Oxaliplatin Prescribing Information
Oxaliplatin is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. Reactions have included anaphylaxis
- History of hypersensitivity reaction to oxaliplatin or other platinum-based drugs.
Serious and fatal hypersensitivity reactions, including anaphylaxis, can occur with oxaliplatin within minutes of administration and during any cycle. Grade 3 to 4 hypersensitivity reactions, including anaphylaxis, occurred in 2% to 3% of patients with colon cancer who received oxaliplatin. Hypersensitivity reactions, including rash, urticaria, erythema, pruritus, and rarely, bronchospasm and hypotension, were similar in nature and severity to those reported with other platinum-based drugs.
Oxaliplatin is contraindicated in patients with hypersensitivity reactions to platinum-based drugs
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.
- Administer oxaliplatin 85 mg/m2 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 Recommended DosageAdminister 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 1Administer oxaliplatin injection 85 mg/m2as an intravenous infusion over 120 minutes and leucovorin 200 mg/m2as an intravenous infusion over 120 minutes at the same time in separate bags, followed by fluorouracil 400 mg/m2as intravenous bolus over 2-4 minutes, followed by fluorouracil 600 mg/m2as a 22-hour continuous infusion.
Day 2Administer leucovorin 200 mg/m2as an intravenous infusion over 120 minutes, followed by fluorouracil 400 mg/m2as intravenous bolus over 2-4 minutes, followed by fluorouracil 600 mg/m2as a 22-hour continuous infusion.
Refer to the prescribing information for fluorouracil and leucovorin for additional information.
- Adjuvant Treatment: Continue treatment for up to 12 cycles or unacceptable toxicity. ()
2.1 Recommended DosageAdminister 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 1Administer oxaliplatin injection 85 mg/m2as an intravenous infusion over 120 minutes and leucovorin 200 mg/m2as an intravenous infusion over 120 minutes at the same time in separate bags, followed by fluorouracil 400 mg/m2as intravenous bolus over 2-4 minutes, followed by fluorouracil 600 mg/m2as a 22-hour continuous infusion.
Day 2Administer leucovorin 200 mg/m2as an intravenous infusion over 120 minutes, followed by fluorouracil 400 mg/m2as intravenous bolus over 2-4 minutes, followed by fluorouracil 600 mg/m2as a 22-hour continuous infusion.
Refer to the prescribing information for fluorouracil and leucovorin for additional information.
- Advanced Colorectal Cancer: Continue treatment until disease progression or unacceptable toxicity. ()
2.1 Recommended DosageAdminister 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 1Administer oxaliplatin injection 85 mg/m2as an intravenous infusion over 120 minutes and leucovorin 200 mg/m2as an intravenous infusion over 120 minutes at the same time in separate bags, followed by fluorouracil 400 mg/m2as intravenous bolus over 2-4 minutes, followed by fluorouracil 600 mg/m2as a 22-hour continuous infusion.
Day 2Administer leucovorin 200 mg/m2as an intravenous infusion over 120 minutes, followed by fluorouracil 400 mg/m2as intravenous bolus over 2-4 minutes, followed by fluorouracil 600 mg/m2as a 22-hour continuous infusion.
Refer to the prescribing information for fluorouracil and leucovorin for additional information.
Injection: 50 mg (5 mg per mL) or 100 mg (5 mg per mL) clear, colorless solution in a single-dose vial.
- Females: Advise female patients of reproductive potential to use effective contraception while receiving oxaliplatin and for 9 months after the final dose.
- Males: Based on its mechanism action as a genotoxic drug, advise males with female partners of reproductive potential to use effective contraception while receiving oxaliplatin and for 6 months after the final dose[see Nonclinical Toxicology (13.1)].
Oxaliplatin is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. Reactions have included anaphylaxis
Serious and fatal hypersensitivity reactions, including anaphylaxis, can occur with oxaliplatin within minutes of administration and during any cycle. Grade 3 to 4 hypersensitivity reactions, including anaphylaxis, occurred in 2% to 3% of patients with colon cancer who received oxaliplatin. Hypersensitivity reactions, including rash, urticaria, erythema, pruritus, and rarely, bronchospasm and hypotension, were similar in nature and severity to those reported with other platinum-based drugs.
Oxaliplatin is contraindicated in patients with hypersensitivity reactions to platinum-based drugs