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Gamimune N (Immune Globulin) - Warnings and Precautions

 
 



WARNINGS

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death.24 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. See PRECAUTIONS and DOSAGE AND ADMINISTRATION sections for important information intended to reduce the risk of acute renal failure.

Gamimune® N, 10% is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Bayer Corporation [1-800-288-8371].

The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient.

Immune Globulin Intravenous (Human), 10% -- Gamimune® N, 10% should be administered only intravenously as the intramuscular and subcutaneous routes have not been evaluated.

Immune Globulin Intravenous (Human), 5% -- Gamimune® N, 5% has, on rare occasions, caused a precipitous fall in blood pressure and a clinical picture of anaphylaxis, even when the patient is not known to be sensitive to immune globulin preparations. These reactions may be related to the rate of infusion. Accordingly, the infusion rate given under DOSAGE AND ADMINISTRATION for Gamimune N, 10% should be closely followed, at least until the physician has had sufficient experience with a given patient. The patient's vital signs should be monitored continuously and careful observation made for any symptoms throughout the entire infusion. Epinephrine should be available for the treatment of an acute anaphylactic reaction.

PRECAUTIONS

GENERAL

Any vial that has been entered should be used promptly. Partially used vials should be discarded. Do not use if turbid. Solution which has been frozen should not be used.

An aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with Immune Globulin Intravenous (Human) treatment. The syndrome usually begins within several hours to two days following Immune Globulin Intravenous (Human) treatment. It is characterized by symptoms and signs including severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, and nausea and vomiting. Cerebrospinal fluid (CSF) studies are frequently positive with pleocytosis up to several thousand cells per mm3, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dL. Patients exhibiting such symptoms and signs should receive a thorough neurological examination, including CSF studies, to rule out other causes of meningitis. AMS may occur more frequently in association with high dose (2 g/kg) Immune Globulin Intravenous (Human) treatment. Discontinuation of Immune Globulin Intravenous (Human) treatment has resulted in remission of AMS within several days without sequelae. 25-28

Assure that patients are not volume depleted prior to the initiation of the infusion of IGIV.

Periodic monitoring of renal function tests and urine output is particularly important in patients judged to have a potential increased risk for developing acute renal failure. Renal function, including measurement of blood urea nitrogen (BUN)/serum creatinine, should be assessed prior to the initial infusion of Gamimune N, 10% and again at appropriate intervals thereafter. If renal function deteriorates, discontinuation of the product should be considered. For patients judged to be at risk for developing renal dysfunction, it may be prudent to reduce the amount of product infused per unit time by infusing Gamimune N, 10% at a rate less than 8 mg IG/kg/min (0.08 mL/kg/min).

INFORMATION FOR PATIENTS

Patients should be instructed to immediately report symptoms of decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath (which may suggest kidney damage) to their physicians.

DRUG INTERACTIONS

Antibodies in Gamimune N, 10% 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 Gamimune N, 10% administration.

Please see DOSAGE AND ADMINISTRATION for other drug interactions.

PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with Gamimune N, 10%. It is not known whether Gamimune N, 10% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Gamimune N, 10% should be given to a pregnant woman only if clearly needed.

Page last updated: 2006-05-25

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