Octagam 5% Generic Name & Formulations
Octagam 5% liquid may be stored for 36 months at +2° C to + 8° C (36° F to 46° F) from the date of manufacture. Within the first 24 months of this shelf life, the product may be stored at ≤ +25° C (77° F). After storage at ≤ +25° C (77° F) the product must be used or discarded.
Do not use after the expiration date.
Do not freeze.
Do not use product that has been frozen.
Octagam 5% Indications
Octagam 5% Dosage and Administration
Adults and Children
Octagam 5% Contraindications
Octagam 5% Boxed Warnings
Thrombosis, Renal Dysfunction and Acute Renal Failure
- Thrombosis may occur with immune globulin intravenous (IGIV) 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.
- Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients who receive IGIV products, including Octagam 5% liquid. Patients predisposed to renal dysfunction include those with a degree of pre-existing renal insufficiency, diabetes mellitus, age >65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV product containing sucrose. Octagam 5% liquid does not contain sucrose.
- For patients at risk of thrombosis, renal dysfunction or acute renal failure, 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.
Octagam 5% Warnings/Precautions
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 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, 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.
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.
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.
No human data are available to indicate the presence or absence of drug-associated risk. Animal reproduction studies have not been conducted with Octagam 5% liquid. It is not known whether Octagam 5% liquid can cause fetal harm when administered to a pregnant woman. Immunoglobulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation.
Nursing Mother Considerations
No human data are available to assess the presence or absence of Octagam 5% in human milk, the effects of Octagam 5% on the breastfed child, and the effects of Octagam 5% on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Octagam 5% liquid and any potential adverse effects on the breastfed infant from Octagam 5% liquid or from the underlying maternal condition. Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate.
Octagam 5% liquid was evaluated in 11 pediatric subjects (age range 6-16 years). There were no obvious differences observed between adults and pediatric subjects with respect to pharmacokinetics, efficacy and safety. No pediatric specific dose requirements were necessary to achieve the desired serum IgG levels.
Patients >65 years of age may be at increased risk for developing certain adverse reactions such as thromboembolic events and acute renal failure.
Clinical studies of Octagam 5% liquid did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Octagam 5% Pharmacokinetics
Studies show that the apparent half-life of Octagam 5% liquid is ~40 days in immunodeficient patients.
Octagam 5% Interactions
It is recommended that Octagam 5% liquid be administered separately from other drugs or medications which the patient may be receiving.
Antibodies in Octagam 5% liquid may interfere with the response to live viral vaccines, such as measles, mumps, and rubella. Inform the immunizing physician of recent therapy with Octagam 5% liquid, so that administration of live viral vaccines, if indicated, can be appropriately delayed 3 or more months from the time of IGIV administration.
Octagam 5% Adverse Reactions
Octagam 5% Clinical Trials
In an open-label, multicenter study, 46 patients (including 10 patients between the ages of 6 and 12, and one 15 years old) with primary humoral immunodeficiency (PI) received Octagam 5% liquid in individualized doses of 300-600 mg/kg every 3 or 4 weeks for 12 months. More than half of the patients (n=27; 59%) were on a 4-week treatment schedule, the remainder received the study drug every 3 weeks. Six patients discontinued the study prematurely.
The study examined the number of episodes of serious infections (pneumonia, bacteremia, sepsis, osteomyelitis, septic arthritis, visceral abscesses, bacterial or viral meningitis) per patient in a year, as well as the number of other infections, number of school or work days missed, the number and length of hospitalizations, and the number of visits to a physician or the emergency department for acute problems. The rate of serious infections per patient per year was 0.1 (5 infections over 43.5 patient-years). There were no other infections documented by positive radiograph or fever during the study period. For summary of secondary efficacy data, see full labeling.
Octagam 5% Note
Octagam 5% Patient Counseling
Inform patients of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. Instruct patients that they should contact their physicians immediately if such symptoms occur.
Instruct patients to immediately report the following signs and symptoms to their health care provider:
- symptoms of thrombosis which may include pain and/or swelling of an arm or leg with warmth over the affected area; discoloration of an arm or leg; unexplained shortness of breath; chest pain or discomfort that worsens on deep breathing; unexplained rapid pulse; numbness or weakness on one side of the body.
- decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath.
- severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting.
- fatigue, increased heart rate, yellowing of the skin or eyes, and dark-colored urine. trouble breathing, chest pain, blue lips or extremities, lightheadedness and fever These may be signs for TRALI which typically occurs within 1 to 6 hours following transfusion.
Inform patients that Octagam 5% liquid is made from human plasma and may contain infectious agents that can cause disease (eg, viruses, and, theoretically, the CJD agent). Inform patients that the risk Octagam 5% liquid may transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing the donated plasma for certain virus infections and by inactivating and/or removing certain viruses during manufacturing. Nevertheless, instruct patients that they should report any symptoms that concern them.
Inform patients that administration of IgG may interfere with the response to live viral vaccines such as measles, mumps and rubella. Inform patients to notify their immunizing physician of therapy with Octagam 5% liquid.