Octagam 5%

Hypersensitivity Reactions 

Severe hypersensitivity reactions may occur. In case of hypersensitivity, discontinue Octagam 5% liquid infusion immediately and institute appropriate treatment. Always have medications such as epinephrine available for immediate treatment of acute severe hypersensitivity reactions. IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactoid reactions when administered Octagam 5% liquid. Patients known to have corn allergies should avoid using Octagam 5% liquid.

Renal Failure 

Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur upon use of IGIV products in predisposed patients. Assure that patients are not volume depleted prior to the initiation of the infusion of Octagam 5% liquid. Assess renal function, including a measurement of blood urea nitrogen (BUN)/serum creatinine, prior to the initial infusion of Octagam 5% liquid and again at appropriate intervals thereafter. It is particularly important to do periodic monitoring of renal function tests and urine output in patients judged to have a potential increased risk of developing acute renal failure. Consider discontinuation of the infusion if renal function deteriorates. For patients judged to be at risk for developing renal dysfunction and/or at risk of developing thrombotic events (such as those with diabetes mellitus or hypovolemia, those who are obese, those who use concomitant nephrotoxic medicinal products, or those who are >65 years of age), administer Octagam 5% liquid at the minimum rate of infusion practicable (less than 0.07 mL/kg/min (3.3 mg/kg/min).

Blood Glucose Monitoring 

Some types of blood glucose testing systems (for example, those based on the glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dyeoxidoreductase methods) falsely interpret the maltose contained in Octagam 5% liquid as glucose. This has resulted in falsely elevated glucose readings and, consequently, in the inappropriate administration of insulin, resulting in life-threatening hypoglycemia. Further, cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated glucose readings. Therefore, always use a glucose-specific method for the measurement of blood glucose, when administering Octagam 5% liquid. Carefully review the product information of the blood glucose testing system, including that of the test strips, to determine if the system is appropriate for use with maltose-containing parenteral products. If any uncertainty exists, contact the manufacturer of the testing system to determine if the system is appropriate for use with maltose-containing parenteral products.

Hyperproteinemia 

Hyperproteinemia, increased serum viscosity and hyponatremia may occur in patients receiving IGIV therapy, including Octagam 5% liquid. The hyponatremia is likely to be a pseudohyponatremia as demonstrated by a decreased calculated serum osmolality or elevated osmolar gap. Distinguishing true hyponatremia from pseudohyponatremia is clinically critical, as treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity and a disposition to thromboembolic events.

Thrombotic events 

Thrombosis may occur following treatment with immune globulin products, including Octagam 5% liquid. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. For patients at risk of thrombosis, administer Octagam 5% liquid at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Aseptic meningitis syndrome 

Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV treatment, including Octagam 5% liquid. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae. The syndrome usually begins within several hours to two days following IGIV treatment and rapid infusion. It is characterized by symptoms and signs including severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea and vomiting. Cerebrospinal fluid (CSF) studies are frequently positive with pleocytosis up to several thousand cells per cu mm, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dl. Conduct a thorough neurological examination on patients exhibiting such signs and symptoms, including CSF studies, to rule out other causes of meningitis. AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV. It appears that patients with a history of migraine may be more susceptible.

Hemolysis 

Octagam 5% liquid may contain blood group antibodies, which may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis. Delayed hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration and acute hemolysis, consistent with intravascular hemolysis, has been reported. Cases of severe hemolysis-related renal dysfunction/failure or disseminated intravascular coagulation have occurred following infusion of IGIV. The following risk factors may be associated with the development of hemolysis following IGIV administration: high doses (eg, ≥ 2 g/kg), given either as a single administration or divided over several days, and non-O blood group. Other individual patient factors, such as an underlying inflammatory state (as may be reflected by, for example, elevated C-reactive protein or erythrocyte sedimentation rate), have been hypothesized to increase the risk of hemolysis following administration of IGIV but their role is uncertain. Hemolysis has been reported following administration of IGIV for a variety of indications. Closely monitor patients for clinical signs and symptoms of hemolysis, particularly patients with risk factors noted above. Consider appropriate laboratory testing in higher risk patients, including measurement of hemoglobin or hematocrit prior to infusion and within approximately 36-96 hours post infusion. If clinical signs and symptoms of hemolysis or a significant drop in hemoglobin or hematocrit have been observed, perform confirmatory laboratory testing. If transfusion is indicated for patients who develop hemolysis with clinically compromising anemia after receiving IGIV, perform adequate cross-matching to avoid exacerbating on-going hemolysis.

Transfusion-Related Acute Lung Injury (TRALI) 

Noncardiogenic pulmonary edema [Transfusion-Related Acute Lung Injury (TRALI)] may occur in patients treated with IGIV products, including Octagam 5% liquid. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever and typically occurs within 1-6 hours after transfusion. Monitor patients for pulmonary adverse reactions. If TRALI is suspected, perform appropriate tests for the presence of antineutrophil antibodies in both the product and patient serum. Patients with TRALI may be managed using oxygen therapy with adequate ventilatory support.

Transmissible Infectious Agents 

Because Octagam 5% liquid is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk of infectious agent transmission has been reduced by screening plasma donors for prior exposure to certain viruses, testing for the presence of certain current virus infections, and including virus inactivation/removal steps in the manufacturing process for Octagam 5% liquid.