Gamunex

Gamunex approved by the FDA

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Gamunex offers an important life-saving, usually life-long, treatment for thousands of patients with primary immunodeficiency (PI), a group of conditions caused by genetic defects in the immune system. Gamunex also is indicated for the acute and chronic treatment of idiopathic thrombocytopenia purpura (ITP), an autoimmune condition characterized by a low platelet count, leading to occasional life-threatening bleeding episodes. The most common side effects noted during clinical trials included: headache, vomiting, fever, nausea, rash and back pain.

What is Gamunex

Gamunex contains Immune Globulin Intravenous (Human), 10%

Gamunex is used to treat primary humoral immunodeficiency, idiopathic thrombocytopenic purpura and pediatric HIV infection. It is also used in allogeneic bone marrow transplantation.

What does Gamunex do?

Immunoprotection: Gamunex can help prevent infections by playing a protective role in diseases where patients suffer from poorly functioning immune systems.

Immunomodulation: Gamunex can help to raise platelets in the blood to prevent bleeding in patients who have immune systems that are not working well.

Serious Warnings and Precautions

Gamunex, like other products made from human plasma, part of our blood, may contain viruses or other agents that can cause infection and illness. However, the processes used to make Gamunex are specifically designed with the ability to destroy or remove these agents if they are present. You should discuss the risks and benefits of this product with your healthcare provider.

Immune Globulin Intravenous (Human) products have been reported to be associated with kidney failure. You should talk to your healthcare provider if you have some kind of kidney disease, diabetes, are over 65, seriously dehydrated, have other diseases (called sepsis and paraproteinemia), or are taking drugs that you were told could damage your kidneys.

Gamunex and other Immune Globulin Intravenous (Human) products have been reported to be associated with the premature destruction of red blood cells, a condition known as hemolytic anemia. Speak with your healthcare professional if you are taking antibiotics, have received a kidney transplant or blood transfusions, or you have a history of blood disorders.

Before you use Gamunex talk to your doctor or pharmacist if you have or have had any of the following conditions:

• have previously been advised that you have Immunoglobulin A (IgA) deficiency

Dosage

Your doctor will determine the dose(s) of Gamunex that you are to receive. Your doctor will give you Gamunex as an infusion (an injection given slowly in the vein).

Interactions with Gamunex

Drugs that may interact with Gamunex include:

• Antibodies in Gamunex may interfere with the response to live viral vaccines such as measles, mumps and rubella. Therefore, use of such vaccines should be deferred until approximately 6 months after Gamunex administration.
• Gamunex is not compatible with saline. If dilution is required, Gamunex may be diluted with 5% dextrose in water (D5W). No other drug interactions or compatibilities have been evaluated.

Gamunex side effects

Gamunex side effects may include: headache, vomiting, nausea, back pain, generalized weakness, joint pain, itching, dizziness, cough, sore throat. If any of these side effects are severe, talk to doctor or pharmacist.

If you experience any of the following side effects: fever, rash, itching or difficulty breathing then contact your doctor or pharmacist immediately.

Aseptic meningitis and hemolytic anemia have been reported to occur infrequently in association with IGIV treatment. Signs and symptoms of aseptic meningitis may include severe headache and/or a stiff neck. Signs and symptoms of hemolytic anemia may include severe generalized weakness, lightheadedness, dark urine, jaundice and/or pale complexion. Please contact your health care provider if you experience these signs or symptoms.

This is not a complete list of side effects. For any unexpected effects while taking Gamunex, contact your doctor or pharmacist.

How to store Gamunex

Gamunex may be stored for 36 months at 2-8°C (36-46°F. It may be stored at temperatures not to exceed 25°C (77°F) for up to 6 months anytime during the 36 month shelf life, after which the product must be immediately used or discarded. Do not freeze. Do not use after expiration date.

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