inotuzumab (Rx)

Brand and Other Names:Besponsa
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 0.9mg/vial

Acute Lymphoblastic Leukemia

Indicated for relapsed/refractory B-cell precursor acute lymphoblastic leukemia

See Dosing Considerations

Cycle 1 for all patients

  • Total dose of inotuzumab: 1.8 mg/m² per 21-day cycle, administered as 3 divided doses
  • Day 1: 0.8 mg/m²
  • Day 8 and 15: 0.5 mg/m²
  • Duration of cycle 1 is 21 days; may extend to 28 days (eg, 7-day treatment-free interval starting on day 21) if patient achieves a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), and/or to allow recovery from toxicity
  • CR is defined as < 5% blasts in bone marrow and absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets ≥ 100 × 10^9/L and absolute neutrophil counts [ANC] ≥ 1 × 10^9/L) and resolution of any extramedullary disease
  • CRi is defined as < 5% blasts in bone marrow and absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets < 100 × 10^9/L and/or ANC < 1 × 10^9/L) and resolution of any extramedullary disease

Patients who achieve a CR or CRi

  • Total dose of inotuzumab is 1.5 mg/m² per 28-day cycle, including a 7-day treatment-free interval starting on day 21, administered as 3 divided doses
  • Day 1, 8, and 15: 0.5 mg/m² IV

Patients who do not achieve a CR or CRi

  • Total dose of inotuzumab is 1.8 mg/m² per 28-day cycle, including a 7-day treatment-free interval starting on day 21 administered as 3 divided doses
  • Day 1: 0.8 mg/m² IV
  • Day 8 and 15: 0.5 mg/m² IV
  • Patients who do not achieve a CR or CRi ≤3 cycles should discontinue treatment

Dosage Modifications

Renal impairment

  • Mild to moderate (CrCl 30-89 mL/min): No dosage adjustment necessary
  • End-stage renal disease (CrCl <30 mL/min) and/or hemodialysis: Safety and efficacy is not established

Hepatic impairment

  • Total bilirubin (≤1.5x ULN) and AST/ALT (≤2.5x ULN): No dosage adjustment necessary
  • Total bilirubin >1.5x ULN and/or AST/ALT >2.5x ULN: Limited safety information; caution with use

Doses within a treatment cycle (eg, Days 8 and/or 15) do not need to be interrupted due to neutropenia or thrombocytopenia but interruptions within a cycle are recommended for non-hematologic toxicities; if dose is reduced due to drug related toxicity, it must not be re-escalated

Hematologic toxicities

  • Baseline absolute neutrophil count (ANC) ≥1 × 10^9/L: If ANC decreases, then interrupt next cycle until ANC ≥1 × 10^9/L; discontinue inotuzumab if low ANC persists for >28 days and is considered an inotuzumab-related toxicity
  • Baseline platelet count >50 × 10^9; /L: If platelet count decreases, then interrupt next cycle if platelet count was ≥50 × 10^9 /L; discontinue inotuzumab if low platelet count persists >28 days and is considered an inotuzumab-related toxicity
  • Baseline ANC>1 × 10^9 /L and/or platelet count <50 × 10^9 /L
    • If ANC or platelet count decreases, then interrupt next cycle of treatment until at least one of following occurs:
    • ANC and platelet count recover to at least baseline levels for prior cycle
    • ANC recovers ≥1 × 10^9 /L and platelet count ≥50 × 10^9 /L
    • Stable/improved disease (based on most recent bone marrow assessment) and ANC and platelet count decrease is correlated to the underlying disease (not considered to be inotuzumab-related toxicity)

Nonhematologic toxicities

  • Venoocclusive disease (VOD) or other severe liver disease: Permanently discontinue
  • Nonhematologic toxicity grade 2 or higher: Interrupt treatment until recovery to
  • Total bilirubin >1.5x ULN and AST/ALT >2.5x ULN
    • Interrupt dosing until recovery of total bilirubin ≤1.5x ULN and AST/ALT ≤2.5x ULN prior to each dose unless due to Gilbert syndrome or hemolysis
    • Permanently discontinue treatment if total bilirubin does not recover ≤1.5x ULN or AST/ALT ≤2.5x ULN
  • Infusion-related reactions
    • Interrupt infusion and institute appropriate medical management; depending on severity of infusion-related reaction, consider discontinuation of infusion or administration of steroids and antihistamines
    • Severe or life-threatening infusion reactions: Permanently discontinue treatment
  • Dose modifications depending on dosing interruption
    • <7 days (within a cycle): Interrupt next dose (maintain a minimum of 6 days between doses)
    • ≥7 days: Omit next dose within current cycle
    • ≥14 days: Once adequate recovery is achieved, decrease total dose by 25% for subsequent cycle; if further dose modifications are required, decrease number of doses to 2 per cycle for subsequent cycles; if dosing modifications are not tolerated, then permanently discontinue treatment

Dosing Considerations

Premedication with a corticosteroid, antipyretic, and antihistamine is recommended prior to dosing

Observe patient during and for at least 1 hr post infusion for infusion-related signs/symptoms

Prior to initial dose, in patients with circulating lymphoblasts, cytoreduction with a combination of hydroxyurea, steroids, and/or vincristine is recommended to achieve a peripheral blast count ≤10,000/mm³

Patients proceeding to hematopoietic stem cell transplantation (HSCT): Duration of inotuzumab treatment is 2 cycles; patients who do not achieve CR or CRi and minimal residual disease (MRD) negativity after 2 cycles may consider a third cycle

Patients not proceeding to HSCT: Additional cycles may be administered; not to exceed 6 cycles

Safety and efficacy not established

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Interactions

Interaction Checker

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              • alfuzosin

                inotuzumab and alfuzosin both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

                alfuzosin and inotuzumab both increase QTc interval. Avoid or Use Alternate Drug.

              • amiodarone

                inotuzumab and amiodarone both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • anagrelide

                inotuzumab and anagrelide both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • apomorphine

                inotuzumab and apomorphine both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • arformoterol

                inotuzumab and arformoterol both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • aripiprazole

                aripiprazole and inotuzumab both increase QTc interval. Avoid or Use Alternate Drug.

              • arsenic trioxide

                inotuzumab and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • artemether

                inotuzumab and artemether both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • artemether/lumefantrine

                inotuzumab and artemether/lumefantrine both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • asenapine

                inotuzumab and asenapine both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • atomoxetine

                atomoxetine and inotuzumab both increase QTc interval. Avoid or Use Alternate Drug.

              • azithromycin

                inotuzumab and azithromycin both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • bedaquiline

                inotuzumab and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • ceritinib

                inotuzumab and ceritinib both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • chloroquine

                inotuzumab and chloroquine both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • chlorpromazine

                inotuzumab and chlorpromazine both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • chlorpropamide

                inotuzumab and chlorpropamide both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • ciprofloxacin

                inotuzumab and ciprofloxacin both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • citalopram

                inotuzumab and citalopram both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • clarithromycin

                inotuzumab and clarithromycin both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • clozapine

                inotuzumab and clozapine both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • crizotinib

                inotuzumab and crizotinib both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • dasatinib

                dasatinib and inotuzumab both increase QTc interval. Avoid or Use Alternate Drug.

              • deferiprone

                deferiprone, inotuzumab. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.

              • degarelix

                inotuzumab and degarelix both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • desflurane

                desflurane and inotuzumab both increase QTc interval. Avoid or Use Alternate Drug.

              • disopyramide

                inotuzumab and disopyramide both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • dofetilide

                inotuzumab and dofetilide both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

                dofetilide increases toxicity of inotuzumab by QTc interval. Avoid or Use Alternate Drug.

              • dolasetron

                inotuzumab and dolasetron both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • droperidol

                inotuzumab and droperidol both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • entrectinib

                inotuzumab and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.

              • eribulin

                inotuzumab and eribulin both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • erythromycin base

                inotuzumab and erythromycin base both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • erythromycin ethylsuccinate

                inotuzumab and erythromycin ethylsuccinate both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • erythromycin lactobionate

                inotuzumab and erythromycin lactobionate both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • erythromycin stearate

                inotuzumab and erythromycin stearate both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • escitalopram

                escitalopram increases toxicity of inotuzumab by QTc interval. Avoid or Use Alternate Drug.

              • ezogabine

                inotuzumab and ezogabine both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • fexinidazole

                fexinidazole and inotuzumab both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels or prolong QT interval.

              • fingolimod

                inotuzumab and fingolimod both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • flecainide

                inotuzumab and flecainide both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • fluconazole

                inotuzumab and fluconazole both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • formoterol

                inotuzumab and formoterol both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • gemifloxacin

                inotuzumab and gemifloxacin both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • glasdegib

                inotuzumab and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

              • goserelin

                inotuzumab and goserelin both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • granisetron

                inotuzumab and granisetron both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • haloperidol

                inotuzumab and haloperidol both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • histrelin

                inotuzumab and histrelin both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • hydroxychloroquine sulfate

                hydroxychloroquine sulfate and inotuzumab both increase QTc interval. Avoid or Use Alternate Drug.

              • ibutilide

                inotuzumab and ibutilide both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • iloperidone

                inotuzumab and iloperidone both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • indacaterol, inhaled

                inotuzumab and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • ivosidenib

                ivosidenib and inotuzumab both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of QTc prolonging drugs with ivosidenib or replace with alternate therapies. If coadministration of a QTc prolonging drug is unavoidable, monitor for increased risk of QTc interval prolongation.

              • lapatinib

                inotuzumab and lapatinib both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • lefamulin

                lefamulin and inotuzumab both increase QTc interval. Avoid or Use Alternate Drug.

              • lenvatinib

                inotuzumab and lenvatinib both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • leuprolide

                inotuzumab and leuprolide both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • levofloxacin

                inotuzumab and levofloxacin both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • lopinavir

                inotuzumab and lopinavir both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • lumefantrine

                inotuzumab and lumefantrine both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • macimorelin

                macimorelin and inotuzumab both increase QTc interval. Avoid or Use Alternate Drug. Macimorelin causes an increase of ~11 msec in the corrected QT interval. Avoid coadministration with drugs that prolong QT interval, which could increase risk for developing torsade de pointes-type ventricular tachycardia. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin.

              • methadone

                inotuzumab and methadone both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • mifepristone

                inotuzumab and mifepristone both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • mobocertinib

                mobocertinib and inotuzumab both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce mobocertinib dose and monitor QTc interval more frequently.

              • moxifloxacin

                inotuzumab and moxifloxacin both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • nilotinib

                inotuzumab and nilotinib both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • ofloxacin

                inotuzumab and ofloxacin both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • ondansetron

                inotuzumab and ondansetron both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • osimertinib

                inotuzumab and osimertinib both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • palifermin

                palifermin increases toxicity of inotuzumab by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              • paliperidone

                inotuzumab and paliperidone both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • panobinostat

                inotuzumab and panobinostat both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • pasireotide

                inotuzumab and pasireotide both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • pazopanib

                inotuzumab and pazopanib both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • pentamidine

                inotuzumab and pentamidine both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • perflutren

                inotuzumab and perflutren both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • pimavanserin

                inotuzumab and pimavanserin both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • pimozide

                inotuzumab and pimozide both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • pitolisant

                inotuzumab and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.

              • procainamide

                inotuzumab and procainamide both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • propafenone

                inotuzumab and propafenone both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • quetiapine

                inotuzumab and quetiapine both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • quinidine

                inotuzumab and quinidine both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • ranolazine

                inotuzumab and ranolazine both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • ribociclib

                inotuzumab and ribociclib both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

                ribociclib increases toxicity of inotuzumab by QTc interval. Avoid or Use Alternate Drug.

              • romidepsin

                inotuzumab and romidepsin both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • saquinavir

                inotuzumab and saquinavir both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • sorafenib

                inotuzumab and sorafenib both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • sotalol

                inotuzumab and sotalol both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • sunitinib

                inotuzumab and sunitinib both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • telavancin

                inotuzumab and telavancin both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • tetrabenazine

                inotuzumab and tetrabenazine both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • thioridazine

                inotuzumab and thioridazine both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • toremifene

                inotuzumab and toremifene both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • trazodone

                inotuzumab and trazodone both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • triptorelin

                inotuzumab and triptorelin both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • vandetanib

                inotuzumab and vandetanib both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • vemurafenib

                inotuzumab and vemurafenib both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • voriconazole

                inotuzumab and voriconazole both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • ziprasidone

                inotuzumab and ziprasidone both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              Monitor Closely (16)

              • albuterol

                albuterol and inotuzumab both increase QTc interval. Use Caution/Monitor.

              • chloroquine

                chloroquine increases toxicity of inotuzumab by QTc interval. Use Caution/Monitor.

              • deutetrabenazine

                inotuzumab and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

              • fostemsavir

                inotuzumab and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.

              • gemtuzumab

                inotuzumab and gemtuzumab both increase QTc interval. Use Caution/Monitor.

              • ofatumumab SC

                ofatumumab SC, inotuzumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • osilodrostat

                osilodrostat and inotuzumab both increase QTc interval. Use Caution/Monitor.

              • oxaliplatin

                oxaliplatin will increase the level or effect of inotuzumab by Other (see comment). Use Caution/Monitor. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.

              • ozanimod

                ozanimod and inotuzumab both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.

              • ponesimod

                ponesimod and inotuzumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • selpercatinib

                selpercatinib increases toxicity of inotuzumab by QTc interval. Use Caution/Monitor.

              • siponimod

                siponimod and inotuzumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • trastuzumab

                trastuzumab, inotuzumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, inotuzumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • triclabendazole

                triclabendazole and inotuzumab both increase QTc interval. Use Caution/Monitor.

              • voclosporin

                voclosporin, inotuzumab. Either increases effects of the other by QTc interval. Use Caution/Monitor.

              Minor (0)

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                Adverse Effects

                >10%

                Thrombocytopenia (51%)

                Neutropenia (49%)

                Infection (48%)

                Neutropenia, grade 3 or higher (48%)

                Thrombocytopenia, grade 3 or higher (42%)

                Anemia (36%)

                Leukopenia (35%)

                Fatigue (35%)

                Hemorrhage (33%)

                Leukopenia, grade 3 or higher (33%)

                Pyrexia (32%)

                Nausea (31%)

                Headache (28%)

                Infection, grade 3 or higher (28%)

                Febrile neutropenia (26%)

                Transaminases increased (26%)

                Anemia, grade 3 or higher (24%)

                Abdominal pain (23%)

                Hyperbilirubinemia (21%)

                Gamma-glutamyltransferase increased (21%)

                Lymphopenia (18%)

                Diarrhea (17%)

                Constipation (16%)

                Lymphopenia, grade 3 or higher (16%)

                Vomiting (15%)

                Stomatitis (13%)

                Alkaline phosphatase increased (13%)

                Decreased appetite (12%)

                Chills (11%)

                1-10%

                Grade 3 or higher

                • Gamma-glutamyltransferase increased (10%)
                • Transaminases increased (7%)
                • Hemorrhage (5%)
                • Fatigue (5%)
                • Hyperbilirubinemia (5%)
                • Pyrexia (3%)
                • Abdominal pain (3%)
                • Headache (2%)
                • Alkaline phosphatase increased (2%)
                • Stomatitis (2%)
                • Nausea (2%)
                • Decreased appetite (1%)
                • Vomiting (1%)
                • Diarrhea (1%)
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                Warnings

                Black Box Warnings

                Hepatoxicity, including VOD

                • Hepatotoxicity, including fatal and life-threatening VOD (also known as sinusoidal obstruction syndrome) reported with relapsed or refractory acute lymphoblastic leukemia (ALL) who received inotuzumab
                • Risk of VOD was greater in patients who underwent HSCT after inotuzumab treatment; use of HSCT conditioning regimens containing 2 alkylating agents and last total bilirubin level ≥ULN before HSCT were significantly associated with an increased risk of VOD
                • Other risk factors include ongoing or prior liver disease, prior HSCT, increased age, later salvage lines, and a greater number of inotuzumab treatment cycles
                • Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of inotuzumab; permanently discontinue treatment if VOD occurs
                • If severe VOD occurs, treat according to standard medical practice

                Increased risk of post-HSCT nonrelapse mortality

                • Reports of higher post-HSCT nonrelapse mortality rate in patients receiving inotuzumab, resulting in a higher Day 100 post-HSCT mortality rate
                • In a clinical trial, the post-HSCT nonrelapse mortality rate was 31/79 (39%) and 8/35 (23%) in inotuzumab arm compared with the investigator’s choice of chemotherapy arm
                • In inotuzumab arm, the most common causes of post-HSCT nonrelapse mortality included VOD and infections
                • Monitor toxicities post-HSCT, including signs and symptoms of infection and VOD

                Contraindications

                None

                Cautions

                Hepatotoxicity, including VOD, reported; monitor closely for signs and symptoms of VOD (eg, increased total bilirubin, hepatomegaly, rapid weight gain, ascites) (see Black Box Warnings)

                Increase risk of posttransplant nonrelapse mortality (see Black Box Warnings)

                QT prolongation reported; caution with history of or predisposition to QT prolongation, currently taking medications known to prolong QT interval, or electrolyte disturbances; obtain baseline ECG and electrolytes levels; monitor periodically during treatment

                In animal studies, embryofetal harm may occur when administered to a pregnant woman (see Pregnancy)

                Myelosuppression

                • Risk of myelosuppression; complications, including infections and bleeding/hemorrhagic events, observed; monitor complete blood cell counts prior to initiating; monitor for signs/symptoms of infection, bleeding/hemorrhage, or other effects of myelosuppression during treatment; if necessary, administer prophylactic anti-infectives and use surveillance testing during and after treatment
                • Management of severe infection, bleeding/hemorrhage, or other effects of myelosuppression, including severe neutropenia or thrombocytopenia, may require dosing interruption, dose reduction, or permanent discontinuation

                Infusion-related reactions

                • Infusion-related reactions may occur; premedicate with a corticosteroid, antipyretic, and antihistamine prior to dosing
                • Monitor closely during and for at least 1 hr after the end of infusion for potential onset of infusion-related reactions (eg, fever, chills, rash, or breathing problems); interrupt infusion and institute appropriate medical management if an infusion-related reaction occurs
                • See Dosage Modifications
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                Pregnancy

                Pregnancy

                Based on its mechanism of action and findings from animal studies, inotuzumab can cause embryofetal harm when administered to a pregnant woman; no available data for use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage

                If used during pregnancy, or if patient becomes pregnant while taking inotuzumab, advise patient of the potential risk to a fetus

                Animal data

                • In rat embryofetal development studies, inotuzumab ozogamicin caused embryofetal toxicity at maternal systemic exposures that were ≥0.4 times exposure in patients at maximum recommended dose, based on AUC; pregnant rats received daily IV doses of inotuzumab ozogamicin up to 0.36 mg/m² during organogenesis; embryofetal toxicities, including increased resorptions and fetal growth restriction, as evidenced by decreased live fetal weights and delayed skeletal ossification, were observed at ≥0.11 mg/m² (~2 times the exposure in patients at maximum recommended dose, based on AUC); fetal growth restriction also occurred at 0.04 mg/m² (~0.4 times the exposure in patients at the maximum recommended dose, based on AUC)

                Females and Males of Reproductive Potential

                • Based on findings in animals, inotuzumab may impair fertility in males and females of reproductive potential
                • Pregnancy testing
                  • Verify the pregnancy status of females of reproductive potential prior to initiating inotuzumab
                • Contraception
                  • Advise females of reproductive potential to avoid becoming pregnant while receiving inotuzumab
                  • Advise females of reproductive potential to use effective contraception during treatment with inotuzumab and for at least 8 months after the last dose
                  • Advise males with female partners of reproductive potential to use effective contraception during treatment with inotuzumab and for at least 5 months after the last dose

                Lactation

                Unknown if distributed in human breast milk

                No data on presence of inotuzumab ozogamicin or its metabolites in human milk, its effects on breastfed infant, or effects on milk production

                Because of potential for adverse reactions in breastfed infants, advise women not to breastfeed during treatment with inotuzumab and for at least 2 months after the last dose

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                CD22-directed antibody-drug conjugate (ADC) recognizes human CD22; small molecule, N-acetyl-gamma-calicheamicin, is a cytotoxic agent that covalently attaches to antibody via a linker

                Nonclinical data suggest anticancer activity of inotuzumab ozogamicin is due to binding of ADC to CD22-expressing tumor cells, followed by internalization of ADC-CD22 complex, and ultimately activating N-acetyl-gamma-calicheamicin 19 dimethylhydrazide, which induces double-strand DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death

                Absorption

                Peak plasma concentration: 308 ng/mL

                AUC: 100,000 ng·h/mL

                Steady-state drug concentration was achieved by cycle 4

                Distribution

                Protein bound: 97%

                Vd: ~12 L

                Metabolism

                N-acetyl-gamma-calicheamicin dimethylhydrazide was primarily metabolized via nonenzymatic reduction

                Elimination

                Clearance, steady state: 0.0333 L/h

                Half-life: 12.3 days

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                Administration

                IV Compatibilities

                0.9% NaCl

                IV Preparation

                Reconstitute each vial with 4 mL of sterile water for injection; reconstituted concentration 0.25 mg/mL

                Gently swirl vial to aid dissolution

                Do not shake; inspect reconstituted solution for particulates and discoloration; reconstituted solution should be clear to opalescent, colorless to slightly yellow, and free of visible foreign matter

                Use reconstituted solution immediately or after being refrigerated (2-8°C; 36-46°F) for up to 4 hr

                Aseptically withdraw calculated amount from vial(s) using a syringe (see full prescribing information for calculation and further preparation information); discard any unused reconstituted solution left in vial

                Add reconstituted solution to an infusion container with 0.9% NaCl to a total volume of 50 mL

                Infusion container made of polyvinyl chloride (PVC), DEHP, non-DEHP-containing polyolefin (polypropylene and/or polyethylene), or ethylene vinyl acetate (EVA) is recommended

                Gently invert infusion container to mix diluted solution; do not shake

                IV Administration

                Filtration is not required: if diluted solution is filtered, polyethersulfone (PES)-, polyvinylidene fluoride (PVDF)-,or hydrophilic polysulfone (HPS)-based filters are recommended

                Do not use filters made of nylon or mixed cellulose ester (MCE)

                Administer diluted solution with 8 hr of reconstitution (from reconstitution through end of administration)

                Infuse diluted solution over 1 hr at a rate of 50 mL/hr at room temperature (20-25°C; 68-77°F)

                Infusion lines made of PVC, DEHP-, or non-DEHP-containing, polyolefin (polypropylene and/or polyethylene), or polybutadiene are recommended

                Do not mix or administer inotuzumab with other medicinal products

                Storage

                All formulations: Protect from light and do not freeze

                Lyophilized powder vial: Refrigerate (2-8°C; 36-46°F) vials and store in original carton

                Reconstituted vial: Refrigerate (2-8°C; 36-46°F) for up to 4 hr

                Diluted solution

                • After start of dilution: Store at room temperature (20-25°C; 68-77°F) for up to 4 hr or refrigerate (2-8°C; 36-46°F) for up to 3 hr

                During administration

                • Store in refrigerator (2-8°C; 36-46°F); allow it to equilibrate at room temperature (20-25°C; 68-77°F); maximum time from reconstitution through end of administration ≤8 hr
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                Images

                No images available for this drug.
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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
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                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.