N
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.
Do not flush the BLINCYTO infusion line especially when changing infusion bags. Flushing when changing bags or at completion of infusion can result in excess dosage and complications thereof. Preparation and administration errors resulting in overdose have occurred [see Dosage and Administration (2.2 and 2.4) and Warnings and Precautions (5.9)].
2.1 DosageA single cycle of treatment of BLINCYTO consists of 4 weeks of continuous intravenous infusion followed by a 2-week treatment-free interval.
For patients at least 45 kg in weight:
- In Cycle 1, administer BLINCYTO at 9 mcg/day on Days 1–7 and at 28 mcg/day on Days 8–28.
- For subsequent cycles, administer BLINCYTO at 28 mcg/day on Days 1–28.
Allow for at least 2 weeks treatment-free between cycles of BLINCYTO.
A treatment course consists of up to 2 cycles of BLINCYTO for induction followed by 3 additional cycles for consolidation treatment (up to a total of 5 cycles).
2.2 AdministrationPremedicate with dexamethasone 20 mg intravenously 1 hour prior to the first dose of BLINCYTO of each cycle, prior to a step dose (such as Cycle 1 day 8), or when restarting an infusion after an interruption of 4 or more hours.
Administer BLINCYTO as a continuous intravenous infusion at a constant flow rate using an infusion pump. The pump should be programmable, lockable, non-elastomeric, and have an alarm.
BLINCYTO infusion bags should be infused over 24 hours or 48 hours [see Dosage and Administration (2.4)]. Infuse the total 240 mL BLINCYTO solution according to the instructions on the pharmacy label on the bag at one of the following constant infusion rates:
- Infusion rate of 10 mL/h for a duration of 24 hours, OR
- Infusion rate of 5 mL/h for a duration of 48 hours
The BLINCYTO solution for infusion must be administered using IV tubing that contains a sterile, non-pyrogenic, low protein-binding, 0.2 micron in-line filter.
Important Note: Do not flush the infusion line, especially when changing infusion bags. Flushing when changing bags or at completion of infusion can result in excess dosage. BLINCYTO should be infused through a dedicated lumen.
At the end of the infusion, any unused BLINCYTO solution in the IV bag and IV lines should be disposed of in accordance with local requirements.
2.3 Dosage AdjustmentsIf the interruption after an adverse event 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 event is longer than 7 days, start a new cycle.
* Based on the Common Terminology Criteria for Adverse Events (CTCAE). Grade 3 is severe, and Grade 4 is life-threatening.
Toxicity
Grade*
Action
Cytokine Release Syndrome
(CRS)
Grade 3 -
Withhold BLINCYTO until resolved, then restart BLINCYTO at 9 mcg/day. Escalate to 28 mcg/day after 7 days if the toxicity does not recur.
Grade 4 - Discontinue BLINCYTO permanently.
Neurological Toxicity
&n |
