PATERSON, N.J. — Amneal Biosciences, the exclusive U.S. distributor for Tepadina, on Thursday began shipping the branded thiotepa. The product is available for purchase through major wholesalers and distributors.
Tepadina is approved to reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia. In addition, the product is approved for the same oncologic indications as generic thiotepa.
“The introduction of 100 mg thiotepa provides pharmacists with a convenient choice of sizes to accommodate larger doses,” explains Amneal Biosciences President, Charles Lucarelli. “We are thrilled to bring to the U.S. a product that is not only valuable to the pediatric transplant process, but in the 100 mg vial that’s been unavailable for years. Now we have a fully FDA-approved thiotepa molecule with options for the reconstituting pharmacist.”
According to Amneal, Tepadina may cause severe marrow suppression, and high doses may cause marrow ablation with resulting infection or bleeding. Hematopoietic progenitor (stem) cell transplantation (HSCT) is required to prevent potentially fatal complications of the prolonged myelosuppression after high doses of Tepadina. Tepadina should be considered potentially carcinogenic in humans. It is contraindicated in patients with severe hypersensitivity to thiotepa and in concomitant use with live or attenuated vaccines. The most common adverse reactions are neutropenia, anemia, thrombocytopenia, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated bilirubin, mucositis, cytomegalovirus infection, hemorrhage, diarrhea, hematuria and rash.
Amneal Biosciences brings Tepadina to the U.S. market on behalf of NDA-holder Adienne SA. “This exclusive distribution partnership with Adienne further demonstrates Amneal’s ability to successfully commercialize complex products in the U.S.,” said Amneal VP of Global Strategy and Corporate Development, Apurva Saraf. “We continue to pursue such strategic partnerships to complement our expansive and diverse internal pipeline.”