PASATRU Solution for injection Ref.[116899] Active ingredients: Garetosmab

2.1 Pregnancy Testing Prior to Treatment with PASATRU

Verify that females of reproductive potential are not pregnant prior to initiating PASATRU [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)].

2.2 Recommended Dosage

The recommended starting dosage of PASATRU is 10 mg/kg administered as an intravenous infusion over 60 minutes once every 4 weeks. The dosage of PASATRU may be decreased to 3 mg/kg administered as an intravenous infusion over 60 minutes once every 4 weeks if 10 mg/kg is not tolerated.

If a dose of PASATRU is missed, administer the dose as soon as possible. Thereafter, PASATRU should be scheduled once every 4 weeks from the date of the last dose.

2.3 Preparation and Administration Instructions

Preparation:

• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. PASATRU is a clear to slightly opalescent, colorless to pale yellow solution. Discard the vial if the solution is cloudy, discolored, or contains particulate matter.
• Each vial is intended for one-time use only.
• Do not shake the vial. Withdraw the required volume from the vial(s) of PASATRU and transfer into an intravenous infusion bag [polyvinyl chloride (PVC), polyolefin (PO), or ethyl vinyl acetate (EVA)] containing a minimum of 50 mL and a maximum of 100 mL of 5% Dextrose Injection, USP to prepare a diluted solution with a final concentration ranging from 0.9 mg/mL to 25 mg/mL.
• Mix the diluted solution by gentle inversion. Do not shake the solution.
• Discard any unused portion left in the vial.

Storage of Infusion Solution:

• Use diluted PASATRU immediately. If not used immediately, store the diluted solution refrigerated at 2°C to 8°C (36°F to 46°F) for no more than 24 hours or at room temperature up to 25°C (77°F) for no more than 16 hours from the time of preparation to the start of infusion.
• Do not freeze the diluted solution.

Administration:

• If refrigerated, allow the diluted solution to come to room temperature prior to administration.
• Administer PASATRU diluted solution by intravenous infusion over 60 minutes using an infusion set constructed of PVC, polyethylene (PE)-lined PVC, or polyurethane (PU). A sterile, in-line or add-on, 0.2-micron to 5-micron polyethersulfone (PES) or polyamide (PA) filter is recommended.
• PASATRU should be administered using an infusion pump to control the rate of infusion.
• Upon completion of the PASATRU infusion, flush the infusion line with an adequate volume of sterile 5% Dextrose Injection, USP to ensure that the entire contents of the infusion bag are administered.
• Do not mix other drugs with PASATRU or administer other drugs concomitantly via the same infusion line.

Store the unopened vial in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.

Do not freeze. Do not shake.