Preparation¹

How to mix POTELIGEO

• 

• • 1.

  • Visually inspect drug product solution for particulate matter and discoloration prior to administration. POTELIGEO is a clear to slightly opalescent colorless solution. Do not use the vial if cloudiness, discoloration, or particulates are observed.

• 

• • 2.

  • Calculate the dose (mg/kg) and number of vials of POTELIGEO needed to prepare the infusion solution based on patient weight. Each vial contains 20 mg of POTELIGEO, which is enough for 20 kg of body weight.

• 

• • 3.

  • Aseptically withdraw the required volume of POTELIGEO into the syringe and transfer into an intravenous (IV) bag^a containing 0.9% Sodium Chloride Injection, USP. The final concentration of the diluted solution should be between 0.1 mg/mL and 3.0 mg/mL.

• 

• • 4.

  • Mix diluted solution by gentle inversion. Do not shake. After preparation, infuse the POTELIGEO solution immediately, or store under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of infusion preparation. Do not freeze. Do not shake.

• 

• • 5.

  • Discard any unused portion left in the vial.

^a The diluted solution is compatible with polyvinyl chloride (PVC) or polyolefin (PO) infusion bags.

Administration

• Administer infusion solution over at least 1 hour through an IV line containing a sterile, low protein binding, 0.22 micron (or equivalent) in-line filter
• Do not mix POTELIGEO with other drugs
• Calculate the dose (mg/kg) and number of vials of POTELIGEO needed to prepare the infusion solution based on patient weight
• Do not co-administer other drugs through the same IV line
• Prepared POTELIGEO is a clear to slightly opalescent colorless solution—without particulates