oxaliplatin injection Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use OXALIPLATIN INJECTION safely and effectively. See full prescribing information for OXALIPLATIN INJECTION.

OXALIPLATIN injection, for intravenous use
Initial U.S. Approval: 2002

WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS

See full prescribing information for complete boxed warning.

Serious and fatal hypersensitivity adverse reactions, including anaphylaxis, can occur with Oxaliplatin within minutes of administration and during any cycle. Oxaliplatin is contraindicated in patients with hypersensitivity reactions to oxaliplatin and other platinum-based drugs. Immediately and permanently discontinue Oxaliplatin for hypersensitivity reactions and administer appropriate treatment. (4, 5.1)

INDICATIONS AND USAGE

Oxaliplatin 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 AND ADMINISTRATION

•
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)
•
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)

DOSAGE FORMS AND STRENGTHS

Injection: 50 mg (5 mg/mL) or 100 mg (5 mg/mL) in a single-dose vial (3)

CONTRAINDICATIONS

•
History of hypersensitivity reaction to oxaliplatin or other platinum-based drugs. (4, 5.1)

WARNINGS AND PRECAUTIONS

•
Peripheral Sensory Neuropathy: Acute and delayed neuropathy can occur. Avoid topical application of ice. Reduce the dose or permanently discontinue Oxaliplatin as recommended. (5.2)
•
Severe Myelosuppression: Delay Oxaliplatin until neutrophils are greater than or equal to 1.5 × 109/L and platelets are greater than or equal to 75 × 109/L. Withhold Oxaliplatin for sepsis or septic shock. Dose reduce after recovery from grade 4 neutropenia, febrile neutropenia, or grade 3–4 thrombocytopenia as recommended. (5.3)
•
Posterior Reversible Encephalopathy Syndrome (PRES): Permanently discontinue Oxaliplatin in patients who develop PRES. (5.4)
•
Pulmonary Toxicity: Withhold Oxaliplatin until investigation excludes interstitial lung disease or pulmonary fibrosis. (5.5)
•
Hepatotoxicity: Monitor liver function tests at baseline, before each subsequent cycle, and as clinically indicated. (5.6)
•
QT Interval Prolongation and Ventricular Arrythmias: Avoid in patients with congenital long QT syndrome. Monitor electrocardiograms in patients with congestive heart failure, bradyarrhythmias, and electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Correct electrolyte abnormalities prior to initiating Oxaliplatin and periodically during treatment. (5.7)
•
Rhabdomyolysis: Permanently discontinue Oxaliplatin if rhabdomyolysis occurs. (5.8)
•
Hemorrhage: Increase frequency of monitoring in patients who are receiving Oxaliplatin with fluorouracil/leucovorin and oral anticoagulants. (5.9)
•
Embryo-Fetal Toxicity: Can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise males and females of reproductive potential to use an effective method of contraception. (5.10, 8.1, 8.3)

ADVERSE REACTIONS

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 Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

•
Females: Advise female patients of reproductive potential to use effective contraception while receiving Oxaliplatin and for 9 months after the final dose. (8.3)
•
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 (13.1).

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 9/2024

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use OXALIPLATIN INJECTION safely and effectively. See full prescribing information for OXALIPLATIN INJECTION.

OXALIPLATIN injection, for intravenous use
Initial U.S. Approval: 2002

WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS

See full prescribing information for complete boxed warning.

Serious and fatal hypersensitivity adverse reactions, including anaphylaxis, can occur with Oxaliplatin within minutes of administration and during any cycle. Oxaliplatin is contraindicated in patients with hypersensitivity reactions to oxaliplatin and other platinum-based drugs. Immediately and permanently discontinue Oxaliplatin for hypersensitivity reactions and administer appropriate treatment. (4, 5.1)

INDICATIONS AND USAGE

Oxaliplatin 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 AND ADMINISTRATION

•
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)
•
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)

DOSAGE FORMS AND STRENGTHS

Injection: 50 mg (5 mg/mL) or 100 mg (5 mg/mL) in a single-dose vial (3)

CONTRAINDICATIONS

•
History of hypersensitivity reaction to oxaliplatin or other platinum-based drugs. (4, 5.1)

WARNINGS AND PRECAUTIONS

•
Peripheral Sensory Neuropathy: Acute and delayed neuropathy can occur. Avoid topical application of ice. Reduce the dose or permanently discontinue Oxaliplatin as recommended. (5.2)
•
Severe Myelosuppression: Delay Oxaliplatin until neutrophils are greater than or equal to 1.5 × 109/L and platelets are greater than or equal to 75 × 109/L. Withhold Oxaliplatin for sepsis or septic shock. Dose reduce after recovery from grade 4 neutropenia, febrile neutropenia, or grade 3–4 thrombocytopenia as recommended. (5.3)
•
Posterior Reversible Encephalopathy Syndrome (PRES): Permanently discontinue Oxaliplatin in patients who develop PRES. (5.4)
•
Pulmonary Toxicity: Withhold Oxaliplatin until investigation excludes interstitial lung disease or pulmonary fibrosis. (5.5)
•
Hepatotoxicity: Monitor liver function tests at baseline, before each subsequent cycle, and as clinically indicated. (5.6)
•
QT Interval Prolongation and Ventricular Arrythmias: Avoid in patients with congenital long QT syndrome. Monitor electrocardiograms in patients with congestive heart failure, bradyarrhythmias, and electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Correct electrolyte abnormalities prior to initiating Oxaliplatin and periodically during treatment. (5.7)
•
Rhabdomyolysis: Permanently discontinue Oxaliplatin if rhabdomyolysis occurs. (5.8)
•
Hemorrhage: Increase frequency of monitoring in patients who are receiving Oxaliplatin with fluorouracil/leucovorin and oral anticoagulants. (5.9)
•
Embryo-Fetal Toxicity: Can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise males and females of reproductive potential to use an effective method of contraception. (5.10, 8.1, 8.3)

ADVERSE REACTIONS

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 Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

•
Females: Advise female patients of reproductive potential to use effective contraception while receiving Oxaliplatin and for 9 months after the final dose. (8.3)
•
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 (13.1).

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 9/2024
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