GAMMAGARD LIQUID is administered:

  • Through an IV catheter into a vein in the hand or arm
  • At one infusion site
  • Administered in a hospital, physician’s office, infusion center, or at home1
  • Every 3 or 4 weeks2
  • Infusion times will vary depending on dosing and patient tolerability2

Before the infusion

  • If this is your first intravenous administration, your insurance company will be contacted for prior authorization
  • Drink plenty of water 24 hours prior to infusion3
  • Bring a book or other materials if you’d like to keep yourself occupied during the infusion
  • Review and sign the consent form stating that you understand risk factors
  • The IV catheter will be placed in the vein

During the infusion

  • Relax and sit comfortably
  • Inform the nurse if you experience any discomfort
  • Vital signs will be monitored3
  • Some common side effects may occur2 (please see front side of this insert)
  • If you experience any serious side effects, stop the infusion and contact your doctor or emergency services immediately

After the infusion

  • Stay well hydrated 24 hours after your infusion3
  • Report any side effects to your doctor or nurse3
  • Record infusion in your infusion logbook3

Infusion to be administered by a healthcare professional at a hospital, physician office, infusion center, or at home.

GAMMAGARD LIQUID is also used to treat adult patients with Multifocal Motor Neuropathy (MMN), a rare disease that causes muscle weakness that worsens over time.

Stop the infusion immediately and contact your healthcare provider or call emergency services if you have any of the following:

Symptoms of thrombosis (blood clots) that may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration (redness) or lump in 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.

Symptoms of a kidney problem that may include: reduced urination, sudden weight gain or swelling in your legs.

Symptoms of a serious allergic reaction that may include: hives, skin rash, itching, swelling in the mouth or throat, trouble breathing, wheezing, fainting or dizziness.

Other serious symptoms including: bad headache with nausea, vomiting, stiff neck, drowsiness, fever, sensitivity to light, painful eye movements; blurred vision; brown or red urine, fast heart rate, yellow skin or eyes; trouble breathing, blue lips or extremities; fever over 100°F.

Tell your healthcare provider if you have a history of thrombosis (blood clots), thrombotic events, poor kidney function or kidney failure.

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 deficiency.

GAMMAGARD LIQUID is made from human blood. It may contain infectious agents that can cause disease e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD), and theoretically, the Creutzfeldt-Jakob disease agent. Patients should report any symptoms that concern them which might be caused by virus infections.

GAMMAGARD LIQUID can make vaccines (e.g., measles, mumps, rubella, or chicken pox vaccines) not work as well. It may also affect your blood test results. Before you get any vaccines or have your blood tested, tell your healthcare provider that you take GAMMAGARD LIQUID.

The following is a list of common side effects seen in clinical trials of GAMMAGARD LIQUID:

MMN (IV administration): Headache, chest discomfort, muscle spasms, muscular weakness, nausea, sore throat, ear pain, and pain in extremity.

Although it is possible to receive IV infusions at home, they are more often given in a hospital or infusion center by a nurse. Whenever giving yourself treatments at home, you should have another responsible person present to help treat side effects or get help should a serious adverse reaction occur. Ask your healthcare provider whether you should have rescue medications, such as antihistamines or epinephrine.

Please see the full Prescribing Information, including the Patient Product Information.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

You may report side effects to Shire Drug Safety at 1-800-999-1785 or drugsafety.us@baxalta.com.

If you have a medical question regarding the use of GAMMAGARD LIQUID, please ask your healthcare provider.

References:

  1. Definition of intravenous (IV). MedicineNet.com. 2012; http://www.medterms.com/script/main/art.asp?articlekey=4021. Accessed July 25, 2012.
  2. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% [package insert]. Westlake Village, CA: Baxter Healthcare Corporation.
  3. Vlam L, Van der Pol WL, Cats EA, et al. Multifocal motor neuropathy: diagnosis, pathogenesis and treatment strategies. Nat Rev Neurol. 2012;8:48-58.
  4. Blaese RM, ed. IDF Guide for Nurses on Immune Globulin therapy for Primary Immunodeficiency Diseases. Towson, MD: Immune Deficiency Foundation.
  5. Policies and Procedures for Infusion Nursing. Norwood, MA: Infusion Nurses Society;2006.
  6. Data on file. Baxter Healthcare Corporation. 2011.

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GAMMAGARD LIQUID

was studied in
the largest clinical
trial in MMN
to
date.6
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