Blincyto Dosage/Direction for Use

Treatment of MRD-positive B-cell Precursor ALL: A treatment course consists of 1 cycle of BLINCYTO for induction followed by up to 3 additional cycles for consolidation.
A single cycle of treatment of BLINCYTO induction or consolidation consists of 28 days of continuous intravenous infusion followed by a 14-day treatment-free interval (total 42 days).
See Table 9 for the recommended dose by patient weight and schedule. Patients greater than or equal to 45 kg receive a fixed-dose. (See Table 9.)

Click on icon to see table/diagram/image

Hospitalization is recommended for the first 3 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiations (e.g., if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is recommended.
Intrathecal chemotherapy prophylaxis is recommended before and during BLINCYTO therapy to prevent central nervous system ALL relapse.
Premedicate with prednisone or equivalent for MRD-positive B-cell Precursor ALL: For adult patients, premedicate with prednisone 100 mg intravenously or equivalent (e.g., dexamethasone 16 mg) 1 hour prior to the first dose of BLINCYTO in each cycle.
For administration of BLINCYTO: See Preparation and Administration of BLINCYTO as 24 Hours, 48 Hours, 72 Hours or 96 Hours Infusion as follows.
Treatment of Relapsed or Refractory B-cell Precursor ALL: A treatment course consists of up to 2 cycles of BLINCYTO for induction followed by 3 additional cycles for consolidation and up to 4 additional cycles of continued therapy.
A single cycle of treatment of BLINCYTO induction or consolidation consists of 28 days of continuous intravenous infusion followed by a 14-day treatment-free interval (total 42 days).
A single cycle of treatment of BLINCYTO continued therapy consists of 28 days of continuous intravenous infusion followed by a 56-day treatment-free interval (total 84 days).
See Table 10 for the recommended dose by patient weight and schedule. Patients greater than or equal to 45 kg receive a fixed-dose and for patients less than 45 kg, the dose is calculated using the patient's body surface area (BSA). (See Table 10.)

Click on icon to see table/diagram/image

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 re-initiation (e.g., if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is recommended.
Intrathecal chemotherapy prophylaxis is recommended before and during BLINCYTO therapy to prevent central nervous system ALL relapse.
Premedicate with dexamethasone: For adult patients, premedicate with 20 mg dexamethasone 1 hour prior to the first dose of BLINCYTO of each cycle, prior to a step dose (such as Cycle 1 day 8), and when restarting an infusion after an interruption of 4 or more hours.
For pediatric patients, premedicate with 5 mg/m² of dexamethasone, to a maximum dose of 20 mg prior to the first dose of BLINCYTO in the first cycle, prior to a step dose (such as Cycle 1 day 8), and when restarting an infusion after an interruption of 4 or more hours in the first cycle.
For administration of BLINCYTO: See 24 Hours, 48 Hours, 72 Hours or 96 Hours Infusion of BLINCYTO as follows for infusion over 24 hours, 48 hours, 72 hours or 96 hours.
Dosage Modifications for Adverse Reactions: If 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. (See Table 11.)

Click on icon to see table/diagram/image

Preparation: It 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 Preparation and Administration Errors under Precautions].
BLINCYTO can be infused over 24 hours, 48 hours, 72 hours or 96 hours. The choice between these options for the infusion duration should be made by the treating physician considering the frequency of the infusion bag changes and the weight of the patient.
For preparation, reconstitution, and administration of BLINCYTO: See Preparation and Administration of BLINCYTO as 24 Hours, 48 Hours, 72 Hours or 96 Hours Infusion as follows.
Aseptic Preparation: Strictly observe aseptic technique 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: Prepare BLINCYTO in a USP <797> compliant facility.
Prepare BLINCYTO in an ISO Class 5 laminar flow hood or better.
Ensure that the admixing area has appropriate environmental specifications, confirmed by periodic monitoring.
Ensure that personnel are appropriately trained in aseptic manipulations and admixing of oncology drugs.
Ensure that personnel wear appropriate protective clothing and gloves.
Ensure that gloves and surfaces are disinfected.
Package Content: 1 package BLINCYTO includes 1 vial of BLINCYTO and 1 vial of IV Solution Stabilizer.
Do not use IV Solution Stabilizer for reconstitution of BLINCYTO. IV Solution Stabilizer is provided with the BLINCYTO package and is used to coat the IV bag prior to addition of reconstituted BLINCYTO to prevent adhesion of BLINCYTO to intravenous bags and intravenous tubing.
More than 1 package of BLINCYTO may be needed to prepare some of the prescribed doses.
Incompatibility Information: BLINCYTO is incompatible with di-ethylhexylphthalate (DEHP) due to the possibility of particle formation, leading to a cloudy solution.
Use polyolefin, PVC DEHP-free, or ethyl vinyl acetate (EVA) infusion bags/pump cassettes.
Use polyolefin, PVC DEHP-free, or EVA IV tubing sets.
Preparation and Administration of BLINCYTO as 24 Hours, 48 Hours, 72 Hours or 96 Hours Infusion: Reconstitute BLINCYTO with preservative-free Sterile Water for Injection, USP. Do not reconstitute BLINCYTO vials with the IV Solution Stabilizer.
To prime the intravenous tubing, use only the solution in the bag containing the FINAL prepared BLINCYTO solution for infusion. Do not prime with 0.9% Sodium Chloride Injection, USP.
Reconstitution of BLINCYTO for 24, 48, 72 or 96 Hours Infusion: 1. Determine the number of BLINCYTO vials needed for a dose and infusion duration.
2. Reconstitute each BLINCYTO vial with 3 mL of preservative-free Sterile Water for Injection, USP by directing the water along the walls of the BLINCYTO vial and not directly on the lyophilized powder. The resulting concentration per BLINCYTO vial is 12.5 mcg/mL. Do not reconstitute BLINCYTO vials with IV Solution Stabilizer.
3. Gently swirl contents to avoid excess foaming. Do not shake.
4. Visually inspect the reconstituted solution for particulate matter and discoloration during reconstitution and prior to infusion. The resulting solution should be clear to slightly opalescent, colorless to slightly yellow. Do not use if solution is cloudy or has precipitated.
Preparation of BLINCYTO Infusion Bag for 24, 48, 72 or 96 Hours Infusion: Verify the prescribed dose and infusion duration for each BLINCYTO infusion bag. To minimize errors, use the specific volumes described in Tables 12 to 13 to prepare the BLINCYTO infusion bag.
Table 12 for patients weighing greater than or equal to 45 kg.
Tables 13 for patients weighing less than 45 kg.
1. Aseptically add 270 mL 0.9% Sodium Chloride Injection, USP to the empty intravenous bag.
2. Aseptically transfer 5.5 mL IV Solution Stabilizer to the intravenous bag containing 0.9% Sodium Chloride Injection, USP. Gently mix the contents of the bag to avoid foaming. Discard the vial containing the unused IV Solution Stabilizer.
3. Aseptically transfer the required volume of reconstituted BLINCYTO [see Reconstitution of BLINCYTO for 24, 48, 72 or 96 Hours Infusion as previously mentioned] into the intravenous bag containing 0.9% Sodium Chloride Injection, USP and IV Solution Stabilizer. Gently mix the contents of the bag to avoid foaming.
Refer to Tables 12 and 13 for the specific volume of reconstituted BLINCYTO.
Discard the vial containing unused BLINCYTO.
4. Under aseptic conditions, attach the intravenous tubing to the intravenous bag with the sterile 0.2 micron in-line filter. Ensure that the intravenous tubing is compatible with the infusion pump.
5. Remove air from the intravenous bag. This is particularly important for use with an ambulatory infusion pump.
6. Prime the intravenous tubing only with the solution in the bag containing the FINAL prepared BLINCYTO solution for infusion.
7. Store at 2°C to 8°C if not used immediately [see Storage Requirements as follows]. (See Tables 12 and 13.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Administration of BLINCYTO for 24-Hour, 48-Hour, 72-Hour or 96-Hour infusion: 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.
The starting volume (270 mL) is more than the volume administered to the patient (240 mL) to account for the priming of the intravenous tubing and to ensure that the patient will receive the full dose of BLINCYTO.
Infuse prepared BLINCYTO final infusion solution according to the instructions on the pharmacy label on the prepared bag at one of the following constant infusion rates: Infusion rate of 10 mL/hour for a duration of 24 hours, OR; Infusion rate of 5 mL/hour for a duration of 48 hours, OR; Infusion rate of 3.3 mL/hour for a duration of 72 hours, OR; Infusion rate of 2.5 mL/hour for a duration of 96 hours.
Administer prepared BLINCYTO final solution using intravenous tubing that contains a sterile, non-pyrogenic, low protein-binding, 0.2 micron in-line filter.
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.
At the end of the infusion, any unused BLINCYTO solution in the intravenous bag and intravenous tubing in accordance with local requirements.
Storage of Reconstituted BLINCYTO: The information in Table 14 indicates the storage time for the reconstituted BLINCYTO vial and prepared infusion bag. (See Table 14.)

Click on icon to see table/diagram/image