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GLASSIA- .alpha.1-proteinase inhibitor human injection, solution


  1. Patient Information
  2. Limitations Of Use:
  3. You Should Not Use Glassia If You:
  4. What Is The Most Important Information That I Should Know About Glassia?
  5. Before Starting Glassia, Tell Your Healthcare Professional If You:
  6. What Are The Possible Or Reasonably Likely Side Effects Of Glassia?
  7. How Do I Store Glassia?
  8. Prepare The Vial(s) For Infusion As Directed By Your Healthcare Professional:
  9. If You Are Pooling Into A Sterile Container (bag):
  10. Prepare The Infusion Set:
  11. Prepare The Infusion Site(s):
  12. Follow Your Healthcare Professionals Instructions For Infusing Glassia:
  13. Record The Infusion:
  14. Distributed By:
  15. Revised: 1/2019document Id:

Patient Information 

  • Inform patients of the early signs of hypersensitivity reactions, including hives, generalized urticaria, chest tightness, dyspnea, wheezing, faintness, hypotension, and anaphylaxis. Advise patients to discontinue use of the product and contact their physician and/or

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

  • The 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.

You Should Not Use Glassia If You: 

  • Have IgA deficiency with antibodies to IgA
  • Have had a severe allergic reaction to human Alpha1-PI products

What Is The Most Important Information That I Should Know About Glassia? 

Severe 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 pressure, or serious allergic reaction. If you have any of these reactions, discontinue use of the product and contact your physician and/or

  • GLASSIA is given directly into the bloodstream.
  • You can get GLASSIA at your healthcare professional's office, clinic, hospital, or delivered directly to your home by a healthcare professional from a limited network of specialty pharmacy providers.
  • Your healthcare professional will decide if self-infusion in your home is right for you. You should be trained on how to do infusions by your healthcare professional.

Before Starting Glassia, Tell Your Healthcare Professional If You: 

  • Have IgA deficiency with antibodies to IgA.
  • Have a history of severe allergic reactions to Alpha1-PI products.

What Are The Possible Or Reasonably Likely Side Effects Of Glassia? 

  • 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.
  • Call your healthcare professional or go to your emergency department right away if you get: Hives, swelling in the mouth or throat, itching, chest tightness, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
  • The 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.

These are not all of the possible side effects for GLASSIA. You can ask your healthcare professional for information that is provided to healthcare professionals. Talk to your healthcare professional about any side effects that bother you or that don't go away.

How Do I Store Glassia? 

Store GLASSIA refrigerated or at room temperature.

  • You can store GLASSIA in the refrigerator (36 F to 46 F [2 C to 8 C]). Do not freeze.
  • You can store GLASSIA at room temperature (up to 77 F [25 C]) for up to one month. You must use GLASSIA within one month once you remove it from the refrigerator. Do not re-refrigerate GLASSIA once the product has been stored at room temperature.
  • Keep the GLASSIA vial in the box until you are ready to administer the product.

Check the expiration date on the carton and vial label. Do not use GLASSIA after the expiration date.

Prepare The Vial(s) For Infusion As Directed By Your Healthcare Professional: 

  • Remove the protective cap from the vial.Figure
  • Wipe the stoppers of each vial that you will need for your dose with a sterile alcohol swab and allow the stopper to dry.Figure
  • As directed by your healthcare professional, you may infuse directly from the vial or pool the recommended number of vials of GLASSIA into an empty, sterile container (bag) for intravenous infusion. Use the product within 3 hours of entering the vial(s) or pooling into a sterile container (bag).

If You Are Pooling Into A Sterile Container (bag): 

  • Attach a vented spike to a sterile syringe.
  • Insert the vented spike into the center of the GLASSIA vial. Note: Do not use the 5 micron filter needle (supplied in the box) to withdraw GLASSIA from the vial.
  • Turn the vial upside down and pull back on the plunger to pull the GLASSIA solution into the syringe(s).Figure
  • Remove the syringe from the vented spike.
  • Point the syringe tip up and gently push the plunger of the syringe to remove the air.
  • Attach a 5 micron filter needle (supplied in each box) to the filled syringe.
  • Wipe the injection port on the empty sterile container (bag) with an alcohol swab.
  • Remove protective cover of needle and insert the needle into the injection port and fill the empty bag.Figure
  • Repeat these steps, if using multiple vials to achieve the desired dose as directed by your healthcare professional, using a new filter needle with each vial.

Prepare The Infusion Set: 

  • Close the roller clamp on the IV infusion set.
  • Attach an in-line 5 micron filter to the end of the IV infusion set.
  • Attach an extension set (if necessary).Figure
  • Remove cap from the IV infusion set spike and insert spike into the infusion port on the bag containing GLASSIA.Figure
  • Hang the pooling bag from an IV pole or hook.
  • Squeeze the drip chamber until it is half-full and fill the IV infusion set as directed by your healthcare professional.

Prepare The Infusion Site(s): 

  • Select an infusion site as directed by your healthcare professional.
  • Rotate infusion sites as directed.
  • Apply a tourniquet and get the injection site ready by wiping the skin well with an alcohol swab (or other suitable solution suggested by your healthcare provider) and wait for the skin to dry.Figure
  • Insert and secure the intravenous needle set as directed by your healthcare professional.
    • Release the tourniquet and flush the intravenous needle set (butterfly) with normal saline to check needle placement is correct. If not successful repeat steps as directed by your healthcare professional.Figure
    • Remove the saline flush syringe and attach the IV infusion set filled with GLASSIA solution.
  • Follow Your Healthcare Professionals Instructions For Infusing Glassia: 

    • Open the roller clamp and administer GLASSIA solution at room temperature at a rate as directed by your healthcare professional. The maximum recommended infusion rate for GLASSIA is 0.2 milliliter per kilogram body weight per minute which will take approximately 15 minutes to infuse.Figure
    • Check infusion site occasionally throughout the infusion.
    • When the infusion is complete, take the needle out of the vein and use sterile gauze to put pressure on the infusion site for several minutes and then apply a sterile bandage.
    • Do not recap the intravenous needle set. Place the needle in a hard-walled sharps container for proper disposal. Do not dispose of these supplies in ordinary household trash.

    Record The Infusion: 

    • Write down the product lot number and expiration date in your treatment record/infusion log.
    • Write down the date, time (start and end), dose, site(s) of infusion (to assist in rotating sites) and any reactions after each infusion. Report all reactions to your healthcare professional.
    • Throw away all open vials, and any unused solution into a sharps container, as recommended by your healthcare professional.

    Distributed By: 

    Kamada Ltd.Baxalta US Inc.Beit KamaLexington, MAMP Negev 853250002421IsraelUSAU.S. License No. 182617H010-GLA-US

    Issue date: 06/2017

    Principal Display Panel - Glassia Carton Label

    NDC 0944-2884-01

    ALPHA-1 PROTEINASE
    INHIBITOR (HUMAN)

    GLASSIA

    Injection Solution

    For Intravenous Administration Only

    50 ml

    KAMADA

    Principal Display Panel - Glassia Carton Label

    Principal Display Panel - Glassia Vial Label

    ALPHA-1 PROTEINASE
    INHIBITOR (HUMAN)

    GLASSIA

    For Intravenous Administration Only

    Injection Solution

    50 ml

    Principal Display Panel - Glassia Vial Label
    GLASSIA
    .alpha.1-proteinase inhibitor human injection, solution
    Product Information
    Product TypePLASMA DERIVATIVEItem Code (Source)NDC:0944-2884
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    .ALPHA.1-PROTEINASE INHIBITOR HUMAN(UNII: F43I396OIS) (.ALPHA.1-PROTEINASE INHIBITOR HUMAN - UNII:F43I396OIS).ALPHA.1-PROTEINASE INHIBITOR HUMAN1 g in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE(UNII: 5QWK665956)
    SODIUM CHLORIDE(UNII: 451W47IQ8X)
    WATER(UNII: 059QF0KO0R)
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0944-2884-011 in 1 CARTON
    1NDC:0944-2884-0250 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12532507/01/2010
    Labeler -Baxalta USA Inc. (079887619)
    Registrant -Kamada Ltd. (600251631)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kamada Ltd.649062486MANUFACTURE(0944-2884) , LABEL(0944-2884) , PACK(0944-2884) , ANALYSIS(0944-2884)

    Revised: 1/2019document Id: 

    4513ccad-ab41-4ce6-90b5-c3761a3633c9Set id: 83473cbb-48e4-42a2-81b6-4c851423da7bVersion: 20Effective Time: 20190130Baxalta USA Inc.



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