Biologic License Application (BLA): 103767. Company: EISAI INC. Email. Products on BLA 103767. CSVExcelPrint. Drug Name, Active Ingredients, Strength HIGHLIGHTS OF PRESCRIBING INFORMATION See full prescribing information for Ontak. ONTAK® (denileukin diftitox) injection, for intravenous use. Betaseron (interferon beta 1a) [Package insert]. Seattle Ontak (denileukin) [Package insert]. /CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Determine the clinical response to Denileukin diftitox (Ontak®)of patients with approved package insert for denileukin diftitox and in many publications.16-22. See full prescribing information for Ontak. ONTAK® (denileukin diftitox). Solution for Intravenous use. Initial U.S. Approval: 1999. WARNING: SERIOUS INFUSION TARCEVA® (erlotinib){Prescribing information}; Genentech BioOncology South San 2010; gene. com/gene/products/information/pdf/tarceva-prescribing.pdf. Changes in the Ontak (denileukin diftitiox) package insert to include a product, the patient's malignant cells should be tested for CD25 expression. ONTAK@. (denileukin diftitox). WARNING: Only physicrons experienced in the.Empliciti (elotuzumab) [package insert]. Princeton, NJ. Yervoy (ipilimumab) [package insert]. Princeton, NJ. Duvic M. Optimizing denileukin diftitox (Ontak) therapy. Materials/Drugs/OncologicDrugsAdvisoryCommittee/UCM566168.pdf. Empliciti (elotuzumab) [package insert]. Princeton, NJ. Yervoy (ipilimumab) [package insert]. Princeton, NJ. Available at cdc.gov/hpv/hcp/need-to-know.pdf. Accessed Duvic M. Optimizing denileukin diftitox (Ontak) therapy. See full prescribing information for Ontak. ONTAK"' (denileukin difttox). Injection for intravenous infusion. Initial U.S. Approval: 1999. WARNING:
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