Gemtuzumab Dosage

Medically reviewed by Drugs.com. Last updated on Sep 18, 2024.

Usual Adult Dose for Acute Myeloid Leukemia

COMBINATION REGIMEN:
Newly-Diagnosed De Novo CD33-Positive Acute Myeloid Leukemia (AML):

• Induction cycle: 3 mg/m2 IV on Days 1, 4, and 7
• Maximum dose: 1 vial/dose
• Consolidation cycle: 3 mg/m2 IV on Day 1
• Maximum dose: 1 vial/dose

SINGLE-AGENT REGIMEN:
Newly-Diagnosed CD33-Positive AML:

• Induction cycle: 6 mg/m2 IV on Day 1 and 3 mg/m2 IV on Day 8
• Continuation cycles: 2 mg/m2 IV on Day 1 every 4 weeks

Relapsed/Refractory CD33-Positive AML: 3 mg/m2 IV on Days 1, 4, and 7

• Maximum dose: 1 vial/dose

Comments:

• This drug should be infused over 2 hours.
• Newly-diagnosed de novo CD33-positive AML (combination regimen): A treatment course consists of 1 induction cycle and 2 consolidation cycles.
• For the first induction cycle and the consolidation cycles, this drug is administered in combination with daunorubicin and cytarabine; the maximum dose of this drug is one 4.5 mg vial.
• If the patient requires a second induction cycle, do NOT administer this drug during the second induction cycle.
• Newly-diagnosed CD33-positive AML (single-agent regimen): A treatment course consists of 1 cycle of induction and up to 8 cycles of continuation therapy; the dose is not limited to one 4.5 mg vial.
• Relapsed/refractory CD33-positive AML (single-agent regimen): Treatment consists of a single course of this drug; the maximum dose is one 4.5 mg vial.

Uses:

• For the treatment of newly-diagnosed CD33-positive AML
• For the treatment of relapsed/refractory CD33-positive AML

Usual Pediatric Dose for Acute Myeloid Leukemia

Newly-Diagnosed De Novo CD33-Positive AML (Combination Regimen):
1 month and older:

• BSA less than 0.6 m2: 0.1 mg/kg IV once
• BSA at least 0.6 m2: 3 mg/m2 IV once

Relapsed/Refractory CD33-Positive AML (Single-Agent Regimen):
2 years and older: 3 mg/m2 IV on Days 1, 4, and 7

• Maximum dose: 1 vial/dose

Comments:

• This drug should be infused over 2 hours.
• Newly-diagnosed de novo CD33-positive AML (combination regimen):
• Induction: For Induction 1, this drug is administered once in combination with standard chemotherapy; this drug is not administered in the second induction cycle.
• Intensification: This drug is not administered in the first or third intensification cycles. For Intensification 2, this drug is administered once in combination with standard chemotherapy; the risks/benefits should be considered before administering this drug during Intensification 2.
• Relapsed/refractory CD33-positive AML (single-agent regimen): Treatment consists of a single course of this drug; the maximum dose is one 4.5 mg vial.

Uses:

• For the treatment of newly-diagnosed CD33-positive AML
• For the treatment of relapsed/refractory CD33-positive AML

Renal Dose Adjustments

Renal dysfunction: Data not available

Liver Dose Adjustments

Monotherapy or Combination Therapy:

• Total bilirubin greater than 2 times the upper limit of normal (2 x ULN) or AST and/or ALT greater than 2.5 x ULN:
• Delay treatment with this drug until recovery of total bilirubin to 2 x ULN or less and AST and ALT to 2.5 x ULN or less before each dose.
• Omit scheduled dose if delayed more than 2 days between sequential infusions.

Dose Adjustments

Blood counts should be monitored frequently through resolution of cytopenias; blood counts and chemistries should be monitored at least 3 times per week through recovery from treatment-related toxicities. Management of some adverse reactions may require dose interruptions or permanent discontinuation of this drug.

DOSAGE MODIFICATION FOR HEMATOLOGIC AND NONHEMATOLOGIC TOXICITIES:
For Patients Receiving This Drug in Combination Therapy:
Persistent thrombocytopenia:

• Adult patients:
• If platelet count does not recover to at least 100 Gi/L within 14 days after the planned start date of the consolidation cycle (14 days after hematologic recovery following previous cycle): Discontinue this drug (do not administer this drug in the consolidation cycles).
• Pediatric patients: Patients should have a platelet count of 75 Gi/L before the next cycle (induction or intensification).

Persistent neutropenia:

• Adult patients:
• If neutrophil count does not recover to greater than 0.5 Gi/L within 14 days after the planned start date of the consolidation cycle (14 days after hematologic recovery following previous cycle): Discontinue this drug (do not administer this drug in the consolidation cycles).
• Pediatric patients: Patients should have a neutrophil count of 1 Gi/L before the next cycle (induction or intensification).

For All Patients Receiving This Drug (Monotherapy or in Combination):
Veno-occlusive disease (VOD): Discontinue this drug.

Infusion-related reactions:

• Interrupt the infusion and start appropriate medical management.
• Administer acetaminophen, diphenhydramine, and/or methylprednisolone (if needed).
• Provide supportive care measures as needed.
• For mild, moderate, or severe infusion-related reactions: Once symptoms resolve, consider resuming the infusion at no more than half the rate at which the reaction occurred; repeat the procedure above if symptoms recur.
• For a severe infusion reaction or any life-threatening infusion reaction: Permanently discontinue this drug.

Other severe or life-threatening nonhematologic toxicities:

• Delay treatment with this drug until recovery to a severity of no more than mild.
• Omit scheduled dose if delayed more than 2 days between sequential infusions.

Precautions

US BOXED WARNING:

• HEPATOTOXICITY: Hepatotoxicity, including severe or fatal hepatic VOD, also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of this drug as a single agent and as part of a combination chemotherapy regimen. After treatment with this drug, patients should be monitored frequently for signs/symptoms of VOD.

CONTRAINDICATIONS:

• History of hypersensitivity to the active component or any of the ingredients

As a single agent:

• Safety and efficacy have not been established in patients younger than 18 years with newly-diagnosed AML.
• Safety and efficacy have not been established in patients younger than 2 years with relapsed/refractory AML.

With standard chemotherapy: Safety and efficacy have not been established in patients younger than 1 month with newly-diagnosed de novo AML.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Before administration of this drug, cytoreduction is recommended for patients with hyperleukocytosis (leukocyte count at least 30 Gi/L).
• Use an in-line 0.2-micron polyethersulfone (PES) filter for infusion of this drug.
• During infusion, protect the IV bag from light using a light-blocking cover; the infusion line does not need to be protected from light.
• Infuse the diluted solution over 2 hours using an infusion set made of polyvinyl chloride (PVC), either di(2-ethylhexyl)phthalate (DEHP) or non-DEHP; polyethylene; or polyurethane.
• Complete the infusion before the end of the allowed 6-hour storage of the diluted solution at room temperature (up to 30C [86F]).
• Do not mix this drug with, or administer as an infusion with, other medicinal products.
• Monitor patients during and for at least 1 hour after completion of the infusion or until signs/symptoms of infusion-related reactions completely resolve.

Premedication:

• Adult patients: Premedicate with acetaminophen (650 mg orally) and diphenhydramine (50 mg orally or IV) 1 hour before dosing of this drug, and methylprednisolone (1 mg/kg [or an equivalent dose of an alternative corticosteroid]) within 30 minutes before infusion of this drug.
• Pediatric patients (1 month and older): Premedicate with acetaminophen (15 mg/kg [maximum: 650 mg/dose) and diphenhydramine (1 mg/kg [maximum: 50 mg/dose]) 1 hour before dosing of this drug, and methylprednisolone (1 mg/kg orally or IV) within 30 minutes before infusion of this drug.
• May administer additional doses of acetaminophen and diphenhydramine every 4 hours after the initial pretreatment dose
• Repeat with the same dose of methylprednisolone (or an equivalent corticosteroid) for any sign of infusion reaction (e.g., fever, chills, hypotension, dyspnea) during the infusion or within 4 hours afterwards.

Storage requirements:

• Lyophilized product: Refrigerate (2C to 8C [36F to 46F]) vials and store in the original carton to protect from light; do not freeze.
• Before reconstitution, allow vials to reach room temperature (up to 30C [86F]) for about 5 minutes.
• Reconstituted solution: If immediate use is not possible, store in the original vial for up to 16 hours in a refrigerator (2C to 8C [36F to 46F]) or up to 3 hours at room temperature (up to 30C [86F]); protect from light and do not freeze.
• Diluted solution: If immediate use is not possible, store up to 18 hours in a refrigerator (2C to 8C [36F to 46F]) and for up to 6 hours at room temperature (up to 30C [86F]); protect from light and do not freeze.
• The allowed time at room temperature (up to 30C [86F]) includes the time needed for preparation of the diluted solution, equilibration (if needed), and the 2 hours necessary to administer to the patient.

Reconstitution/preparation techniques:

• Reconstitute and dilute this drug before administration; do not shake.
• Doses must be mixed to a concentration between 0.075 to 0.234 mg/mL.
• Doses less than 3.9 mg must be prepared for administration by syringe; protect from light.
• Doses at least 3.9 mg should be diluted in a syringe or a PVC with DEHP, non-PVC polyolefin, or ethylene vinyl acetate IV infusion bag; protect from light.
• The manufacturer product information should be consulted.

IV compatibility:

• Compatible: Sterile Water for Injection, USP; 0.9% Sodium Chloride Injection

General:

• This is a cytotoxic drug; special handling and disposal procedures should be followed as applicable.
• Appropriate measures should be used to prevent tumor lysis syndrome.

Monitoring:

• Cardiovascular: ECGs in patients with history of/predisposition for QTc prolongation and in those with electrolyte disturbances (before starting therapy and as needed during administration)
• General: Alkaline phosphatase (before each dose of this drug); vital signs (often during infusion); for signs/symptoms of infusion-related reactions (during and for at least 1 hour after infusion); electrolytes in patients with history of/predisposition for QTc prolongation and in those with electrolyte disturbances (before starting therapy and as needed during administration)
• Hematologic: Blood counts (before each dose of this drug; frequently after treatment)
• Hepatic: ALT, AST, and total bilirubin (before each dose of this drug); for signs/symptoms of VOD (frequently after treatment)

Patient advice:

• Monitor signs/symptoms of liver toxicity (including rapid weight gain, right upper quadrant pain/tenderness, hepatomegaly, and ascites) regularly during therapy.
• Report signs/symptoms of bleeding/hemorrhage during therapy.
• Contact your health care provider if signs/symptoms of infusion-related reactions (including symptoms such as fever, chills, rash, or breathing problems) occur.
• Patients of childbearing potential: Inform your health care provider of a known/suspected pregnancy; use effective contraception during therapy and for at least 6 months after the last dose.
• Male patients with partners of childbearing potential: use effective contraception during therapy and for at least 3 months after the last dose.
• Do not breastfeed during therapy and for at least 1 month after the last dose.

See also:

Further information

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