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Important Safety Information for GAMUNEX-C

GAMUNEX-C, Immune Globulin Injection (Human), 10% Caprylate/ Chromatography Purified, is approved to treat primary humoral immunodeficiency disease (PI). If you have PI, you may take GAMUNEX-C under the skin (subcutaneously) or in a vein (intravenously.) GAMUNEX-C is also approved to treat other patients with idiopathic thrombocytopenic purpura (ITP) and chronic inflammatory demyelinating polyneuropathy (CIDP), but they may only take it intravenously. You may only take GAMUNEX-C by subcutaneous injection if you have PI.

If you take GAMUNEX-C or a similar Immune Globulin (Human) product intravenously, you could experience serious kidney disease and death. You may have symptoms of decreased urination, sudden weight gain, swelling in your legs (edema), or shortness of breath. You are more likely to develop serious kidney disease if you already have a kidney problem, have Type II diabetes (diabetes mellitus), or are older than 65. You are more likely to develop serious kidney disease if you are dehydrated, have blood poisoning (sepsis), have high protein content in your blood, or if you are receiving other medicines that are harmful to your kidneys. Tell your healthcare professional immediately if your medical history is similar to what we describe here, and especially if you start having any of these symptoms while taking GAMUNEX-C.

You are more likely to develop serious kidney disease if you take an Immune Globulin product that contains sugar (sucrose). GAMUNEX-C does not contain sugar. If your situation makes you more likely to experience serious kidney disease, you should take GAMUNEX-C at the lowest concentration available and the slowest infusion rate that is practical.

Do not take GAMUNEX-C if you have an allergy to Immune Globulin. Tell your healthcare professional if you have had a serious reaction to other medicines that contain Immune Globulin. Also tell your healthcare professional if you have Immunoglobulin A (IgA) deficiency.

You may not take GAMUNEX-C subcutaneously if you have CIDP or ITP. If you have ITP and take GAMUNEX-C subcutaneously, you could experience a very serious and life-threatening black and blue wound (hematoma, which is a large pocket of blood within a tissue).

You could possibly experience high protein content in your blood, thickening of your blood (increased serum viscosity), and low levels of sodium in the blood due to Immune Globulin.

You could possibly experience serious and life-threatening blood clots (thromboembolism) due to Immune Globulin. You might have symptoms of chest pain, shortness of breath, leg pain, or swelling of the legs or feet. You would be more likely to experience a blood clot if you have a history of hardening of the arteries (atherosclerosis), stroke, heart attack, or heart failure (low volume of blood pumped by the heart). You may also be more likely to get a blood clot if you are older than 65, if you have a blood clotting disorder, if you are inactive for long periods of time (such as long bed rest for an infirmity), or if you have thickening of your blood.

You could experience other serious and life-threatening problems due to Immune Globulin. You could get a lung problem called TRALI (transfusion-related acute lung Injury), or have fluid on the lungs (pulmonary edema) that is not the result of heart failure. You could get a blood problem called hemolytic anemia (common symptoms include increased heart rate, fatigue, yellow skin or eyes, and dark colored urine). You could get aseptic meningitis, a type of brain inflammation with symptoms of severe headache, stiff neck, fatigue, fever, sensitivity to light, painful eye movements, nausea, and vomiting.

We do not recommend higher doses, such as 1g/kg for 1-2 days, if you have a condition of higher than normal body fluid volumes or where increasing the body fluid volume may be a concern.

After you take GAMUNEX-C, you will have a rise in your blood antibody level which could cause some blood antibody tests to give false results.

The most common side effects in a clinical study with PI patients who got subcutaneous injections of GAMUNEX-C were redness, swelling and itching at the infusion site, and headache, fatigue, pain (including pain in the back, joints arms, and legs) and fever. In clinical studies with PI patients who got GAMUNEX-C intravenously, the most common side effects were headache, cough, nausea, inflammation of the throat (which is the most common cause of sore throat), and redness, swelling and itching at the injection site. In a clinical study with CIDP patients who got GAMUNEX-C intravenously, the most common side effects were headache, fever, chills, high blood pressure, rash, nausea, physical weakness, and loss of strength. In clinical trials with ITP patients who got GAMUNEX-C intravenously, the most common side effects were headache, vomiting, fever, nausea, back pain, and rash.

The most serious side effects in clinical studies were a blood clot to the lung (pulmonary embolism) in one patient with a history of this condition (CIDP), a flare-up of an existing type of anemia (autoimmune pure red cell aplasia) in one patient (PI), and heart inflammation (myocarditis) in one patient (ITP).

Please see full Prescribing Information for Gamunex-C.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.