Generic Name: immune globulin (Injection route)
Immune globulin intravenous (human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number .
Immune globulin intravenous (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Use caution in patients predisposed to acute renal failure and administer at the minimum concentration available and the minimum rate of infusion practicable in such patients. Higher rates of renal failure were associated with IGIV products containing sucrose. GAMMAGARD S/D and PREVIGEN do not contain sucrose .
Commonly used brand name(s):
Available Dosage Forms:
Immune globulin intravenous (IGIV) belongs to a group of medicines known as immunizing agents. IGIV is used to prevent or treat some illnesses that can occur when your body does not produce enough of its own immunity to prevent those diseases. This includes primary humoral immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).
IGIV should be administered only by or under the supervision of your doctor or other health care professional.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, IGIV is used in certain patients with the following medical conditions:
In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of IGIV in children. However, safety and efficacy have not been established in children with CIDP.
Although appropriate studies on the relationship of age to the effects of IGIV have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of IGIV in the elderly. However, elderly patients are more likely to have age-related kidney disease or to develop blood clotting problems, which may require an adjustment of dose in patients receiving IGIV.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain immune globulin. It may not be specific to Iveegam. Please read with care.
A nurse or other trained health professional will give you this vaccine. This vaccine is given through a needle placed in one of your veins or as a shot into one of your muscles.
Make sure your doctor knows if you are on any special diet, such as a low-sodium or low-sugar diet.
Waiting at least 2 to 3 weeks after receiving live virus vaccines before receiving IGIV, depending on the vaccine received.
Waiting at least 5 to 11 months after receiving IGIV before receiving live virus vaccines, depending on the vaccine to be received.
It is very important that your doctor check you at regular visits for any problems that may be caused by this medicine. Blood and urine tests will be needed to check for unwanted effects.
This vaccine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from vaccines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these vaccines. Although the risk is low, talk with your doctor if you have concerns.
This vaccine may cause a serious type of allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive this vaccine.
Check with your doctor right away if you start to have stiff neck, drowsiness, fever, severe headache, nausea and/or vomiting, painful eye movements, or sensitivity to light. These could be symptoms of a serious condition called aseptic meningitis syndrome (AMS).
This vaccine may cause hemolysis or hemolytic anemia. Tell your doctor right away if you have stomach or back pain, dark urine, decreased urination, increased heart rate, tiredness, or yelloweyes or skin after you receive the vaccine.
Check with your doctor right away if you start having chest pain; difficult, fast, or noisy breathing, sometimes with wheezing; blue lips and fingernails; pale skin; increased sweating; coughing that sometimes produces a pink frothy sputum; shortness of breath; or swelling of the legs and ankles, after you have received this vaccine. These may be symptoms of a serious lung problem.
This vaccine may also cause blood clots, especially in patients with history of blood clotting problems, heart disease, atherosclerosis (narrowing of blood vessels), or blood problems, and those who stay in bed for a long time because of surgery or illness. Check with your doctor right away if you suddenly have chest pain, shortness of breath, severe headache, leg pain, or problems with vision, speech, or walking. .
Check with your doctor right away if you start having red or dark brown urine; lower back or side pain; sudden weight gain; swollen face, arms, or legs; decreased urine output; or any problems with urination after you receive this vaccine. These may be symptoms of a serious kidney problem. .
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:More common
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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