TEPADINA® (thiotepa) for Injection Full Prescribing Information

 

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http://www.amneal.com/wp-content/uploads/2017/04/TEPADINA-ISI-PI.pdf

INDICATIONS AND USAGE

TEPADINA is an alkylating drug indicated:

  • 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.
  • For treatment of adenocarcinoma of the breast or ovary.
  • For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities.
  • For treatment of superficial papillary carcinoma of the urinary bladder.

Important Safety Information

WARNING: SEVERE MYELOSUPPRESSION, CARCINOGENICITY

  • TEPADINA may cause severe marrow suppression, and high doses may cause marrow ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters. 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

 

TEPADINA is contraindicated for patients with severe hypersensitivity to thiotepa and concomitant use with live or attenuated vaccines.

Myelosuppression: The consequence of treatment with high doses of TEPADINA together with other chemotherapy is profound myelosuppression.
Hypersensitivity: Clinically significant hypersensitivity reactions, including anaphylaxis, have occurred following administration of TEPADINA.
Cutaneous toxicity: TEPADINA and/or its active metabolites may be excreted in part via skin patients receiving high-dose therapy. This may cause skin discoloration, pruritus, blistering, desquamation, and peeling that may be more severe in the groin, axillae, skin folds, in the neck area, and under dressings.
Concomitant Use of Live and Attenuated Vaccines: Do not administer live or attenuated viral or bacterial vaccines to a patient treated with TEPADINA until the immunosuppressive effects have resolved.
Hepatic Veno-Occlusive Disease: Hepatic veno-occlusive disease may occur in patients who have received high-dose TEPADINA in conjunction with busulfan and cyclophosphamide.
Central Nervous System Toxicity: Fatal encephalopathy has occurred in patients treated with high doses of TEPADINA.
Carcinogenicity: There is an increased risk of a secondary malignancy with use of TEPADINA.
Embryo-Fetal toxicity: TEPADINA can cause fetal harm when administered to a pregnant woman.

The most common adverse reactions (incidence greater than 10%) are neutropenia, anemia, thrombocytopenia, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated bilirubin, mucositis, cytomegalovirus infection, hemorrhage, diarrhea, hematuria and rash.

The most serious adverse events include acute and chronic graft-versus-host disease, subarachnoid hemorrhage; seizure, veno-occlusive disease, gastrointestinal hemorrhage and pneumonia.

 

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