Page 27 - InsideOut Magazine

For the treatment of adults with
chronic immune thrombocytopenic purpura (ITP)
ImmImumneunGeloGbluolbinulin IntrInavtreanvoeunso(uHsu(mHuamn)a1n0)%10% LiqLuiqduPidrePpraerpaatiroantion
Preserving Immunoglobulin Integrity
Manufactured Using Well-Controlled Processing Steps Designed to Be Gentle and to Preserve the Structural and Functional Integrity of Its Immunoglobulin G (IgG)1-3
■ Formulated to Mitigate Tolerability Issues in Adult Patients With Chronic ITP4 ■ Provides a Rapid Increase in Platelets With Sustained Control of Bleeding4
■ Offers a High Rate of Infusion Without Compromising Tolerability4
■ Convenient, Ready-to-Use, Easy-to-Store, Liquid Formulation*
Octagam 10% Liquid—The Art of Manufacturing IGIV
WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE
Please see accompanying Highlights of Full Prescribing Information for additional important information.
■ Thrombosis may occur with immune globulin intravenous (IGIV) products, including Octagam 10%. 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 nephropathy, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Octagam 10% does not contain sucrose.
■ For patients at risk of thrombosis, renal dysfunction or renal failure, administer Octagam 10% at the minimum 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.
Important Safety Information
Octagam 10% is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. Octagam 10% contains trace amounts of IgA (average 106 μg/mL in a 10% solution). It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity. The most serious drug-related adverse event reported with Octagam 10% treatment was a headache (0.9% of subjects). The most common drug-related adverse reactions reported in >5% of the subjects during a clinical trial were headache, fever, and increased heart rate.
www.octagamus.net
©2015. Octapharma USA, Inc. All rights reserved. Print Date 2/15. GAM10-002-PAD
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