Version July 2025
Cytokine release syndrome (CRS), occurred in patients receiving obecabtagene autoleucel. Do not administer obecabtagene autoleucel to patients with active infection or inflammatory disorders. Prior to administering obecabtagene autoleucel, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS.
Immune effector cell-associated neurotoxicity syndrome (ICANS), including fatal or life-threatening reactions, occurred in patients receiving obecabtagene autoleucel, including concurrently with CRS or after CRS resolution. Monitor for neurologic signs and symptoms after treatment with obecabtagene autoleucel. Prior to administering obecabtagene autoleucel, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage neurologic toxicities. Provide supportive care and/or corticosteroids, as needed.
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies.
Dosage guidance:
Safety: For autologous use only. Confirm patient identity matches infusion bag(s) prior to infusion. Confirm availability of obecabtagene autoleucel prior to initiating lymphodepleting chemotherapy. Ensure tocilizumab and emergency equipment are available for immediate access prior to infusion and during recovery period. Premedicate with acetaminophen approximately 30 minutes prior to obecabtagene autoleucel infusion. Avoid prophylactic systemic corticosteroids, as corticosteroids may interfere with obecabtagene autoleucel activity.
Dosing: The dosage regimen is determined by the assessment of tumor burden (bone marrow blast percentage) obtained within 7 days prior to the start of lymphodepleting chemotherapy. Review the release for infusion certificate and dose schedule planner for the actual cell counts and volumes to be infused and to select the appropriate dosage regimen based on bone marrow blast percentage. Strictly follow administration instructions to minimize dosing errors.
Dosage form information: Obecabtagene autoleucel is provided as a total dose for infusion in 3 to 5 infusion bags for split dose administration. Bags are supplied in color-coded bag configurations including specific doses of CD19 chimeric antigen receptor (CAR)-positive viable T cells (10 × 106 [blue], 100 × 106 [orange], and 300 × 106 [red]); the orange and red bag doses will be suspended in 1 or more infusion bags. Prior to preparation, verify the number of bags received and required for the indicated day 1 and/or day 10 (±2 days) dose(s).
Clinical considerations: Administer prophylactic antimicrobials according to local guidelines. Do not administer to patients with active infection or inflammatory disorders. A treatment course consists of 1) A bone marrow assessment obtained within 7 days prior to initiation of lymphodepleting chemotherapy to determine the obecabtagene autoleucel dosing regimen, 2) lymphodepleting chemotherapy (with fludarabine for 4 days and cyclophosphamide for 2 days), and 3) obecabtagene autoleucel infusion on day 1, which is 3 days (±1 day) after completion of lymphodepleting chemotherapy, allowing a minimum 48-hour washout; a second split dose will be administered on day 10 (±2 days).
Acute lymphoblastic leukemia, B-cell precursor, relapsed or refractory:
Note: Delay obecabtagene autoleucel treatment in patients with severe intercurrent infection. In patients requiring supplemental oxygen, only infuse obecabtagene autoleucel if considered appropriate by the treating physician based on the risks and benefits of the treatment.
IV: Total dose: 410 × 106 CD19 chimeric antigen receptor (CAR)–positive viable T cells administered as a split dose infusion (see table below) on day 1 and day 10 (±2 days).
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Bone marrow blast >20% |
Bone marrow blast ≤20% | |
|---|---|---|
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a The dosage regimen is determined by the assessment of tumor burden (bone marrow blast percentage) obtained within 7 days prior to the start of lymphodepleting chemotherapy. b If the bone marrow assessment results are inconclusive, repeat a biopsy or aspirate only if lymphodepleting chemotherapy has not started. If results remain inconclusive, proceed with dosing schedule for bone marrow blast >20%. c The Release for Infusion Certificate (provided in shipper and on manufacturer scheduling portal) indicates the exact volume to be administered via syringe. | ||
|
Day 1 |
10 × 106 CAR-positive viable T cells (blue bag) administered via syringe c |
100 × 106 CAR-positive viable T cells (orange bag) administered via bag infusion |
|
Day 10 (±2 days) |
100 × 106 CAR-positive viable T cells (orange bag) administered via bag infusion AND 300 × 106 CAR-positive viable T cells (red bag) administered via bag infusion |
10 × 106 CAR-positive viable T cells (blue bag) administered via syringe c AND 300 × 106 CAR-positive viable T cells (red bag) administered via bag infusion |
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
|
Adverse Reaction |
Severity |
Obecabtagene Autoleucel Second Split Dose (Day 10 ± 2 Days) Dosage Modification |
|---|---|---|
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a CRS = cytokine release syndrome; ICANS = immune effector cell–associated neurotoxicity syndrome. | ||
|
CRS (following the first split dose) |
Any |
At first signs of CRS, immediately evaluate patient for hospitalization, institute supportive care management based on severity, and consider further management per current practice guidelines. |
|
Grade 2 |
Consider postponing obecabtagene autoleucel infusion up to day 21 to allow for resolution of CRS to ≤ grade 1. | |
|
≥ Grade 3 |
Discontinue obecabtagene autoleucel. | |
|
ICANS (following the first split dose) |
Any |
At the first sign of neurotoxicity (including ICANS), immediately evaluate patients for hospitalization, institute supportive care management based on severity, and consider further management per current practice guidelines. |
|
Grade 1 |
Consider postponing obecabtagene autoleucel infusion up to day 21 to allow for complete resolution of ICANS. | |
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≥ Grade 2 |
Discontinue obecabtagene autoleucel. | |
|
Hemophagocytic lymphohistiocytosis/macrophage activation syndrome |
Any |
Administer treatment per institutional standards. |
|
Hypogammaglobulinemia |
Any |
Manage per institutional guidance, including immunoglobulin replacement, antibiotic or antiviral prophylaxis, and infection precautions. |
|
Infection (at the time of infusion) |
Any |
Treat infection appropriately. |
|
≥ Grade 3 |
Consider postponing obecabtagene autoleucel infusion up to day 21 until severe intercurrent infection is controlled. If febrile neutropenia occurs, evaluate for infection and manage according to treatment guidelines as clinically indicated. | |
|
Pulmonary or cardiac toxicity (following the first split dose) |
≥ Grade 3 |
Discontinue obecabtagene autoleucel. |
|
Requirement for supplementary oxygen |
≥ Grade 3 |
Consider postponing obecabtagene autoleucel infusion up to day 21 to allow for resolution of adverse reaction. |
|
Other clinically relevant adverse reaction (following the first split dose) |
≥ Grade 3 |
Consider postponing obecabtagene autoleucel infusion up to day 21 to allow for resolution of adverse reaction. |
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Cardiovascular: Edema (12%), hypotension (23%), tachycardia (12%)
Dermatologic: Skin rash (17%)
Endocrine & metabolic: Weight loss (11%)
Gastrointestinal: Abdominal pain (16%), constipation (11%), decreased appetite (13%), diarrhea (26%), nausea (29%; grades ≥3: 2%), vomiting (18%)
Hematologic & oncologic: Anemia (grades 3/4: 43%), febrile neutropenia (26%; grades ≥3: 26%), hemorrhage (20%; grades ≥3: 4%), leukopenia (grades 3/4: 87%), lymphocytopenia (grades 3/4: 90%), neutropenia (grades 3/4: 72%), thrombocytopenia (grades 3/4: 48%)
Hypersensitivity: Cytokine release syndrome (75%)
Infection: Infection (44% to 67%; including bacterial infection [26%], fungal infection [15%], serious infection, viral infection [16%])
Nervous system: Chills (11%), dizziness (14%), fatigue (22%), headache (22%), neurotoxicity (64%; including encephalopathy [21%], immune effector cell-associated neurotoxicity syndrome [ICANS: 24%]), pain (23%)
Neuromuscular & skeletal: Musculoskeletal pain (36%)
Respiratory: Cough (14%)
Miscellaneous: Fever (29%)
1% to 10%:
Cardiovascular: Cardiac arrhythmia (5%), heart failure (1%), palpitations (2%), thrombosis (5%)
Dermatologic: Dermal ulcer (2%)
Endocrine & metabolic: Adrenocortical insufficiency (2%), increased serum iron (hyperferritinemia: 10%)
Gastrointestinal: Stomatitis (5%)
Hematologic & oncologic: Disorder of hemostatic components of blood (10%; grades ≥3: 6%), hemophagocytic lymphohistiocytosis (including macrophage activation syndrome: 2%), hypogammaglobulinemia (10%; grades ≥3: 2%)
Hepatic: Ascites (4%), increased serum aspartate aminotransferase (10%)
Hypersensitivity: Infusion-related reaction (2%)
Immunologic: Graft-versus-host disease (4%)
Nervous system: Delirium (5%), motor dysfunction (6%), seizure (2%), tremor (8%)
Ophthalmic: Visual impairment (2%)
Renal: Kidney impairment (7%)
Respiratory: Pleural effusion (4%), respiratory failure (8%)
Frequency not defined:
Nervous system: Anxiety, insomnia
Respiratory: Hypoxia
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Cytokine release syndrome: Cytokine release syndrome (CRS) occurred in three-fourths of patients following treatment with obecabtagene autoleucel; grade 3 CRS also occurred in a small number of patients. The most common manifestations of CRS included fever, hypotension, and hypoxia. The median time to onset of CRS was 8 days (range: 1 to 23 days), with a median duration of 5 days (range: 1 to 21 days). Over two-thirds of treated patients experienced CRS after the first split dose infusion, but prior to the second split dose infusion; median time to onset of CRS in these patients was 6 days (range: 1 to 10 days). In patients developing CRS, the primary treatment was tocilizumab, with approximately one-fifth of patients also receiving corticosteroids. Patients should seek immediate medical attention if signs/symptoms of CRS occur at any time.
• Cytopenias: Prolonged cytopenias, including anemia, neutropenia, and thrombocytopenia, may occur for several weeks after treatment with lymphodepleting chemotherapy and obecabtagene autoleucel. In patients who were responders to obecabtagene autoleucel, approximately three-fourths experienced ≥ grade 3 cytopenias (including neutropenia and thrombocytopenia) that persisted >30 days following infusion; approximately one-fourth of patients experienced ≥ grade 3 cytopenias (including neutropenia and thrombocytopenia) that persisted >60 days following infusion.
• Hemophagocytic lymphohistiocytosis/macrophage activation syndrome: Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) has been observed with obecabtagene autoleucel, including fatal and life-threatening reactions. HLH/MAS was reported in a small number of patients, and included grade 3 and grade 4 events with a time of onset at day 22 and day 41, respectively. There was a fatal event following obecabtagene autoleucel with ongoing HLH/MAS that had not resolved and concurrent immune effector cell–associated neurotoxicity syndrome (ICANS) (death attributed to sepsis).
• Hypersensitivity: Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO), an excipient in obecabtagene autoleucel.
• Hypogammaglobulinemia: Hypogammaglobulinemia and B-cell aplasia may occur in patients after treatment with obecabtagene autoleucel, including grade 3 events. B-cell aplasia was observed in over 90% of patients at 3 months and in 80% of patients at 6 months.
• Infections: Severe, including life-threatening and fatal, infections have occurred with obecabtagene autoleucel. Non–COVID-19 infections of all grades occurred in two-thirds of patients; ≥ grade 3 non–COVID-19 infections also occurred. Febrile neutropenia (≥ grade 3) occurred in approximately one-fourth of patients; febrile neutropenia may be concurrent with CRS. Potentially severe or life-threatening viral reactivation can occur in patients treated with therapies directed against B cells, including obecabtagene autoleucel. There is no experience with manufacturing obecabtagene autoleucel in patients who are positive for HIV, or with active hepatitis B virus or active hepatitis C virus.
• Neurologic toxicities: Neurologic toxicities, including ICANS, occurred in approximately two-thirds of patients following treatment with obecabtagene autoleucel; cases included ≥ grade 3, life-threatening, and fatal events. Neurotoxicity may occur concurrently with CRS, or after CRS resolution. The median time to onset of neurologic toxicities was 10 days (range: 1 to 246 days) with a median duration of 13 days (range: 1 to 904 days). Approximately one-half of treated patients experienced neurologic toxicities after the first split dose infusion, but prior to the second split dose infusion; median time to onset of neurologic toxicities in these patients was 6 days (range: 1 to 11 days). The most common symptoms of neurologic toxicities included ICANS, headache, encephalopathy, dizziness, tremor, anxiety, insomnia, and delirium. ICANS occurred in approximately one-fourth of treated patients, including some ≥ grade 3 events; one-third of patients that experienced ICANS had an onset following the first split dose infusion, but prior to the second split dose infusion. Median time to onset of ICANS was 8 days (range: 1 to 10 days) and 6.5 days (range: 2 to 22 days) following the first and second infusions, respectively, with a median duration of 8.5 days (range: 1 to 53 days). A majority of patients received treatment for ICANS, including high-dose corticosteroids in all treated patients and prophylactic antiepileptics in some patients. Patients should seek immediate medical attention if signs/symptoms of neurologic toxicity (including ICANS) occur. Due to the potential for neurologic events, including altered mental status or seizures, patients receiving obecabtagene autoleucel are at risk for altered or decreased consciousness and/or decreased coordination in the 8 weeks following administration or until resolution of the neurologic event. Patients should refrain from driving and other hazardous occupations or activities (eg, operating heavy or potentially dangerous machinery) for at least 8 weeks following obecabtagene autoleucel cell infusion.
• Secondary malignancies: Patients treated with obecabtagene autoleucel may develop secondary malignancies. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies. Mature T-cell malignancies, including CAR-positive tumors, may present as soon as weeks following obecabtagene autoleucel infusion, and may include fatal outcomes. If a secondary malignancy occurs, contact the manufacturer (1-855-288-5227) for reporting and to obtain instructions on the collection of patient samples for testing.
Concurrent drug therapy issues:
• Immunizations: Vaccination with live viral vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy treatment, during obecabtagene autoleucel treatment, and until immune recovery following treatment. The safety of immunization with live viral vaccines during or following treatment with obecabtagene autoleucel has not been studied.
Dosage form specific issues:
• Dimethyl sulfoxide: Obecabtagene autoleucel contains DMSO, which is associated with serious hypersensitivity reactions, including anaphylaxis.
• Universal precautions: Obecabtagene autoleucel contains autologous human blood cells that are genetically modified with a replication-incompetent lentiviral vector; follow universal precautions and facility biosafety guidelines for handling and disposal to avoid potential transmission of infectious diseases.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Intravenous:
Aucatzyl: 410 million cells (1 ea) [contains albumin human, dimethyl sulfoxide, edetic acid (edta)]
No
Suspension (Aucatzyl Intravenous)
410000000CELLS (per each): $0.00
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Obecabtagene autoleucel must be administered at qualified treatment centers; information is available from the manufacturer at https://www.aucatzylhcp.com/atc-locator/.
IV: For IV use only. Administer in a health care facility. Coordinate the timing of administration with thawing. Strictly follow administration instructions to minimize dosing errors. A central line or large peripheral venous access line for blood products may be used for administration. Apply universal precautions and facility biosafety guidelines for product handling.
Prior to administration: Review the release for infusion certificate and dose schedule planner for the actual cell counts and volumes to be infused and to select the appropriate dosage regimen based on bone marrow blast percentage obtained within 7 days prior to the start of lymphodepletion. Ensure tocilizumab and emergency equipment are available for immediate access prior to infusion and during recovery period. Confirm patient identity and match to patient identifiers on the release for infusion certificate and infusion bag (contact manufacturer and do not infuse if identifiers do not match). Premedicate with acetaminophen approximately 30 minutes prior to obecabtagene autoleucel infusion. Avoid prophylactic systemic corticosteroids, as corticosteroids may interfere with obecabtagene autoleucel activity.
Administration of 10 × 106 CD19 CAR-positive viable T-cell dose (blue bag) via syringe : The specific volume of the 10 × 106 dose is specified on the release for infusion certificate; withdraw only the volume specified from the infusion bag. Draw the volume specified on the release for infusion certificate from the infusion bag using the smallest Luer lock tip syringe necessary (1, 3, 5, or 10 mL) fitted with a Luer lock bag spike; do not use a leukodepleting filter, do not use the syringe to mix the cells. Prime tubing set with NS prior to infusion. Once drawn into the syringe, verify the volume of obecabtagene autoleucel and administer as a slow IV push within 60 minutes after thawing at a rate of approximately 0.5 mL/minute. After the syringe content has infused, flush the administration tubing/line with 60 mL of NS. Dispose of the unused portion of obecabtagene autoleucel according to facility biosafety guidelines.
Administration of 100 × 106 (orange bag) and 300 × 106 (red bag) CAR-positive viable T-cell dose via bag infusion: The specific volume of the dose(s) is specified on the release for infusion certificate. Prime tubing set with NS prior to infusion. Infuse obecabtagene autoleucel via gravity or peristaltic infusion pump within 60 minutes after thawing at an infusion rate within 0.1 to 27 mL/minute. After the entire contents of the infusion bag(s) has infused, rinse the bag with 30 mL of NS and flush the administration tubing/line with 60 mL of NS. If more than one infusion bag is required, administer all bags as instructed, and prime and rinse with all bags. Thaw one bag at a time and do not initiate thawing of the next bag until infusion of the previous bag is complete.
Monitor patient closely (for signs/symptoms of cytokine release syndrome and neurotoxicity, including immune effector cell–associated neurotoxicity syndrome) daily at the health care facility during and for at least 14 days following the first split dose cell infusion; patient should remain within proximity of the facility for at least 4 weeks after each infusion for monitoring.
Acute lymphoblastic leukemia, B-cell precursor, relapsed or refractory: Treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia in adults.
Obecabtagene autoleucel may be confused with afamitresgene autoleucel, axicabtagene ciloleucel, betibeglogene autotemcel, brexucabtagene autoleucel, ciltacabtagene autoleucel, elivaldogene autotemcel, exagamglogene autotemcel, idecabtagene vicleucel, lifileucel, lisocabtagene maraleucel, lovotibeglogene autotemcel, sipuleucel-T, tisagenlecleucel.
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor
Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Miscellaneous Oncologic Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
Corticosteroids (Systemic): May decrease therapeutic effects of CAR-T Cell Immunotherapy. Corticosteroids (Systemic) may increase adverse/toxic effects of CAR-T Cell Immunotherapy. Specifically, the severity and duration of neurologic toxicities may be increased. Management: Avoid use of corticosteroids as premedication before treatment with CAR-T cell immunotherapy agents. Corticosteroids are indicated and may be required for treatment of toxicities such as cytokine release syndrome or neurologic toxicity. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): CAR-T Cell Immunotherapy may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: The CDC recommends that CAR-T-cell recipients who received COVID-19 vaccine prior to or during treatment with CAR-T-cell therapy should be revaccinated with a primary vaccine series at least 3 months (12 weeks) after CAR-T-cell therapy. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Denosumab: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification
Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification
Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Mumps- Rubella- or Varicella-Containing Live Vaccines may increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification
Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Verify pregnancy status in patients who could become pregnant.
Pregnancy testing is recommended prior to use in patients who could become pregnant.
Refer to the cyclophosphamide and fludarabine monographs for information related to use of effective contraception in patients using these medications for lymphodepleting chemotherapy. The duration of contraception needed following obecabtagene autoleucel administration is not known. Potential pregnancies (following treatment) should be discussed with the prescriber.
Animal reproduction studies have not been conducted. Based on the mechanism of action, fetal toxicity, including B-cell lymphocytopenia, may occur.
Outcome data are available from a patient who became pregnant 6 months after treatment during a clinical trial; a premature delivery at 30 weeks' gestation was reported. Potential pregnancies (following treatment) should be discussed with the prescriber.
It is not known if obecabtagene autoleucel is present in breast milk.
According to the manufacturer, the decision to breastfeed should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Assess tumor burden via bone marrow blasts within 7 days prior to the start of lymphodepletion. Screen for hepatitis B virus (HBV), hepatitis C virus, and HIV if clinically indicated prior to collection of cells for manufacturing. Verify pregnancy status in patients who could become pregnant. Monitor blood counts after obecabtagene autoleucel infusion. Monitor immunoglobulin levels.
Monitor closely for cytokine release syndrome (CRS) and signs/symptoms of immune effector cell–associated neurotoxicity syndrome (ICANS) during therapy and for at least 4 weeks after each infusion. Monitor patient daily (for signs/symptoms of CRS and neurotoxicity [including ICANS]) at the health care facility for at least 14 days after the first split dose cell infusion. Monitor for signs/symptoms of infection before and after treatment (including febrile neutropenia and viral reactivation). Monitor lifelong for secondary malignancies (including T-cell malignancies). Monitor for signs/symptoms associated with hemophagocytic lymphohistiocytosis/macrophage activation syndrome. Monitor patient for hypersensitivity reactions during and after obecabtagene autoleucel infusion.
The American Society of Clinical Oncology HBV screening and management provisional clinical opinion (Ref) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Obecabtagene autoleucel is a CD19-directed genetically modified autologous T-cell immunotherapy in which a patient's T cells are reprogrammed via transduction with a lentiviral vector to express an anti-CD19 chimeric antigen receptor (CAR). The CAR T-cell construct includes an anti-CD19 targeting domain consisting of a CD19 single chain variable fragment (scFv) linked to CD3-zeta and 4-1BB costimulatory domains. The scFv in obecabtagene autoleucel has a lower affinity for CD19 than other available anti-CD19 CAR-T products, secondary to a fast off rate, contributing to decreased cell-cell contact, potentially reduced cytokine release syndrome and T-cell exhaustion, and improved CAR-T persistence (Ref). Engagement of anti-CD19 CAR-positive T cells with CD19 expressed on target cells leads to activation of the anti-CD19 CAR-positive T cells and subsequent downstream signaling through the CD3-zeta domain; proliferation and persistence of the anti-CD19 CAR-positive T cells is enhanced by the presence of the 4-1BB co-stimulatory domain. This binding to CD19 results in anti-tumor activity and killing of CD19-expressing target cells.
Note: Obecabtagene autoleucel exhibits an initial rapid expansion (a higher expansion was observed in patients with bone marrow blast >20% compared to patients with bone marrow blast ≤20%). Patients who developed cytokine release syndrome (CRS) or immune effector cell–associated neurotoxicity syndrome (ICANS) experienced higher CAR T-cell expansion (Cmax and AUC0-28d) compared to patients without CRS or ICANS.
Onset: Peak elevation of plasma cytokines observed within the first month after infusion.
Duration: Maximum observed persistency: 36.5 months; median duration of response: 14.1 months.
Time to peak: Median time to maximal expansion to peak: 14 days (range: 2 to 55 days).
