Protection Against Infection for Patients with PI | Octagam 5%

Octagam 5% provides protection against serious infection for patients with PI^1-3

In an open-label, multicenter study, 46 patients with PI received octagam 5% in individualized doses of 300-600 mg/kg every 3 or 4 weeks for 12 months
Primary efficacy endpoint: number of episodes of serious infections per patient per year.
Secondary efficacy endpoint: number of other infections documented by radiograph or fever during the study period

0.1 Serious Infections, Infographic

ZERO Other Infections, Infographic

Serious infections are defined as pneumonia, bactermia, sepsis, osteomyelitis, septic arthritis, visceral abscesses, and bacterial or viral meningitis
Contains a broad spectrum of IgG antibodies to protect against infections
Serious infection rate of only 0.1/patient/year in pivotal trial
IgG levels after 6 months of therapy still achieved >85% of baseline
(levels after first infusion) for both 3- and 4-week administration schedules
Mean 40.7-day IgG half-life in patients

Low incidence of lost daily time over 12 months²^*

Days Missed Infographic

Visit to Dr-ER Infographic

Days in Hospital Infographic

Secondary efficacy endpoint: number of days of work/school missed; number and days of hospitalizations; number of visits to physicians for acute problems and/or visits to hospital emergency rooms

Total days or visits for reported events across all 46 patients was 349

^*Days or visits per subject per year are estimates

References:

Octapharma. Data on file.
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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