Indication

GLASSIA is a liquid medicine containing human Alpha1-Proteinase Inhibitor (Alpha1-PI) also known as alpha1-antitrypsin (AAT),

Step-by-Step Guide
which is purified from human blood. The main purpose of infusing GLASSIA is to increase the levels of the AAT protein in your
blood and lungs. AAT protein protects the lung tissue by blocking certain enzyme-caused damage. Such damage can lead to
severe lung disease, such as emphysema.
Limitations of Use:

for Preparation and

• T
 he effects of increasing the AAT protein levels with GLASSIA or any other Alpha1-PI product on worsening pulmonary function
and progression of emphysema have not been proven in clinical trials.
• The long-term effects of AAT replacement and maintenance therapy with GLASSIA have not been studied.
• GLASSIA is not intended as a therapy in individuals with lung disease other than severe Alpha1-PI deficiency.

Detailed Important Risk Information

SEVERE ALLERGIC REACTIONS
• Y
 ou should not use GLASSIA if you have immunoglobulin A (IgA) deficiency with antibodies to IgA or have had a severe allergic
Administration
reaction to human Alpha1-PI products.
• S
 evere allergic reactions can occur with GLASSIA. Your doctor will inform you about signs of allergic reactions which include
hives, swelling in the mouth or throat, itching, tightness in the chest, trouble breathing, wheezing, faintness, low blood
for patients and caregivers
pressure, or serious allergic reaction. If you have any of these reactions, discontinue use of the product and contact your
physician and/or seek immediate emergency care, depending on the severity of the reaction.
TRANSMISSION OF INFECTIOUS AGENTS
• G
 LASSIA is made from human plasma and therefore the possibility of transmitting infectious agents (e.g., viruses) cannot be
totally excluded. Risk of transmitting an infectious agent has been reduced with donor screening, plasma testing and removal
of certain viruses during the manufacturing process. Despite these measures, such products may still potentially transmit
human infectious agents.
SIDE EFFECTS
• A
 possible side effect to GLASSIA is worsening or flare-up of your chronic obstructive pulmonary disease (COPD) in which your
breathing gets worse than usual.
• T
 he most common side effects are headache and upper respiratory tract infections. Other possible side effects of GLASSIA
include: cough, sinus infection, chest discomfort, dizziness, increased liver enzymes, shortness of breath, nausea, and fatigue.

You are encouraged to report negative side effects of GLASSIA by contacting FDA at
1-800-FDA-1088 or www.fda.gov/medwatch or Kamada Ltd. at 1-866-GLASSIA.

Please see the accompanying GLASSIA full Prescribing Information and Patient Product Information.

Reference: 1. GLASSIA [Alpha1-Proteinase Inhibitor (Human)] [package insert]. Westlake Village, CA: Baxalta US Inc.

©2016 Shire US Inc., Lexington, MA 02421. All rights reserved. 1-800-828-2088.

SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.
Glassia is a registered trademark of Kamada Ltd., and used under license.
June 2016 USBS/341/16-0006
 Before you begin: 1
Check the vial(s) of GLASSIA:
2
Gather all supplies

Step-by-Step Do not attempt to do an infusion unless you or your caregiver have been taught
how by your healthcare professional. • Do not use if the protective cap is missing or broken. • Prepare a clean flat surface and gather all the materials you will

Guide for
• Check the expiration date, and let the vial(s) of need for the infusion.
A caregiver should be present during infusion to monitor for signs of a GLASSIA [Alpha1-Proteinase Inhibitor (Human)] warm up • If your doctor has prescribed epinephrine pen and/or other
severe allergic reaction. Refer to the Detailed Important Risk Information to room temperature. Do not apply heat, place in hot water, supportive care for certain severe allergic symptoms, keep it
for more information on severe allergic reactions on the back of this guide.

Preparation and
or microwave. close at hand during your infusion. Carefully follow your doctor’s
• Check that the color is clear and colorless to yellow-green. instructions and training if you have to administer the prescribed
If you or your caregiver will be administering GLASSIA outside a healthcare
• Do not use if the solution is cloudy. medicine for a severe allergic reaction.
setting, ask your doctor about an epinephrine pen and/or other supportive
• It may contain a few (protein) particles. • Wash your hands and allow them to dry.

Administration
care for certain severe allergic reactions. Ask your doctor to make sure you
• Do not shake the vial(s). • Apply gloves as directed by your healthcare professional
receive training on how and when to use any prescribed supportive care
• Open supplies as shown by your healthcare professional.
medicine and keep it close at hand when administering GLASSIA.

for patients and caregivers1 Always follow the specific instructions given by your healthcare
professional. The steps listed here are general guidelines for using
GLASSIA [Alpha1-Proteinase Inhibitor (Human)]. If you are unsure of the
procedures, call your healthcare professional before using.
Prepare the vial(s) for infusion If you are pooling into a sterile • Remove protective cover of needle and
3 as directed by your healthcare container (bag): insert the needle into the injection port
professional: • Attach a vented spike to and fill the empty bag.
• Remove the protective cap from the vial. a sterile syringe.
Supplies needed: • Wipe the stopper of each vial that you will • Insert the vented spike into the
• Repeat these steps, if using multiple
vials, to achieve the desired dose
Provided: need for your dose with a sterile alcohol center of the GLASSIA vial. as directed by your healthcare
swab; allow the stopper(s) to dry. • Turn the vial upside down and pull professional, using a new filter
• GLASSIA product vials, as prescribed by your
• Infuse directly from the vial or pool back on the plunger to pull the needle with each vial.
healthcare professional (HCP)
the recommended number of vials of GLASSIA solution into the syringe.
• 5 micron sterile filter needle GLASSIA into an empty, sterile container • Remove the syringe from the vented spike.
Not Provided: (bag) for intravenous (IV) infusion, as • Point the syringe tip up and gently push the plunger of the
directed by your healthcare professional. syringe to remove the air.
• Tourniquet • Use the product within 3 hours of • Attach the supplied 5-micron filter needle to the filled syringe.
• Alcohol swabs entering the vial(s) or pooling into a sterile • Wipe the injection port on the empty sterile container (bag) with
• Intravenous (IV) needle set container (bag). an alcohol swab.
• Vented transfer device(s) (vented spike)
• 5 micron in-line filter
Prepare the infusion set: Prepare the infusion site(s): Insert and secure the IV
• 60 mL sterile syringe(s)
• Sterile IV infusion container (bag), if necessary 4 5 6 needle set as directed by your
healthcare professional.
• Administration infusion set • Close the roller clamp on the • Select an infusion site as directed by • Release the tourniquet and flush the
• Extension set, if necessary IV infusion set. your healthcare professional. IV needle set (butterfly) with normal
• Bandage • Attach an in-line 5 micron filter to the • Rotate infusion sites as directed. saline to check if needle placement
• Tape end of the IV infusion set. • Apply a tourniquet and get the is correct. If not successful repeat
• Attach an extension set (if necessary). injection site ready by wiping the skin steps as directed by your healthcare
• Sterile gauze • Remove cap from the IV infusion set well with an alcohol swab (or other professional.
• Sharps container spike and insert spike into the infusion suitable solution suggested by your healthcare provider) and wait • Remove the saline flush syringe and attach the IV infusion set
• IV pole or hook port on the bag containing GLASSIA. for the skin to dry. filled with GLASSIA solution.
• Clean gloves, if necessary • Hang the pooling bag from an
IV pole or hook.
• Infusion log
• Squeeze the drip chamber until it is
half-full and fill the IV infusion set as
directed by your healthcare professional.

Please see the GLASSIA [Alpha1-
Proteinase Inhibitor (Human)]
Indication and Detailed Important
• Open the roller clamp and administer
Risk Information on back cover and
the accompanying full Prescribing
Information.
Follow your healthcare professional’s • Check infusion site occasionally throughout the infusion. Record the infusion:
7 instructions for infusing GLASSIA: • When the infusion is complete, take the needle out of the vein and 8
use sterile gauze to put pressure on the infusion site for several
minutes; then apply a sterile bandage. • Write down the following in your treatment record/infusion log:
GLASSIA solution at room temperature • Do not recap the IV needle set. - Product lot number and expiration date
at a rate as directed by your healthcare • Place the needle in a hard-walled sharps container for - Date, time (start and end), dose, site(s) of infusion
professional. The maximum proper disposal. - Any reactions after each infusion
recommended infusion rate for GLASSIA • Do not dispose of these supplies in ordinary household trash. • Report all reactions to your healthcare professional.
is 0.2 mL per kilogram body weight per • Throw away all open vials, and any unused
minute which will take solution into a sharps container, as recommended
approximately 15 minutes to infuse. by your healthcare professional.