BESPONSA 1 mg Powder for Concentrate for Solution for infusion

• Patients should be advised to use effective contraceptive measures to avoid pregnancy. Women should continue the use of the contraceptive for at least 8 months after the last dose, while males should continue the use of the contraception for at least 5 months after the last dose. • Do not breastfeed during and for at least two months after the last dose of inotuzumab ozogamicin therapy. • Inotuzumab ozogamicin may affect fertility status both in men and women. Patients should therefore be advised to store their sperm or egg in a sperm or egg bank if they wish to plan a pregnancy after the completion of the treatment. • Monitor liver functions during the treatment to avoid life-threatening liver problems such as veno-occlusive disease. • The complete blood cell count and signs and symptoms of bleeding, infection (which may indicate low blood counts) should be monitored before, during and after treatment with inotuzumab ozogamicin. The dose can either be reduced or the treatment can be discontinued if blood counts reduce due to the treatment. • Patients should be monitored closely during and for at least 1 hour after the infusion for serious or life-threatening infusion reactions such as fever, chills, breathing difficulties or rashes. • Monitoring of ECG and electrolytes level is recommended while using inotuzumab ozogamicin particularly in patients with cardiac illness before and during the treatment.