How to use Xalico:

Administer Xalico 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 Xalico 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 2-4 minutes, followed by fluorouracil 600 mg/m2 as a 22-hour continuous infusion. Day 2 Administer leucovorin 200 mg/m2 as an intravenous infusion over 120 minutes, followed by fluorouracil 400 mg/m2 as intravenous bolus over 2-4 minutes, followed by fluorouracil 600 mg/m2 as a 22-hour continuous infusion. Refer to the prescribing information for fluorouracil and leucovorin for additional information.

Prolongation of infusion time for Xalico from 2 hours to 6 hours may mitigate acute toxicities, such as non-life threatening infusion-related reactions.

Injection: 50 mg (5 mg/mL) or 100 mg (5 mg/mL) clear, colorless solution in a single-dose vial.

Xalico is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. Reactions have included anaphylaxis.

Xalico is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

• Do not freeze.
• Protect the concentrated solution from light.
• Dilute concentrated solution with 250 to 500 mL of 5% Dextrose Injection, USP. Do not dilute with sodium chloride solution or other chloride-containing solutions.
• Store diluted solution for no more 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]). Protection from light is not required.
• Visually inspect for particulate matter and discoloration prior to administration and discard if present. · Do not mix Xalico or administer Xalico through the same infusion line concurrently with alkaline medications or media (such as basic solutions of fluorouracil).
• Flush the infusion line with 5% Dextrose Injection, USP prior to administration of any concomitant medication.
• Do not use needles or intravenous administration sets containing aluminum parts for the preparation or mixing of Xalico. Aluminum has been reported to cause degradation of platinum compounds.
• Administer Xalico as an intravenous infusion over 120 minutes concurrently with leucovorin over 120 minutes in separate bags.