CD19 monoclonal antibodies
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Blincyto Dosage

Drug Detail:Blincyto (Blinatumomab [ blin-a-toom-oh-mab ])

Generic Name: BLINATUMOMAB 12.5ug in 1mL;

Dosage Form: injection

Drug Class: CD19 monoclonal antibodies

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

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.
  • 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, 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 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 Injection, USP (containing 0.9% benzyl alcohol).

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)
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-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 of 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 Injection, USP (containing 0.9% benzyl alcohol).

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 3. 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 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 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.
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 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

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), 48 hours (preservative-free), 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.

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 Injection, USP (containing 0.9% benzyl alcohol).

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 intravenous 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 the recommended dose.

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, DEHP-free PVC, or ethyl vinyl acetate (EVA) infusion bags/pump cassettes.
  • Use polyolefin, DEHP-free PVC, or EVA intravenous tubing sets.

Preparation and Administration of BLINCYTO as a 24-Hour or 48-Hour 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.

2.5.1 Reconstitution of BLINCYTO for 24-Hour or 48-Hour 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.

2.5.2 Preparation of BLINCYTO Infusion Bag for 24-Hour 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 4 and 5 to prepare the BLINCYTO infusion bag.

  • Table 4 for patients weighing 45 kg or more
  • Table 5 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 solution 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 Table 4 for patients weighing 45 kg or more for the specific volume of reconstituted BLINCYTO.
      • Refer to Table 5 for patients weighing less than 45 kg (dose based on BSA) 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 refrigerated at 2°C to 8°C (36°F to 46°F) if not used immediately [see Dosage and Administration (2.7)].
Table 4. For Patients Weighing 45 kg or More: Volumes to Add to Intravenous Bag
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
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
Table 5. For Patients Weighing Less Than 45 kg: Volumes to Add to Intravenous Bag
0.9% Sodium Chloride Injection, USP (starting volume) 270 mL
IV Solution Stabilizer (fixed volume for 24-hour and 48-hour infusion) 5.5 mL
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

2.5.3 Administration of BLINCYTO for 24-Hour or 48-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
  • Administer prepared BLINCYTO final infusion solution using intravenous tubing that contains a sterile, non-pyrogenic, low protein-binding, 0.2 micron in-line filter. For 7-day bag administration information see section 2.6.3 below [see Dosage and Administration (2.6)].
  • 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, infuse BLINCYTO through a dedicated lumen.
  • At the end of the infusion, discard any unused BLINCYTO solution in the intravenous bag and intravenous tubing in accordance with local requirements.

Preparation and Administration of BLINCYTO as a 7-Day Infusion using Bacteriostatic 0.9% Sodium Chloride Injection, USP (Preservative)

​Use preservative-free Sterile Water for Injection to reconstitute BLINCYTO. Do not reconstitute BLINCYTO vials with the IV Solution Stabilizer.

Do not use an in-line filter with a 7-day infusion bag.

Prime the intravenous tubing only with the solution in the bag containing the FINAL prepared solution for infusion. Do not prime with 0.9% Sodium Chloride Injection, USP.

2.6.1 Reconstitution of BLINCYTO for 7-Day Infusion

  1. Determine the number of BLINCYTO vials needed for a dose.
  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 the 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.

2.6.2 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 6 to prepare the BLINCYTO infusion bag.

  1. Aseptically add 90 mL Bacteriostatic 0.9% Sodium Chloride Injection, USP to the empty intravenous bag.
  2. Aseptically transfer 2.2 mL IV Solution Stabilizer to the intravenous bag containing Bacteriostatic 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 solution into the intravenous bag containing Bacteriostatic 0.9% Sodium Chloride Injection, USP and IV Solution Stabilizer. Gently mix the contents of the bag to avoid foaming.
    • Refer to Table 6 for the specific volume of reconstituted BLINCYTO. Discard the vial containing unused BLINCYTO.
  4. Aseptically add the required volume of 0.9% Sodium Chloride Injection, USP to the intravenous bag to obtain a final volume of 110 mL. Gently mix the contents of the bag to avoid foaming.
    • Refer to Table 6 for the specific volume of 0.9% Sodium Chloride Injection, USP.
  5. Under aseptic conditions, attach the intravenous tubing to the intravenous bag.
    • Ensure that the intravenous tubing is compatible with the infusion pump.
    • Do not use an in-line filter for a 7-day bag.
  6. Remove air from the intravenous bag. This is particularly important for use with an ambulatory infusion pump.
  7. Prime the intravenous tubing only with the solution in the bag containing the FINAL prepared BLINCYTO solution for infusion.
  8. Store refrigerated at 2°C to 8°C (36°F to 46°F) if not used immediately [see Dosage and Administration (2.7)].
Table 6. For 7-Day Infusion: Volumes to Add to Intravenous Bag for 28 mcg/day and 15 mcg/m2/day
*
The safety of the administration of BLINCYTO at a BSA of less than 0.4 m2 has not been established.
Bacteriostatic 0.9% Sodium Chloride Injection, USP (starting volume) 90 mL
IV Solution Stabilizer (fixed volume for 7-day infusion) 2.2 mL
Reconstituted BLINCYTO Specific volume listed below in table
Quantity Sufficient (q.s.) with 0.9% Sodium Chloride Injection, USP to a Final Volume of 110 mL Specific volume listed below in table
Infusion Duration 7 days
Infusion Rate 0.6 mL/hour
​Patient Weight Dose BSA (m2)* Reconstituted
BLINCYTO		 Volume of 0.9% Sodium
Chloride Injection, USP needed to q.s. to a Final Volume of 110 mL
Volume Vials
Fixed-Dose
45 kg or More 28 mcg/day N/A 16.8 mL 6 1 mL
BSA-Based Dose
​Less than 45 kg 15 mcg/m2/day 1.5 – 1.59 14 mL 5 3.8 mL
1.4 – 1.49 13.1 mL 5 4.7 mL
1.30 – 1.39 12.2 mL 5 5.6 mL
1.20 – 1.29 11.3 mL 5 6.5 mL
1.10 – 1.19 10.4 mL 4 7.4 mL
1 – 1.09 9.5 mL 4 8.3 mL
0.9 – 0.99 8.6 mL 4 9.2 mL
0.8 – 0.89 7.7 mL 3 10.1 mL
0.7 – 0.79 6.8 mL 3 11 mL
0.6 – 0.69 5.9 mL 3 11.9 mL
0.5 – 0.59 5 mL 2 12.8 mL
0.4 – 0.49 4.1 mL 2 13.7 mL

2.6.3 Administration of BLINCYTO as a 7-Day 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 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 intravenous tubing and to ensure that the patient will receive the full dose of BLINCYTO.
  • Do not use an in-line filter for a 7-day bag.
  • Infuse prepared BLINCYTO final infusion 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, infuse BLINCYTO through a dedicated lumen.
  • At the end of the infusion, dispose of any unused BLINCYTO solution in the intravenous bag and intravenous tubing in accordance with local requirements.

Storage of Reconstituted BLINCYTO

The information in Table 7 indicates the storage time for the reconstituted BLINCYTO vial and prepared infusion bag.

Table 7. 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 Infusion Bag
(Preservative-free)		 48 hours* 8 days
Prepared BLINCYTO Infusion Bag
(with Preservative)		 7 days* 14 days
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