancer. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer oxaliplatin 85 mg/m 2 as an intravenous infusion over 120 minutes concurrently with leucovorin over 120 minutes in separate bags, followed by fluorouracil on Day 1 of each 14-day cycle. Administer fluorouracil and leucovorin on Day 2 as recommended. ( 2.1 ) Adjuvant Treatment : Continue treatment for up to 12 cycles or unacceptable toxicity. ( 2.1 ) Advanced Colorectal Cancer : Continue treatment until disease progression or unacceptable toxicity. ( 2.1 ) 2.1 Recommended Dosage Administer oxaliplatin injection in combination with fluorouracil and leucovorin every 2 weeks. For adjuvant treatment, continue treatment for up to 12 cycles or unacceptable toxicity. For advanced colorectal cancer, continue treatment until disease progression or unacceptable toxicity. Day 1 Administer oxaliplatin injection 85 mg/m 2 as an intravenous infusion over 120 minutes and leucovorin 200 mg/m 2 as an intravenous infusion over 120 minutes at the same time in separate bags, followed by fluorouracil 400 mg/m 2 as intravenous bolus over 2-4 minutes, followed by fluorouracil 600 mg/m 2 as a 22-hour continuous infusion. Day 2 Administer leucovorin 200 mg/m 2 as an in…
Contraindications
4 CONTRAINDICATIONS Oxaliplatin is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.1 )] . History of hypersensitivity reaction to oxaliplatin or other platinum-based drugs. ( 4 , 5.1 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Drugs that Prolong the QT Interval QT interval prolongation and ventricular arrhythmias can occur with oxaliplatin [see Warnings and Precautions ( 5.7 )] . Avoid coadministration of oxaliplatin with medicinal products with a known potential to prolong the QT interval. 7.2 Use with Nephrotoxic Products Because platinum-containing species are eliminated primarily through the kidney, clearance of these products may be decreased by coadministration of potentially nephrotoxic compounds [see Clinical Pharmacology ( 12.3 )] . Avoid coadministration of oxaliplatin with medicinal products known to cause nephrotoxicity. 7.3 Use with Anticoagulants Prolonged prothrombin time and INR occasionally associated with hemorrhage have been reported in patients who received oxaliplatin with fluorouracil/leucovorin while on anticoagulants [see Warnings and Precautions ( 5.9 ), Adverse Reactions ( 6.2 )] . Increase frequency of monitoring in patients who are receiving oxaliplatin with fluorouracil/leucovorin and oral anticoagulants.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Peripheral Sensory Neuropathy [see Warnings and Precautions ( 5.2 )] Severe Myelosuppression [see Warnings and Precautions ( 5.3 )] Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions ( 5.4 )] Pulmonary Toxicity [see Warnings and Precautions ( 5.5 )] Hepatotoxicity [see Warnings and Precautions ( 5.6 )] QT Interval Prolongation and Ventricular Arrhythmias [see Warnings and Precautions ( 5.7 )] Rhabdomyolysis [see Warnings and Precautions ( 5.8 )] Hemorrhage [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (incidence greater than or equal to 40%) were peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue, and stomatitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying …
Frequently Asked Questions
What is oxaliplatin used for?
oxaliplatin contains oxaliplatin. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is oxaliplatin a controlled substance?
oxaliplatin is not classified as a controlled substance by the DEA.
What is the generic name for oxaliplatin?
The generic name for oxaliplatin is oxaliplatin. There are 12 other brand versions of oxaliplatin.
What is the NDC code for oxaliplatin 5 mg/mL?
The NDC (National Drug Code) for oxaliplatin 5 mg/mL is 42677-337, listed by Shandong New Time Pharmaceutical Co., Ltd..