Eider Carmona has Primary Immunodeficiency (PI). He uses Baxter's KIOVIG Human Normal Immunoglobulin (marketed as GAMMAGARD LIQUID Immune Globulin Intravenous in the United States) to bolster his immune system.
When Eider Carmona was growing up in the small town of El Retiro, about 30 minutes outside the city of Medellin in western Colombia, he was constantly getting sick. His maladies included ear infections, pneumonia, colds and other conditions that wouldn't necessarily be serious if not for the fact that they were coming in waves.
This went on for two years, resulting in multiple hospitalizations and many doses of antibiotics. But a short time later, Eider always found himself back at the hospital with some other problem. Finally, at age two, Eider was given a blood test that diagnosed his condition as Primary Immunodeficiency (PI). His immune system was not producing enough antibodies to fight infection. PI is actually a group of under-diagnosed diseases characterized by one or more components of the immune system not functioning properly.
Today, thanks to medical advances, many forms of PI can be treated through regular infusions of immunoglobulin, or antibodies, which circulate through the blood to protect the body from disease. Eider uses Baxter's KIOVIG Human Normal Immunoglobulin (marketed as GAMMAGARD LIQUID Immune Globulin Intravenous in the United States) - a highly purified formulation of antibodies derived from human plasma - to bolster his immune system.
Experts estimate that 90 percent of children who see a doctor due to frequent infections have allergies or other illnesses, making PI difficult to diagnose. Baxter works with physicians and patient advocate groups, such as the Jeffrey Modell Foundation, to increase awareness and diagnosis of the disease worldwide.
"I feel like I have a normal life," says Eider, now an active 15-year-old high school sophomore. "Most of my friends at school aren't even aware that I have this condition."
Today, Eider is an outstanding student, plays volleyball and, like most teenagers, enjoys video games. He still lives in El Retiro with his parents and two siblings - a 17-year-old sister and 11-year-old brother - and receives monthly intravenous (IV) infusions of KIOVIG at a hospital in Medellin. "The nurses administer my therapy," he says.
Detailed Important Risk Information for GAMMAGARD LIQUID
Use of Immune Globulin Intravenous (Human) (IGIV) products, particularly those containing sucrose, has been reported to be associated with renal dysfunction, acute renal failure, osmotic nephropathy, and death. Patients at risk of acute renal failure include those with any degree of pre-existing renal insufficiency, diabetes mellitus, advanced age (above 65 years of age), volume depletion, sepsis, paraproteinemia, or those receiving known nephrotoxic drugs. GAMMAGARD LIQUID does not contain sucrose.
For patients at risk of renal dysfunction or failure, administer GAMMAGARD LIQUID at the minimum infusion rate practicable.
GAMMAGARD LIQUID is contraindicated in patients who have had a history of anaphylactic or severe systemic reactions to the administration of human immunoglobulin.
GAMMAGARD LIQUID is contraindicated in IgA deficient patients with antibodies to IgA and a history of hypersensitivity.
Severe hypersensitivity reactions may occur, even in patients who had tolerated previous treatment with human normal immunoglobulin.
Assure that patients are not volume depleted prior to the initiation of infusion of GAMMAGARD LIQUID. In patients who are at risk of developing renal dysfunction, because of pre-existing renal insufficiency or predisposition to acute renal failure administer GAMMAGARD LIQUID at the minimum rate of infusion practicable. If renal function deteriorates, consider discontinuation of GAMMAGARD LIQUID.
Hyperproteinemia, increased serum viscosity and hyponatremia may occur in patients receiving GAMMAGARD LIQUID.
Thromboembolic events have been reported in association with IGIV (including GAMMAGARD LIQUID). Patients at risk for thromboembolic events include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, obesity, diabetes mellitus, acquired or inherited thrombophilic disorder, a history of vascular disease, or a history of a previous thrombotic or thromboembolic event.
Aseptic Meningitis Syndrome (AMS) has been reported to occur with GAMMAGARD LIQUID administration. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.
GAMMAGARD LIQUID contains blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells (RBC) with immunoglobulin, causing a positive direct antiglobulin reaction and, hemolysis. Acute intravascular hemolysis has been reported, and delayed hemolytic anemia can develop due to enhanced RBC sequestration.
Non-cardiogenic pulmonary edema (TRALI) has been reported to occur following GAMMAGARD LIQUID administration.
GAMMAGARD LIQUID 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.
The most common adverse reactions (reported in > 5% of clinical trial subjects) occurring during or within 72 hours of the end of an infusion were headache, fever, fatigue, vomiting, chills, infusion site events, nausea, dizziness, pain in extremity, diarrhea, cough, pruritus and pharyngeal pain.
Please see the Full Prescribing Information for GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] for full prescribing details.