Oxaliplatin

OXALIPLATIN- oxaliplatin injection, solution
FOSUN PHARMA USA INC.

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/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 to 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 intravenous infusion over 120 minutes, followed by fluorouracil 400 mg/m 2 as intravenous bolus over 2 to 4 minutes, followed by fluorouracil 600 mg/m 2 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 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/m 2.
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 × 10 9 /L and platelets greater than or equal to 75 × 10 9 /L. Reduce oxaliplatin injection dose to 75 mg/m 2.
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/m 2 along with a dose reduction of fluorouracil to 300 mg/m 2 as an intravenous bolus and 500 mg/m 2 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/m 2.
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 × 10 9 /L and platelets greater than or equal to 75 × 10 9 /L. Reduce oxaliplatin injection dose to 65 mg/m 2.
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/m 2 along with a dose reduction of fluorouracil to 300 mg/m 2 as an intravenous bolus and 500 mg/m 2 as a 22-hour continuous infusion.

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