Blinatumomab
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]
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Black Box Warning
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WARNINGTITLE
See full prescribing information for complete Boxed Warning.
CYTOKINE RELEASE SYNDROME AND NEUROLOGICAL TOXICITIES
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Overview
Blinatumomab is an antineoplastic agent that is FDA approved for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).. There is a Black Box Warning for this drug as shown here. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Acute lymphoblastic leukemia
- BLINCYTO is indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
- This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials
Dosing Information
- 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 reinitiation (eg, if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is recommended.
- Do not flush the BLINCYTO infusion line especially when changing infusion bags. Flushing when changing bags or at completion of infusion can result in excess dosage and complications thereof. Preparation and administration errors resulting in overdose have occurred .
Dosage
- A single cycle of treatment of BLINCYTO consists of 4 weeks of continuous intravenous infusion followed by a 2-week treatment-free interval.
- For patients at least 45 kg in weight:
- In Cycle 1, administer BLINCYTO at 9 mcg/day on Days 1–7 and at 28 mcg/day on Days 8-28.
- For subsequent cycles, administer BLINCYTO at 28 mcg/day on Days 1–28.
- Allow for at least 2 weeks treatment-free between cycles of BLINCYTO.
- A treatment course consists of up to 2 cycles of BLINCYTO for induction followed by 3 additional cycles for consolidation treatment (up to a total of 5 cycles).
Administration
- Premedicate with dexamethasone 20 mg intravenously 1 hour prior to the first dose of BLINCYTO of each cycle, prior to a step dose (such as Cycle 1 day 8), or when restarting an infusion after an interruption of 4 or more hours.
- 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.
- BLINCYTO infusion bags should be infused over 24 hours or 48 hours . Infuse the total 240 mL BLINCYTO solution according to the instructions on the pharmacy label on the bag at one of the following constant infusion rates:
- Infusion rate of 10 mL/h for a duration of 24 hours, OR
- Infusion rate of 5 mL/h for a duration of 48 hours
- The BLINCYTO solution for infusion 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 infusion line, especially when changing infusion bags. Flushing when changing bags or at completion of infusion can result in excess dosage. BLINCYTO should be infused through a dedicated lumen.
- At the end of the infusion, any unused BLINCYTO solution in the IV bag and IV lines should be disposed of in accordance with local requirements.
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.
table02
Reconstitution and Preparation of Solution for Infusion
- 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) .
Gather Supplies
NOTE: 1 package BLINCYTO includes 1 vial of BLINCYTO and 1 vial of IV Solution Stabilizer.
- Before preparation, ensure you have the following supplies ready:
- 1 package of BLINCYTO for preparation of 9 mcg/day dose infused over 24 hours at a rate of 10 mL/h, 9 mcg/day dose infused over 48 hours at a rate of 5 mL/h, and 28 mcg/day dose infused over 24 hours at a rate of 10 mL/h
- 2 packages of BLINCYTO for preparation of 28 mcg/day dose infused over 48 hours at a rate of 5 mL/h
- The following supplies are also required, but not included in the package:
- Sterile, single-use disposable syringes
- 21- to 23- gauge needle(s) (recommended)
- Preservative-free Sterile Water for Injection, USP
- 250 mL 0.9% Sodium Chloride IV bag
- To minimize the number of aseptic transfers, it is recommended to use a 250 mL-prefilled IV bag. 250 mL-prefilled IV bags typically contain overfill with a total volume of 265 to 275 mL. BLINCYTO dose calculations provided in section 2.4.4 are based on a starting volume of 265 mL to 275 mL 0.9% Sodium Chloride.
- Use only polyolefin, PVC non-di-ethylhexylphthalate (non-DEHP), or ethyl vinyl acetate (EVA) infusion bags/pump cassettes.
- Polyolefin, PVC non-DEHP, or EVA IV tubing with a sterile, non-pyrogenic, low protein-binding 0.2 micron in-line filter
- Ensure that the IV tubing is compatible with the infusion pump.
Aseptic Preparation
- Aseptic technique must be strictly observed 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:
- Preparation must be done in a USP <797> compliant facility.
- Preparation must be done in an ISO Class 5 laminar flow hood or better.
- The admixing area should have appropriate environmental specifications, confirmed by periodic monitoring.
- Personnel should be appropriately trained in aseptic manipulations and admixing of oncology drugs.
- Personnel should wear appropriate protective clothing and gloves.
- Gloves and surfaces should be disinfected.
SPECIAL CONSIDERATIONS TO SUPPORT ACCURATE PREPARATION
- IV Solution Stabilizer is provided with the BLINCYTO package and is used to coat the prefilled IV bag prior to addition of reconstituted BLINCYTO to prevent adhesion of BLINCYTO to IV bags and IV lines. Therefore, add IV Solution Stabilizer to the IV bag containing 0.9% Sodium Chloride. Do not use IV Solution Stabilizer for reconstitution of BLINCYTO.
- The entire volume of the admixed BLINCYTO will be more than the volume administered to the patient (240 mL) to account for the priming of the IV line and to ensure that the patient will receive the full dose of BLINCYTO.
- When preparing an IV bag, remove air from IV bag. This is particularly important for use with an ambulatory infusion pump.
- Use the specific volumes described in the admixing instructions to minimize errors in calculation.
Preparation of BLINCYTO Solution for Infusion Using a Prefilled 250 mL 0.9% Sodium Chloride IV Bag
- Specific admixing instructions are provided for each dose and infusion time. Verify the prescribed dose and infusion time of BLINCYTO and identify the appropriate dosing preparation section listed below. Follow the steps for reconstituting BLINCYTO and preparing the IV bag.
- 9 mcg/day infused over 24 hours at a rate of 10 mL/h.
- 9 mcg/day infused over 48 hours at a rate of 5 mL/h.
- 28 mcg/day infused over 24 hours at a rate of 10 mL/h.
- 28 mcg/day infused over 48 hours at a rate of 5 mL/h.
Preparation of BLINCYTO 9 mcg/day infused over 24 hours at a rate of 10 mL/h
- Use a prefilled 250 mL 0.9% Sodium Chloride IV bag. 250 mL-prefilled bags typically contain overfill to a total volume of 265 to 275 mL. If necessary adjust the IV bag volume by adding or removing 0.9% Sodium Chloride to achieve a starting volume between 265 and 275 mL.
- Using a 10 mL syringe, aseptically transfer 5.5 mL of IV Solution Stabilizer to the IV bag with 0.9% Sodium Chloride. Gently mix the contents of the bag to avoid foaming. Discard remaining IV Solution Stabilizer vial.
- Using a 5 mL syringe, reconstitute one vial of BLINCYTO using 3 mL of preservative-free Sterile Water for Injection, USP. Direct preservative-free Sterile Water for Injection, USP, toward the side of the vial during reconstitution. Gently swirl contents to avoid excess foaming. Do not shake.
- Do not reconstitute BLINCYTO with IV Solution Stabilizer.
- The addition of preservative-free Sterile Water for Injection, USP, to the lyophilized powder results in a final BLINCYTO concentration of 12.5 mcg/mL.
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.
- Using a 1 mL syringe, aseptically transfer 0.83 mL of reconstituted BLINCYTO into the IV bag. Gently mix the contents of the bag to avoid foaming.
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 and prime the IV line only with the prepared solution for infusion. Do not prime with 0.9% Sodium Chloride.
- Store at 2°C to 8°C if not used immediately.
Preparation of BLINCYTO 9 mcg/day infused over 48 hours at a rate of 5 mL/h
- Use a prefilled 250 mL 0.9% Sodium Chloride IV bag. 250 mL-prefilled bags typically contain overfill to a total volume of 265 to 275 mL. If necessary adjust the IV bag volume by adding or removing 0.9% Sodium Chloride to achieve a starting volume between 265 and 275 mL.
- Using a 10 mL syringe, aseptically transfer 5.5 mL of IV Solution Stabilizer to the IV bag with 0.9% Sodium Chloride. Gently mix the contents of the bag to avoid foaming. Discard remaining IV Solution Stabilizer vial.
- Using a 5 mL syringe, reconstitute one vial of BLINCYTO using 3 mL of preservative-free Sterile Water for Injection, USP. Direct preservative-free Sterile Water for Injection, USP, toward the side of the vial during reconstitution. Gently swirl contents to avoid excess foaming. Do not shake.
- Do not reconstitute BLINCYTO with IV Solution Stabilizer.
- The addition of preservative-free Sterile Water for Injection, USP, to the lyophilized powder results in a final BLINCYTO concentration of 12.5 mcg/mL.
- 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.
- Using a 3 mL syringe, aseptically transfer 1.7 mL of reconstituted BLINCYTO into the IV bag. Gently mix the contents of the bag to avoid foaming.
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 and prime the IV line only with the prepared solution for infusion. Do not prime with 0.9% Sodium Chloride.
- Store at 2°C to 8°C if not used immediately.
Preparation of BLINCYTO 28 mcg/day infused over 24 hours at a rate of 10 mL/h
- Use a prefilled 250 mL 0.9% Sodium Chloride IV bag. 250 mL-prefilled bags typically contain overfill to a total volume of 265 to 275 mL. If necessary adjust the IV bag volume by adding or removing 0.9% Sodium Chloride to achieve a starting volume between 265 and 275 mL.
- Using a 10 mL syringe, aseptically transfer 5.6 mL of IV Solution Stabilizer to the IV bag with 0.9% Sodium Chloride. Gently mix the contents of the bag to avoid foaming. Discard remaining IV Solution Stabilizer vial.
- Using a 5 mL syringe, reconstitute one vial of BLINCYTO using 3 mL of preservative-free Sterile Water for Injection, USP. Direct preservative-free Sterile Water for Injection, USP, toward the side of the vial during reconstitution. Gently swirl contents to avoid excess foaming. Do not shake.
- Do not reconstitute BLINCYTO with IV Solution Stabilizer.
- The addition of preservative-free Sterile Water for Injection, USP, to the lyophilized powder results in a final BLINCYTO concentration of 12.5 mcg/mL.
- 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.
- Using a 3 mL syringe, aseptically transfer 2.6 mL of reconstituted BLINCYTO into the IV bag. Gently mix the contents of the bag to avoid foaming.
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 and prime the IV line only with the prepared solution for infusion. Do not prime with 0.9% Sodium Chloride.
- Store at 2°C to 8°C if not used immediately.
Preparation of BLINCYTO 28 mcg/day infused over 48 hours at a rate of 5 mL/h
- Use a prefilled 250 mL 0.9% Sodium Chloride IV bag. 250 mL-prefilled bags typically contain overfill to a total volume of 265 to 275 mL. If necessary adjust the IV bag volume by adding or removing 0.9% Sodium Chloride to achieve a starting volume between 265 and 275 mL.
- Using a 10 mL syringe, aseptically transfer 5.6 mL of IV Solution Stabilizer to the IV bag with 0.9% Sodium Chloride. Gently mix the contents of the bag to avoid foaming. Discard remaining IV Solution Stabilizer vials.
- Use two vials of BLINCYTO. Using a 5 mL syringe, reconstitute each vial of BLINCYTO using 3 mL of preservative-free Sterile Water for Injection, USP. Direct preservative-free Sterile Water for Injection, USP, toward the side of the vial during reconstitution. Gently swirl contents to avoid excess foaming. Do not shake.
- Do not reconstitute BLINCYTO with IV Solution Stabilizer.
- The addition of preservative-free Sterile Water for Injection, USP, to the lyophilized powder results in a final BLINCYTO concentration of 12.5 mcg/mL.
- 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.
- Using a 3 mL syringe, aseptically transfer 5.2 mL of reconstituted BLINCYTO into the IV bag (2.7 mL from one vial and the remaining 2.5 mL from the second vial). Gently mix the contents of the bag to avoid foaming.
- 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 and prime the IV line only with the prepared solution for infusion. Do not prime with 0.9% Sodium Chloride.
- Store at 2°C to 8°C if not used immediately.
Storage Requirements
- The information in Table 1 indicates the storage time for the reconstituted BLINCYTO vial and prepared IV bag containing BLINCYTO solution for infusion. Lyophilized BLINCYTO vial and IV Solution Stabilizer may be stored for a maximum of 8 hours at room temperature.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Blinatumomab in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Blinatumomab in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Blinatumomab FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Blinatumomab in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Blinatumomab in pediatric patients.
Contraindications
There is limited information regarding Blinatumomab Contraindications in the drug label.
Warnings
|
WARNINGTITLE
See full prescribing information for complete Boxed Warning.
CYTOKINE RELEASE SYNDROME AND NEUROLOGICAL TOXICITIES
|
There is limited information regarding Blinatumomab Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Blinatumomab Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Blinatumomab Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Blinatumomab Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Blinatumomab in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Blinatumomab in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Blinatumomab during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Blinatumomab in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Blinatumomab in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Blinatumomab in geriatric settings.
Gender
There is no FDA guidance on the use of Blinatumomab with respect to specific gender populations.
Race
There is no FDA guidance on the use of Blinatumomab with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Blinatumomab in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Blinatumomab in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Blinatumomab in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Blinatumomab in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Blinatumomab Administration in the drug label.
Monitoring
There is limited information regarding Blinatumomab Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Blinatumomab and IV administrations.
Overdosage
There is limited information regarding Blinatumomab overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Blinatumomab Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Blinatumomab Mechanism of Action in the drug label.
Structure
There is limited information regarding Blinatumomab Structure in the drug label.
Pharmacodynamics
There is limited information regarding Blinatumomab Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Blinatumomab Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Blinatumomab Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Blinatumomab Clinical Studies in the drug label.
How Supplied
There is limited information regarding Blinatumomab How Supplied in the drug label.
Storage
There is limited information regarding Blinatumomab Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Blinatumomab Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Blinatumomab interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Blinatumomab Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Blinatumomab Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.