Oxaliplatin PhaRes - Injection Oxaliplatin - 50mg/Vial 1 5ml Vial(s) / 5ml Vial ZAS Corporation Introduction: Oxaliplatin PhaRes is used in the treatment of cancer of colon and rectum. It shows its working by stopping or slowing down the growth of cancer cells. Oxaliplatin PhaRes is given as an injection into vein by a qualified medical professional. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects.... Uses of Oxaliplatin PhaRes: Cancer of colon and rectum Side effects of Oxaliplatin PhaRes: NauseaFatigueAnemia (low number of red blood cells)VomitingDiarrheaDecreased white blood cell count (neutrophils)Low blood plateletsIncreased liver enzymesPeripheral neuropathy (tingling and numbness of feet and hand)Stomatitis (Inflammation of the mouth) How to use Oxaliplatin PhaRes: Your doctor or nurse will give you this medicine. Kindly do not self administer. How Oxaliplatin PhaRes works: Oxaliplatin PhaRes is an anti-cancer medication. It works by damaging the genetic material (DNA and RNA) of the cancer cells which stops their growth and multiplication. What if you forget to take Oxaliplatin PhaRes?: If you miss a dose of Oxaliplatin PhaRes, please consult your doctor. Indication: Colorectal cancer, Colon cancer 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) 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... 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 Contraindication: Pregnancy. Peripheral neuropathy with functional impairment. Severe renal impairment. Mode 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. Precaution: 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 Side Effect: >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. Interaction: 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.