Safety and Tolerability for Patients with PI | Octagam 5%

The most common adverse reactions observed during treatment with octagam 5% during clinical trial
(> 5%) were headache and nausea^1,2

Adverse reactions observed with octagam 5%¹
	No. of subjects (%)	No. of infusions (%)
Total	46 (100)	654 (100)
Headache	7 (15)	18 (3)
Nausea	3 (7)	4 (0.6)

Clinical trial database includes a multicenter study in 46 children and adults with PI (mean age, 31.5 years). Subjects participated in the study for a mean of 346 days and received 300-450 mg/kg every 21 days or 400-600 mg/kg every 28 days. Infusions were initiated at a rate of 30 mg/kg/hr for first 30 minutes, and, if tolerated, could be advanced to a maximum tolerated rate not exceeding 200 mg/kg/hr. Over half of subjects were male (n=28; 61%); more than half were on the 28-day schedule (n=27; 59%)

Pre-medications were used in 165/654 infusions (25%) and in 14/46 patients (30%)
Infusions were slowed or interrupted in 9/489 infusions (1.8%) without pre-medication and in 10/165 infusions (6%) with pre-medication
Among 12 serious adverse events were reported in 6 patients, 11 were unrelated to octagam 5%
One serious adverse event (Calculus renal NOS) was reported just before the next infusion, and was not temporarily related to the previous infusion

No subject withdrew from the study due to an adverse event or adverse reaction

Reference:

Octagam 5% Full Prescribing Information. Paramus, NJ: Octapharma; rev April 2022.
Ochs HD, Pinciaro PJ. The octagam® Study Group. Octagam® 5%, an intravenous IgG product, is efficacious and well tolerated in subjects with primary immunodeficiency diseases. J Clin Immunol. 2004;24(3):309-314.

Indications and Important Safety Information for octagam^® (Immune Globulin Intravenous [Human] 5% Liquid Preparation)

WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE
Please see Full Prescribing Information for complete boxed warning and other important information.

Indications and Important Safety Information for octagam^® (Immune Globulin Intravenous [Human] 5% Liquid Preparation)

WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE
Please see Full Prescribing Information for complete boxed warning and other important information.

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 vascular catheters, hyperviscosity, and cardiovascular risk factors.
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with IgIV products, including octagam^® 5% liquid. Renal dysfunction and acute renal failure occur more commonly with IgIV products 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.

Indications and Use
octagam 5% is an immune globulin intravenous 5% liquid indicated for treatment of primary humoral immunodeficiency (PI), such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Important Safety Information

Contraindications
octagam^® 5% liquid is contraindicated in patients who have acute severe hypersensitivity reactions to human immunoglobulin; in IgA-deficient patients with antibodies against IgA and history of hypersensitivity; in patients with acute hypersensitivity reaction to corn. octagam^® 5% liquid contains maltose, a disaccharide which is derived from corn. Patients known to have corn allergies should avoid using octagam^® 5% liquid.

Warnings and Precautions
Monitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at risk of developing acute renal failure.

Falsely elevated blood glucose readings may occur during and after the infusion of octagam 5% liquid with some glucometer and test strip systems.

Hyperproteinemia, increased serum viscosity, and hyponatremia occur in patients receiving lglV therapy.

Thrombosis may occur following treatment with immune globulin products, including octagam 5% liquid. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Aseptic meningitis syndrome has been reported with octagam 5% liquid and other lglV treatments, especially with high doses or rapid infusion.

Hemolytic anemia can develop subsequent to lglV therapy due to enhanced RBC sequestration.

lglV recipients should be monitored for pulmonary adverse reactions such as transfusion-related acute lung injury (TRALI).

The product is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent.

Adverse Events
The most serious adverse reactions observed with octagam 5% liquid treatment have been immediate anaphylactic reactions, aseptic meningitis, and hemolytic

The most common adverse reactions with an incidence of >5% during a clinical trial were headache and nausea.

Please see octagam 5%^® full Prescribing Information

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