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In 1979, the U.S. Food and Drug Administration (FDA) began "...
Gammagard Consumer (continued)
Flushing, headache, dizziness, chills, muscle cramps, back/joint pain, fever, nausea, or vomiting may occur. Tell your doctor or other health care professional immediately if any of these effects occur, persist, or worsen. Pain, redness, and swelling at the injection site may also occur. If these effects continue or become bothersome, tell your doctor.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, fainting, fast/irregular heartbeat, unusual tiredness.
Rarely, this product may contain substances that could cause infections because it is made from human blood. Though the risk is very low due to careful screening of blood donors, discuss the risks and benefits with your doctor. Tell your doctor immediately if you develop any signs of infection such as persistent sore throat/fever, yellowing eyes/skin, or dark urine.
Treatment with this medication may rarely cause a serious inflammation of the brain (aseptic meningitis syndrome) several hours to 2 days after your treatment. Get medical help right away if you develop severe headache, stiff neck, drowsiness, high fever, sensitivity to light, eye pain, or severe nausea/vomiting.
Lung problems may rarely occur 1 to 6 hours after your treatment. You will be monitored closely for any lung problems after your treatment.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Gammagard (immune globulin) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: See also Warning section.
Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other immunoglobulin products (such as CMV IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain immune system problems (immunoglobulin A deficiency, monoclonal gammopathies), diabetes, high blood pressure, high blood fats (triglycerides), migraines, current blood infection (sepsis), kidney disease, severe loss of body fluids (dehydration).
Some immune globulin products should not be used in people who have a certain metabolic hereditary problem (such as fructose/sucrose intolerance). Ask your doctor for more details.
Some immune globulin products are made with maltose. This substance can cause false high blood sugar levels when your blood sugar is normal or even low. If you have diabetes, check with your pharmacist whether the product you are using contains maltose and whether your blood sugar testing supplies will work with this product. Rarely, serious problems have occurred when too much insulin was given because of false high sugar readings or when low blood sugar went untreated.
Tell your doctor of any recent or planned immunizations/vaccinations. This medication may prevent a good response to certain live viral vaccines (such as measles, mumps, rubella, varicella). If you have recently received any of these vaccines, your doctor may have you tested for a response or have you vaccinated again later. If you plan on getting any of these vaccines, your doctor will instruct you about the best time to receive them so you get a good response.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the effects on the kidneys.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.
Additional Gammagard Information
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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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