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.
NOTE: The package does not include preservative-free Sterile Water for Injection, USP, which should be used to reconstitute the lyophilized BLINCYTO® powder.
Please see full Prescribing Information for complete reconstitution and preparation instructions.
Refrigerate vials of BLINCYTO® and IVSS at 2°C to 8°C (36°F to 46°F) in the original packaging.
Do not freeze.
Protect the vials of BLINCYTO® and IVSS from light until time of use.
The information provided here is an abbreviated summary and does not replace the Prescribing Information. Please consult the Prescribing Information when preparing BLINCYTO®.
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:
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.
Determine the number of BLINCYTO® vials needed for a dose and infusion duration
Gently swirl the contents to avoid excess foaming. Do not shake.
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.
In order to prepare BLINCYTO® solution for 24- or 48-hour infusion, you will need to know:1
It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose).1
Verify the prescribed dose and infusion duration for each BLINCYTO® infusion bag. To minimize errors, use the specific volumes described in the tables below to prepare the BLINCYTO® infusion bag.
Aseptically add 270 mL of 0.9% Sodium Chloride Injection, USP to the empty IV bag.
Aseptically transfer 5.5 mL of IVSS to the IV bag containing 0.9% Sodium Chloride Injection, USP.
Aseptically transfer the required volume of reconstituted BLINCYTO® into the IV bag containing 0.9% Sodium Chloride Injection, USP and IVSS.
0.9% Sodium Chloride injection, USP (starting volume) | 270 mL | |||||
IV Solution Stabilizer (fixed volume for 24-hour and 48-hour infusion durations) | 5.5 mL | |||||
For patients weighing ≥ 45 kg (fixed dose) | ||||||
---|---|---|---|---|---|---|
Infusion Duration | Dose | Infusion rate | Reconstituted BLINCYTO® | |||
Volume | Vials | |||||
24 hours | ||||||
9 mcg/day | 10 mL/hour | 0.83 mL | 1 | |||
28 mcg/day | 10 mL/hour | 2.6 mL | 1 | |||
48 hours | ||||||
9 mcg/day | 5 mL/hour | 1.7 mL | 1 | |||
28 mcg/day | 5 mL/hour | 5.2 mL | 2 | |||
For patients weighing < 45 kg (BSA-based dose) |
Infusion Duration | Dose | Infusion rate | BSA (m2) | Reconstituted BLINCYTO® | ||
---|---|---|---|---|---|---|
Volume | Vials | |||||
24 hours | 5 mcg/m2 / day |
10 mL/ hour |
||||
1.5–1.59 | 0.7 mL | 1 | ||||
1.4–1.49 | 0.66 mL | 1 | ||||
1.3–1.39 | 0.61 mL | 1 | ||||
1.2–1.29 | 0.56 mL | 1 | ||||
1.1–1.19 | 0.52 mL | 1 | ||||
1–1.09 | 0.47 mL | 1 | ||||
0.9–0.99 | 0.43 mL | 1 | ||||
0.8–0.89 | 0.38 mL | 1 | ||||
0.7–0.79 | 0.33 mL | 1 | ||||
0.6–0.69 | 0.29 mL | 1 | ||||
0.5–0.59 | 0.24 mL | 1 | ||||
0.4–0.49 | 0.2 mL | 1 | ||||
24 hours | 15 mcg/m2 / day |
10 mL/ hour |
||||
1.5–1.59 | 2.1 mL | 1 | ||||
1.4–1.49 | 2 mL | 1 | ||||
1.3–1.39 | 1.8 mL | 1 | ||||
1.2–1.29 | 1.7 mL | 1 | ||||
1.1–1.19 | 1.6 mL | 1 | ||||
1–1.09 | 1.4 mL | 1 | ||||
0.9–0.99 | 1.3 mL | 1 | ||||
0.8–0.89 | 1.1 mL | 1 | ||||
0.7–0.79 | 1 mL | 1 | ||||
0.6–0.69 | 0.86 mL | 1 | ||||
0.5–0.59 | 0.72 mL | 1 | ||||
0.4–0.49 | 0.59 mL | 1 | ||||
48 hours | 5 mcg/m2 / day |
5 mL/ hour |
||||
1.5–1.59 | 1.4 mL | 1 | ||||
1.4–1.49 | 1.3 mL | 1 | ||||
1.3–1.39 | 1.2 mL | 1 | ||||
1.2–1.29 | 1.1 mL | 1 | ||||
1.1–1.19 | 1 mL | 1 | ||||
1–1.09 | 0.94 mL | 1 | ||||
0.9–0.99 | 0.85 mL | 1 | ||||
0.8–0.89 | 0.76 mL | 1 | ||||
0.7–0.79 | 0.67 mL | 1 | ||||
0.6–0.69 | 0.57 mL | 1 | ||||
0.5–0.59 | 0.48 mL | 1 | ||||
0.4–0.49 | 0.39 mL | 1 | ||||
48 hours | 15 mcg/m2 / day |
5 mL/ hour |
||||
1.5–1.59 | 4.2 mL | 2 | ||||
1.4–1.49 | 3.9 mL | 2 | ||||
1.3–1.39 | 3.7 mL | 2 | ||||
1.2–1.29 | 3.4 mL | 2 | ||||
1.1–1.19 | 3.1 mL | 2 | ||||
1–1.09 | 2.8 mL | 1 | ||||
0.9–0.99 | 2.6 mL | 1 | ||||
0.8–0.89 | 2.3 mL | 1 | ||||
0.7–0.79 | 2 mL | 1 | ||||
0.6–0.69 | 1.7 mL | 1 | ||||
0.5–0.59 | 1.4 mL | 1 | ||||
0.4–0.49 | 1.2 mL | 1 |
Under aseptic conditions, attach the IV tubing to the IV bag with the sterile 0.2 micron in-line filter.
Remove air from the IV bag. This is particularly important for use with an ambulatory infusion pump.
Store at 2°C to 8°C (36°F to 46°F) if not used immediately.*
*Additional storage directions and maximum storage times are listed in the BLINCYTO® Prescribing Information.
IMPORTANT NOTE: Do not flush the BLINCYTO® infusion line or IV 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 multilumen venous catheter, BLINCYTO® should be infused through a dedicated lumen.
In order to prepare BLINCYTO® solution for a 7-day infusion, you will need to know:
It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose).
When preparing BLINCYTO® solution for infusion, it is important to remember the volume of reconstituted BLINCYTO® used differs depending on the dose, infusion duration, and patient's weight/BSA.
Verify the prescribed dose and infusion duration for each BLINCYTO® infusion bag. To minimize errors, use the specific volumes described in the table below to prepare the BLINCYTO® infusion bag.
Aseptically add 90 mL Bacteriostatic 0.9% Sodium Chloride Injection, USP to the empty IV bag.
Aseptically transfer 2.2 mL IVSS to the IV bag containing the Bacteriostatic 0.9% Sodium Chloride Injection, USP.
Aseptically transfer the required volume of reconstituted BLINCYTO® into the IV bag containing Bacteriostatic 0.9% Sodium Chloride Injection, USP and IVSS.
Bacteriostic 0.9% Sodium Chloride (starting volume) | 90 mL | |||
IVSS (fixed volume for 7-day infusion) | 2.2 mL | |||
Dose | BSA (m2) | Vials | Reconstituted BLINCYTO® | 0.9% Sodium Chloride, USP to qs to a final volume of 110 mL§ |
---|---|---|---|---|
For patients weighing 45 kg or more | ||||
28 mcg/day
Infused over 7 days at a rate of 0.6 mL/hour |
6 | 16.8 mL | 1 mL | |
For patients weighing 22 kg to less than 45 kg (BSA -based dose ) | ||||
15 mcg/m2/day
Infused over 7 days at a rate of 0.6 mL/hour |
||||
1.5–1.59 | 5 | 14 mL | 3.8 mL | |
1.4–1.49 | 5 | 13.1 mL | 4.7 mL | |
1.3–1.39 | 5 | 12.2 mL | 5.6 mL | |
1.2–1.29 | 5 | 11.3 mL | 6.5 mL | |
1.1–1.19 | 4 | 10.4 mL | 7.4 mL | |
1–1.09 | 4 | 9.5 mL | 8.3 mL | |
0.9–0.99 | 4 | 8.6 mL | 9.2 mL |
Aseptically transfer the required volume of 0.9% Sodium Chloride Injection, USP to the IV bag to a final volume of 110 mL.
Under aseptic conditions, attach the IV tubing to the IV bag.
Remove air from the IV bag. This is particularly important for use with an ambulatory infusion pump.
Store at 2°C to 8°C (36°F to 46°F) if not used immediately.**
**Additional storage directions and maximum storage times are listed in the BLINCYTO® Prescribing Information.
IMPORTANT NOTE: Do not flush the BLINCYTO® infusion line or IV 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 multilumen venous catheter, BLINCYTO® should be infused through a dedicated lumen.
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
Reference: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen.