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GAMMAGARD LIQUID (immune globulin infusion- human injection, solution


  1. See Fda Approved Patient Labeling (information For Patients And Instructions For Use For Pi Patients Only). Inform Patients To Immediately Report The Following Signs And Symptoms To Their Healthcare Provider:
  2. Patient Information
  3. Gammagard Liquid Can Cause The Following Serious Reactions:
  4. What Is Gammagard Liquid?
  5. Who Should Not Use Gammagard Liquid?
  6. How Should I Use Gammagard Liquid?
  7. What Should I Avoid While Taking Gammagard Liquid?
  8. What Are The Possible Or Reasonably Likely Side Effects Of Gammagard Liquid?
  9. During The Infusion Of Gammagard Liquid, Look Out For The First Signs Of The Following Common Side Effects:
  10. How Do I Store Gammagard Liquid?
  11. In The Refrigerator:
  12. Room Temperature:
  13. Resources At Baxalta Available To The Patients:

See Fda Approved Patient Labeling (information For Patients And Instructions For Use For Pi Patients Only). Inform Patients To Immediately Report The Following Signs And Symptoms To Their Healthcare Provider: 

Decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath. [SeeWarnings and Precautions(5.2)]
Instruct patients to immediately report symptoms of thrombosis. These symptoms may include pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body. [SeeWarnings and Precautions (5.4)]
Severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting. [SeeWarnings and Precautions(5.5)]
Increased heart rate, fatigue, yellowing of the skin or eyes, and dark-colored urine.[See Warnings and Precautions(5.6)]
Trouble breathing, chest pain, blue lips or extremities, or fever that can occur 1 to 6 hours after an infusion of GAMMAGARD LIQUID. [SeeWarnings and Precautions (5.7)]

Prior to starting GAMMAGARD LIQUID ask about a history of IgA deficiency, allergic reactions to immune globulin or other blood products. Patients with a history of allergic reactions should not be treated subcutaneously at home until several treatments have been administered and tolerated under medical supervision.

Inform patients that GAMMAGARD LIQUID is made from human plasma and may contain infectious agents that can cause disease (e.g., viruses and, theoretically, the vCJD agent). The risk of GAMMAGARD LIQUID transmitting an infectious agent has been reduced by screening plasma donors for prior exposure, testing donated plasma, and inactivating or removing certain viruses during manufacturing. Patients should report any symptoms that concern them which might be caused by virus infections. [SeeWarnings and Precautions(5.8)]

Inform patients that GAMMAGARD LIQUID can interfere with their immune response to live viral vaccines such as measles, mumps, rubella and varicella, and instruct patients to notify their healthcare professional of this potential interaction when they are receiving vaccinations. [SeeDrug Interactions(7)]

Subcutaneous (SC) Administration Only

Self-administrationIf self-administration is deemed to be appropriate by the physician, clear instructions and training on subcutaneous infusion should be given to the patient/caregiver, and the demonstration of their ability to independently administer subcutaneous infusions should be documented.

Ensure the patient understands the importance ofconsistentweekly subcutaneous infusion to maintain appropriate steady IgG levels.
Instruct the patient to keep a treatment diary/log book. This diary/log book should include information about each infusion such as, the time, date, dose, lot number(s) and any reactions.
Inform the patient that mild to moderate local infusion-site reactions (e.g., swelling and redness) are a common side effect of subcutaneous treatment, but to contact their healthcare professional if a local reaction increases in severity or persists for more than a few days.

BAXALTAand GAMMAGARD LIQUIDare trademarks of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc.
SHIRE and the Shire Logo are trademarks or registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.

Baxalta US Inc.
Lexington, MA 02421 USA
U.S. License No. 2020

17G009-GLD-US

Patient Information 

GAMMAGARD LIQUID

Immune Globulin Infusion (Human) 10%

For Intravenous and Subcutaneous Administration

Information for Patients

The following summarizes important information about GAMMAGARD LIQUID. Please read it carefully before using this medicine. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about GAMMAGARD LIQUID. If you have any questions after reading this, ask your healthcare provider.

Gammagard Liquid Can Cause The Following Serious Reactions: 

Severe allergic reactions causing difficulty in breathing or skin rashes
Decreased kidney function or kidney failure
Blood clots in the heart, brain, lungs or elsewhere in the body
Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting
Dark colored urine, swelling, fatigue, or difficulty breathing

What Is Gammagard Liquid? 

GAMMAGARD LIQUID is a ready-to-use, liquid medicine that contains immunoglobulin G (IgG) antibodies, which protect the body against infection.

GAMMAGARD LIQUID is used to treat patients with primary immunodeficiency diseases (PI) and patients with multifocal motor neuropathy (MMN).

There are many forms of PI. The most common types of PI result in an inability to make a very important type of protein called antibodies, which help the body fight off infections from bacteria or viruses. GAMMAGARD LIQUID is made from human plasma that is donated by healthy people. GAMMAGARD LIQUID contains antibodies collected from these healthy people that replace the missing antibodies in PI patients.

MMN is a rare disease that causes muscle weakness that worsens over time. It affects the strength of the lower parts of arms and hands more than the legs, usually without affecting the touch sensation.

Who Should Not Use Gammagard Liquid? 

Do not use GAMMAGARD LIQUID if you have a known history of a severe allergic reaction to immune globulin or other blood products. If you have such a history, discuss this with your healthcare provider to determine if GAMMAGARD LIQUID can be given to you. Tell your healthcare provider if you have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.

How Should I Use Gammagard Liquid? 

GAMMAGARD LIQUID is given into a vein (intravenously) or under the skin (subcutaneously). For patients with PI, infusions into the vein are usually given every 3 or 4 weeks whereas infusions under the skin are given every week. For patients with MMN, infusions are given into a vein every 2 to 4 weeks as ordered by your physician. You and your healthcare provider will decide which way is best for you. Most of the time infusions under the skin are given at home by patients or caregivers. Although it is possible to give yourself infusions into the vein at home they are more often given in a hospital or infusion center by a nurse.

Instructions for giving GAMMAGARD LIQUID under the skin (subcutaneously) are provided in the Instructions for Use brochure. Only use GAMMAGARD LIQUID by yourself after you have been instructed by your healthcare provider.

What Should I Avoid While Taking Gammagard Liquid? 

GAMMAGARD LIQUID can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your healthcare provider that you take GAMMAGARD LIQUID.

Tell your healthcare provider if you are pregnant, or plan to become pregnant, or if you are nursing.

What Are The Possible Or Reasonably Likely Side Effects Of Gammagard Liquid? 

The following one or more possible reactions may occur at the site of infusion. These generally go away within a few hours, and are less likely after the first few infusions.

Mild or moderate pain
Redness
Swelling
Bruising
Itching
Warmth

During The Infusion Of Gammagard Liquid, Look Out For The First Signs Of The Following Common Side Effects: 

Headache
Chills/Shaking chills
Migraine
Dizziness
Fever
Nausea/Vomiting
Fatigue
Faster Heart Rate
Itching
Upper Abdominal Pain
Rash/Hives
Increased Blood Pressure
Cough
Muscle cramps
Chest pain/tightness
Sore throat

If any of the following problems occur after starting treatment with GAMMAGARD LIQUID, stop the infusion immediately and contact your healthcare provider or call emergency services. These could be signs of a serious problem.

Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation of the lining around your brain.
Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot.
Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver problem or a blood problem.
Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem.
Fever over 100 F. This could be a sign of an infection.

These are not all of the possible side effects with GAMMAGARD LIQUID. You can ask your healthcare provider for physician's information leaflet. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Whenever giving yourself treatments at home, you should have another responsible person present to help treat side effects or get help if you have a serious adverse reaction occur. Ask your healthcare provider whether you should have rescue medications, such as antihistamines or epinephrine.

How Do I Store Gammagard Liquid? 

Store vials in their original boxes to protect from light. Do not freeze GAMMAGARD LIQUID.

You can store GAMMAGARD LIQUID in the refrigerator or at room temperature. The maximum storage time for GAMMAGARD LIQUID depends on the storage temperature you choose.

In The Refrigerator: 

at 2 to 8 C (36 to 46 F) for up to 36 months.

Room Temperature: 

up to 25 C (77 F) for up to 24 months.

The refrigerator and room temperature expiration dates are printed on the vial labels and the box. Always check the expiration date. You should not use the product after the expiration date.

Note: If you remove GAMMAGARD LIQUID from the refrigerator and store it at room temperature, do not refrigerate again.

Resources At Baxalta Available To The Patients: 

For more information on patient resources, education, or insurance assistance please visitwww.immunedisease.com.

Detailed Instructions for Subcutaneous Administration for Patients with PI ONLY

Do not begin subcutaneous treatment with GAMMAGARD LIQUID until you have received instructions as detailed above and are comfortable that you can perform all the steps on your own.

1. If refrigerated, remove GAMMAGARD LIQUID from refrigerator- remove the product box from the refrigerator and take the vial out of the box.

Allow vials to reach room temperature. This may take up to 60 minutes.

Do not heat up the product or shake the product.

If stored at room temperature, take the vial out of the box.

Check:

Expiration date. Do not use beyond expiration date.
Vial to see if it is clear and colorless to light yellow. If it is cloudy or has particles, do not use.
Protective cap is on the vial. Do not use the product if it does not have the cap.

Repeat this step with as many boxes of GAMMAGARD LIQUID as necessary.

2. Gather all suppliesCollect all the items you will need for the infusion: vial(s) of GAMMAGARD LIQUID, infusion supplies (needle sets, transfer needles, alcohol swabs, syringes, gauze, and tape), sharps container, infusion pump, and treatment logbook.

3. Prepare a clean work area-Clean a work area with an antibacterial cleaner and place all gathered items on the clean surface. Find a quiet work area with as few distractions as possible.

Clean a work area with an antibacterial cleaner and place all gathered items on the clean surface. Find a quiet work area with as few distractions as possible.

4. Wash hands-Wash your hands thoroughly. Put on clean gloves if your health care provider has instructed you to wear them.

5. GAMMAGARD LIQUID preparation-If GAMMAGARD LIQUID is received in a bag or syringe, skip to step 7.

Remove the cap from the vial. Wipe the vial stopper with an alcohol swab and allow to air dry (at least 30 seconds).

If GAMMAGARD LIQUID is received in a bag or syringe, skip to step 7.  Remove the cap from the vial. Wipe the vial stopper with an alcohol swab and allow to air dry (at least 30 seconds).

6. Fill syringe from GAMMAGARD LIQUID vial(s)Remove sterile syringe from package and attach to a sterile needle. Pull back on plunger of the syringe to fill it with air, which should equal the amount of liquid you will be taking from the vial. Insert needle into the center of the vial stopper. Inject air into the vial and withdraw GAMMAGARD LIQUID into the syringe. (Example: If withdrawing 50 mL of GAMMAGARD LIQUID, inject 50 mL of air into the vial).

If multiple vials are required to achieve the desired dose, repeat this step.

If using a vented spike, it is not necessary to inject air into the vial with the syringe. Attach a sterile syringe to the spike, insert the spike into the center of the stopper, and pull back on the plunger to withdraw the desired volume.

Remove sterile syringe from package and attach to a sterile needle. Pull back on plunger of the syringe to fill it with air, which should equal the amount of liquid you will be taking from the vial. Insert needle into the center of the vial stopper. Inject air into the vial and withdraw GAMMAGARD LIQUID into the syringe.

7. Prepare the infusion pump and tubingIf using a syringe driver pump, attach the syringe filled with GAMMAGARD LIQUID to the needle set. On a hard surface, gently push down on the plunger to fill (prime) the pump tubing up to the needle hub. This will ensure that no air is left in the tubing and needle (see picture).

If using a portable pump with GAMMAGARD LIQUID in a bag, follow manufacturer's instructions for preparing the pump and administration tubing, if needed.

If using a syringe driver pump, attach the syringe filled with GAMMAGARD LIQUID to the needle set. On a hard surface, gently push down on the plunger to fill (prime) the pump tubing up to the needle hub. This will ensure that no air is left in the tubing and needle .

8. Select the infusion sites- Select the number of infusion sites based on the volume of the total dose. It is recommended that you not inject more than 20 mL for children and 30 mL for adults into each infusion site.

See figure for potential locations of infusion sites (e.g., upper arms, abdomen, thighs, and lower back). Make sure sites are at least 2 inches apart. Avoid bony areas, visible blood vessels, scars and areas of inflammation (irritation) or infection.

Select the number of infusion sites based on the volume of the total dose. It is recommended that you not inject more than 20 mL for children and 30 mL for adults into each infusion site.

9. Clean the infusion site(s)-Clean the infusion site(s) with an alcohol swab. Allow to dry (at least 30 seconds).

Clean the infusion site(s) with an alcohol swab. Allow to dry (at least 30 seconds).

10. Insert the needleRemove the needle cover. Firmly grasp skin and pinch at least one inch of skin between two fingers. Insert needle with a rapid motion straight into the skin at a 90 degree angle. Tape the needle in place. Repeat this step for each infusion site.

Remove the needle cover.  Firmly grasp skin and pinch at least one inch of skin between two fingers.   Insert needle with a rapid motion straight into the skin at a 90 degree angle.  Tape the needle in place. Repeat this step for each infusion site.

11. Check for proper needle placementBefore starting the infusion, check each needle for correct placement by gently pulling back on the attached syringe plunger and looking for any blood in the needle tubing. If you see any blood, remove and throw away the needle into the sharps container. Repeat filling (priming) and needle insertion steps in a different infusion site with a new needle.

Before starting the infusion, check each needle for correct placement by gently pulling back on the attached syringe plunger and looking for any blood in the needle tubing.  If you see any blood, remove and throw away the needle into the sharps container. Repeat filling (priming) and needle insertion steps in a different infusion site with a new needle.

12. Secure the needle to the skin and start infusion- Secure the needle(s) in place by putting a sterile clear bandage over the needle.

Follow the manufacturer's instructions to turn pump on. Check infusion sites occasionally throughout the infusion.

Secure the needle(s) in place by putting a sterile clear bandage over the needle.

13. Remove needle setAfter the infusion is complete, remove the needle set by pulling it straight out. Gently press a small piece of gauze over the needle site and cover with a protective dressing.

Throw away any unused product in the vial and the disposable supplies into the sharps container. Dispose of the sharps container using instructions provided with the container, or contact your healthcare provider.

After the infusion is complete, remove the needle set by pulling it straight out. Gently press a small piece of gauze over the needle site and cover with a protective dressing

14. Record the infusion- Remove the peel-off label from GAMMAGARD LIQUID vial, which has the product lot number and expiration date, and place the label in your treatment diary/log book. Write down the date, time, dose, and any reactions after each infusion.

BAXALTAand GAMMAGARD LIQUIDare trademarks of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc.

Baxalta US Inc.
Lexington, MA 02421 USA
U.S. License No. 2020

17G009-GLD-US



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