IG Living August-September 2010
Total Page:16
File Type:pdf, Size:1020Kb
IMMUNE GLOBULIN COMMUNITY www.IGLiving.com August-September 20010 1 0 for Exercise Options for CIDP Patients A Review of Medicare and Disability Programs How Patients Can Connect With a Community WHAT DOES YOUR GUT SAY? TREATING IBS AND IBD — PAGE 42 HIGHLIGHTS OF PRESCRIBING INFORMATION CONTRAINDICATIONS ADVERSE REACTIONS These highlights do not include all the information • Anaphylactic or severe systemic reactions to Most common adverse reactions with an incidence needed to use octagam®, Immune Globulin human immunoglobulin of > 5% during a clinical trial were headache and Intravenous (Human), safely and effectively. • IgA deficient patients with antibodies against nausea. To report SUSPECTED ADVERSE REACTIONS, IgA and a history of hypersensitivity contact Octapharma at 1-866-766-4860 or ® • Patients with acute hypersensitivity reaction FDA at 1-800-FDA-1088 or www.fda.gov/medwatch OCTAGAM to corn Immune Globulin Intravenous DRUG INTERACTIONS WARNINGS AND PRECAUTIONS • The passive transfer of antibodies may confound (Human) 5% Liquid Preparation • IgA deficient patients with antibodies against the results of serological testing. IgA are at greater risk of developing severe • The passive transfer of antibodies may interfere Initial U.S. Approval: 2004 hypersensitivity and anaphylactic reactions. with the response to live viral vaccines. RECENT MAJOR CHANGES Epinephrine should be available immediately to Warnings and Precautions - Hyperproteinemia 8/2008 treat any acute severe hypersensitivity reactions. USE IN SPECIFIC POPULATIONS • Monitor renal function, including blood urea • Pregnancy: no human or animal data. WARNING: ACUTE RENAL DYSFUNCTION nitrogen and serum creatinine, and urine Use only if clearly needed. and RENAL FAILURE output in patients at risk of developing acute • In patients over age 65 or in any person at risk See full prescribing information for renal failure. of developing renal insufficiency, do not exceed complete boxed warning. • Falsely elevated blood glucose readings may the recommended dose, and infuse octagam® ® • Renal dysfunction, acute renal failure, occur during and after the infusion of octagam 5% liquid at the minimum infusion rate osmotic nephrosis, and death may be 5% liquid with some glucometer and test practicable. associated with Immune Globulin strip systems. Intravenous (Human) (IGIV) products in • Hyperproteinemia, increased serum viscosity HOW SUPPLIED predisposed patients. and hyponatremia occur in patients receiving 1g 2.5g 5g 10g 25g IGIV therapy. Size 20ml 50ml 100ml 200ml 500ml • Renal dysfunction and acute renal failure • Thrombotic events have occurred in patients occur more commonly in patients NDC# 67467-843-01 67467-843-02 67467-843-03 67467-843-04 67467-843-05 receiving IGIV therapy. Monitor patients with NDC# 68209-843-01 68209-843-02 68209-843-03 68209-843-04 receiving IGIV products containing known risk factors for thrombotic events; ® sucrose. octagam 5% liquid does not consider baseline assessment of blood viscosity contain sucrose. for those at risk of hyperviscosity. Manufactured by: • Administer IGIV products at the minimum • Aseptic Meningitis Syndrome has been reported OCTAPHARMA Pharmazeutika concentration available and the minimum with octagam® 5% liquid and other IGIV Produktionsges.m.b.H. infusion rate practicable. treatments, especially with high doses or Oberlaaer Strasse 235 rapid infusion. A-1100 Vienna, Austria • Hemolytic anemia can develop subsequent to INDICATIONS AND USAGE IGIV therapy due to enhanced RBC ® Distributed by: •octagam is an immune globulin intravenous sequestration. Octapharma USA, Inc. (human), 5% liquid, indicated for treatment of • IGIV recipients should be monitored for 121 River Street, Suite 1201 primary humoral immunodeficiency (PI). pulmonary adverse reactions (TRALI). • The product is made from human plasma Hoboken, NJ 07030 DOSAGE FORMS AND STRENGTHS and may contain infectious agents, e.g. viruses Tel: 201-604-1130 ® octagam 5% liquid is supplied in and, theoretically, the Creutzfeldt-Jakob Fax: 201-604-1131 1.0 g, 2.5 g, 5 g , 10 g or 25 g single-use bottles disease agent. www.octapharma.com/usa ©2009 Octapharma USA Inc. All rights reserved. 4/2009 A clear solution IMPORTANT SAFETY INFORMATION octagam® is contraindicated in individuals with intolerance to immunoglobulins, especially in immunoglobulin A (IgA) deficiency, when the patient has IgE mediated antibodies to IgA. Immune Globulin intravenous (Human) (IGIV) Immune globulin intravenous (human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic 5% liquid preparation nephrosis, and death. Other possible side effects with octagam® include: aseptic meningitis, If you’ve been looking for an IGIV solution, hemolysis, transfusion-related acute lung disease ® (TRALI) and thrombotic events. take a look at . Immune Globulin Intravenous (Human) products ® have been reported to be associated with various has earned its reputation for safety minor reactions, such as headache, chills, backache, and documented clinical efficacy1. chest pain, fever, allergic reactions, arthralgia, dizziness, changes in blood pressure, cutaneous To ensure tolerability 1, ® is carefully reactions and/or nausea and vomiting. Cases of reversible aseptic meningitis and migraine and produced to retain as many of the isolated cases of reversible hemolytic anemia and characteristics of natural plasma as possible. reversible increases in liver function tests have been observed with octagam®. Immediate anaphylactic With over 40 million grams of ® and hypersensitivity reactions are a remote infused world-wide, Octapharma is committed possibility. As with all medicines made from human to helping PI patients live more active and plasma, the risk of spreading infectious agents, healthier lives. including viruses, cannot be completely eliminated. Some types of blood glucose testing systems Ask your health care provider today about ® falsely interpret the maltose contained in octagam ® as glucose. This has resulted in falsely elevated and find out if it could be the right glucose readings and, consequently, in the solution for you. inappropriate administration of insulin, resulting in life-threatening hypoglycemia. For clinical or technical questions, please call See brief summary of PI on facing page. our Medical Affairs team at 888-429-4535. 1Ochs HD, Pinciaro PJ and 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 August-September 20010 1 0 Contents Features Up Front Preventive Care 16 for Patients with 5 Contributing Experts Chronic Illness Writers in this issue By Ronale Tucker Rhodes, MS, 6 Editorial and Kris McFalls Unveiling the Invisible Disease By Ronale Tucker Rhodes, MS Exercise for CIDP 7 Faces of IG Living 22 By Matthew David Hansen, From our Facebook page DPT, MPT, BSPTS Did You Know? A Review of Medicare 29 and Disability Programs 8 Immunology 101 Humoral Components: By Jennifer Kester The Role of the IgG Antibody By Terry O. Harville, MD, PhD 10 Industry News Research, science, product Sources and insurance updates 42 Product Directory 14 Product Safety News What Does Your Gut Say? Infusion Pumps: By Kris McFalls New FDA Initiative Launched to Reduce Device Risks 44 Book Corner By Ronale Tucker Rhodes, MS New and useful reading 45 Resource Center Lifestyle Community foundations, associations, forums and Let’s Talk! 32 other resources By Trudie Mitschang Ask Kris 34 About IG Living By Kris McFalls IG Living is the only magazine dedicated to bringing comprehensive healthcare information, immune globulin information, community and reimbursement news, and resources for successful living directly to immune globulin consumers and Building Lifelong Relationships their healthcare providers. 35 IG Living, (ISSN 1949-4548), published bimonthly, is a community service provided by FFF Enterprises, 41093 County By Ever Fecske Center Drive, Temecula, CA 92591, (800) 843-7477 x1362, fax (951) 699-9655. Subscriptions to IG Living are free, and readers may subscribe at www.IGLiving.com or by calling (800) 843-7477 x1351. Not Age Appropriate 36 The opinions expressed in IG Living are those of the authors alone and do not represent the opinions, policies or positions By Cheryl L. Haggard of FFF Enterprises, the Board of Directors, the IG Living Advisory Board or editorial staff. This material is provided for general information only. FFF Enterprises does not give medical advice or engage in the practice of medicine. FFF Enterprises under no circumstances recommends any particular treatment for any individual and in all cases recommends 38 Transitions: that individuals consult with a physician before pursuing any course of treatment. Treating the Child Within All manuscripts should be submitted in MS Word, in Arial font. Manuscripts should be between 650 and 1,300 words in length, with unjustified margins and without any other formatting. Submission guidelines are available for download By Ronale Tucker Rhodes, MS from the Contact Us page on www.IGLiving.com. Email manuscripts to [email protected]. IG Living retains the right to edit submissions. The contents of each submission and their accuracy are the responsibility of the author(s) and must be Patient-to-Patient: original work that has not been, nor will be, published elsewhere, without the written permission of IG Living. A copyright 40 agreement attesting to this and transferring