Prescription Drug Information: Oxaliplatin

OXALIPLATIN- oxaliplatin injection, solution
Mylan Institutional LLC

WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS

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 [see Contraindications (4)]. Immediately and permanently discontinue oxaliplatin for hypersensitivity reactions and administer appropriate treatment for management of the hypersensitivity reaction [see Warnings and Precautions (5.1)].

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.

2 DOSAGE AND ADMINISTRATION

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/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 Dosage Modification for Adverse Reactions

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

Permanently discontinue oxaliplatin injection 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 Reactions

Severity

Oxaliplatin Injection Dosage Modifications

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

Persistent Grade 2

Consider reducing oxaliplatin injection dose to 75 mg/m2.

Persistent Grade 3

Consider discontinuing oxaliplatin injection.

Grade 4

Discontinue oxaliplatin injection.

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 injection dose to 75 mg/m2.

Grade 3 to 4 thrombocytopenia

Gastrointestinal Adverse Reactions [see Adverse Reactions (6.1)]

Grade 3 to 4

After recovery, reduce oxaliplatin injection 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 Reactions

Severity

Oxaliplatin Injection Dosage Modifications

Neuropathy [see Warnings and Precautions (5.2)]

Persistent Grade 2

Consider reducing oxaliplatin injection dose to 65 mg/m2.

Persistent Grade 3

Consider discontinuing oxaliplatin injection.

Grade 4

Discontinue oxaliplatin injection.

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 injection dose to 65 mg/m2.

Grade 3 to 4 thrombocytopenia

Gastrointestinal Adverse Reactions [see Adverse Reactions (6.1)]

Grade 3 to 4

After recovery, reduce oxaliplatin injection 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 Dosage Modifications for 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 injection dose to 65 mg/m2 [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

2.4 Preparation and Administration

Oxaliplatin injection 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 injection or administer oxaliplatin injection 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 injection. Aluminum has been reported to cause degradation of platinum compounds.
Administer oxaliplatin injection as an intravenous infusion over 120 minutes concurrently with leucovorin over 120 minutes in separate bags.

3 DOSAGE FORMS AND STRENGTHS

Injection: 50 mg (5 mg/mL) or 100 mg (5 mg/mL) clear, colorless solution in a single-dose vial.

4 CONTRAINDICATIONS

Oxaliplatin injection 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)].

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