Gamunex-C
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Gamunex-C

Important Safety Information

Gamunex-C is an immune globulin injection used for treating primary humoral immunodeficiency (PI) in patients two years of age and older. It’s also used for idiopathic thrombocytopenic purpura (ITP) in adults and children and chronic inflammatory demyelinating polyneuropathy (CIDP) in adult patients.

Gamunex-C could increase the risk of life-threatening blood clots — especially on patients with a history of atherosclerosis, stroke, heart attack, heart failure, or a blood clotting disorder. The risk could also increase in patients who are elderly, use estrogens, experience thickening of the blood, or have been inactive for long periods of time (such as those on bed rest). Tell your doctor immediately if you experience any of the following symptoms:

  • Pain and/or swelling of the arms or legs
  • Warmth over the swollen limbs
  • Discoloration of affected limbs
  • Shortness of breath
  • Chest pain that worsens when taking deep breaths
  • Rapid heart rate
  • Numbness
  • Weakness on one side of the body

Taking Gaumex-C may cause an increase in blood antibody levels. This could cause the blood in antibody tests to produce false results.

What is the most important information I should know about Gamunex-C?

If you have a history of kidney disease, blood infections, high protein content in your blood, are dehydrated, or are also taking other medications that may be harmful to your kidneys, taking any immune globulin medication — such as Glamunex-C — could lead to serious kidney disease or death. Seek emergency medical care immediately if you experience decreased urination, swelling of the legs, shortness of breath, and/or sudden weight gain.

Talk to your doctor about your entire medical history — as well as medications you’re currently taking, regardless of whether they’re prescribed, over-the-counter, herbal, or vitamins. Also mention if you have ever had a serious reaction to medications with human immune globulin or if you have an immunoglobulin A 9IgA0 deficiency. If you are at a higher risk of developing serious kidney disease, your medical provider may suggest taking Gamunex-C at the lowest concentration available, and at a lower infusion rate.

You will have to be monitored closely to check your kidney function and urine output. And, since Gamunex-Ci is made from human blood, it may carry a risk of transmitting viruses and Creutzfeldt-Jakob disease (CJD).

Side Effects of Gamunex-C

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

  • Infusion-site reactions (redness, swelling, and itching)
  • Extreme tiredness
  • Head or neck pain
  • Runny nose
  • Nasal congestion
  • Sneezing
  • Coughing
  • Sputum production
  • Joint pain
  • Loose stools
  • Stomach discomfort
  • Depression
  • Red rash or bumps
  • Itchy, swollen, and/or tender skin with or without blisters
  • Throbbing or pulsing sensation on one side of the head
  • Muscle pain
  • Common cold
  • Flu
  • Fever
  • Sore throat
  • Shivering
  • Discoloration of the skin
  • Back pain

Gamunex-C could also increase the risk of developing aseptic meningitis (brain inflammation). Tell your doctor right away if you experience any of the following symptoms:

  • Severe headache
  • Stiff neck
  • Painful eye movements
  • Fever
  • Sensitivity to light
  • Fatigue
  • Nausea
  • Vomiting

Gamunex-C could also cause patients to develop hemolytic anemia. Tell your doctor immediately if you experience any of the following:

  • Increased heart rate
  • Yellowing of the skin or eyes
  • Dark-colored urine

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

Gamunex-C is an immune globulin injection used for treating primary humoral immunodeficiency (PI) in patients two years of age and older, idiopathic thrombocytopenic purpura (ITP) in adults and children, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adult patients. The recommended dosage will vary depending on the patient’s age and condition being treated. Ensure that patients with renal insufficiency are not volume depleted.

Please refer to the full prescribing information.