Obecabtagene Autoleucel Dosage

Medically reviewed by Drugs.com. Last updated on Feb 4, 2025.

Usual Adult Dose for Acute Lymphoblastic Leukemia

The total recommended dose is 410 x 10(6) CD19 chimeric antigen receptor-positive viable T cells intravenously, supplied in 3 to 5 infusion bags.

Comments:

• The manufacturer product information should be consulted.
• The treatment regimen consists of a split dose infusion to be administered on Day 1 and Day 10.
• The dosing regimen is determined by the tumor burden assessed by bone marrow blast percentage from a sample that's been obtained 7 days prior to the start of lymphodepletion.
• The volume to be infused is variable and is calculated based on the concentration of CD19 CAR-positive viable T cells.
• Reference the Release for Infusion certificate and Dose Schedule Planner for actual cell counts, volumes to be infused, and appropriate dosing regimen.

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

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Cytokine Release Syndrome (CRS) following the first split dose:

• Grade 2: Consider postponing further infusions up to Day 21 to allow for CRS to resolve to grade 1 or less.
• Grade 3 or greater: Discontinue treatment.

Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) following the first split dose:

• Grade 1: Consider postponing further infusions up to Day 21 to allow for the ICANS to completely resolve.
• Grade 2 or greater: Discontinue treatment.

Pulmonary or cardiac toxicities following the first split dose:

• Grade 3 or greater: Discontinue treatment.

Severe intercurrent infection at the time of infusion:

• Grade 3 or greater: Consider postponing infusion up to Day 21 until the severe intercurrent infection is controlled.

Precautions

US BOXED WARNINGS:

• CRS was reported in patients receiving this drug. Do not give this drug to patients with current infections or inflammatory diseases. Before administration, ensure that medical personnel have access to emergency medications and resuscitative equipment to manage any potential CRS.
• Fatal and serious neurological reactions can occur in patients taking this medication, including ICANS, either at the same time as CRS or after CRS has resolved. It is important to watch for neurological symptoms and signs after the treatment. Ensure that medical staff have emergency medications and equipment available to intervene, should neurological toxicities occur. Supportive care and/or corticosteroids may also be required.
• Following the treatment of hematologic malignancies with BCMA-and CD19-directed genetically modified autologous T cell immunotherapies, T cell malignancies were reported.

CONTRAINDICATIONS: None

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:

• The manufacturer product information should be consulted.
• This drug is for autologous use only.
• Contact Autolus Inc at 1-855-288-5227 if there are any discrepancies between the labels and the patient identifiers.

Storage requirements:

• Store this drug frozen in the vapor phase of liquid nitrogen (below -150C)

Reconstitution/preparation techniques:

• The manufacturer product information should be consulted.
• A bone marrow assessment must be performed within 7 days prior to initiating lymphodepleting chemotherapy as per appropriate protocols.
• Confirm the availability of this drug prior to lymphodepleting therapy.
• Thaw prior to infusion and do not refreeze after thawing.

Monitoring:

• Hematologic: Perform periodic monitoring of blood counts.
• Immunologic: Monitor patients for at least 4 weeks for signs of CRS.
• Oncologic: Monitor for secondary malignancies for the lifetime of the patient. Contact Autolus Inc at 1-855-288-5227 if patient is diagnosed with a secondary malignancy.
• Nervous System: Monitor patients for at least 4 weeks for signs of ICANS.

Patient advice:

• Do not drive or operate heavy or potentially dangerous machinery for at least eight weeks after infusion with this drug.
• Advise patient that there may be a manufacturing failure and the subsequent need for a second manufacturing of this drug after a second leukapheresis collection.
• Patients should be made aware that further therapy could be required alongside lymphodepletion before the manufacturing of this drug is completed. Therefore, the potential for adverse events to occur is heightened during the period leading up to the infusion process.
• Inform patient to be seen immediately if the following develop:
• Cytokine Release Syndrome: Fever, hypotension, and hypoxia
• Neurologic Toxicity/ICANS: Headache, dizziness, anxiety, insomnia, delirium, tremor, encephalopathy
• Prolonged Cytopenias: Neutropenia, anemia, thrombocytopenia, bleeding
• Severe infections
• Secondary Malignancies

Further information

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

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