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GAMMAPLEX SUPPORT FOR HEALTHCARE PROVIDERS


Co-Pay Assistance

If you need co-pay assistance for your patient please visit GAMMAPLEX Co-Pay Assistance Portal For Providers by clicking the button below. Eligible patients can receive up to $2,000 per year ($1000 maximum for the first fill, and $250 for subsequent fills) to cover the deductible, co-pay, and/or coinsurance for GAMMAPLEX.

    ELIGIBILITY CRITERIA FOR CO-PAY ASSISTANCE

    • Patients must be commercially insured.
    • Patients must express a financial need.
    • Patients' health plan permits members to participate in co-pay assistance programs.

    RESTRICTIONS

    • Not valid for prescriptions eligible for reimbursement by any federal or state healthcare programs, such as Medicare, Medicaid, Medigap, Veterans Affairs, Department of Defense, Tricare, or any other federal or state-funded programs.
    GAMMAPLEX Co-Pay Assistance Portal For Providers



Additional Reimbursement Support

For any inquiries or assistance with reimbursement, please don't hesitate to contact our dedicated Support Team at (888) 262-8040. We are fully committed to guiding you through any questions or concerns you may encounter.

Please reach out to our Reimbursement Support Team at (888) 262-8040 if your patient:

  • Requires benefit verification
  • Requires prior authorization

We're here to support you every step of the way and eagerly anticipate the opportunity to assist you.



This program is subject to change or discontinuation by Kedrion Biopharma Inc. at any time, for any reason, and with or without prior notice.

Indication and Important Safety Information for 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.

Gammaplex 10% is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) in adults.

WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE

  • Thrombosis may occur with immune globulin products, including Gammaplex 10%. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.

  • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients who receive immune globulin intravenous (IGIV) products, including Gammaplex 10%.

  • Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing 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 for hyperviscosity.


    • Gammaplex 10% is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin and IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.

    In patients at risk of developing acute renal failure, monitor renal function, including blood urea nitrogen (BUN), serum creatinine and urine output. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy.

    Aseptic meningitis syndrome (AMS) may occur with IGIV treatment. AMS usually begins within several hours to 2 days following IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae. 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. Noncardiogenic pulmonary edema may occur in patients following IGIV treatment (i.e. transfusion-related acute lung injury [TRALI]). Monitor patients for pulmonary adverse reactions. 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%.

    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.

    Please see 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.

    You may also call Kedrion at 1-866-398-0825 or email US_Medicalinfo@kedrion.com