EXPERT PERSPECTIVES: The MAVORIC Trial скачать в хорошем качестве

EXPERT PERSPECTIVES: The MAVORIC Trial

Please see Important Safety Information below. Andrei Shustov, MD has been compensated by Kyowa Kirin for his participation in this video. Hear Andrei Shustov, MD discuss the value of key endpoints used in the phase 3 MAVORIC trial. Dr Shustov also shares his thoughts about the patient types he considers appropriate for treatment with POTELIGEO and the most common adverse reactions reported in MAVORIC. To find out more, visit: https://www.poteligeohcp.com. INDICATION POTELIGEO® (mogamulizumab-kpkc) injection for intravenous infusion is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. IMPORTANT SAFETY INFORMATION Warnings and Precautions Dermatologic toxicity: Monitor patients for rash throughout the course of treatment. For patients who experienced dermatologic toxicity in Trial 1, the median time to onset was 15 weeks, with 25% of cases occurring after 31 weeks. Interrupt POTELIGEO for moderate or severe rash (Grades 2 or 3). Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). Infusion reactions: Most infusion reactions occur during or shortly after the first infusion. Infusion reactions can also occur with subsequent infusions. Monitor patients closely for signs and symptoms of infusion reactions and interrupt the infusion for any grade reaction and treat promptly. Permanently discontinue POTELIGEO for any life-threatening (Grade 4) infusion reaction. Infections: Monitor patients for signs and symptoms of infection and treat promptly. Autoimmune complications: Interrupt or permanently discontinue POTELIGEO as appropriate for suspected immune-mediated adverse reactions. Consider the benefit/risk of POTELIGEO in patients with a history of autoimmune disease. Complications of allogeneic HSCT after POTELIGEO: Increased risks of transplant complications have been reported in patients who received allogeneic HSCT after POTELIGEO. Follow patients closely for early evidence of transplant-related complications. Adverse Reactions The most common adverse reactions (reported in ≥10% of patients) with POTELIGEO in the clinical trial were rash, including drug eruption (35%), infusion reaction (33%), fatigue (31%), diarrhea (28%), drug eruption (24%), upper respiratory tract infection (22%), musculoskeletal pain (22%), skin infection (19%), pyrexia (17%), edema (16%), nausea (16%), headache (14%), thrombocytopenia (14%), constipation (13%), anemia (12%), mucositis (12%), cough (11%), and hypertension (10%). You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch. Please see full Prescribing Information. [https://www.poteligeohcp.com/assets/f...] This video is intended for US audiences only.