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.
Hospitalization is recommended for the first 9 days of the first cycle and the first 2 days of the second cycle.
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.
When not hospitalized, patients may potentially be treated with BLINCYTO® at one of the following locations:
Patients may have the option of receiving BLINCYTO® treatment at home after the initial hospital stay recommendation, with supervision by a healthcare professional
With infusion bag changes required only once weekly, the BLINCYTO® 7-day continuous IV infusion option* may give you added flexibility when transitioning your patients from inpatient to outpatient treatment.
Administration of BLINCYTO® requires cIV infusion for delivery at a constant flow rate using an infusion pump that is programmable, lockable, non-elastomeric, and has an alarm.
BLINCYTO® infusion bags are admixed to infuse over:
The information provided here is an abbreviated summary and does not replace the Prescribing Information. Please consult the Prescribing Information when preparing BLINCYTO®.
The final volume of infusion solution is more than the volume administered to the patient to account for the priming of the IV tubing and to ensure that the patient will receive the full dose of BLINCYTO®.
At the end of the infusion, any unused BLINCYTO® solution in the IV bag and IV tubing should be disposed of in accordance with local requirements.
IMPORTANT NOTE: Do not flush the BLINCYTO® infusion line or intravenous catheter, especially when changing infusion bags. Flushing when changing bags or at completion of infusion can result in excess dosage and complications thereof. When administering via a multi-lumen venous catheter, BLINCYTO® should be infused through a dedicated lumen.
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.
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. |
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.
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