Ready-to-Use Vial Supply and Storage | Octagam 5%

Available in a range of convenient, ready-to-use vials, with a choice of filling sizes to meet individual needs

Octagam 5% liquid is supplied in 1.0 g, 2.5 g, 5 g, or 10 g single-use bottles

octagam 5% 20ml 1g box vial

1.0 g (20 mL)

NDC Number
68982-840-01

octagam 5% 50ml 2.5g box vial

2.5 g (50 mL)

NDC Number
68982-840-02

octagam 5% 100ml_5g box vial

5 g (100 mL)

NDC Number
68982-840-03

octagam 5% 200ml 10g box vial

10 g (200 mL)

NDC Number
68982-840-04

Storage

Octagam 5% liquid may be stored for 24 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture

Do not freeze. Do not use frozen product

Do not use after expiration date

Any unused product or waste material should be disposed of in accordance with local requirements

Octagam 5% liquid is not supplied with an infusion set
If a filtered infusion set is used (not mandatory), filter size must be 0.2 – 200 microns

Reference:

Octagam 5% Full Prescribing Information. Paramus, NJ: Octapharma; rev April 2022.

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

FOR U.S. HEALTHCARE PROFESSIONALS ONLY

The information on this website has been specifically created for U.S. healthcare professionals (HCPs)