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Blincyto Dosage

Generic name: BLINATUMOMAB 12.5ug in 1mL;
Dosage form: injection

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Dosage

• 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.

• See Table 1 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).

Table 1. Recommended BLINCYTO Dosage and Schedule

Patient Weight
Cycle Greater than or equal to 45 kg (fixed-dose) Less than 45 kg
(BSA-based dose)
Induction Cycle 1
Days 1-7 9 mcg/day 5 mcg/m2/day
(not to exceed 9 mcg/day)
Days 8-28 28 mcg/day 15 mcg/m2/day
(not to exceed 28 mcg/day)
Days 29-42 14-day treatment-free interval 14-day treatment-free interval
Induction Cycle 2
Days 1-28 28 mcg/day 15 mcg/m2/day
(not to exceed 28 mcg/day)
Days 29-42 14-day treatment-free interval 14-day treatment-free interval
Consolidation Cycles 3-5
Days 1-28 28 mcg/day 15 mcg/m2/day
(not to exceed 28 mcg/day)
Days 29-42 14-day treatment-free interval 14-day treatment free interval
Continued Therapy Cycles 6-9
Days 1-28 28 mcg/day 15 mcg/m2/day
(not to exceed 28 mcg/day)
Days 29-84 56-day treatment-free interval 56-day treatment-free interval

• 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).

Special Considerations

• 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.

• 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 Section 2.5 for infusion over 24 hours or 48 hours.
° See Section 2.6 for infusion over 7 days using Bacteriostatic 0.9% Sodium Chloride, USP (containing 0.9% benzyl alcohol). This option is available for patients weighing greater than or equal to 22 kg. It is not recommended for use in patients weighing less than 22 kg.

Dosage Adjustments

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.

Toxicity Grade* Patients Greater Than
or Equal to 45 kg
Patients Less Than 45 kg
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.
Withhold BLINCYTO until resolved, then restart BLINCYTO at 5 mcg/m2/day. Escalate to 15 mcg/m2/day after 7 days if the toxicity does not recur.
Grade 4 Discontinue BLINCYTO permanently.
Neurological Toxicity 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.
Withhold BLINCYTO until no more than Grade 1 (mild) and for at least 3 days, then restart BLINCYTO at 5 mcg/m2/day. Escalate to 15 mcg/m2/day after 7 days if the toxicity does not recur. If the toxicity occurred at 5 mcg/m2/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.
Withhold BLINCYTO until no more than Grade 1 (mild), then restart BLINCYTO at 5 mcg/m2/day. Escalate to 15 mcg/m2/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.
*Based on the Common Terminology Criteria for Adverse Events (CTCAE). Grade 3 is severe, and Grade 4 is life-threatening.

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 Warnings and Precautions (5.10)].

BLINCYTO can be infused over 24 hours (preservative-free) or 48 hours (preservative-free), or 7 days (with preservative). 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. The 7- day infusion is not recommended for patients weighing less than 22 kg.

For preparation, reconstitution, and administration of BLINCYTO:

▪ See Section 2.5 for infusion over 24 hours or 48 hours.

▪ See Section 2.6 for infusion over 7 days using Bacteriostatic 0.9% Sodium Chloride, USP (containing 0.9% benzyl alcohol). This option is available for patients weighing greater than or equal to 22 kg. It is not recommended for patients weighing less than 22 kg.

Call 1-800-77-AMGEN (1-800-772-6436) if you have questions about the reconstitution and preparation of BLINCYTO.

2.4.1 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.

2.4.2 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 IV bags and IV tubing.

• More than 1 package of BLINCYTO may be needed to prepare some of the prescribed doses.

2.4.3 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.

24-Hour or 48-Hour Infusion of BLINCYTO

2.5.1 Preparation of BLINCYTO Infusion Bag for 24- or 48-Hour Infusion

Verify the prescribed dose and infusion duration for each BLINCYTO infusion bag. To minimize errors, use the specific volumes described in Tables 2 to 4 to prepare the BLINCYTO infusion bag.

• Table 2 for patients weighing greater than or equal to 45 kg

• Tables 3 and 4 for patients weighing less than 45 kg

1. Aseptically add 270 mL 0.9% Sodium Chloride Injection, USP to the IV bag.

2. Aseptically transfer 5.5 mL IV Solution Stabilizer to the IV 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 reconstituted BLINCYTO [see Dosage and Administration (2.5.2)] into the IV 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 2 to 4 for the specific volume of reconstituted BLINCYTO.

4. Under aseptic conditions, attach the IV tubing to the IV bag with the sterile 0.2 micron in-line filter.
• Ensure that the IV tubing is compatible with the infusion pump.

5. Remove air from the IV bag. This is particularly important for use with an ambulatory infusion pump. Prime the IV tubing only with the prepared solution for infusion. Do not prime with 0.9% Sodium Chloride Injection, USP.

6. Store at 2°C to 8°C if not used immediately [see Dosage and Administration (2.7)].

Table 2. For Patients Weighing Greater Than or Equal to 45 kg: Volumes to Add to IV Bag
0.9% Sodium Chloride Injection, USP (starting volume) 270 mL
IV Solution Stabilizer 5.5 mL
Dose Infusion Duration Infusion Rate Reconstituted
BLINCYTO
9 mcg/day 24 hours 10 mL/hour 0.83 mL
48 hours 5 mL/hour 1.7 mL
28 mcg/day 24 hours 10 mL/hour 2.6 mL
48 hours 5 mL/hour 5.2 mL*

* 2 packages of BLINCYTO are needed for preparation of 28 mcg/day dose infused over 48 hours at a rate of 5 mL/hour.

Table 3. For Patients Weighing Less Than 45 kg: Volumes to Add to IV Bag for 5 mcg/m2/day Dose
0.9% Sodium Chloride Injection, USP (starting volume) 270 mL
IV Solution Stabilizer 5.5 mL
Dose Infusion Duration Infusion Rate BSA (m2) Reconstituted BLINCYTO
5 mcg/m2/day 24 hours 10 mL/hour 1.5 – 1.59 0.7 mL
1.4 – 1.49 0.66 mL
1.3 – 1.39 0.61 mL
1.2 – 1.29 0.56 mL
1.1 – 1.19 0.52 mL
1 – 1.09 0.47 mL
0.9 – 0.99 0.43 mL
0.8 – 0.89 0.38 mL
0.7 – 0.79 0.33 mL
0.6 – 0.69 0.29 mL
0.5 – 0.59 0.24 mL
0.4 – 0.49 0.2 mL
5 mcg/m2/day 48 hours 5 mL/hour 1.5 – 1.59 1.4 mL
1.4 – 1.49 1.3 mL
1.3 – 1.39 1.2 mL
1.2 – 1.29 1.1 mL
1.1 – 1.19 1 mL
1 – 1.09 0.94 mL
0.9 – 0.99 0.85 mL
0.8 – 0.89 0.76 mL
0.7 – 0.79 0.67 mL
0.6 – 0.69 0.57 mL
0.5 – 0.59 0.48 mL
0.4 – 0.49 0.39 mL

Table 4. For Patients Weighing Less Than 45 kg: Volumes to Add to IV Bag for 15 mcg/m2/day Dose
0.9% Sodium Chloride Injection, USP (starting volume) 270 mL
IV Solution Stabilizer 5.5 mL
Dose Infusion Duration Infusion Rate BSA (m2) Reconstituted BLINCYTO
15 mcg/m2/day 24 hours 10 mL/hour 1.5 – 1.59 2.1 mL
1.4 – 1.49 2 mL
1.3 – 1.39 1.8 mL
1.2 – 1.29 1.7 mL
1.1 – 1.19 1.6 mL
1 – 1.09 1.4 mL
0.9 – 0.99 1.3 mL
0.8 – 0.89 1.1 mL
0.7 – 0.79 1 mL
0.6 – 0.69 0.86 mL
0.5 – 0.59 0.72 mL
0.4 – 0.49 0.59 mL
15 mcg/m2/day 48 hours 5 mL/hour 1.5 – 1.59 4.2 mL*
1.4 – 1.49 3.9 mL*
1.3 – 1.39 3.7 mL*
1.2 – 1.29 3.4 mL*
1.1 – 1.19 3.1 mL*
1 – 1.09 2.8 mL
0.9 – 0.99 2.6 mL
0.8 – 0.89 2.3 mL
0.7 – 0.79 2 mL
0.6 – 0.69 1.7 mL
0.5 – 0.59 1.4 mL
0.4 – 0.49 1.2 mL

* 2 packages of BLINCYTO are needed for preparation of 15 mcg/m2/day dose infused over 48 hours at a rate of 5 mL/hour for patients with a BSA greater than 1.09 m2.

2.5.2 Reconstitution of BLINCYTO

1. Add 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 (resulting in a final BLINCYTO concentration of 12.5 mcg/mL).

Do not reconstitute BLINCYTO with IV Solution Stabilizer.

2. Gently swirl contents to avoid excess foaming. Do not shake.

3. 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.

2.5.3 Administration

• 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.

• Prepared BLINCYTO infusion bags [see Dosage and Administration (2.5.1)] should be infused over 24 hours or 48 hours.

• The starting volume (270 mL) is more than the volume administered to the patient (240 mL) to account for the priming of the IV tubing and to ensure that the patient will receive the full dose of BLINCYTO.

• Infuse BLINCYTO 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

• The BLINCYTO solution 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 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 IV bag and IV tubing should be disposed of in accordance with local requirements.

7-Day Infusion of BLINCYTO using Bacteriostatic Saline

This option is not recommended for use in patients weighing less than 22 kg [see Warnings and Precautions (5.12) and Use in Specific Populations (8.4)].

2.6.1 Preparation of BLINCYTO Infusion Bag for 7-Day Infusion

Verify the prescribed dose and infusion duration for each BLINCYTO infusion bag. To minimize errors, use the specific volumes described in Table 5 to prepare the BLINCYTO infusion bag.

1. Aseptically add 90 mL Bacteriostatic 0.9% Sodium Chloride, USP to the empty IV bag.

2. Aseptically transfer 2.2 mL IV Solution Stabilizer to the IV bag containing the saline solution. Gently mix the contents of the bag to avoid foaming. Discard the vial containing the unused IV Solution Stabilizer.

3. Aseptically transfer reconstituted BLINCYTO [see Dosage and Administration (2.6.2)] into the IV bag containing the saline solution and IV Solution Stabilizer. Gently mix the contents of the bag to avoid foaming.

• Refer to Table 5 for the specific volume of reconstituted BLINCYTO.

4. Aseptically add 0.9% Sodium Chloride Injection, USP to the IV bag to a final volume of 110 mL resulting in 0.74% benzyl alcohol. Gently mix the contents of the bag to avoid foaming.

• Refer to Table 5 for the specific volume of 0.9% Sodium Chloride Injection, USP

5. Under aseptic conditions, attach the IV tubing to the IV bag. An in-line filter is not required for a 7-day bag.

• Ensure that the IV tubing is compatible with the infusion pump.

6. Remove air from the IV bag. This is particularly important for use with an ambulatory infusion pump. Prime the IV tubing only with the prepared solution for infusion. Do not prime with 0.9% Sodium Chloride Injection, USP.

7. Store at 2°C to 8°C if not used immediately [see Dosage and Administration (2.7)].

Table 5. For 7-Day Infusion: Volumes to Add to IV Bag for 28 mcg/day and 15 mcg/m2/day; Not Recommended for Patients Less Than 22 kg
Bacteriostatic 0.9% Sodium Chloride (starting volume) 90 mL
IV Solution Stabilizer 2.2 mL
Reconstituted BLINCYTO Specific volume listed below in table
Quantity Sufficient (qs) with 0.9% Sodium Chloride, USP to a Final Volume of 110 mL
Infusion Duration 7 days
Infusion Rate 0.6 mL/hour
Patient Weight Dose BSA (m2) Number of BLINCYTO Packages Reconstituted
BLINCYTO
0.9% Sodium
Chloride Injection, USP to qs to a Final Volume of 110 mL

Greater than or equal to 45 kg
(fixed-dose)
28 mcg/day 6 16.8 mL 1 mL
22-45 kg
(BSA-based dose)
15 mcg/m2/day 1.5 – 1.59 5 14 mL 3.8 mL
1.4 – 1.49 5 13.1 mL 4.7 mL
1.30 – 1.39 5 12.2 mL 5.6 mL
1.20 – 1.29 5 11.3 mL 6.5 mL
1.10 – 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

2.6.2 Reconstitution of BLINCYTO

1. Add 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 (resulting in a final BLINCYTO concentration of 12.5 mcg/mL).

Do not reconstitute BLINCYTO with IV Solution Stabilizer.

2. Gently swirl contents to avoid excess foaming. Do not shake.

3. 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.

2.6.3 Administration

• 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.

• Prepared BLINCYTO infusion bags [see Dosage and Administration (2.6.1)] should be infused over 7 days.

• The final volume of infusion solution (110 mL) will be more than the volume administered to the patient (100 mL) to account for the priming of the IV tubing and to ensure that the patient will receive the full dose of BLINCYTO.

• Infuse BLINCYTO solution according to the instructions on the pharmacy label on the prepared bag at an infusion rate of 0.6 mL/hour for a duration of 7 days.

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 IV bag and IV tubing should be disposed of in accordance with local requirements.

Storage Requirements

The information in Table 6 indicates the storage time for the reconstituted BLINCYTO vial and prepared infusion bag.

Store lyophilized BLINCYTO and IV Solution Stabilizer vials for a maximum of 8 hours at room temperature in the original carton to protect from light [see How Supplied/Storage and Handling (16.2)].

Table 6. Storage Time for Reconstituted BLINCYTO Vial and Prepared BLINCYTO Infusion Bag
Maximum Storage Time
Room Temperature
23°C to 27°C
(73°F to 81°F)
Refrigerated
2°C to 8°C
(36°F to 46°F)
Reconstituted BLINCYTO Vial 4 hours 24 hours
Prepared BLINCYTO Infusion Bag
(Preservative-Free)
48 hours* 8 days
Prepared BLINCYTO Infusion Bag
(with Preservative)
7 days* 14 days

* Storage time includes infusion time. If the prepared BLINCYTO infusion bag is not administered within the time frames and temperatures indicated, it must be discarded; it should not be refrigerated again.

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