bsp;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 toxicity does not recur. If the toxicity occurred at 9 mcg/day, or if the toxicity 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 toxicity does not recur. If the toxicity takes more than 14 days to resolve, discontinue BLINCYTO permanently.
Grade 4 - Consider discontinuing BLINCYTO permanently.
2.4 Reconstitution and Preparation of Solution for InfusionIt is very important that the instructions for preparation (including admixing) and administration provided in this section are strictly followed to minimize medication errors (including underdose and overdose) [see Warnings and Precautions (5.9)].
Call 1-800-77-AMGEN (1-800-772-6436) if you have questions about the reconstitution and preparation of BLINCYTO.
2.4.1 Gather Supplies
NOTE: 1 package BLINCYTO includes 1 vial of BLINCYTO and 1 vial of IV Solution Stabilizer.
Bfore preparation, ensure you have the following supplies ready:
1 package of BLINCYTO for preparation of 9 mcg/day dose infused over 24 hours at a rate of 10 mL/h, 9 mcg/day dose infused over 48 hours at a rate of 5 mL/h, and 28 mcg/day dose infused over 24 hours at a rate of 10 mL/h
2 packages of BLINCYTO for preparation of 28 mcg/day dose infused over 48 hours at a rate of 5 mL/h
The following supplies are also required, but not included in the package:
Sterile, single-use disposable syringes
21- to 23- gauge needle(s) (recommended)
Preservative-free Sterile Water for Injection, USP
250 mL 0.9% Sodium Chloride IV bag
To minimize the number of aseptic transfers, it is recommended to use a 250 mL-prefilled IV bag. 250 mL-prefilled IV bags typically contain overfill with a total volume of 265 to 275 mL. BLINCYTO dose calculations provided in section 2.4.4 are based on a starting volume of 265 mL to 275 mL 0.9% Sodium Chloride.
Use only polyolefin, PVC non-di-ethylhexylphthalate (non-DEHP), or ethyl vinyl acetate (EVA) infusion bags/pump cassettes.
Polyolefin, PVC non-DEHP, or EVA IV tubing with a sterile, non-pyrogenic, low protein-binding 0.2 micron in-line filter
Ensure that the IV tubing is compatible with the infusion pump.
2.4.2 Aseptic Preparation
Aseptic technique must be strictly observed when preparing the solution for infusion since BLINCYTO vials do not contain antimicrobial preservatives. To prevent accidental contamination, prepare BLINCYTO according to aseptic standards, including but not limited to:
Preparation must be done in a USP <797> compliant facility.
Preparation must be done in an ISO Class 5 laminar flow hood or better.
The admixing area should have appropriate environmental specifications, confirmed by periodic monitoring.
Personnel should be appropriately trained in aseptic manipulations and admixing of oncology drugs.
Personnel should wear appropri |
