Arixatin (Oxaliplatin) is a platinum-based chemotherapy drug that damages the DNA of cancer cells, preventing them from replicating. This inhibits or slows cancer cell growth and ultimately leads to cell death.
Arixatin contains oxaliplatin, a third-generation platinum chemotherapeutic used mainly in colorectal cancer. It forms reactive platinum species that create DNA crosslinks (particularly at guanine N7) in cancer cells, thereby blocking DNA replication/transcription and causing cell-cycle–nonspecific cytotoxicity. In practice, oxaliplatin is given intravenously (no oral absorption) in combination regimens. Its key uses are adjuvant therapy for stage III (resected) colon cancer and first-line therapy for advanced (metastatic) colorectal cancer. In current practice, FOLFOX (oxaliplatin + 5-FU/LV) or CAPOX/XELOX (oxaliplatin + oral capecitabine) are standard regimens. Arixatin is available as a 50 mg and 100 mg concentrated solution for IV infusion. The 100 mg pack will be provided with a complimentary infusion set for patient convenience.
Arixatin 50 Concentrated Solution for IV Infusion: Each vial contains Oxaliplatin BP 50 mg as 10 ml concentrated solution for IV infusion.
Arixatin 100 Concentrated Solution for IV Infusion: Each vial contains Oxaliplatin BP 100 mg as 20 ml concentrated solution for IV infusion.
Arixatin Injection is a platinum-based drug used in combination with infusional fluorouracil and leucovorin, which applies to the following indications:
Adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.
Treatment of advanced colorectal cancer
Day 1: Administration of Arixatin 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: Administration of leucovorin 200 mg/m2 as an intravenous infusion over 120 minutes, followed by fluorouracil 400mg/m2 as intravenous bolus over 2 to 4 minutes, followed by fluorouracil 600 mg/m2 as a 22-hour continuous infusion.
Reduction of the dose of Oxaliplatin Injection may be required If there are persistent Grade 2 neurosensory events that do not resolve. After recovery from Grade 3/4 gastrointestinal toxicities (despite prophylactic treatment) or Grade 4 neutropenia or febrile neutropenia or Grade 3/4 thrombocytopenia. The dose for adjuvant setting will be 75 mg/m2 and 65 mg/m2 for advanced colorectal cancer. The next dose will be delayed until neutrophils become ≥ 1.5 × 109/l and platelets ≥ 75 × 109/l.
Important Dosing Considerations For patients with severe renal impairment (creatinine clearance < 30 ml/min), the initial recommended dose is 65 mg/m2. Oxaliplatin Injection will be discontinued if there are persistent Grade 3 neurosensory events.
Dose Modifications for Patients with Renal Impairment In patients with severe renal impairment (creatinine clearance [CLcr] less than 30 ml/min.), reduction of the Oxaliplatin Injection dose to 65 mg/m2 . PREPARATION AND ADMINISTRATION Oxaliplatin Injection is a cytotoxic drug. Special handling and disposal procedures should be applicable as follows: The concentrated solution will be diluted with 250 to 500 ml of 5% Dextrose Injection. The diluted solution should not be stored for longer 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]). Visual inspection is required for particulate matter and discoloration prior to administration and discard if present. Dilution with sodium chloride solution or other chloride-containing solutions must not be performed. Alkaline medications or media (such as basic solutions of fluorouracil) should not be mixed with Oxaliplatin Injection or administered through the same infusion line concurrently. The infusion line should be flushed with 5% Dextrose Injection, prior to administration of any concomitant medication. Intravenous administration sets or needles containing aluminum parts should not be used for the preparation or mixing of Oxaliplatin Injection. Aluminum has been reported to cause degradation of platinum compounds.
There is no known antidote for Oxaliplatin overdose. Patients suspected of receiving an overdose should be monitored, and supportive treatment should be administered. In addition to thrombocytopenia, the anticipated complications of an Oxaliplatin overdose include hypersensitivity reaction, myelosuppression, nausea, vomiting, diarrhea and neurotoxicity.
Allergic Reactions: Monitor for development of rash, urticaria, erythema, pruritus, bronchospasm, and hypotension. Neuropathy: Reduce the dose or discontinue Oxaliplatin Injection if necessary. Severe Neutropenia: Delay Oxaliplatin Injection until neutrophils are ≥1.5 x 109/l. Withhold Oxaliplatin Injection for sepsis. Pulmonary Toxicity: May need to discontinue Oxaliplatin injection until interstitial lung disease or pulmonary fibrosis are excluded. Hepatotoxicity: Monitor liver function tests. Cardiovascular Toxicity: Correct hypokalemia or hypomagnesemia prior to initiating Oxaliplatin Injection. Rhabdomyolysis: Discontinue Oxaliplatin Injection if rhabdomyolysis occurs. Embryo-Fetal Toxicity: Can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise males and females of reproductive potential to use an effective method of contraception.
The most common adverse reactions (incidence ≥ 40%) are peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue and stomatitis
No specific cytochrome P-450-based drug interaction studies have been conducted.
Pregnancy: Based on direct interaction with DNA, Oxaliplatin Injection can cause fetal harm when administered to a pregnant woman Nursing mothers: Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with Oxaliplatin Injection and for 3 months after the final dose. Pediatric use: The effectiveness of Oxaliplatin Injection in children has not been established. Geriatric use: No significant effect of age on the clearance of ultrafilterable platinum has been observed. Females and Males of Reproductive Potential: Based on animal studies, Oxaliplatin Injection may impair fertility in males and females.
Arixatin 50 Concentrated Solution for IV Infusion: Each box contains 1 vial of Oxaliplatin BP 50 mg.
Arixatin 100 Concentrated Solution for IV Infusion: Each box contains 1 vial of Oxaliplatin BP 100 mg, one IV infusion set (with butterfly needle), one disposable syringe (10 ml), one alcohol pad and one first aid bandage.
FR
DE