Blinatumomab (Monograph)

Brand name: Blincyto
Drug class: Antineoplastic Agents

Medically reviewed by Drugs.com on May 10, 2025. Written by ASHP.

Introduction

Antineoplastic agent; a CD3 T-cell-engaging anti-CD19 monoclonal antibody.^{1 11 12 13 15}

Uses for Blinatumomab

Acute Lymphoblastic Leukemia

Treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) ≥0.1% in adults and pediatric patients ≥1 month of age.^{1 17}

Treatment of relapsed or refractory CD19-positive B-cell precursor ALL in adults and pediatric patients ≥1 month of age.^{1 2 18 19 20}

Treatment of CD19-positive Philadelphia chromosome (Ph)-negative B-cell precursor ALL in the consolidation phase of multiphase chemotherapy in adults and pediatric patients ≥1 month of age.^{21 22}

Designated an orphan drug by FDA for use in ALL.³

Blinatumomab Dosage and Administration

General

Pretreatment Screening

• Verify pregnancy status in women of reproductive potential.¹

• Assess laboratory parameters such as ALT, AST, gamma-glutamyl transferase (GGT), and total bilirubin prior to initiating blinatumomab therapy.¹

Patient Monitoring

• Monitor laboratory parameters such as WBC, absolute neutrophil count (ANC), ALT, AST, GGT, and total bilirubin, among others, in patients receiving blinatumomab therapy. ¹

• Monitor for manifestations of neurologic toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS). ¹

• Monitor for infection during therapy. ¹

• Monitor for signs or symptoms of cytokine release syndrome (CRS). ¹

• Monitor for signs or symptoms of tumor lysis syndrome (TLS). ¹

• Monitor for signs or symptoms of pancreatitis.¹

• Monitor pediatric patients at risk for acid-base imbalances (e.g., with immature alcohol metabolism, underlying predisposing conditions, or receiving certain concomitant medications) for new or worsening acidosis when preservative-containing blinatumomab is administered.¹ Avoid administration of preservative-containing blinatumomab (72-hour, 96-hour, 7-day infusion) in patients weighing <5.4 kg. ¹

Premedication and Prophylaxis

• Appropriate prophylaxis with pretreatment non-toxic cytoreduction and adequate fluid hydration recommended to prevent TLS. ¹

• Premedication with corticosteroid therapy recommended in all patients prior to the initial cycle of blinatumomab therapy, and may be recommended during subsequent cycles or therapy interruptions (e.g., interruption for ≥4 hours) based on the clinical indication. ¹

• Prophylaxis with intrathecal chemotherapy recommended prior to and during blinatumomab therapy to prevent CNS acute lymphoblastic leukemia (ALL) relapse. ¹

Dispensing and Administration Precautions

Handling and Disposal

• Procedures for proper handling (e.g., use of gloves and protective clothing) and disposal of antineoplastic agents should be followed.¹

• Medication errors resulting in underdosage or overdosage of blinatumomab have occurred in patients receiving the drug.¹ Exercise extra care to ensure proper preparation and administration of blinatumomab.¹

• Based on the Institute for Safe Medication Practices (ISMP), blinatumomab is a high-alert medication that has a heightened risk of causing significant patient harm when used in error.¹⁶

Other General Considerations

• Administer in a hospital setting during the first and second treatment cycles; the recommended duration of hospitalization varies depending on the clinical indication for which blinatumomab therapy is being prescribed.¹ During initiation of all subsequent cycles and for therapy interruptions (e.g., interruption for ≥4 hours), drug administration under healthcare provider supervision or in a hospital setting may also be recommended.¹

Administration

IV Administration

Administer by continuous IV infusion over 24 or 48 hours (preservative-free), or 72 hours, 96 hours, or 7 days (with preservative).¹

Preservative-containing infusions (72-hour, 96-hour, or 7-day) not recommended in patients weighing <5.4 kg.¹

Blinatumomab powder for injection must be reconstituted and diluted prior to administration; preparation steps differ based on the duration of the blinatumomab infusion.¹

Consult manufacturer instructions for use in the blinatumomab prescribing information for details on preparation, reconstitution, and administration of blinatumomab infusion.¹

Dosage

Pediatric Patients

MRD-positive B-cell Precursor ALL

IV

Pediatric patients ≥1 month of age: One cycle of induction, followed by up to 3 additional cycles of consolidation therapy.¹

Fixed dosage recommended in patients weighing ≥45 kg, and body surface area (BSA)-based dosage recommended in patients weighing <45 kg, as indicated in Table 1.¹

Hospitalization recommended during first 3 days of first cycle, and during first 2 days of second cycle.¹ For all subsequent cycle starts and re-initiations (e.g., therapy interruption for ≥4 hours), supervision by a healthcare provider or hospitalization recommended.¹

Premedicate with 5 mg/m² (maximum 20 mg dose) of dexamethasone (IV or oral) prior to the first dose of blinatumomab in the first cycle and when restarting an infusion after an interruption of ≥4 hours in the first cycle.¹

Relapsed or Refractory B-cell Precursor ALL

IV

Pediatric patients ≥1 month of age: Up to 2 cycles of induction, followed by 3 additional cycles of consolidation, followed by up to 4 additional cycles of continued therapy.¹

Fixed dosage recommended in patients weighing ≥45 kg, and BSA-based dosage recommended in patients weighing <45 kg, as indicated in Table 2.¹

Hospitalization recommended during first 9 days of first cycle, and during first 2 days of second cycle.¹ For all subsequent cycle starts and re-initiations (e.g., therapy interruption for ≥4 hours), supervision by a healthcare provider or hospitalization recommended.¹

Premedicate with 5 mg/m² (maximum 20 mg) of dexamethasone (IV or oral) prior to the first dose of blinatumomab in the first cycle, prior to a step dose (e.g., cycle 1 day 8), and when restarting an infusion after an interruption of ≥4 hours during the first cycle.¹

Ph-negative B-cell Precursor ALL in the Consolidation Phase

IV

Pediatric patients ≥1 month of age: A single cycle of blinatumomab consolidation consists of 28 days of continuous IV infusion followed by a 2-week rest period (total of 42 days)

Fixed dosage recommended in patients weighing ≥45 kg, and BSA-based dosage recommended in patients weighing <45 kg, as indicated in Table 3.¹

Hospitalization recommended during first 3 days of the first consolidation cycle and for the first 2 days of the second consolidation cycle.¹ During all subsequent cycles and when reinitiating therapy following an interruption lasting ≥4 hours, hospitalization or supervision by a healthcare provider recommended.¹

Premedicate with IV or oral dexamethasone 5 mg/m² (maximum 20 mg) prior to the first dose of blinatumomab in the first cycle, and when reinitiating therapy following an interruption lasting ≥4 hours during the first cycle.¹

Adults

MRD-positive B-cell Precursor ALL

IV

One cycle of induction, followed by up to 3 additional cycles of consolidation therapy.¹

Fixed dosage recommended in patients weighing ≥45 kg, and BSA-based dosage recommended in patients weighing <45 kg, as indicated in Table 1.¹

Hospitalization recommended during first 3 days of first cycle, and during first 2 days of second cycle.¹ For all subsequent cycle starts and re-initiations (e.g., therapy interruption for ≥4 hours), supervision by a healthcare provider or hospitalization recommended.¹

Premedicate with 100 mg of prednisone IV or equivalent (e.g., dexamethasone 16 mg) 1 hour prior to the first dose of blinatumomab in each cycle.¹

Relapsed or Refractory B-cell Precursor ALL

IV

Up to 2 cycles of induction, followed by 3 additional cycles of consolidation, followed by up to 4 additional cycles of continued therapy.¹

Fixed dosage recommended in patients weighing ≥45 kg, and BSA-based dosage recommended in patients weighing <45 kg, as indicated in Table 2.¹

Hospitalization recommended during first 9 days of first cycle, and during first 2 days of second cycle.¹ For all subsequent cycle starts and re-initiations (e.g., therapy interruption for ≥4 hours), supervision by a healthcare provider or hospitalization recommended.¹

Premedicate with 20 mg of dexamethasone (IV or oral) 1 hour prior to the first dose of blinatumomab in each cycle, prior to a step dose (e.g., cycle 1 day 8), and when therapy is interrupted for ≥4 hours.¹

Ph-negative B-cell Precursor ALL in the Consolidation Phase

IV

A single cycle of blinatumomab consolidation consists of 28 days of continuous IV infusion followed by a 2-week rest period (total of 42 days).¹

Fixed dosage recommended in patients weighing ≥45 kg, and BSA-based dosage recommended in patients weighing <45 kg, as indicated in Table 3.¹

Hospitalization recommended during first 3 days of the first consolidation cycle and for the first 2 days of the second consolidation cycle.¹ During all subsequent cycles and when reinitiating therapy following an interruption lasting ≥4 hours, hospitalization or supervision by a healthcare provider recommended.¹

Premedicate with IV dexamethasone 20 mg administered 1 hour prior to the first dose of blinatumomab in each cycle.¹

Dosage Modification for Toxicity

If interruption of therapy is required for ≤7 days, continue current cycle for a total of 28 days (including the treatment days prior to and after the interruption).¹

If therapy is interrupted for >7 days, initiate a new cycle.¹

Grade 3 or 4 Clinically Relevant Adverse Effects

If grade 3 adverse effects occur in a patient weighing ≥45 kg, interrupt therapy until resolution to grade 0 or 1; resume therapy at reduced dosage of 9 mcg daily if the adverse effect resolves in ≤14 days.¹ Dosage may be re-escalated to 28 mcg daily if the adverse effect does not recur within 7 days.¹

If grade 3 adverse effects occur in a patient weighing <45 kg, interrupt therapy until resolution to grade 0 or 1; resume therapy at reduced dosage of 5 mcg/m² daily if the adverse effect resolves in ≤14 days.¹ Dosage may be re-escalated to 15 mcg/m² mcg daily if the adverse effect does not recur within 7 days.¹

If the adverse effect persists for >14 days following interruption of therapy in patients of any weight, permanently discontinue blinatumomab therapy.¹

If grade 4 adverse effects occur in patients of any weight, consider permanently discontinuing blinatumomab therapy.¹

Cytokine Release Syndrome

If grade 3 cytokine release syndrome (CRS) occurs in a patient weighing ≥45 kg, interrupt therapy until CRS resolves; resume therapy at reduced dosage of 9 mcg daily.¹ Dosage may be re-escalated to 28 mcg daily if CRS does not recur within 7 days.¹ Administer dexamethasone 8 mg (IV or oral) every 8 hours for up to 3 days, and taper thereafter over 4 days.¹

If grade 3 CRS occurs in a patient weighing <45 kg, interrupt therapy until CRS resolves; resume therapy at reduced dosage of 5 mcg/m² daily.¹ Dosage may be re-escalated to 15 mcg/m² daily if CRS does not recur within 7 days.¹ Administer dexamethasone 5 mg/m² (maximum dose 8 mg) IV or orally every 8 hours for up to 3 days, and taper thereafter over 4 days.¹

If grade 4 CRS occurs in patients of any weight, permanently discontinue blinatumomab therapy and administer dexamethasone as above.¹

Neurologic Toxicity

If grade 2 immune effector cell-associated neurotoxicity syndrome (ICANS) occurs in a patient weighing ≥45 kg, withhold therapy until ICANS resolves; resume therapy at a reduced dosage of 9 mcg daily.¹ Administer systemic corticosteroids and provide patient management in accordance with current practice guidance.¹ Dosage may be re-escalated to 28 mcg daily if the toxicity does not recur within 7 days.¹

If grade 2 ICANS occurs in a patient weighing <45 kg, withhold therapy until ICANS resolves; resume therapy at a reduced dosage of 5 mcg/m² daily.¹ Administer systemic corticosteroids and provide patient management in accordance with current practice guidance.¹ Dosage may be re-escalated to 15 mcg/m² daily if the toxicity does not recur within 7 days.¹

If grade 3 neurologic events (including ICANS) occur in a patient weighing ≥45 kg, interrupt therapy until resolution to grade 0 or 1 for ≥3 days; resume therapy at reduced dosage of 9 mcg daily.¹ Dosage may be re- escalated to 28 mcg daily if the toxicity does not recur within 7 days.¹ If ICANS occurs, administer systemic corticosteroids and provide patient management in accordance with current practice guidance.¹

If grade 3 neurologic events (including ICANS) occur in a patient weighing <45 kg, interrupt therapy until resolution to grade 0 or 1; resume therapy at a reduced dosage of 5 mcg/m² daily.¹ Dosage may be re-escalated to 15 mcg/m² daily if the toxicity does not recur within 7 days.¹ If ICANS occurs, administer systemic corticosteroids and provide patient management in accordance with current practice guidance.¹

If neurologic events occur at a dosage of 9 mcg daily (in patients weighing ≥45 kg) or 5 mcg/m² daily (in patients weighing <45 kg) or persist for >7 days following interruption of therapy, permanently discontinue blinatumomab therapy.¹

If >1 seizure occurs or if grade 4 neurologic events (including ICANS) occur in any patient, permanently discontinue blinatumomab therapy.¹ Manage patients who develop ICANS in accordance with practice guidance and administer systemic corticosteroids.¹

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.¹

Renal Impairment

No specific dosage recommendations at this time.¹

Geriatric Patients

No specific dosage recommendations at this time.¹

Cautions for Blinatumomab

Contraindications

• Known hypersensitivity to the drug or any ingredient in the formulation.¹

Warnings/Precautions

Warnings

Cytokine Release Syndrome

Cytokine release syndrome (CRS), sometimes life-threatening or fatal, reported (see Boxed Warning); median onset to cytokine release observed 2 days following initiation of blinatumomab.¹

Manifestations of CRS include fever, headache, nausea, asthenia, hypotension, elevated ALT, AST, and bilirubin concentrations and disseminated intravascular coagulation.¹ Infusion-related reactions may be clinically indistinguishable from manifestations of CRS, capillary leak syndrome, and hemophagocytic histiocytosis/macrophage activation syndrome.¹ Closely monitor patients for signs and symptoms of CRS.¹ Advise patients receiving blinatumomab on an outpatient basis to contact their healthcare provider if signs or symptoms of CRS occur.¹ Interruption or discontinuance of therapy and administration of systemic corticosteroids may be necessary.¹

Neurologic Toxicity

Serious or life-threatening neurologic toxicities can occur (see Boxed Warning); neurologic toxicities reported in approximately 65% of patients.¹ Headache and tremor most common (≥10% of patients).¹ Grade ≥3 neurologic toxicities (e.g., encephalopathy, seizures, speech impairment, disturbances in consciousness, confusion and disorientation, coordination and balance disorders) can occur.¹ Cranial nerve disorders also reported.¹ Signs and symptoms of immune effector cell-associated neurotoxicity syndrome (ICANS) reported in 7.5% of patients; can occur with or without concurrent CRS, or following resolution of CRS.¹ Neurologic toxicity generally resolves following treatment interruption; however, discontinuance of therapy may be necessary.¹ Used in a limited number of patients with active ALL in the CNS or history of neurologic events.¹ Patients with Down syndrome may have higher seizure risk.¹ Monitor patients for manifestations of neurologic toxicities, including ICANS.¹ Advise patients receiving blinatumomab on an outpatient basis to contact their healthcare provider if signs or symptoms occur.¹ Interruption or discontinuance of therapy and/or administration of systemic corticosteroids may be necessary.¹

Other Warnings and Precautions

Infections

Serious infections (e.g., sepsis, pneumonia, bacteremia, opportunistic infections, catheter-site infections), sometimes life-threatening or fatal, reported.¹

Initiate prophylactic anti-infective therapy as appropriate and employ surveillance testing during blinatumomab therapy.¹ Monitor patients for signs and symptoms of infection; initiate appropriate anti-infective treatment as clinically indicated.¹

Tumor Lysis Syndrome

Tumor lysis syndrome, sometimes life-threatening or fatal, reported.¹

Monitor patients for signs and symptoms of tumor lysis syndrome; interruption or discontinuance of blinatumomab therapy may be necessary.¹ Initiate appropriate prophylactic measures (e.g., pretreatment nontoxic cytoreduction, adequate hydration during therapy).¹

Neutropenia and Febrile Neutropenia

Neutropenia and febrile neutropenia, sometimes life-threatening, reported.¹

Monitor CBC, including differential.¹ If prolonged neutropenia occurs, interrupt therapy.¹

Effects on Ability to Drive and Use Machines

May cause loss of consciousness, ICANS, or seizures.¹ Patients should not drive a motor vehicle or engage in hazardous occupations or activities (e.g., operating hazardous machinery) while receiving the drug.¹

Elevated Liver Enzymes

Transient increases in hepatic enzyme concentrations reported; median time to onset is 3 days (19 days outside the setting of CRS).¹ Mostly occurs in association with CRS.¹

Evaluate serum ALT, AST, γ-glutamyltransferase (γ-glutamyltranspeptidase, GGT, GGTP), and total bilirubin concentrations prior to and during blinatumomab therapy.¹ If ALT and/or AST concentrations >5 times the ULN or total bilirubin concentrations >3 times the ULN occur, interrupt blinatumomab therapy.¹

Pancreatitis

Cases of pancreatitis, some fatal, reported.¹

Evaluate patients who show signs and symptoms of pancreatitis.¹ Interruption or discontinuance of therapy may be necessary.¹

Leukoencephalopathy

Cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy reported, particularly in those who previously received cranial irradiation and antileukemic chemotherapy (including systemic high-dose methotrexate or intrathecal cytarabine).¹ The clinical importance of these changes is not known.¹

Preparation and Administration Errors

Medication errors resulting in underdosage or overdosage of blinatumomab have occurred.¹ Exercise extra care to ensure proper preparation and administration of the drug.¹

Immunization

Safety of immunization with live virus vaccines during or following blinatumomab not studied.¹ Avoid vaccination with live vaccines for ≥2 weeks prior to initiating blinatumomab, during therapy, and until immune system recovery after the last blinatumomab cycle.¹

Benzyl Alcohol Toxicity in Neonates

Serious, sometimes fatal, neonatal “gasping syndrome” reported in very-low-birth weight (VLBW) neonates weighing <1500 grams at birth and in early preterm neonates (born <34 weeks’ gestation) receiving IV medications containing benzyl alcohol as a preservative.¹ Possible higher risk in early preterm VLBW neonates due to impaired alcohol metabolism.¹

Use preservative-free preparations of blinatumomab in neonatal patients.¹ If preservative-containing blinatumomab is used in a neonatal patient, consider the combined daily load of benzyl alcohol from blinatumomab and other products containing benzyl alcohol or excipients such as ethanol or propylene glycol.¹

Monitor neonates receiving blinatumomab with preservatives for new or worsening acidosis.¹ Preservative-containing preparations of blinatumomab (72-hour, 96-hour, and 7-day infusion) not recommended in patients weighing <5.4 kg.¹

Fetal/Neonatal Morbidity and Mortality

Due to mechanism of action, may cause fetal harm.¹ Blinatumomab activates T-cells and causes cytokine release, potentially compromising pregnancy maintenance.¹ Blinatumomab can also cause B-cell lymphocytopenia in infants exposed to blinatumomab in utero.¹ Inform women of potential fetal risk.¹

Verify pregnancy status in females of reproductive potential prior to initiation of blinatumomab.¹ Advise females of reproductive potential to use effective contraception during treatment and for 48 hours following the last dose of blinatumomab.¹

Immunogenicity

Antibodies to blinatumomab, including neutralizing antibodies to the drug, reported.¹ Pharmacokinetics may be affected.¹ Clinical evidence suggests no impact on efficacy or safety.¹

Specific Populations

Pregnancy

May cause fetal harm if administered during pregnancy.¹ No data available in pregnant women to assess the drug-associated risk.¹

Blinatumomab causes immune activation, which may compromise pregnancy maintenance.¹ Infants exposed to blinatumomab in utero can develop B-cell lymphocytopenia.¹ Inform women of the potential fetal risk.¹

In infants exposed to blinatumomab in utero, monitor the infant’s B lymphocytes before initiating live virus vaccines.¹

Lactation

No data on whether blinatumomab is distributed into breast milk.¹ The effects on the breast-fed child from exposure and the effects on milk production are not known.¹ Advise patients to avoid breastfeeding during therapy and for 48 hours following the last dose.¹

Females and Males of Reproductive Potential

May cause fetal harm.¹ Verify pregnancy status in females of reproductive potential prior to initiating.¹ Advise females of reproductive potential to use effective contraception during treatment and for 48 hours following the last dose.¹

Pediatric Use

Safety and efficacy for any indication not established in pediatric patients <1 month of age.¹

In clinical studies of pediatric patients with relapsed or refractory B-cell precursor ALL, adverse effects from blinatumomab therapy were similar to those observed in adults, although some adverse effects occurred at a ≥10% higher frequency, including: pyrexia, hypertension, anemia, infusion-related reactions, thrombocytopenia, leukopenia, and weight increase.¹ Incidence of neurologic toxicities not different in patients <2 years of age compared to other age groups; however, presentation differed, with agitation, headache, insomnia, somnolence, and irritability reported.¹ Increased incidence of hypokalemia also reported in infants compared to other pediatric age groups and adults.¹

Serious, sometimes fatal adverse effects, including neonatal “gasping syndrome” (characterized by CNS depression, metabolic acidosis, and gasping respirations), reported in VLBW neonates weighing <1500 grams at birth, and in early preterm neonates (born earlier than 34 weeks’ gestation) who received IV medications containing benzyl alcohol as a preservative.¹ When possible, use preservative-free preparations of blinatumomab in neonatal patients.¹ If blinatumomab with preservatives is used in a neonatal patient, consider the combined daily metabolic load of benzyl alcohol from blinatumomab and other products containing benzyl alcohol or excipients such as ethanol or propylene glycol.¹ Blinatumomab 72-hour infusion with preservatives and 96-hour infusion with preservatives contain 2.5 mg of benzyl alcohol per mL; blinatumomab 7-day infusion with preservatives contains 7.4 mg of benzyl alcohol per mL.¹ These preparations (72-hour, 96-hour, and 7-day infusion) not recommended for use in patients weighing <5.4 kg.¹

Monitor pediatric patients receiving blinatumomab with preservatives for new or worsening metabolic acidosis.¹

Geriatric Use

In clinical studies of blinatumomab, approximately 7% of patients were ≥65 years of age.¹ Efficacy and safety of the drug was generally similar regardless of patient age, except for increased incidence of neurologic toxicities (e.g., cognitive disorder, encephalopathy, confusion) and serious infections in patients ≥65 years of age.¹

Hepatic Impairment

Clinically significant differences in blinatumomab pharmacokinetics not observed in patients with mild (total bilirubin ≤ULN and AST>ULN or total bilirubin >1-1.5 times ULN with any AST) or moderate hepatic impairment (total bilirubin >1.5-3 times ULN with any AST).¹ Effect of severe hepatic impairment (total bilirubin >3 times ULN with any AST) on blinatumomab pharmacokinetics not known.¹

Renal Impairment

Formal pharmacokinetic studies not conducted.¹ Clearance affected by moderate renal impairment; however, high interpatient variability was apparent.¹

Not studied in patients with severe renal impairment (Cl_cr 15-29 mL/minute) or in those receiving hemodialysis.¹

Common Adverse Effects

Adverse effects reported in ≥20% of patients receiving blinatumomab in clinical studies include pyrexia, infusion-related reactions, infection, headache, musculoskeletal pain, neutropenia, nausea, anemia, thrombocytopenia, and diarrhea.¹

Drug Interactions

No formal drug interaction studies to date.¹

Drugs Metabolized by Hepatic Microsomal Enzymes

Transient release of cytokines may result in suppression of CYP isoenzymes and potentially increase serum concentrations of drugs metabolized by CYP isoenzymes.^{1 8} Risk of drug interactions is highest during days 1–9 of cycle 1 and days 1–2 of cycle 2.¹

Monitor for toxicity and/or changes in serum concentrations in patients receiving CYP substrates, particularly those with a low therapeutic index that require individualized dosing; adjust dosage of the CYP substrate as needed.¹

Specific Drugs

Blinatumomab Pharmacokinetics

Absorption

Bioavailability

Steady-state concentrations are dose proportional in adults over the dosage range of 5–90 mcg/m² daily and reached within 1 day in patients receiving blinatumomab by continuous IV infusion.¹

In pediatric patients, pharmacokinetics of blinatumomab are linear over IV dosage range of 5–30 mcg/m² daily.¹

Distribution

Extent

Not known whether blinatumomab is distributed into human milk.¹

Elimination

Metabolism

Not characterized.¹ Expected to be degraded into small peptides and amino acids via catabolic pathways.¹

Elimination Route

Negligible amounts of the drug are detectable in urine at steady state.^{1 5}

Half-life

2.2 hours in adults.¹

2.14 hours in pediatric patients.¹

Special Populations

Approximately 2-fold difference in mean clearance between patients with moderate renal impairment (Cl_cr 30–59 mL/minute) and those with normal renal function; however, high interpatient variability was apparent and clearance values in patients with renal impairment were within the range observed in patients with normal renal function.¹

Age, sex, race, ethnicity, Philadelphia chromosome status, mild hepatic impairment (total bilirubin ≤ULN and AST >ULN or total bilirubin 1–1.5 times ULN with any AST), or moderate hepatic impairment (total bilirubin >1.5–3 times ULN with any AST) do not have meaningful effects on pharmacokinetics of blinatumomab.¹

Pharmacokinetics of blinatumomab are influenced by body surface area (BSA; 0.4-2.9 m²), supporting BSA-based dosing in patients weighing <45 kg.¹

Stability

Storage

Parenteral

Powder for Injection

Unreconstituted drug and IV solution stabilizer: 2–8°C in original package to protect from light.¹ Do not freeze.¹ May store at room temperature for up to 8 hours.¹

Reconstituted drug: 23–27°C for up to 4 hours or 2–8°C for up to 24 hours.¹

Diluted infusion solution (preservative-free): 23–27°C for up to 48 hours (including infusion time) or 2–8°C for up to 8 days.¹ Do not freeze.¹

Diluted infusion solution (72-hour and 96-hour bags, preservative-containing): 23–27°C for up to 4 days (including infusion time) or 2–8°C for up to 14 days.¹

Diluted infusion solution (7-day bags, preservative-containing): 23–27°C for up to 7 days (including infusion time) or 2–8°C for up to 14 days.¹

Actions

• Single-chain antibody composed of the variable fragments of antibodies to CD3 and CD19 connected by a nonglycosylated, nonimmunogenic linker protein that allows for rotational flexibility and close proximity of malignant CD19⁺ B cells to CD3⁺ T cells.^{11 12 14 15}

• Binds specifically to CD3 signaling chain of the T-cell receptor (TCR) complex and antigen CD19 on normal and malignant B lymphocytes.^{1 2 11 12 13}

• Apoptosis of CD19⁺ B cells occurs following activation of endogenous T cells.^{1 11 13 14}

• Causes initial redistribution of peripheral T cells, decreased peripheral B-cell counts, and transient release of proinflammatory cytokines (interleukin-2 [IL-2], interleukin-4 [IL-4], interleukin-6 [IL-6], interleukin-10 [IL-10], tumor necrosis factor [TNF; TNF-α], interferon gamma).^{1 11 15} Incidence and intensity of elevated cytokine levels are greatest during initial 48 hours of first treatment cycle.¹

Advice to Patients

• Advise patients to read the manufacturer's medication guide before beginning treatment and each time blinatumomab is administered.¹

• Inform patients of the risk of cytokine release syndrome and infusion-related reactions.¹ Advise patients to immediately report signs and symptoms of such reactions (e.g., pyrexia, fatigue, nausea, vomiting, chills, hypotension, rash, wheezing).¹

• Inform patients of the risk of neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).¹ Advise patients to inform their clinician immediately if signs and symptoms of neurologic toxicity (e.g., seizures, speech impairment, loss of consciousness, confusion, loss of balance) occur.¹ Advise patients to avoid driving or engaging in hazardous occupations or activities (e.g., operating hazardous machinery) while receiving the drug.¹

• Inform patients of the risk of infections.¹ Instruct patients to immediately contact their clinician if symptoms suggestive of an infection develop.¹ Advise patients to keep the IV injection site clean in order to reduce the risk of catheter-related infection.¹

• Inform patients of the risk of pancreatitis and advise them to contact their healthcare provider immediately for signs and symptoms of pancreatitis, including severe and persistent stomach pain (with or without nausea and vomiting).¹

• Advise patients to avoid adjusting settings on the infusion pump.¹ Advise patients to inform their clinician immediately if a problem with the infusion pump occurs or if the pump alarm sounds.¹

• Advise patients to inform their clinician if they are or plan to become pregnant or plan to breast-feed.¹ Inform patients of the potential fetal risk.¹ Advise women of reproductive potential to use effective contraception during blinatumomab therapy, and for 48 hours following the final dose.¹ Advise women not to breast-feed during therapy and for 48 hours following the final dose.¹

• Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary and herbal supplements, as well as any concomitant illnesses.¹

• Advise patients of other important precautionary information.¹

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care. For further information on the handling of antineoplastic agents, see the ASHP Guidelines on Handling Hazardous Drugs at [Web].

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Biological Products Related to blinatumomab

Find detailed information on biosimilars for this medication.

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