#高警訊藥品

轉移性結腸直腸癌、復發/轉移性胃癌、轉移型胰臟癌
Colorectal cancer (stage III or advanced); Gastric cancer (Metastatic); Pancreatic cancer (advanced or metastatic)

Antineoplastic Agent, Alkylating Agent; Platinum Analog
Following intracellular hydrolysis, the platinum compound binds to DNA forming cross-links which inhibit DNA replication and transcription, resulting in cell death. Cytotoxicity is cell-cycle nonspecific.

Distribution:
1. Vd 440 L
2. Protein binding: >90% primarily albumin and gamma globulin (irreversible binding to platinum)
Metabolism:
Nonenzymatic (rapid and extensive), forms active and inactive derivatives
Half-life elimination:
1. Children: Median 293 hours
2. Adults: (Distribution Alpha phase) 0.43 hours; (Beta phase) 16.8 hours; (Terminal) 392 hours
Excretion:
Urine (~54%); feces (~2%)

Hypersensitivity to oxaliplatin, other platinum-containing compounds, or any component of the formulation.

In general, chemotherapy should be avoided in the first trimester, there should be a 3-week time period between the last chemotherapy dose and anticipated delivery, and chemotherapy should not be administered beyond week 33 of gestation.

Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends discontinuing breastfeeding during oxaliplatin treatment and for 3 months after the last oxaliplatin dose.

1. Gastrointestinal: Abdominal pain, anorexia, constipation, diarrhea, nausea, stomatitis, vomiting
2. Hematologic & oncologic: Anemia, leukopenia. thrombocytopenia
3. Hepatic: Increased serum AST, ALT, or bilirubin
4. Nervous system: Fatigue, headache, insomnia, pain, peripheral neuropathy
5. Neuromuscular & skeletal: Back pain
6. Respiratory: Cough, dyspnea
7. Miscellaneous: Fever

Colon cancer, stage III: (adjuvant therapy, in combination with infusional fluorouracil/leucovorin)
IV 85 mg/m2 every 2 weeks for up to 12 cycles
Colorectal cancer: (advanced, in combination with infusional fluorouracil/leucovorin)
IV 85 mg/m2 every 2 weeks until disease progression or unacceptable toxicity

Limited data available, several regimens reported

1. CrCl ≥30 mL/minute: No initial dosage adjustment necessary
2. CrCl <30 mL/minute: Reduce initial dose from 85 mg/m2 to 65 mg/m2

Mild, moderate, or severe impairment: No dosage adjustment necessary