As a global healthcare company, BioTherapeutics is aimed on saving and sustaining the lives of people with rare conditions. Over the last two decades, we've committed ourselves to providing therapies for patients across a broad range of treatment needs, such as:
Primary immunodeficiency (PI), including common variable immune deficiency (cvid) and X-linked agammaglobulinemia (XLA) |
Alpha-1 antitrypsin deficiency (AATD)Please see Important Risk Information |
Immune thrombocytopenic purpura (ITP)Please see Important Risk Information |
Severe congenital Protein C deficiency (SCPCD)Please see Important Risk Information |
Treatment of hypovolemiaPlease see Important Risk Information |
We share the understanding of healthcare professionals, patients and caregivers that the challenges of rare conditions do not end with therapy. That's why BioTherapeutics also offers insurance assistance, patient assistance programs that provide continued access to therapy such as GARDian, and partnerships with advocacy organizations like the Immune Deficiency Foundation (IDF), Jeffrey Modell Foundation (JMF), and Alpha-1 Foundation. We're committed to building a network of programs and support for people challenged by rare conditions.
BioTherapeutics, believes in giving people with rare conditions more ordinary days, so they can spend time on the things that make life extraordinary.
Baxter's Government Affairs and Public Policy (GAPP) teams work with lawmakers, governments, and policymakers around the globe to support patient access to Baxter's therapies, increase understanding of the benefits of those therapies, and address barriers to care and explore possible solutions. This includes working directly with governments to improve the regulatory environment and reimbursement structure for Baxter's therapies. Baxter also collaborates with, clinicians, non-governmental organizations (NGOs), and patient groups on other coordinated efforts to increase access to care for millions of patients around the world.
US GAPP partners with our key stakeholders to educate US public policymakers on the need for screening and testing of diseases such as PIs and AATD, ensure reimbursement policies allow for access to plasma-based therapies in the appropriate therapeutic setting, and protect patients' ability to work with their physician in selecting the optimal therapy for their medical needs.
GAMMAGARD LIQUID is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
GAMMAGARD LIQUID is contraindicated in patients with known anaphylactic or severe hypersensitivity responses to Immune Globulin (Human). Patients with severe selective IgA deficiency (IgA < 0.05 g/L) may develop anti-IgA antibodies that can result in a severe anaphylactic reaction.
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.
Glycine, an amino acid, is used as a stabilizer. GAMMAGARD LIQUID does not contain sucrose.
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.
Components used in the packaging of this product are latex-free.
Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity, hypercoagulable disorders, and prolonged periods of immobilization.
IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis.
Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.
Various mild and moderate reactions, such as headache, fever, fatigue, chills, flushing, dizziness, urticaria, wheezing or chest tightness, nausea, vomiting, rigors, back pain, chest pain, muscle cramps, and changes in blood pressure may occur with infusions of Immune Globulin Intravenous (Human).
A sterile, nonpyrogenic preparation of albumin in a single-dosage
Sterile, stable, lyophilized preparation of purified alpha 1-proteinase inhibitor
