Novartis Expands Transplant Portfolio with Hecoria®, the First Generic Tacrolimus That Can be Prescribed by Brand Name
Apr 2, 2012 - 1:59:47 PM
Now available in US pharmacies, Hecoria (tacrolimus) capsules are approved for the prevention of organ rejection in certain kidney and liver transplant patients
(HealthNewsDigest.com) - East Hanover, N.J., April 2, 2012 — Novartis today announced the US introduction and availability of Hecoria® (tacrolimus) capsules, the first generic tacrolimus that can be prescribed by its brand name. Now available in pharmacies, Hecoria is an AB-rated generic therapeutic bioequivalent to Prograf® (tacrolimus capsules). Hecoria is approved by the US Food and Drug Administration (FDA) for the prevention of organ rejection in patients receiving liver or kidney transplants.
Following organ transplantation, patients require lifelong treatment with immunosuppressants.1 Many transplant patients are faced with complicated post-transplant medication regimens and significant financial burden. As a branded generic, Hecoria offers an option for healthcare providers who seek to have their patients receive the same brand of tacrolimus at every prescription refill, at the affordable price of a generic. Available in 0.5 mg, 1 mg and 5 mg capsules, Hecoria is the only tacrolimus that has its brand name printed on the capsule. Patients can identify Hecoria when dispensed at a pharmacy.
Currently, there are more than 112,000 patients awaiting an organ transplant.2 In 2010, nearly 17,000 patients received a kidney transplant, and more than 6,000 received a liver transplant, all of whom will need lifelong treatment with immunosuppressants.2
“Novartis pioneered medicines to facilitate transplantation with the introduction of cyclosporine more than 25 years ago. Today, Novartis is proud to offer the broadest portfolio of transplant immunosuppressants on the market,” said Usman Azam, MD, head of US Medical & Drug Regulatory Affairs, Novartis Pharmaceuticals Corporation. “Hecoria complements our extensive portfolio of transplant immunosuppressant medications, and underscores our ongoing commitment to delivering a broad range of treatment options to our customers and their patients.”
The FDA approval of Hecoria was based on the approved Sandoz Abbreviated New Drug Application (ANDA) and comparative, randomized, single-dose, 2-way crossover, bioavailability studies of Prograf and tacrolimus 5 mg capsules performed in healthy volunteers following a standard meal and under fasting conditions. Results demonstrated that tacrolimus and Prograf capsules are bioequivalent under fed and fasting conditions.
Health plans will generally reimburse Hecoria as an AB-rated generic and will generally make the medication available to patients at a generic price. Novartis is committed to improving access to medications for those most in need through its Patient Assistance Program, and is offering the same level of financial support for Hecoria as for other branded Novartis products. Patients experiencing financial hardship who have no third-party coverage may be eligible to receive financial support for Hecoria through the Novartis Patient Assistance Program. For information about the Novartis Patient Assistance Program, visit http://www.patientassistancenow.com.
Hecoria is marketed and distributed by Novartis Pharmaceuticals Corporation and manufactured by Sandoz, the generic pharmaceuticals division within the Novartis group of companies.
About Hecoria® (tacrolimus) capsules
Hecoria (tacrolimus) capsules are calcineurin-inhibitor immunosuppressants indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver or kidney transplants. It is recommended that Hecoria be used concomitantly with adrenal corticosteroids. In kidney transplant recipients, it is recommended that Hecoria be used in conjunction with azathioprine or mycophenolate mofetil. Careful and frequent monitoring of tacrolimus trough concentrations is recommended for all patients receiving this product.
Hecoria should not be used simultaneously with cyclosporine. Use with sirolimus is not recommended in liver transplant. The safety and efficacy of Hecoria with sirolimus has not been established in kidney transplant. Tacrolimus injection should be reserved for patients unable to take Hecoria orally. It is not known if Hecoria is safe and effective in children who have had a kidney transplant.
Important Safety Information for Hecoria® (tacrolimus) capsules
Patients receiving Hecoria are at increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression. Patients receiving Hecoria are at increased susceptibility to bacterial, viral, fungal and protozoal infections, including opportunistic infections. Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Hecoria.
Potential serious adverse events associated with Hecoria include lymphoma and other malignancies, serious infections, polyoma virus infections, cytomegalovirus (CMV) infections, new onset diabetes after transplant, nephrotoxicity, neurotoxicity, hyperkalemia, hypertension, myocardial hypertrophy and pure red cell aplasia. Use with sirolimus is not recommended in liver transplant due to increased risk of serious adverse reactions. Immunizations with live vaccines should be avoided.
In kidney transplant, the most common adverse reactions (≥ 30%) were infection, tremor, hypertension, abnormal renal function, constipation, diarrhea, headache, abdominal pain, insomnia, nausea, hypomagnesemia, urinary tract infection, hypophosphatemia, peripheral edema, asthenia, pain, hyperlipidemia, hyperkalemia and anemia. In liver transplant, the most common adverse reactions (≥ 40%) were tremor, headache, diarrhea, hypertension, nausea, abnormal renal function, abdominal pain, insomnia, paresthesia, anemia, pain, fever, asthenia, hyperkalemia, hypomagnesemia and hyperglycemia.
Prograf® is a registered trademark of Astellas Pharma US.
Please see full Prescribing Information, including Boxed Warnings.
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