Dosage

• Administer 60 mg/kg body weight of GLASSIA once weekly by intravenous infusion.
• Dose ranging studies using efficacy endpoints have not been performed.
• The carton and label on each vial of GLASSIA show the actual amount of functionally active Alpha1-PI in milligrams.

Preparation

1. Use aseptic technique.
2. Allow the product to reach room temperature prior to infusing and administer within three hours of entering the vials.
3. Inspect the vial of GLASSIA. The solution should be clear and colorless to yellow-green and may contain a few protein particles. Discard if the product is cloudy.
4. The product is suitable for infusion directly from the vial or pooled into a sterile container for intravenous infusion.
5. Use a vented spike (not supplied) to withdraw the solution from the vial.
6. Then use a needle (not supplied) to transfer the solution into the intravenous infusion container.
7. If using multiple vials to achieve the desired dose, pool GLASSIA into the infusion container by repeating Steps 5 and 6 with a new vented spike and transfer needle for each vial.

Administration

For intravenous infusion only.

GLASSIA should be administered by a healthcare professional or self-administered by the patient/caregiver after appropriate training. For self-administration, provide the patient/caregiver with detailed instructions and adequate training for infusion in the home or other appropriate setting [see Patient Counseling Information (17)].

1. Use aseptic technique.
2. Inspect parenteral products visually for particulate matter and discoloration prior to administration whenever solution and container permit.
3. Administer GLASSIA alone. Do not mix with other agents or diluting solutions.
4. When infusing directly from the vials, use a vented spike (not supplied). If the contents of vials have been pooled to a sterile intravenous container, use an appropriate intravenous administration set.
5. Always use a 5 micron in-line filter (minimum filter diameter of 32 mm to ensure optimal performance, not supplied) during infusion.
6. Administer GLASSIA within three hours of entering the vials to avoid the potential ill effect of any inadvertent microbial contamination.
7. Administer GLASSIA at room temperature through an appropriate intravenous administration set at a rate not to exceed 0.2 mL/kg body weight per minute, and as determined by the response and comfort of the patient. The recommended dosage of 60 mg/kg at a rate of 0.2 mL/kg/min will take approximately 15 minutes to infuse.
8. Monitor the infusion rate closely during administration and observe the patient for signs of infusion related reactions. If infusion related adverse reactions occur, reduce the rate or interrupt the infusion as appropriate until the symptoms subside. Resume the infusion at a rate tolerated by the patient, except in the case of severe reaction [see Warnings and Precautions (5.1)].
9. Following administration, discard all open vials, unused solution and administration equipment.