octagam^® is contraindicated in individuals with Intolerance to immunoglobulins, especially in immunoglobulin A (IgA) deficiency, when the patient has IgE mediated antibodies to IgA.

Immune Globulin intravenous (Human) (IGIV) 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 preexisting 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 stabilizer accounted for a disproportionate share of the total number.

octagam^® does not contain sucrose.
See PRECAUTIONS and DOSAGE AND ADMINISTRATION sections of the Prescribing Information for important information intended to reduce the risk of acute renal failure.

octagam^® is made from human plasma of US origin. 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. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. 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 Octapharma (Tel. no. 1-866 766 4860). The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient.

octagam^® contains maltose that can be falsely interpreted as glucose by certain blood glucose monitoring / test systems. This has resulted in falsely elevated glucose readings and, consequently, in the inappropriate administration of insulin, resulting in life-threatening hypoglycemia.  Also, cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated glucose readings.  Accordingly, when administering octagam^® or other parenteral maltose- containing products, the measurement of blood glucose must be done with a glucose-specific method. The product information of the blood glucose testing system, including that of the test strips, should be carefully reviewed 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. For further information click here

Adverse Reactions

In general, reported adverse reactions to octagam^® in patients with either congenital or acquired immunodeficiencies are similar in kind and frequency to other IGIV products. Various minor reactions, such as headache, chills, backache, chest pain, fever, allergic reactions, arthralgia, dizziness, changes in blood pressure, cutaneous reactions and/or nausea and vomiting may occasionally occur. Reactions to intravenous immunoglobulins tend to be related to the rate of infusion. Cases of reversible aseptic meningitis and migraine and isolated cases of reversible hemolytic anemia and reversible increases in liver function tests have been observed with octagam^®.

Immediate anaphylactic and hypersensitivity reactions are a remote possibility. Epinephrine should be available for treatment of any acute anaphylactoid reaction. (See Warnings).

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