oxaliplatin injection Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Administer Oxaliplatin 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 85 mg/m2 as an intravenous infusion over 120 minutes and leucovorin 200 mg/m2 as an intravenous infusion over 120 minutes at the same time in separate bags, followed by fluorouracil 400 mg/m2 as intravenous bolus over 2 to 4 minutes, followed by fluorouracil 600 mg/m2 as a 22-hour continuous infusion.

Day 2

Administer leucovorin 200 mg/m2 as an intravenous infusion over 120 minutes, followed by fluorouracil 400 mg/m2 as intravenous bolus over 2 to 4 minutes, followed by fluorouracil 600 mg/m2 as a 22-hour continuous infusion.

Refer to the prescribing information for fluorouracil and leucovorin for additional information.

2.2 Dose Modifications for Adverse Reactions

Prolongation of infusion time for Oxaliplatin from 2 hours to 6 hours may mitigate acute toxicities, such as non-life‑threatening infusion-related reactions.

Permanently discontinue Oxaliplatin for any of the following:

Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
Posterior reversible encephalopathy syndrome (PRES) [see Warnings and Precautions (5.4)]
Confirmed interstitial lung disease or pulmonary fibrosis [see Warnings and Precautions (5.5)]
Rhabdomyolysis [see Warnings and Precautions (5.8)]

Refer to the fluorouracil and leucovorin prescribing information for dosage modifications for adverse reactions.

Dosage Modifications for Adjuvant Treatment

Dosage modifications for adverse reactions for adjuvant treatment are presented in Table 1.

Table 1: Dosage Modifications for Adjuvant Treatment in Patients with Stage III Colon Cancer
Adverse ReactionsSeverityOxaliplatin Dosage Modifications

Peripheral Sensory Neuropathy [see Warnings and Precautions (5.2)]

Persistent Grade 2

Consider reducing Oxaliplatin dose to 75 mg/m2.

Persistent Grade 3

Consider discontinuing Oxaliplatin.

Grade 4

Discontinue Oxaliplatin.

Myelosuppression [see Warnings and Precautions (5.3), Adverse Reactions (6.1)]

Grade 4 neutropenia or febrile neutropenia

Delay the next dose until neutrophils greater than or equal to 1.5 × 109/L and platelets greater than or equal to 75 × 109/L.
Reduce Oxaliplatin dose to 75 mg/m2.

Grade 3–4 thrombocytopenia

Gastrointestinal Adverse Reactions [see Adverse Reactions (6.1)]

Grade 3–4

After recovery, reduce Oxaliplatin dose to 75 mg/m2 along with a dose reduction of fluorouracil to 300 mg/m2 as an intravenous bolus and 500 mg/m2 as a 22-hour continuous infusion.

Dosage Modifications for Advanced Colorectal Cancer

Dosage modifications for adverse reactions for advanced colorectal cancer are presented in Table 2.

Table 2: Dosage Modifications for Advanced Colorectal Cancer
Adverse ReactionsSeverityOxaliplatin Dosage Modifications

Neuropathy [see Warnings and Precautions (5.2)]

Persistent Grade 2

Consider reducing Oxaliplatin dose to 65 mg/m2.

Persistent Grade 3

Consider discontinuing Oxaliplatin.

Grade 4

Discontinue Oxaliplatin.

Myelosuppression [see Warnings and Precautions (5.3), Adverse Reactions (6.1)]

Grade 4 neutropenia or febrile neutropenia

Delay the next dose until neutrophils greater than or equal to 1.5 × 109/L and platelets greater than or equal to 75 × 109/L.
Reduce Oxaliplatin dose to 65 mg/m2.

Grade 3–4 thrombocytopenia

Gastrointestinal Adverse Reactions [see Adverse Reactions 6.1)]

Grade 3–4

After recovery, reduce Oxaliplatin dose to 65 mg/m2 along with a dose reduction of fluorouracil to 300 mg/m2 as an intravenous bolus and 500 mg/m2 as a 22-hour continuous infusion.

2.3 Dose Modifications for Patients with Renal Impairment

In patients with severe renal impairment (creatinine clearance [CLcr] less than 30 mL/min, calculated by the Cockcroft-Gault equation), reduce the Oxaliplatin dose to 65 mg/m2 [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

2.4 Preparation and Administration

Oxaliplatin is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
Do not freeze.
Protect the concentrated solution from light.
Dilute concentrated solution with 250 to 500 mL of 5% Dextrose Injection, USP. Do not dilute with sodium chloride solution or other chloride-containing solutions.
Store diluted solution for no more than 6 hours at room temperature (20°C to 25°C [68°F to 77°F]) or 24 hours under refrigeration (2°C to 8°C [36°F to 46°F]). Protection from light is not required.
Visually inspect for particulate matter and discoloration prior to administration and discard if present.
Do not mix Oxaliplatin or administer Oxaliplatin through the same infusion line concurrently with alkaline medications or media (such as basic solutions of fluorouracil).
Flush the infusion line with 5% Dextrose Injection, USP prior to administration of any concomitant medication.
Do not use needles or intravenous administration sets containing aluminum parts for the preparation or mixing of Oxaliplatin. Aluminum has been reported to cause degradation of platinum compounds.
Administer Oxaliplatin as an intravenous infusion over 120 minutes concurrently with leucovorin over 120 minutes in separate bags.

Find oxaliplatin injection medical information:

Find oxaliplatin injection medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

oxaliplatin injection Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Administer Oxaliplatin 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 85 mg/m2 as an intravenous infusion over 120 minutes and leucovorin 200 mg/m2 as an intravenous infusion over 120 minutes at the same time in separate bags, followed by fluorouracil 400 mg/m2 as intravenous bolus over 2 to 4 minutes, followed by fluorouracil 600 mg/m2 as a 22-hour continuous infusion.

Day 2

Administer leucovorin 200 mg/m2 as an intravenous infusion over 120 minutes, followed by fluorouracil 400 mg/m2 as intravenous bolus over 2 to 4 minutes, followed by fluorouracil 600 mg/m2 as a 22-hour continuous infusion.

Refer to the prescribing information for fluorouracil and leucovorin for additional information.

2.2 Dose Modifications for Adverse Reactions

Prolongation of infusion time for Oxaliplatin from 2 hours to 6 hours may mitigate acute toxicities, such as non-life‑threatening infusion-related reactions.

Permanently discontinue Oxaliplatin for any of the following:

Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
Posterior reversible encephalopathy syndrome (PRES) [see Warnings and Precautions (5.4)]
Confirmed interstitial lung disease or pulmonary fibrosis [see Warnings and Precautions (5.5)]
Rhabdomyolysis [see Warnings and Precautions (5.8)]

Refer to the fluorouracil and leucovorin prescribing information for dosage modifications for adverse reactions.

Dosage Modifications for Adjuvant Treatment

Dosage modifications for adverse reactions for adjuvant treatment are presented in Table 1.

Table 1: Dosage Modifications for Adjuvant Treatment in Patients with Stage III Colon Cancer
Adverse ReactionsSeverityOxaliplatin Dosage Modifications

Peripheral Sensory Neuropathy [see Warnings and Precautions (5.2)]

Persistent Grade 2

Consider reducing Oxaliplatin dose to 75 mg/m2.

Persistent Grade 3

Consider discontinuing Oxaliplatin.

Grade 4

Discontinue Oxaliplatin.

Myelosuppression [see Warnings and Precautions (5.3), Adverse Reactions (6.1)]

Grade 4 neutropenia or febrile neutropenia

Delay the next dose until neutrophils greater than or equal to 1.5 × 109/L and platelets greater than or equal to 75 × 109/L.
Reduce Oxaliplatin dose to 75 mg/m2.

Grade 3–4 thrombocytopenia

Gastrointestinal Adverse Reactions [see Adverse Reactions (6.1)]

Grade 3–4

After recovery, reduce Oxaliplatin dose to 75 mg/m2 along with a dose reduction of fluorouracil to 300 mg/m2 as an intravenous bolus and 500 mg/m2 as a 22-hour continuous infusion.

Dosage Modifications for Advanced Colorectal Cancer

Dosage modifications for adverse reactions for advanced colorectal cancer are presented in Table 2.

Table 2: Dosage Modifications for Advanced Colorectal Cancer
Adverse ReactionsSeverityOxaliplatin Dosage Modifications

Neuropathy [see Warnings and Precautions (5.2)]

Persistent Grade 2

Consider reducing Oxaliplatin dose to 65 mg/m2.

Persistent Grade 3

Consider discontinuing Oxaliplatin.

Grade 4

Discontinue Oxaliplatin.

Myelosuppression [see Warnings and Precautions (5.3), Adverse Reactions (6.1)]

Grade 4 neutropenia or febrile neutropenia

Delay the next dose until neutrophils greater than or equal to 1.5 × 109/L and platelets greater than or equal to 75 × 109/L.
Reduce Oxaliplatin dose to 65 mg/m2.

Grade 3–4 thrombocytopenia

Gastrointestinal Adverse Reactions [see Adverse Reactions 6.1)]

Grade 3–4

After recovery, reduce Oxaliplatin dose to 65 mg/m2 along with a dose reduction of fluorouracil to 300 mg/m2 as an intravenous bolus and 500 mg/m2 as a 22-hour continuous infusion.

2.3 Dose Modifications for Patients with Renal Impairment

In patients with severe renal impairment (creatinine clearance [CLcr] less than 30 mL/min, calculated by the Cockcroft-Gault equation), reduce the Oxaliplatin dose to 65 mg/m2 [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

2.4 Preparation and Administration

Oxaliplatin is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
Do not freeze.
Protect the concentrated solution from light.
Dilute concentrated solution with 250 to 500 mL of 5% Dextrose Injection, USP. Do not dilute with sodium chloride solution or other chloride-containing solutions.
Store diluted solution for no more than 6 hours at room temperature (20°C to 25°C [68°F to 77°F]) or 24 hours under refrigeration (2°C to 8°C [36°F to 46°F]). Protection from light is not required.
Visually inspect for particulate matter and discoloration prior to administration and discard if present.
Do not mix Oxaliplatin or administer Oxaliplatin through the same infusion line concurrently with alkaline medications or media (such as basic solutions of fluorouracil).
Flush the infusion line with 5% Dextrose Injection, USP prior to administration of any concomitant medication.
Do not use needles or intravenous administration sets containing aluminum parts for the preparation or mixing of Oxaliplatin. Aluminum has been reported to cause degradation of platinum compounds.
Administer Oxaliplatin as an intravenous infusion over 120 minutes concurrently with leucovorin over 120 minutes in separate bags.
Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.