Success stories
Grifols wants to help improve the lives of people with primary immunodeficiency (PI)
At Grifols, the makers of GAMUNEX-C, reaching a higher level of patient care is the motivation behind everything we do. Once a year, we sponsor Patient Day at our plant in North Carolina. We are actively involved with advocacy organizations and patient support groups to help improve the lives of people like those you’ll meet here.
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 16, 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 4 years old when she was diagnosed with dysgammaglobulinemia, a PI and 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 individual experiences and results may vary, GAMUNEX-C has made a difference in our lives. Kinsey and Garret went from missing nearly a month of school a year to regular attendance. 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-C has helped us to manage our PI so we can focus on the things we love to do.
*Gail Moore is a paid consultant to Grifols.
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 go away for a month or two, they'd soon return. Needless to say, I was really frustrated.
My doctor agreed my infections were uncommon and, after no luck with antibiotics, referred me to a specialist. The specialist did a sinus scan and he couldn't even see my sinuses. After several unsuccessful rounds of antibiotics, 3 hours of testing, and visits to another specialist and an allergist/immunologist, I was told I wasn't allergic to anything and additional testing was required.
Blood work finally revealed that I had common variable immune deficiency (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 primary immunodeficiency 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 else 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-C, I have been able to continue my career as a professional magician. I love to entertain and make people laugh. Thanks to Grifols, I have also 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-C 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-C and 17 (23%) for Gamimune® N, 10%; (P=0.06)2
Important Safety Information for GAMUNEX-C
GAMUNEX-C, Immune Globulin Injection (Human), 10% Caprylate/ Chromatography Purified, is approved to treat primary humoral immunodeficiency disease (PI). If you have PI, you may take GAMUNEX-C under the skin (subcutaneously) or in a vein (intravenously.) GAMUNEX-C is also approved to treat other patients with idiopathic thrombocytopenic purpura (ITP) and chronic inflammatory demyelinating polyneuropathy (CIDP), but they may only take it intravenously. You may only take GAMUNEX-C by subcutaneous injection if you have PI.
If you take GAMUNEX-C or a similar Immune Globulin (Human) product intravenously, you could experience serious kidney disease and death. You may have symptoms of decreased urination, sudden weight gain, swelling in your legs (edema), or shortness of breath. You are more likely to develop serious kidney disease if you already have a kidney problem, have Type II diabetes (diabetes mellitus), or are older than 65. You are more likely to develop serious kidney disease if you are dehydrated, have blood poisoning (sepsis), have high protein content in your blood, or if you are receiving other medicines that are harmful to your kidneys. Tell your healthcare professional immediately if your medical history is similar to what we describe here, and especially if you start having any of these symptoms while taking GAMUNEX-C.
You are more likely to develop serious kidney disease if you take an Immune Globulin product that contains sugar (sucrose). GAMUNEX-C does not contain sugar. If your situation makes you more likely to experience serious kidney disease, you should take GAMUNEX-C at the lowest concentration available and the slowest infusion rate that is practical.
Do not take GAMUNEX-C if you have an allergy to Immune Globulin. Tell your healthcare professional if you have had a serious reaction to other medicines that contain Immune Globulin. Also tell your healthcare professional if you have Immunoglobulin A (IgA) deficiency.
You may not take GAMUNEX-C subcutaneously if you have CIDP or ITP. If you have ITP and take GAMUNEX-C subcutaneously, you could experience a very serious and life-threatening black and blue wound (hematoma, which is a large pocket of blood within a tissue).
You could possibly experience high protein content in your blood, thickening of your blood (increased serum viscosity), and low levels of sodium in the blood due to Immune Globulin.
You could possibly experience serious and life-threatening blood clots (thromboembolism) due to Immune Globulin. You might have symptoms of chest pain, shortness of breath, leg pain, or swelling of the legs or feet. You would be more likely to experience a blood clot if you have a history of hardening of the arteries (atherosclerosis), stroke, heart attack, or heart failure (low volume of blood pumped by the heart). You may also be more likely to get a blood clot if you are older than 65, if you have a blood clotting disorder, if you are inactive for long periods of time (such as long bed rest for an infirmity), or if you have thickening of your blood.
You could experience other serious and life-threatening problems due to Immune Globulin. You could get a lung problem called TRALI (transfusion-related acute lung Injury), or have fluid on the lungs (pulmonary edema) that is not the result of heart failure. You could get a blood problem called hemolytic anemia (common symptoms include increased heart rate, fatigue, yellow skin or eyes, and dark colored urine). You could get aseptic meningitis, a type of brain inflammation with symptoms of severe headache, stiff neck, fatigue, fever, sensitivity to light, painful eye movements, nausea, and vomiting.
We do not recommend higher doses, such as 1g/kg for 1-2 days, if you have a condition of higher than normal body fluid volumes or where increasing the body fluid volume may be a concern.
Because GAMUNEX-C is made from human blood, we must warn you that you could get a virus disease, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.After you take GAMUNEX-C, you will have a rise in your blood antibody level which could cause some blood antibody tests to give false results.
The most common side effects in a clinical study with PI patients who got subcutaneous injections of GAMUNEX-C were redness, swelling and itching at the infusion site, and headache, fatigue, pain (including pain in the back, joints arms, and legs) and fever. In clinical studies with PI patients who got GAMUNEX-C intravenously, the most common side effects were headache, cough, nausea, inflammation of the throat (which is the most common cause of sore throat), and redness, swelling and itching at the injection site. In a clinical study with CIDP patients who got GAMUNEX-C intravenously, the most common side effects were headache, fever, chills, high blood pressure, rash, nausea, physical weakness, and loss of strength. In clinical trials with ITP patients who got GAMUNEX-C intravenously, the most common side effects were headache, vomiting, fever, nausea, back pain, and rash.
The most serious side effects in clinical studies were a blood clot to the lung (pulmonary embolism) in one patient with a history of this condition (CIDP), a flare-up of an existing type of anemia (autoimmune pure red cell aplasia) in one patient (PI), and heart inflammation (myocarditis) in one patient (ITP).
Please see full Prescribing Information for Gamunex-C.
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.
Copyright © 2012. Grifols Therapeutics Inc., a subsidiary of Grifols Inc. All rights reserved.