Available as:
Indications
X-PLAT Injection is used for:
Colorectal cancer, Colon cancer
Adult Dose
Intravenous
Advanced colorectal cancer
Adult:
Day 1: Oxaliplatin 85 mg/m² IV + leucovorin 200 mg/m² IV infused over 2 hr, THEN
5-FU 400 mg/m² IV bolus over 2-4 minutes, THEN
5-FU 600 mg/m² IV infusion in D5W (500 mL) over 22 hr
Day 2: Same regimen WITHOUT oxaliplatin
Repeat every 2 weeks
Adjuvant therapy in stage III colon cancer
Adult:
Day 1: Oxaliplatin 85 mg/m² IV + leucovorin 200 mg/m² IV infused over 2 hr, THEN
5-FU 400 mg/m² IV bolus over 2-4 minutes, THEN
5-FU 600 mg/m² IV infusion in D5W (500 mL) over 22 hr
Day 2: Same regimen WITHOUT oxaliplatin
Every 2 wk; given for 12 cycles, for a total of 6 months
Dose Modification
If persistent Grade 2 neuropathy, decrease dose to 75 mg/m²
If persistent Grade 3 neuropathy, consider discontinuing oxaliplatin
After recovery from grade 3/4 GI or grade 3/4 hematological toxicity: Decrease dose to 75 mg/m² , AND decrease 5-FU by 20% (300 mg/m² bolus, 500 mg/m² infusion)
Child Dose
Safety and efficacy not established
Renal Dose
Renal Impairment
Exposure of unbound platinum tends to increase in renally impaired patients
Mild (CrCl 50-80 mL/min): No dosage adjustment required
Moderate (CrCl 30-49 mL/min): No dosage adjustment required
Severe (CrCl <30 mL/min): Reduce starting dose
Administration
IV Preparation
Reconstitute by adding 10 mL (for 50 mg vial) or 20 mL (for 100 mg vial) of SWI or D5W. Dilute required amount of reconstituted solution in an infusion solution of 250-500 mL of D5W. Do NOT use NS or chloride-containing solutions
Do not use aluminum-containing needles or IV administration sets that may come in contact with carboplatin (aluminum can react causing precipitate formation and loss of potency)
IV Administration
Flush infusion line with D5W prior to administration of oxaliplatin or any concomitant drug
Use separate bags for oxaliplatin and leucovorin (administered through Y-site)
Contra Indications
Pregnancy. Peripheral neuropathy with functional impairment. Severe renal impairment.
Precautions
Should be administered under the supervision of an experienced cancer chemotherapy physician. Use appropriate precautions for handling and disposal. Monitor neurological status and dose should be reduced if symptoms are prolonged or severe. Monitor blood counts during treatment and courses should not be repeated until blood counts have recovered. Caution in elderly, moderate degrees of renal impairment. Avoid using aluminum-containing needles or IV admin sets that may come into contact with oxaliplatin as aluminum has been reported to cause degradation of platinum compounds. Lactation.
Lactation: not known if excreted in milk
Pregnancy-Lactation
Interactions
May decrease plasma levels of digoxin. May increase risk of toxicity with nephrotoxic drugs. When administered as sequential infusions, taxane derivatives (docetaxel, paclitaxel) should be administered before oxaliplatin to limit myelosuppression and enhance efficacy.
Adverse Effects
Side effects of Oxaliplatin :
>10%
Peripheral neuropathy (76%),Anemia (64%),Nausea (64%),Fatigue (61%),Diarrhea (46%),Vomiting (37%),Abdominal pain (31%),Constipation (31%),Thrombocytopenia (30%),Fever (25%),Anorexia (20%),Leukopenia (13%),Dyspnea (13%),Cough (11%)
1-10%
Edema (10%),Neutropenia (7%),Pharyngolaryngeal dysesthesia (1-2%)
<1%
Pulmonary fibrosis,Posterior leukoencephalopathy syndrome
Frequency Not Defined
Anaphylactic-like reaction (uncommon),Pulmonary fibrosis (uncommon)
Potentially Fatal: Anaphylaxis, pulmonary fibrosis.
Mechanism of Action
Oxaliplatin, a platinum-containing complex similar to cisplatin, is an alkylating agent. After intracellular hydrolysis, the platinum compound binds to DNA forming cross-links which inhibit DNA replication and transcription, resulting in cell death.
Note
X-PLAT 50mg/ml Injection manufactured by Cipla Ltd.. Its generic name is Oxaliplatin. X-PLAT is availble in Nepal.
Farmaco Nepal drug index information on X-PLAT Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.