GEMTUZUMAB INJ

Clinical Criteria Summary

Exclusion Criteria: Do not administer if any of the following are present: hypersensitivity to gemtuzumab or components; pregnancy (known/positive test) and/or actively breastfeeding; Tbili > 2x ULN, AST > 2.5x ULN, and ALT > 2.5x ULN; hyperleukocytosis (leukocyte count > 30 Gi/L); adverse-risk cytogenetics.
Inclusion Criteria: Fulfillment of one of the following is required: previously untreated CD-33 positive AML in adults fit for intensive induction (in combination with standard 7+3 induction of daunorubicin and cytarabine); previously untreated CD-33 positive AML in adults age > 60 years (as monotherapy if not a candidate for or declines intensive induction); relapsed or refractory CD-33 positive AML in adults (as monotherapy).

Exclude pregnancy prior to receiving gemtuzumab; provide contraceptive counseling on potential risks vs. benefits if pregnancy occurs during treatment.
Advise females of reproductive potential to use effective contraception during treatment and for at least 6 months after the last dose.
Advise males with female partners of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose.
Advise women not to breastfeed during treatment and for at least 1 month after the last dose.

Premedicate with acetaminophen 650 mg PO and diphenhydramine 50 mg PO or IV given 1 hour prior to gemtuzumab.
AND administer methylprednisolone 1 mg/kg (or equivalent corticosteroid) within 30 minutes prior to gemtuzumab.
Additional acetaminophen and diphenhydramine may be administered every 4 hours after the initial pre-treatment dose.
Repeat methylprednisolone or equivalent corticosteroid for any sign of infusion reaction during infusion or within 4 hours afterwards.
Use appropriate measures to prevent Tumor Lysis Syndrome (TLS).

Check ALT, AST, total bilirubin, and alkaline phosphatase prior to each dose.
Monitor for signs/symptoms of Veno-Occlusive Disease (VOD) following treatment.
Monitor TLS parameters for those at risk.
Monitor for infusion-related reactions during or within 24 hours following a dose; premedicate prior to each infusion; monitor vital signs frequently during infusion; continue monitoring for at least 1 hour post-infusion or until signs/symptoms completely resolve.
Check CBC prior to each dose and frequently throughout treatment until resolution of cytopenias; monitor for signs/symptoms of bleeding (cytopenias can be prolonged).
Obtain ECG and electrolytes prior to therapy start and as needed if patient has history/predisposition for QTc prolongation or is taking QT-prolonging medications.
Perform pregnancy test in women of childbearing potential at baseline.

Severe infusion reaction or any life-threatening infusion reaction.
Persistent thrombocytopenia and/or neutropenia if blood counts do not recover within 14 days after hematologic recovery from the previous cycle (or within 14 days following the planned start date of consolidation cycle).
Evidence of VOD.

Hyperleukocytosis: Recommend cytoreduction prior to initiating gemtuzumab.
Hepatotoxicity/VOD Risk: Boxed warning for VOD/SOS, particularly with higher monotherapy doses, mod/severe hepatic impairment at baseline, or pre/post-HSCT (ALFA-0701 utilized a 2-month interval between last dose and HSCT).
Bleed Risk: Prolonged thrombocytopenia may increase bleed risk; evaluate blood counts prior to each dose and throughout therapy; monitor for bleeding.
QT Interval Prolongation: Associated with calicheamicin; evaluate patient risk prior to initiation and monitor appropriately.
Adverse-Risk Cytogenetics: No improvement in EFS noted; for newly diagnosed disease treated with gemtuzumab + chemotherapy, consider whether potential benefit outweighs risks when cytogenetic results become available.
Other Targeted Therapies: Not tested in combination with target therapy for specific AML mutations (e.g., FLT3); refer to respective CFU for those regimens.

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