Blinatumomab

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Blinatumomab
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]

Disclaimer

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Black Box Warning

WARNINGTITLE
See full prescribing information for complete Boxed Warning.
CYTOKINE RELEASE SYNDROME AND NEUROLOGICAL TOXICITIES
  • Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as recommended.
  • Neurological toxicities, which may be severe, life-threatening, or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as recommended.

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.

table03

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

  • BLINCYTO is contraindicated in patients with known hypersensitivity to blinatumomab or to any component of the product formulation.

Warnings

WARNINGTITLE
See full prescribing information for complete Boxed Warning.
CYTOKINE RELEASE SYNDROME AND NEUROLOGICAL TOXICITIES
  • Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as recommended.
  • Neurological toxicities, which may be severe, life-threatening, or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as recommended.
Cytokine Release Syndrome
  • Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO.
  • Infusion reactions have occurred with the BLINCYTO infusion and may be clinically indistinguishable from manifestations of CRS.
  • Serious adverse events that may be associated with CRS included pyrexia, headache, nausea, asthenia, hypotension, increased alanine aminotransferase, increased aspartate aminotransferase, and increased total bilirubin; these events infrequently led to BLINCYTO discontinuation. Life-threatening or fatal CRS was infrequently reported in patients receiving BLINCYTO. In some cases, disseminated intravascular coagulation (DIC), capillary leak syndrome (CLS), and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) have been reported in the setting of CRS.
  • Patients should be closely monitored for signs or symptoms of these events. Management of these events may require either temporary interruption or discontinuation of BLINCYTO .
Neurological Toxicities
  • In patients receiving BLINCYTO in clinical trials, neurological toxicities have occurred in approximately 50% of patients. The median time to onset of any neurological toxicity was 7 days. Grade 3 or higher (severe, life-threatening, or fatal) neurological toxicities following initiation of BLINCYTO administration occurred in approximately 15% of patients and included encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders. The majority of events resolved following interruption of BLINCYTO, but some resulted in treatment discontinuation.
  • Monitor patients receiving BLINCYTO for signs and symptoms of neurological toxicities, and interrupt or discontinue BLINCYTO as recommended.
Infections
  • In patients receiving BLINCYTO in clinical trials, serious infections such as sepsis, pneumonia, bacteremia, opportunistic infections, and catheter-site infections were observed in approximately 25% of patients, some of which were life-threatening or fatal. As appropriate, administer prophylactic antibiotics and employ surveillance testing during treatment with BLINCYTO. Monitor patients for signs and symptoms of infection and treat appropriately.
Tumor Lysis Syndrome
  • Tumor lysis syndrome (TLS), which may be life-threatening or fatal, has been observed in patients receiving BLINCYTO. Appropriate prophylactic measures, including pretreatment nontoxic cytoreduction and on-treatment hydration, should be used for the prevention of TLS during BLINCYTO treatment. Monitor for signs or symptoms of TLS. Management of these events may require either temporary interruption or discontinuation of BLINCYTO.
Neutropenia and Febrile Neutropenia
  • Neutropenia and febrile neutropenia, including life-threatening cases, have been observed in patients receiving BLINCYTO. Monitor laboratory parameters (including, but not limited to, white blood cell count and absolute neutrophil count) during BLINCYTO infusion. Interrupt BLINCYTO if prolonged neutropenia occurs.
Effects on Ability to Drive and Use Machines
  • Due to the potential for neurologic events, including seizures, patients receiving BLINCYTO are at risk for loss of consciousness [see Warnings and Precautions (5.2)]. Advise patients to refrain from driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO is being administered.
Elevated Liver Enzymes
  • Treatment with BLINCYTO was associated with transient elevations in liver enzymes. Although the majority of these events were observed in the setting of CRS, some were observed outside of this setting. For these events, the median time to onset was 15 days. *In patients receiving BLINCYTO in clinical trials, Grade 3 or greater elevations in liver enzymes occurred in approximately 6% of patients outside the setting of CRS and resulted in treatment discontinuation in less than 1% of patients.
  • Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), and total blood bilirubin prior to the start of and during BLINCYTO treatment. Interrupt BLINCYTO if the transaminases rise to greater than 5 times the upper limit of normal or if bilirubin rises to more than 3 times the upper limit of normal.
Leukoencephalopathy
  • Cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO, especially in patients with prior treatment with cranial irradiation and antileukemic chemotherapy (including systemic high-dose methotrexate or intrathecal cytarabine). The clinical significance of these imaging changes is unknown.
Preparation and Administration Errors
  • Preparation and administration errors have occurred with BLINCYTO treatment. Follow instructions for preparation (including admixing) and administration strictly to minimize medication errors (including underdose and overdose)

Adverse Reactions

Clinical Trials Experience

  • The following adverse reactions are discussed in greater detail in other sections of the label:
  • Cytokine Release Syndrome
  • Neurological Toxicities
  • Infections
  • Tumor Lysis Syndrome
  • Neutropenia and Febrile Neutropenia
  • Effects on Ability to Drive and Use Machines
  • Elevated Liver Enzymes
  • Leukoencephalopathy
  • Preparation and Administration Errors
Clinical Trials Experience
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • The safety data described in this section reflect exposure to BLINCYTO in clinical trials in which 212 patients with relapsed or refractory ALL received up to 28 mcg/day. All patients received at least one dose of BLINCYTO. The median age of the study population was 37 years (range: 18 to 79 years), 63% were male, 79% were White, 3% were Asian, and 3% were Black or African American.
  • The most common adverse reactions (≥ 20%) were pyrexia (62%), headache (36%), peripheral edema (25%), febrile neutropenia (25%), nausea (25%), hypokalemia (23%), and constipation (20%).
  • Serious adverse reactions were reported in 65% of patients. The most common serious adverse reactions (≥ 2%) included febrile neutropenia, pyrexia, pneumonia, sepsis, neutropenia, device-related infection, tremor, encephalopathy, infection, overdose, confusion, Staphylococcal bacteremia, and headache.
  • Adverse reactions of Grade 3 or higher were reported in 80% of patients. Discontinuation of therapy due to adverse reactions occurred in 18% of patients treated with BLINCYTO. The adverse reactions reported most frequently as the reason for discontinuation of treatment included encephalopathy and sepsis. Fatal adverse events occurred in 15% of patients. The majority of these events were infections. No fatal adverse events occurred on treatment among patients in remission.
  • The adverse reactions with ≥ 10% incidence for any grade or ≥ 5% incidence for Grade 3 or higher are summarized in Table 2.

table04

  • Additional important adverse reactions that did not meet the threshold criteria for inclusion in Table 2 were:
  • Blood and lymphatic system disorders: leukocytosis (2%), lymphopenia (1%)
  • Cardiac disorders: tachycardia (8%)
  • General disorders and administration site conditions: edema (5%)
  • Immune system disorders: cytokine storm (1%)
  • Investigations: decreased immunoglobulins (9%), increased blood bilirubin (8%), increased gamma-glutamyl-transferase (6%), increased liver enzymes (1%)
  • Metabolism and nutrition disorders: tumor lysis syndrome (4%), hypoalbuminemia (4%)
  • Nervous system disorders: encephalopathy (5%), paresthesia (5%), aphasia (4%), convulsion (2%), memory impairment (2%), cognitive disorder (1%), speech disorder (< 1%)
  • Psychiatric disorders: confusion (7%), disorientation (3%)
  • Vascular disorders: capillary leak syndrome (< 1%).
  • Hypersensitivity reactions related to BLINCYTO treatment were hypersensitivity (1%) and bronchospasm (< 1%).
Immunogenicity
  • As with all therapeutic proteins, there is potential for immunogenicity. The immunogenicity of BLINCYTO has been evaluated using either an electrochemiluminescence detection technology (ECL) or an enzyme-linked immunosorbent assay (ELISA) screening immunoassay for the detection of binding anti-blinatumomab antibodies. For patients whose sera tested positive in the screening immunoassay, an in vitro biological assay was performed to detect neutralizing antibodies.
  • In clinical studies, less than 1% of patients treated with BLINCYTO tested positive for binding anti-blinatumomab antibodies. All patients who tested positive for binding antibodies also tested positive for neutralizing anti-blinatumomab antibodies.
  • Anti-blinatumomab antibody formation may affect pharmacokinetics of BLINCYTO. No association was seen between antibody development and development of adverse events.
  • If formation of anti-blinatumomab antibodies with a clinically significant effect is suspected, contact Amgen at 1-800-77-AMGEN (1-800-772-6436) to discuss antibody testing.
  • The detection of anti-blinatumomab antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to blinatumomab with the incidence of antibodies to other products may be misleading.

Postmarketing Experience

There is limited information regarding Blinatumomab Postmarketing Experience in the drug label.

Drug Interactions

  • No formal drug interaction studies have been conducted with BLINCYTO. Initiation of BLINCYTO treatment causes transient release of cytokines that may suppress CYP450 enzymes. The highest drug- drug interaction risk is during the first 9 days of the first cycle and the first 2 days of the second cycle in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index. In these patients, monitor for toxicity (eg, warfarin) or drug concentrations (eg, cyclosporine). Adjust the dose of the concomitant drug as needed

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.

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