Blincyto 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.

Tumor lysis syndrome (TLS), which may be life-threatening or fatal, has occurred in patients receiving certain monoclonal antibodies. Patients with high tumor burden and/or high circulating lymphocyte counts (greater than 25 x 10[9]/L) are at greater risk for developing TLS. Tumor lysis prophylaxis with anti-hyperuricemics and hydration prior to infusion may be recommended or should be considered. Electrolyte abnormalities should be corrected, and renal function and fluid balance should be monitored in patients who develop TLS. It is recommended to monitor for signs/symptoms of TLS, and temporary interruption or discontinuation of therapy might be required.

The use of blinatumomab has been associated with transient elevations in liver enzymes. Care should be exercised when using this agent in patients with liver impairment. It is recommended to monitor liver enzymes before the start of therapy and periodically as clinically appropriate. Interrupt treatment if the transaminases levels rise to greater than 5 times the upper limit of normal or if bilirubin rises to more than 3 times the upper limit normal.

Serious neurological toxicity such as encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders have been reported with the use of blinatumomab therapy. Monitor therapy closely if administered to patients with or predisposed to neurological impairment and interruption or discontinuation of therapy might be appropriate in some cases.

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 studies of blinatumomab have been conducted in patients with renal impairment. Pharmacokinetic analyses showed an approximately 2-fold difference in mean blinatumomab clearance values between patients with moderate renal impairment (CrCl ranging from 30 to 59 mL/min, N = 21) and normal renal function. However, high interpatient variability was observed (CV% up to 96.8%), and clearance values in renal impaired patients were essentially within the range observed in patients with normal renal function. Close monitoring is recommended in patients with severe renal impairment (CrCl less than 30 mL/min) or patients on hemodialysis as there is no information available.