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flipper44

03/29/15 1:46 PM

#31954 RE: dpinvest #31952

After the initial 2-3 injections, Direct is probably best suited for 2-3 week intervals because that is the length of time of a typical immune response. Once the effector t-cells at the end of each immune response window commit aptosis, a new injection of DCVax-Direct can be injected.

On the other hand, here is an example of Cart-T infusion dosing. It is quite intense.

DOSAGE AND ADMINISTRATION
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 Dosage
? A 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:
- InCycle1,administerBLINCYTOat9mcg/dayonDays1–7andat28mcg/dayonDays8–28. - Forsubsequentcycles,administerBLINCYTOat28mcg/dayonDays1–28.
? 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).