The most common adverse reactions (reported in ?20% of patients randomized to mogamulizumab) were rash (including drug eruption), infusion-related reactions, fatigue, diarrhea, upper respiratory tract infection and musculoskeletal pain.^L11770 Due to various adverse effects related to this drug, the adverse reactions have been categorized by organ system. Because of the risk of serious/fatal ADRs, patients administered mogamulizumab should be carefully monitored.^A36743

Upper respiratory tract infection: This may occur due to decreased immunity following the administration of this drug. Monitor for signs of respiratory infection including fever, cough and shortness of breath.^L4171

Dermatological: Patients must contact their healthcare provider immediately if they experience a new or worsening skin rash. Treatment should be temporarily interrupted for moderate or severe skin rashes and permanently discontinued for a life-threatening rash. Fatal and life-threatening skin adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have occurred in recipients of mogamulizumab. Rash (drug eruption) is one of the most common adverse reactions associated with mogamulizumab.L4171,L11770
Infusion Reactions: Patients must contact their healthcare provider immediately for signs or symptoms of infusion reactions. Treatment should be suspended for any infusion reaction and permanently discontinued for any life-threatening infusion reaction.^L4171

Infections: Patients must contact their healthcare provider if they experience fever or other signs of infection. Infections should be monitored and treated promptly.^L4171

Autoimmune Complications: Immune-mediated or possibly immune-mediated reactions have included myositis, myocarditis, polymyositis, hepatitis, pneumonitis, and a variant of Guillain- Barré syndrome.^L11770 Patients must notify their healthcare provider of any history of autoimmune disease. Treatment should be suspended or permanently discontinued as appropriate.^L4171
Fatal and life-threatening immune-mediated complications have been reported in recipients of this drug.^L11770

Musculoskeletal pain: This drug may cause musculoskeletal pain.^L11770

A note on complications of allogeneic hematopoietic stem cell transplantation: Patients must be aware of the possible risk of post-transplant complications when taking this agent. Patients should be monitored for severe acute graft-versus-host disease (GVHD) and steroid-refractory GVHD.

Females of Reproductive Potential: Females who are able to become pregnant should use an effective method of birth control during treatment with Poteligeo and for at least three months after the last dose.^L4171