Blinatumomab Disease Interactions

The administration of live vaccines should be avoided during therapy with blinatumomab. Vaccination with live virus vaccines is not recommended for at least 2 weeks prior to start of therapy, during treatment, and until the immune system has recovered following last cycle of blinatumomab. It is recommended to be up-to-date with all required immunizations, as recommended by current immunization guidelines, before initiating therapy.

Cranial MRI changes showing leukoencephalopathy have been observed in patients receiving blinatumomab, especially in patients with prior treatment with cranial irradiation and antileukemic chemotherapy (including systemic high-dose methotrexate or intrathecal cytarabine). The clinical significance of these imaging changes is unknown.

No formal pharmacokinetic studies have been conducted in patients with hepatic impairment. Data has indicated that there are no clinically significant differences in exposure to blinatumomab based on mild or moderate hepatic impairment.

Some formulations of blinatumomab contain benzyl alcohol (a preservative). Pediatric patients with immature pathways for alcohol metabolism or with underlying conditions that could predispose to acid base imbalance may be at risk for serious adverse reactions, including fatal reactions and the "gasping syndrome". Early preterm very low birth weight neonates (less than 1500 g) may be at higher risk. Use the preservative-free preparations of blinatumomab where possible in neonates and consider the combined daily metabolic load of benzyl alcohol from all sources. Monitor neonatal patients receiving blinatumomab with preservative for new or worsening metabolic acidosis.

Blinatumomab may cause serious or life-threatening neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome. There is limited experience with blinatumomab in patients with active acute lymphoblastic leukemia in the CNS or a history of neurologic events. Patients with a history or presence of clinically relevant CNS pathology were excluded from clinical studies.

The use of blinatumomab may cause life-threatening neutropenia, and febrile neutropenia. It is recommended to monitor complete blood counts during the infusion. Therapy interruption is recommended for prolonged neutropenia. Care and close monitoring is recommended, in particular for any episodes of fever.

Fatal pancreatitis has been observed in patients treated with blinatumomab in combination with dexamethasone. Care should be exercised when using blinatumomab in combination with dexamethasone in patients with pancreatic disorders. Management of pancreatitis may require either temporary interruption or discontinuation of these agents.

No formal pharmacokinetic (PK) studies of blinatumomab have been conducted in patients with renal impairment. There is no data available in patients with severe renal impairment (CrCl 15 to 29 mL/min) or in patients on hemodialysis. PK analyses in patients with moderate renal impairment (CrCl 30 to 59 mL/min) determined blinatumomab clearance to be essentially within the range observed in patients with normal renal function.