Blincyto Dosage

Generic name: BLINATUMOMAB 12.5ug in 1mL;
Dosage form: injection
Drug class: Bispecific T-cell engagers (BiTE)

Medically reviewed by Drugs.com. Last updated on Dec 19, 2024.

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 1 for the recommended dose by patient weight and schedule. Patients weighing 45 kg or more receive a fixed-dose. For patients weighing less than 45 kg, the dose is calculated using the patient's body surface area (BSA).

Table 1. Recommended BLINCYTO Dose and Schedule for the Treatment of MRD-positive B-cell Precursor ALL
Cycle	Patients Weighing 45 kg or More (Fixed-dose)	Patients Weighing Less Than 45 kg (BSA-based dose)
Induction Cycle 1
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 2-4
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

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 pediatric patients, premedicate with 5 mg/m2 of dexamethasone intravenously or orally, to a maximum dose of 20 mg, prior to the first dose of BLINCYTO in the first cycle and when restarting an infusion after an interruption of 4 or more hours in the first cycle.
For administration of BLINCYTO:
- See Instructions for Use for infusion over 24 hours or 48 hours.
- See Instructions for Use for infusion over 72 hours, 96 hours, or 7 days using Bacteriostatic 0.9% Sodium Chloride Injection (containing 0.9% benzyl alcohol). The administration of BLINCYTO as a 72-hour, 96-hour, and 7-day infusion is not recommended for patients weighing less than 5.4 kg.

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 2 for the recommended dose by patient weight and schedule. Patients weighing 45 kg or more receive a fixed-dose and for patients weighing less than 45 kg, the dose is calculated using the patient's BSA.

Table 2. Recommended BLINCYTO Dose and Schedule for the Treatment of Relapsed or Refractory B-cell Precursor ALL
Cycle	Patients Weighing 45 kg or More (Fixed-dose)	Patients Weighing Less Than 45 kg (BSA-based dose)
Cycle	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

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-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 dexamethasone:
- For adult patients, premedicate with 20 mg of dexamethasone intravenously or orally 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 intravenously or orally, 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 Instructions for Use for infusion over 24 hours or 48 hours.
- See Instructions for Use for infusion over 72 hours, 96 hours, or 7 days using Bacteriostatic 0.9% Sodium Chloride Injection (containing 0.9% benzyl alcohol). The administration of BLINCYTO as a 72-hour, 96-hour, and 7-day infusion is not recommended for patients weighing less than 5.4 kg.

Treatment of B-cell Precursor ALL in the Consolidation Phase

A single cycle of BLINCYTO monotherapy in consolidation is 28 days of continuous infusion followed by a 14-day treatment-free interval (total 42 days).
Patients weighing 45 kg or more receive a fixed-dose, and for patients weighing less than 45 kg, the dose is calculated using the patient's BSA (see Table 3).

Table 3. Recommended BLINCYTO Dose and Schedule in the Consolidation Phase of Treatment of B-cell Precursor ALL
BLINCYTO Consolidation Cycle	Patients Weighing 45 kg or More (Fixed-dose)	Patients Weighing Less Than 45 kg (BSA-based dose)
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

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 dexamethasone:
- For adult patients, premedicate with dexamethasone 20 mg intravenously within 1 hour prior to the first dose of BLINCYTO of each cycle.
- For pediatric patients, premedicate with 5 mg/m2 of dexamethasone intravenously or orally, to a maximum dose of 20 mg prior to the first dose of BLINCYTO in the first cycle and when restarting an infusion after an interruption of 4 or more hours in the first cycle.
For administration of BLINCYTO:
- See Instructions for Use for infusion over 24 hours or 48 hours.
- See Instructions for Use for infusion over 72 hours, 96 hours, or 7 days using Bacteriostatic 0.9% Sodium Chloride Injection (containing 0.9% benzyl alcohol). The administration of BLINCYTO as a 72-hour, 96-hour, and 7-day infusion is not recommended for patients weighing less than 5.4 kg.

Dosage Modifications for Adverse Reactions

If the interruption after an adverse reaction 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 reaction is longer than 7 days, start a new cycle.

Table 4. Dosage Modifications for Adverse Reactions
Adverse Reaction	Grade*	Patients Weighing 45 kg or More	Patients Weighing Less Than 45 kg
* Based on the Common Terminology Criteria for Adverse Events (CTCAE). Grade 3 is severe, and Grade 4 is life-threatening.
Cytokine Release Syndrome (CRS)	Grade 3	Interrupt BLINCYTO. Administer dexamethasone 8 mg every 8 hours intravenously or orally for up to 3 days and taper thereafter over 4 days. When CRS is resolved, restart BLINCYTO at 9 mcg/day, and escalate to 28 mcg/day after 7 days if the adverse reaction does not recur.	Interrupt BLINCYTO. Administer dexamethasone 5 mg/m2 (maximum 8 mg) every 8 hours intravenously or orally for up to 3 days and taper thereafter over 4 days. When CRS is resolved, restart BLINCYTO at 5 mcg/m2/day, and escalate to 15 mcg/m2/day after 7 days if the adverse reaction does not recur.
	Grade 4	Discontinue BLINCYTO permanently. Administer dexamethasone as instructed for Grade 3 CRS.
Neurological Toxicity	Seizure	Discontinue BLINCYTO permanently if more than one seizure occurs.
	Grade 2 ICANS	Interrupt BLINCYTO until ICANS resolves. Administer corticosteroids and manage according to current practice guidelines. When ICANS is resolved, restart BLINCYTO at 9 mcg/day. Escalate to 28 mcg/day after 7 days if the adverse reaction does not recur.	Interrupt BLINCYTO until ICANS resolves. Administer corticosteroids and manage according to current practice guidelines. When ICANS is resolved, restart BLINCYTO at 5 mcg/m2/day. Escalate to 15 mcg/m2/day after 7 days if the adverse reaction does not recur.
	Grade 3 Neurologic Events including ICANS	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 adverse reaction does not recur. If the adverse reaction occurred at 9 mcg/day, or if the adverse reaction 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 adverse reaction does not recur. If the adverse reaction occurred at 5 mcg/m2/day, or if the adverse reaction takes more than 7 days to resolve, discontinue BLINCYTO permanently.
		If ICANS, administer corticosteroids and manage according to current practice guidelines.
	Grade 4	Discontinue BLINCYTO permanently.
	Neurologic Events including ICANS	If ICANS, administer corticosteroids and manage according to current practice guidelines.
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 adverse reaction does not recur. If the adverse reaction 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 adverse reaction does not recur. If the adverse reaction takes more than 14 days to resolve, discontinue BLINCYTO permanently.
	Grade 4	Consider discontinuing BLINCYTO permanently.

Preparation and Administration of BLINCYTO

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).

BLINCYTO can be infused over 24 hours (preservative-free), 48 hours (preservative-free), 72 hours (with preservative), 96 hours (with preservative), or 7 days (with preservative). The choice between these options for the infusion duration should be made by the treating healthcare provider considering the frequency of the infusion bag changes and the weight of the patient. The administration of BLINCYTO as a 72-hour, 96-hour, and 7-day infusion is not recommended for patients weighing less than 5.4 kg.

For preparation, reconstitution, and administration of BLINCYTO:

The BLINCYTO Instructions for Use contains more detailed instructions on the preparation of infusion.

The preparation steps differ based on the infusion duration. Follow the steps specific to the infusion duration you are preparing.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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

Storage of Reconstituted BLINCYTO

The information in Table 5 indicates the storage time for the reconstituted BLINCYTO vial and prepared infusion bag.

Table 5. 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)
* 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.
Reconstituted BLINCYTO Vial	4 hours	24 hours
Prepared BLINCYTO 24-Hour and 48-Hour Infusion Bag (Preservative-free)	48 hours*	8 days
Prepared BLINCYTO 72-Hour and 96-Hour Infusion Bag (with Preservative)	4 days*	14 days
Prepared BLINCYTO 7-Day Infusion Bag (with Preservative)	7 days*	14 days