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The PROOF is in the patient experience
Gail Moore with her children Kinsey and Garret

Gail Moore* with her children, Kinsey and Garret
Lakeland, Florida

As a child, I grew up in a household centered around sickness. My mother constantly battled illnesses that physicians could not explain. I now know she lived most of her life with primary immunodeficiency (PI) disease without ever being diagnosed.

When I became a mother, I started to recognize similar symptoms in both of my children as well as myself. My daughter, Kinsey, and my son, Garret, were very susceptible to infections. Kinsey, now 15, experienced bloodstream infections, and Garret, now 14, suffered from recurrent sinus and lung infections. I always felt physically fatigued and seemed to catch everything that was going around. While my friends and my children’s friends were healthy and strong, we were always at the doctor’s office. I knew something was wrong.

Kinsey was 3 years old when she was diagnosed with dysgammaglobulinemia, a PI and a rare blood disorder. I was diagnosed 5 years ago with common variable immune deficiency (CVID), and Garret was just diagnosed last year with dysgammaglobulinemia.

While not all individuals may experience the same benefits, GAMUNEX, an IGIV therapy, has made a difference in our lives. Kinsey and Garret went from missing nearly a month of school a year to regular attendance at school. Garret is an avid guitarist and basketball player, while Kinsey enjoys gymnastics and a rigorous dance schedule. She has even traveled to France to study abroad!

As an advocate for the PI community, I travel all over the country to talk to groups about the disease and the importance of an open and trusting patient-doctor relationship.

GAMUNEX has helped my family to manage our PI so we can focus on the things we love to do.

*Gail Moore is a paid consultant to Talecris.

Manny Sperling

Manny Sperling
Cleveland, Ohio

As a child, I was healthy, allergy-free, and had boundless energy. Years later, I suddenly began to acquire chronic sinus infections. I knew something wasn’t right. My doctor prescribed various antibiotics, and while the infections might have gone away for a month or two, they'd soon return. Needless to say, I was really frustrated.

My doctor agreed that my infections were uncommon and, after no luck with antibiotics, referred me to a specialist. The specialist did a sinus scan, but he couldn’t even see my sinuses. After several unsuccessful rounds of antibiotics, 3 hours of testing, and visits to a specialist and an allergist/immunologist, I was told I wasn’t allergic to anything and additional testing would be required.

Blood work finally revealed that I had common variable immunodeficiency (CVID), the most prevalent primary immunodeficiency (PI) disorder. My condition made me more susceptible to infections, but my doctors quickly reassured me that regular IGIV therapy would help protect me. What a relief! In less than a month, I went in for my first IGIV infusion. My doctors were fantastic—they explained everything to me and walked me through the entire process.

Since my diagnosis, my family and I have attended PI patient events such as picnics and “patient days,” so we could meet other patients and learn as much as possible about the disease. No one in my family has PI, so it was important to me that everyone in my family understood what was happening and felt comfortable with my need to take IGIV therapy.

Because of GAMUNEX, I have been able to continue my career as a professional magician. I love to entertain and to make people laugh. Thanks to Talecris, I also have had the opportunity to perform at Immune Deficiency Foundation summer picnics and at the Triangle United Way's 2007 "Old Reliable Run." I thoroughly enjoyed entertaining at these events because I got to interact with doctors and other patients.

In patients with PI, GAMUNEX demonstrated proven efficacy:

  • No validated cases of pneumonia1
  • Significantly fewer cases of validated and clinically defined acute sinusitis (P=0.012)1
  • The number of patients with at least one validated infection during the 9-month study period was 9 (12%) for GAMUNEX and 17 (23%) for Gamimune® N, 10%; (P=0.06)2

Important Safety Information for GAMUNEX

Gamunex, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, is indicated for the treatment of primary humoral immunodeficiency disease (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Gamunex does not contain sucrose. Glycine, a natural amino acid, is used as a stabilizer.

Gamunex is contraindicated in individuals with acute severe hypersensitivity reactions to Immune Globulin (Human). It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity.

There have been reports of noncardiogenic pulmonary edema [Transfusion-Related Lung Injury (TRALI)], hemolytic anemia, and aseptic meningitis in patients administered with IGIV.

Thrombotic events have been reported in association with IGIV. Patients at risk for thrombotic events may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy.

Gamunex is made from human plasma. Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

In clinical studies, the most common adverse reactions with Gamunex were headache, fever, chills, hypertension, rash, nausea, and asthenia (in CIDP); headache, cough, injection site reaction, nausea, pharyngitis, and urticaria (in PI); and headache, vomiting, fever, nausea, back pain, and rash (in ITP). The most serious adverse reactions were pulmonary embolism (PE) in one subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in one subject (in PI), and myocarditis in one subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP).

Please see accompanying GAMUNEX full Prescribing Information for complete prescribing details.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

References:

  1. Roifman CM, Schroeder H, Berger M, et al, and the IGIV-C in PID Study Group. Comparison of the efficacy of IGIV-C, 10% (caprylate/chromatography) and IGIV-SD, 10% as replacement therapy in primary immune deficiency: a randomized double-blind trial. Int Immunopharmacol. 2003;3:1325-1333.

  2. GAMUNEX [package insert]. Research Triangle Park, NC: Talecris Biotherapeutics, Inc.; 2008.