"The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVII] deficiency).
Gamunex Patient Information Including Side Effects
Brand Names: Carimune, Flebogamma, Gammagard (obsolete), Gammagard S/D, Gammaplex, Gammar-P I.V., Gamunex, Polygam S/D, Privigen, Sandoglobulin
Generic Name: immune globulin (intravenous) (IGIV) (Pronunciation: im MYOON GLOB yoo lin)
- What is immune globulin intravenous (IVIG) (Gamunex)?
- What are the possible side effects of immune globulin?
- What is the most important information I should know about immune globulin?
- What should I discuss with my health care provider before using immune globulin?
- How is immune globulin intravenous given?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while using immune globulin?
- What other drugs will affect immune globulin?
- Where can I get more information?
What is immune globulin intravenous (IVIG) (Gamunex)?
Immune globulin intravenous is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.
Immune globulin is used to treat primary immune deficiency, and to reduce the risk of infection in individuals with poorly functioning immune systems such as those with chronic lymphocytic leukemia (CLL). IGIV is also used to increase platelets (blood clotting cells) in people with idiopathic thrombocytopenic purpura (ITP) and to prevent aneurysm caused by a weakening of the main artery in the heart associated with Kawasaki syndrome.
Immune globulin is also used to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a debilitating nerve disorder that causes muscle weakness and can affect daily activities.
Immune globulin may also be used for purposes not listed in this medication guide.
What are the possible side effects of immune globulin?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- urinating less than usual or not at all;
- drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
- swelling, weight gain, feeling short of breath;
- wheezing, chest tightness;
- feeling like you might pass out;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
- black or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- red or pink urine;
- sudden numbness or weakness, sudden severe headache, confusion, problems with vision or speech;
- chest pain, sudden cough, wheezing, rapid breathing, warmth or swelling in one or both legs;
- fever with headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions); or
- pale or yellowed skin, dark colored urine, fever, confusion or weakness.
Less serious side effects may include:
- mild headache;
- tired feeling;
- back pain, muscle cramps;
- minor chest pain; or
- flushing (warmth, redness, or tingly feeling).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the Gamunex (immune globulin intravenous (human) 10%) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about immune globulin?
Immune globulin can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before using immune globulin, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.
Before using immune globulin intravenous, tell your doctor if you have kidney disease, diabetes (especially if you use insulin), a history of stroke or blood clot, heart disease, high blood pressure, a condition called paraproteinemia, or if you are over 65 years old.
To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your kidney function may also need to be tested. Visit your doctor regularly.
This medication can cause unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using immune globulin.
Immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.
Additional Gamunex Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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