• What is GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10%?

GAMMAGARD LIQUID is the first and only FDA-approved treatment for adult patients with Multifocal Motor Neuropathy (MMN). In randomized, withdrawal, double-blind placebo controlled clinical study in 44 adult patients with MMN, GAMMAGARD LIQUID was shown to improve muscle strength and reduce disability in adult patients with MMN.1

GAMMAGARD LIQUID is made from human plasma. It may carry a risk of transmitting viruses and theoretically vCJD agent. Patients should report to their healthcare provider any symptoms that concern them which might be caused by virus infections.

  • How is GAMMAGARD LIQUID administered?

GAMMAGARD LIQUID is administered into a vein, also called intravenously (IV). Most often, IVIG infusions are given every 2 to 4 weeks for MMN. Infusion time will vary depending on infusion rate, dose administered, and patient tolerability. GAMMAGARD LIQUID infusions can be administered at a hospital, physician office, infusion center, or at home by a healthcare professional.1,2

  • What are the risks associated with infusions of GAMMAGARD LIQUID?

During the infusion of GAMMAGARD LIQUID, look out for the first signs of the following common side effects:

  • Headache
  • Migraine
  • Fever
  • Fatigue
  • Itching
  • Rash/Hives
  • Cough
  • Chest pain/tightness
  • Chills/Shaking chills
  • Dizziness
  • Nausea/Vomiting
  • Faster Heart Rate
  • Upper Abdominal Pain
  • Increased Blood Pressure
  • Muscle cramps
  • 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, 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 the physician's information leaflet. Tell your healthcare provider about any side effect that bothers you or that does not go away.

  • Who should not be treated with 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.

  • Are there any resources available for patients receiving IgG infusions?

Shire offers a number of educational resources and services that may be helpful to adults living with MMN and their caregivers.

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. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% [package insert]. Westlake Village, CA: Baxter Healthcare Corporation.
  2. 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.

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