The Gammaplex Copay Program is designed for patients who are having difficulty paying their out-of-pocket costs for their IVIG prescription. Patient eligibility: • Patients must express a need for financial assistance or difficulty paying copay • Patients must have coverage under a private US insurance plan.
Full Answer
How do I request co-pay assistance for gammaplex?
If your patient’s primary payer drug claim is billed under medical benefits, you can request Gammaplex 5% (immune globulin intravenous [human], 5%) or Gammaplex 10% (immune globulin intravenous [human], 10%) co-pay assistance using this portal.
What is gammaplex 10% used for?
Gammaplex 10% (immune globulin intravenous [human], 10% liquid) is indicated for replacement therapy in primary humoral immunodeficiency (PI) in adults and pediatric patients two years of age and older.
Is gammaplex 10% safe for TRALI?
If TRALI is suspected, test product and patient’s serum for anti-neutrophil antibodies. Gammaplex 10% is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent. No cases of transmission of viral diseases or CJD have been associated with the use of Gammaplex 10%.
What are the contraindications for the use of gammaplex 10%?
Gammaplex 10% is contraindicated in patients who have had a history of anaphylactic or severe systemic reactions to human immune globulin and IgA deficient patients with antibodies to IgA and a history of hypersensitivity.
What does Gammaplex treat?
Gammaplex (immune globulin intravenous [human], 5% liquid) is an immune globulin intravenous (human) 5% liquid indicated for the treatment of primary humoral immunodeficiency (PI) in adults and pediatric patients two years of age and older and for the treatment of chronic immune thrombocytopenic purpura (ITP).
How long does it take to infuse Gammaplex?
Initially, the rate of infusion should be 0.5 mg/kg/min for 15 minutes and increased gradually every 15 minutes to 4 mg/kg/min as a maintenance infusion rate until the total dose is administered.
Who manufactures Gammaplex?
ELSTREE, UK AND DURHAM, NC - Bio Products Laboratory Limited (BPL), a leading manufacturer of plasma-derived protein therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved Gammaplex® 10% (immune globulin intravenous [human], 10% liquid) for the treatment of primary immunodeficiency (PI ...
What is a Gammaplex injection?
Gammaplex is an Immune Globulin Intravenous (Human), 5% Liquid indicated for replacement therapy in primary humoral immunodeficiency (PI) in adults and pediatric patients two years of age and older.
What is IVIG infusion?
WHAT IS IVIG? Intravenous immune globulin ("IVIG") is a product made up of antibodies that can be given intravenously (through a vein). Antibodies are proteins that your body makes to help you fight infections.
What is gamunex C infusion?
Gamunex-C is an immune globulin injection used for treating primary humoral immunodeficiency (PI) in patients two years of age and older, idiopathic thrombocytopenic purpura (ITP) in adults and children, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adult patients.
What is Gammaplex made of?
Gammaplex is made from human plasma and may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease agent (5.9). Passive transfer of antibodies may confound serologic testing (5.10).
What companies make IVIG?
Pharmaceutical companies that manufacture different brands of IVIG are:Biotest AG.Octapharma AG.Grifols, S.A.LFB Biotechnologies.Takeda Pharmaceutical Company, Limited (Shire PLC)Bio Products Laboratory, Ltd.Baxter International, Inc.ADMA Biologics, Inc.More items...
Who owns gammagard?
Takeda manufactures Cuvitru, Gammagard Liquid, Gammagard S/D, and HyQvia.
Do they still give gamma globulin shots?
Use as medical treatment Such injections are less common in modern medical practice than they were previously, and injections of gamma globulin previously recommended for travelers have largely been replaced by the use of hepatitis A vaccine.
How do you give immunoglobulin injection?
How is it taken? IVIg is given through a drip into a vein, this is known as intravenous infusion. It is sometimes given as an injection into a muscle if you're only taking it to increase your immunoglobulin levels following other treatments. You'll need to go to a hospital each time you have the treatment.
How is immune globulin made?
Immune globulin is prepared from pooled plasma from 3000-10,000 healthy blood donors. In some instances, blood from as many as 100,000 donors is used. The entire array of variable (antigen-binding) regions of antibodies in normal serum is contained in IVIG.
What are Gammagard infusions?
GAMMAGARD LIQUID is a ready-to-use liquid medicine that is given in a vein (intravenously) or under the skin (subcutaneously) to treat primary immunodeficiency (PI) in people 2 years and older and given in a vein to treat multifocal motor neuropathy (MMN) in adults. Important Safety Information.
Does gamunex need to be filtered?
Filtering is not necessary, but if used, a pore size of 15 microns or larger will be less likely to slow infusion, especially with higher solution concentrations; 0.2 micron antibacterial filters may be used. -Administer by a separate infusion line. Do not mix with other medications or fluids.
Does gammagard need a filter?
Do not mix with other medications or fluids; do not mix with other IVIG products. -Use of an in-line filter is optional. A pore size of at least 15 microns may not slow the infusion rate. -Begin the infusion rate at 0.01 mL/kg/minute and increase to 0.02 mL/kg/minute after 15 to 30 minutes.
Who manufactures Panzyga?
PANZYGA - Pfizer NDCs U.S. Physician Prescribing Information.
What is gammaplex 10%?
Gammaplex 10% (immune globulin intravenous [human], 10% liquid) is indicated for replacement therapy in primary humoral immunodeficiency (PI) in adults and pediatric patients two years of age and older. This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
What are the adverse reactions of Gammaplex?
The most common adverse reactions in adult subjects receiving Gammaplex 10% in the PI clinical trial were headache, migraine, and pyrexia. The most common adverse reaction in pediatric subjects receiving Gammaplex 10% in the PI clinical trial was headache. There were no serious product-related adverse reactions observed in adult or pediatric clinical trial subjects with PI. The safety of Gammaplex 10% has not been established in patients with ITP. However, the safety profile for Gammaplex 5% has been studied in subjects with ITP, and it is anticipated that the safety profile for both formulations are comparable for ITP patients. The most common adverse reactions in adult subjects receiving Gammaplex 5% in the chronic ITP clinical trial were headache, vomiting, nausea, pyrexia, arthralgia, and dehydration. Serious adverse reactions observed in clinical trial subjects with ITP were headache, vomiting and dehydration.
Where to report side effects of prescription drugs?
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.
Does Gammaplex 10% contain sucrose?
Gammaplex 10% does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer Gammaplex 10% at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk ...
Is Gammaplex a registered trademark?
Gammaplex ® is a registered trademark of Bio Products Laboratory Limited.
Is Gammaplex 5% a hereditary intolerance?
Gammaplex 5% is contraindicated in patients who have had a history of anaphylactic or severe systemic reactions to human immune globulin; a hereditary intolerance to fructose and in infants and neonates for whom sucrose or fructose tolerance has not been established; and IgA deficient patients with antibodies to IgA and a history of hypersensitivity.
Is gammaplex 10% a virus?
Gammaplex 10% is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent. No cases of transmission of viral diseases or CJD have been associated with the use of Gammaplex 10%.
What is gammaplex used for?
Gammaplex (immune globulin intravenous) is a member of the immune globulins drug class and is commonly used for Idiopathic Thrombocytopenic Purpura, and Primary Immunodeficiency Syndrome.
How much does Gammaplex cost?
The cost for Gammaplex intravenous solution 5% is around $940 for a supply of 100 milliliters, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.
How much does a free drug card save?
The free Drugs.com Discount Card works like a coupon and can save you up to 80% or more off the cost of prescription medicines, over-the-counter drugs and pet prescriptions.
Does Gammaplex have coupons?
Gammaplex Coupons and Rebates. Gammaplex offers may be in the form of a printable coupon, rebate, savings card, trial offer, or free samples. Some offers may be printed right from a website, others require registration, completing a questionnaire, or obtaining a sample from the doctor's office. There are currently no Manufacturer Promotions ...
What is gammaplex 10%?
Gammaplex 10% (immune globulin intravenous [human], 10% liquid) is indicated for replacement therapy in primary humoral immunodeficiency (PI) in adults and pediatric patients two years of age and older. This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
What are the adverse reactions of Gammaplex?
The most common adverse reactions in adult subjects receiving Gammaplex 10% in the PI clinical trial were headache, migraine, and pyrexia. The most common adverse reaction in pediatric subjects receiving Gammaplex 10% in the PI clinical trial was headache. There were no serious product-related adverse reactions observed in adult or pediatric clinical trial subjects with PI. The safety of Gammaplex 10% has not been established in patients with ITP. However, the safety profile for Gammaplex 5% has been studied in subjects with ITP, and it is anticipated that the safety profile for both formulations are comparable for ITP patients. The most common adverse reactions in adult subjects receiving Gammaplex 5% in the chronic ITP clinical trial were headache, vomiting, nausea, pyrexia, arthralgia, and dehydration. Serious adverse reactions observed in clinical trial subjects with ITP were headache, vomiting and dehydration.
Where to report side effects of prescription drugs?
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.
Is gammaplex a registered trademark?
Gammaplex®is a registered trademark of Bio Products Laboratory Limited.
Is gammaplex 10% a virus?
Gammaplex 10% is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent. No cases of transmission of viral diseases or CJD have been associated with the use of Gammaplex 10%.
Can AMS be associated with IGIV?
AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV. Hemolysis and hemolytic anemia can develop subsequent to IGIV treatments. Patient risk factors that may be associated with development of hemolysis include high dose (>2 g/kg), non-O blood group, and underlying inflammatory state.
Does Gammaplex 10% contain sucrose?
Gammaplex 10% does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer Gammaplex 10% at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration.
What is gammaplex 10%?
Gammaplex ® 10% (immune globulin intravenous [human], 10% liquid) is indicated for replacement therapy in primary humoral immunodeficiency (PI) in adults. This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
What are the eligibility guidelines for co-pay assistance?
Patient must express financial need. Patient must have coverage for the product under a private US insurance plan. Not valid for prescriptions eligible for reimbursement by any federal or state healthcare program, such as Medicare, Medicare advantage plans, Medicaid, PCIP, Champus, TriCare, ...
Is gammaplex 10% a virus?
Gammaplex 10% is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent. No cases of transmission of viral diseases or CJD have been associated with the use of Gammaplex 10%.
What is gammaplex 10%?
Gammaplex 10% is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) in adults. Thrombosis may occur with immune globulin products, including Gammaplex 10%.
Is gammaplex 10% a virus?
Gammaplex 10% is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent. No cases of transmission of viral diseases or CJD have been associated with the use of Gammaplex 10%.
Does Gammaplex 10% contain sucrose?
Gammaplex 10% does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer Gammaplex 10% at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration.
Can AMS be associated with IGIV?
AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV. Hemolysis and hemolytic anemia can develop subsequent to IGIV treatments. Patient risk factors that may be associated with development of hemolysis include high dose (>2 g/kg), non-O blood group, and underlying inflammatory state.
What is gammaplex 10%?
Gammaplex 10% (immune globulin intravenous [human], 10% liquid) is indicated for replacement therapy in primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
How long does gammaplex last?
Each vial has a label with a peel-off strip showing the product name and batch number.When stored between 2 °C [35.6 °F] and 25 °C [77 °F]), GAMMAPLEX 10% has a shelf life of 36 months.Keep GAMMAPLEX 10% in its original carton to protect it from light.
What happens after immunoglobulin infusion?
After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results , with the potential formisleading interpretation
What happens after plasma is collected?
After the plasma is collected, it is thoroughly screened and tested to ensure that it is free from viruses and other infectious agents. The manufacturing process that purifies Gammaplex 10% from plasma includes three additional steps to remove or inactivate any viruses that might be present.
Does Gammaplex cause hemolysis?
GAMMAPLEX 10% may contain blood group antibodies that can act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin test (DAT) (Coombs’ test) result and hemolysis4. Delayed hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration; acute hemolysis, consistent with intravascular hemolysis, has been reported5. Cases of severe hemolysis-related renal dysfunction/failure or disseminated intravascular coagulation have occurred following infusion of IGIV.The following risk factors may be associated with the development of hemolysis following IGIV administration: high doses (e.g. ≥2 g/kg), given either as a single administration or divided over several days, and non-O blood group6. Other individual patient factors, such as an underlying inflammatory state (as may be reflected by, for example, elevated C-reactive protein or erythrocyte sedimentation rate), have been hypothesized to increase the risk of hemolysis following administration of IGIV7, but their role is uncertain. Hemolysis has been reported following administration of IGIV for a variety of indications, including ITP and PI4.Closely monitor patients for clinical signs and symptoms of hemolysis, particularly patients with risk factors noted above. Consider appropriate laboratory testing in higher risk patients, including measurement of hemoglobin or hematocrit prior to infusion and within approximately 36 to 96 hours post infusion. If clinical signs and symptoms of hemolysis or a significant drop in hemoglobin or hematocrit have been observed, perform confirmatory laboratory testing. If transfusion is indicated for patients who develop hemolysis with clinically compromising anemia after receiving IGIV, perform adequate cross-matching to avoid exacerbating on-going hemolysis.
