BLINCYTO® is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.
BLINCYTO® is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.
Interruption and reinitiation1
For all subsequent cycle starts and reinitiation (eg, if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is recommended.
Dose adjustments1
If the interruption after an adverse reaction is no longer than 7 days, continue the same cycle to a total of 28 days of infusion inclusive of days before and after the interruption in that cycle. If an interruption due to an adverse reaction is longer than 7 days, start a new cycle.
Adverse Reaction | Grade* | Patients Weighing ≥ 45 kg | Patients Weighing < 45 kg |
Cytokine Release Syndrome (CRS) | Grade 3 | Interrupt BLINCYTO®. Administer dexamethasone 8 mg every 8 hours intravenously or orally for up to 3 days, and taper thereafter over 4 days. When CRS is resolved, restart BLINCYTO® at 9 mcg/day, and escalate to 28 mcg/day after 7 days if the adverse reaction does not recur. |
Interrupt BLINCYTO®. Administer dexamethasone 5 mg/m2 (maximum 8 mg) every 8 hours intravenously or orally for up to 3 days, and taper thereafter over 4 days. When CRS is resolved, restart BLINCYTO® at 5 mcg/m2/day, and escalate to 15 mcg/m2/day after 7 days if the adverse reaction does not recur. |
Grade 4 | Discontinue BLINCYTO® permanently. Administer dexamethasone as instructed for Grade 3 CRS. | ||
Neurological Toxicity† | Seizure | Discontinue BLINCYTO® permanently if more than one seizure occurs. | |
Grade 3 | Withhold BLINCYTO® until no more than Grade 1 (mild) and for at least 3 days, then restart BLINCYTO® at 9 mcg/day. Escalate to 28 mcg/day after 7 days if the adverse reaction does not recur. If the adverse reaction occurred at 9 mcg/day, or if the adverse reaction takes more than 7 days to resolve, discontinue BLINCYTO® permanently. | Withhold BLINCYTO® until no more than Grade 1 (mild) and for at least 3 days, then restart BLINCYTO® at 5 mcg/m2/day. Escalate to 15 mcg/m2/day after 7 days if the adverse reaction does not recur. If the adverse reaction occurred at 5 mcg/m2/day, or if the adverse reaction takes more than 7 days to resolve, discontinue BLINCYTO® permanently. | |
Grade 4 | Discontinue BLINCYTO® permanently. | ||
Other Clinically Relevant Adverse Reactions | Grade 3 | Withhold BLINCYTO® until no more than Grade 1 (mild), then restart BLINCYTO® at 9 mcg/day. Escalate to 28 mcg/day after 7 days if the adverse reaction does not recur. If the adverse reaction takes more than 14 days to resolve, discontinue BLINCYTO® permanently. | Withhold BLINCYTO® until no more than Grade 1 (mild), then restart BLINCYTO® at 5 mcg/m2/day. Escalate to 15 mcg/m2/day after 7 days if the adverse reaction does not recur. If the adverse reaction takes more than 14 days to resolve, discontinue BLINCYTO® permanently. |
Grade 4 | Consider discontinuing BLINCYTO® permanently. |
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
BLINCYTO® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for BLINCYTO®.
BLINCYTO® is a registered trademark of Amgen Inc.
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/Archive/CTCAE_4.0_2009-05-29_QuickReference_8.5x11.pdf. Accessed September 20, 2021.