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Inotuzumab Ozogamicin Dosage

Medically reviewed by Drugs.com. Last updated on May 6, 2024.

Applies to the following strengths: 0.9 mg

Usual Adult Dose for Acute Lymphoblastic Leukemia

Cycle 1 (total dose is 1.8 mg/m2/cycle):

Duration of therapy: Cycle 1 is 21 days in duration, but may be extended to 28 days (7-day therapy free interval starting on Day 21) if the patient achieves a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), and/or to allow for recovery from toxicity

Subsequent Cycles:
For patients who achieve a CR or CRi (total dose is 1.5 mg/m2/cycle):
Duration of therapy: 28 days (7-day therapy free interval starting on Day 21)
OR
For patients who do not achieve a CR or CRi (total dose is 1.8 mg/m2/cycle):
Duration of therapy: 28 days (7-day therapy free interval starting on Day 21); patients who do not achieve a CR or CRi within 3 cycles should discontinue therapy

For patients proceeding to hematopoietic stem cell transplant (HSCT):

For patients not proceeding to HSCT:

Comments:

Use: For the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

Renal Dose Adjustments

Mild (CrCl 60 to 89 mL/min), moderate (CrCl 30 to 59 mL/min), or severe (CrCl 15 to 29 mL/min) renal impairment: No adjustment recommended.
End stage renal disease (CrCl less than 15 mL/min): Data not available

Liver Dose Adjustments

See DOSE ADJUSTMENTS for nonhematologic toxicity.

Dose Adjustments

Dose Adjustments for Hematologic Toxicities:

If platelet count is 50 x 10(9)/L or greater prior to start of therapy:
If ANC is less than 1 x 10(9)/L and/or platelet count is less than 50 x 10(9)/L prior to start of therapy:
1) ANC and platelet counts recover to at least baseline levels for the prior cycle
OR
2) ANC recovers to 1 x 10(9)/L or greater and platelet count recovers to 50 x 10(9)/L or greater
OR
3) Stable or improved disease (based on most recent bone marrow assessment) and the ANC and platelet count decrease is due to the underlying disease (not considered to have been caused by this drug).

Dose Adjustments for Nonhematologic Toxicities:

Dose Adjustments Depending on Duration of Dosing Interruption Due to Nonhematologic Toxicity:

Precautions

US BOXED WARNINGS:
HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME AND INCREASED RISK OF POST-HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY HEPATOTOXICITY, INCLUDING VOD:

INCREASED RISK OF POST-HSCT NON-RELAPSE MORTALITY:

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:


Storage requirements:

Reconstitution/preparation techniques:

General:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.