Gammagard
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Gammagard

Important Safety Information

Gammagard Liquid (immune globulin infusion) is used to treat patients with primary immunodeficiency (PI) who are two years of age and older. It is also used to treat adults with multifocal motor neuropathy (MMN). It contains immunoglobulin (Ig) antibodies, which protect the body against infections. These antibodies are collected from healthy individuals and transferred to PI patients. Since Gammagard Liquid is made from human plasma, it may carry a risk of transmitting viruses.

Some patients have experienced serious health issues after undergoing treatment with Gammagard Liquid. The most common ones include:

  • Decreased kidney function or kidney failure
  • Blood clots in the heart, brain, or lungs
  • Dark-colored urine
  • Swelling
  • Fatigue
  • Breathing difficulties
  • Severe headaches
  • Drowsiness
  • Fever
  • Painful eye movements
  • Nausea and/or vomiting

Prior to starting treatment, talk with your doctor about your entire medical history. Also mention all medications you’re currently taking — regardless of whether they’re prescribed, over-the-counter, herbal supplements, or vitamins.

What is the most important information I should know about Gammagard Liquid?

Gammagard liquid could cause severe allergic reactions that result in breathing difficulties and skin rashes. Do not use this medication if you have had a severe allergic reaction to immune globulin or other blood products, or if you have selective or severe immunoglobulin A (IgA) deficiency.

Gammagard Liquid can make vaccines not work efficiently. Prior to getting any vaccination — especially if it’s for measles, mumps, rubella, or chickenpox — let your medical provider know you’re undergoing treatment with Gammagard Liquid.

It is unknown whether Gammagard Liquid would have an effect on a fetus. Tell your doctor if you’re pregnant, there’s a possibility you may be pregnant, or if you’re planning on conceiving. There is insufficient data regarding its effect on babies, so tell your doctor if you’re currently breastfeeding or are planning on doing so.

Side Effects of Gammagard Liquid

As with all prescription medications, using Gammagard Liquid carries a risk of side effects. These could range in severity from person to person. The most common ones include:

  • Headaches
  • Muscle spasms
  • Muscular weakness
  • Chest discomfort
  • Sore throat
  • Ear pain
  • Pain in the hands or feet
  • Nausea

Some individuals experience more serious side effects that could be life-threatening. Tell your doctor immediately and discontinue use if you experience any of the listed below — as they could be indications of kidney, liver, heart, or lung problems, infection, or blood clots.

  • Sensitivity to light
  • Fever higher than 100F
  • Chest pain
  • Blue lips or extremities
  • Chest pain
  • Brown urine
  • Fast heart rate
  • Yellowing of the skin and/or eyes
  • Pain, swelling, warmth, redness, or lumps on legs and/or arms
  • Severe headaches with nausea and vomiting
  • Stiff neck
  • Hives, swelling of the mouth or throat, itching, breathing difficulties, dizziness, wheezing, and/or fainting.

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

Gammagard Liquid is used to treat patients with primary immunodeficiency (PI) who are two years of age and older. It is also used to treat adults with multifocal motor neuropathy (MMN). The dosage will vary depending on the type of condition being treated and the age of the patient.

Please refer to the full prescribing information.