Version May 2024
The FDA has received reports of T-cell malignancies in patients treated with BCMA-directed or CD19-directed autologous CAR T cell immunotherapies. Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, the FDA is investigating the identified risk of T-cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action.
Further information may be found at https://www.fda.gov/safety/medical-product-safety-information/bcma-directed-or-cd19-directed-autologous-chimeric-antigen-receptor-car-t-cell-immunotherapies-fda.
Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with idecabtagene vicleucel. Do not administer idecabtagene vicleucel to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with idecabtagene vicleucel, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with idecabtagene vicleucel. Provide supportive care and/or corticosteroids as needed.
Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with idecabtagene vicleucel. HLH/MAS can occur with CRS or neurologic toxicities.
Prolonged cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with idecabtagene vicleucel.
Idecabtagene vicleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS.
Dosage guidance:
Safety: For autologous use only. Confirm patient identity matches cassette and infusion bag prior to infusion. Confirm availability of autologous idecabtagene vicleucel prior to initiating lymphodepleting chemotherapy. Ensure tocilizumab (at least 2 doses) and emergency equipment are available prior to idecabtagene vicleucel infusion and during recovery period. Premedicate with acetaminophen 650 mg orally and diphenhydramine 12.5 mg IV or 25 to 50 mg orally (or other H1 antihistamine) ~30 to 60 minutes prior to idecabtagene vicleucel infusion. Avoid prophylactic dexamethasone or other systemic corticosteroids as they may interfere with the idecabtagene vicleucel activity.
Clinical considerations: A treatment course consists of 1) lymphodepleting chemotherapy (with fludarabine and cyclophosphamide) for 3 days, and 2) idecabtagene vicleucel infusion 2 days after completion of lymphodepleting chemotherapy. Administer prophylactic antimicrobials as clinically indicated. Consider antiviral therapy to prevent viral reactivation as appropriate.
Multiple myeloma, relapsed or refractory: Note: Delay idecabtagene vicleucel infusion up to 7 days for unresolved serious adverse events (particularly pulmonary or cardiac events, or hypotension), including events due to prior chemotherapies, and for active infections or inflammatory disorders.
IV: Target dose range: 300 to 460 × 106 CAR-positive viable T cells.
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).
Cytokine release syndrome: Monitor for cytokine release syndrome (CRS); if fever, hypoxia, and hypotension occur, evaluate for other causes, and manage as appropriate. If CRS is suspected, manage according to the table below. If CRS occurs, monitor closely for cardiac and organ function until resolution of symptoms; consider antiseizure prophylaxis with levetiracetam. Monitor patients with ≥ grade 2 CRS (eg, hypotension unresponsive to fluids or hypoxia requiring supplemental oxygen) with continuous cardiac telemetry and pulse oximetry. Consider intensive care monitoring/support for severe or life-threatening CRS.
Consider alternate treatment options (eg, higher corticosteroid dose, alternative anticytokine agents, anti-T cell therapies) for CRS refractory to first line interventions (tocilizumab or tocilizumab and corticosteroids). Refractory CRS is characterized by fevers, end-organ toxicity (eg, hypoxia, hypotension) not improving within 12 hours of first line interventions, or development of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).
If concurrent neurologic toxicity is suspected during CRS, administer more aggressive corticosteroid intervention (based on the CRS and neurotoxicity tables), tocilizumab (according to CRS table), and antiseizure medications (according to neurotoxicity table).
|
CRS grade |
Tocilizumaba |
Corticosteroidsb |
|---|---|---|
|
a Also see tocilizumab monograph. | ||
|
b If corticosteroids are initiated, continue corticosteroids for at least 3 doses and taper over a maximum of 7 days. | ||
|
Grade 1: Symptoms require symptomatic treatment only (fever, nausea, fatigue, headache, myalgia, malaise) |
If ≥72 hours after infusion, manage symptomatically. If <72 hours after cell infusion, consider tocilizumab 8 mg/kg (maximum dose: 800 mg) IV over 1 hour. |
Consider dexamethasone 10 mg IV every 24 hours. |
|
Grade 2: Symptoms require and respond to moderate intervention. Oxygen requirement <40% FiO2, or hypotension responsive to fluids or low dose of one vasopressor, or grade 2 organ toxicity. |
Administer tocilizumab 8 mg/kg (maximum dose: 800 mg) IV over 1 hour. Repeat every 8 hours as needed if not responsive to IV fluids or increasing supplemental oxygen. Maximum of 3 tocilizumab doses per 24 hours, and maximum total of 4 tocilizumab doses. |
Consider dexamethasone 10 mg IV every 12 to 24 hours. |
|
If no improvement within 24 hours or rapid progression, repeat tocilizumab and escalate dexamethasone to 20 mg IV every 6 to 12 hours. If no improvement within 24 hours or continued rapid progression, switch to methylprednisolone 2 mg/kg IV, followed by methylprednisolone 0.5 mg/kg IV every 6 hours. After 2 tocilizumab doses, consider alternative anticytokine agents. Do not exceed 3 tocilizumab doses per 24 hours, and maximum total of 4 tocilizumab doses. | ||
|
Grade 3: Symptoms require and respond to aggressive intervention. Fever, oxygen requirement ≥40% FiO2, or hypotension requiring high-dose or multiple vasopressors, or grade 3 organ toxicity, or grade 4 transaminitis. |
Manage per grade 2. |
Administer dexamethasone 10 mg IV every 12 hours. |
|
If no improvement within 24 hours or rapid CRS progression, repeat tocilizumab and escalate dexamethasone to 20 mg IV every 6 to 12 hours. If no improvement within 24 hours or continued rapid progression, switch to methylprednisolone 2 mg/kg IV, followed by methylprednisolone 0.5 mg/kg IV every 6 hours. After 2 tocilizumab doses, consider alternative anticytokine agents. Do not exceed 3 tocilizumab doses per 24 hours, and maximum total of 4 tocilizumab doses. | ||
|
Grade 4: Life-threatening symptoms. Ventilator support required, CVVHD required or grade 4 organ toxicity (excluding transaminitis). |
Manage per grade 2. |
Administer dexamethasone 20 mg IV every 6 hours. |
|
After 2 tocilizumab doses, consider alternative anticytokine agents. Do not exceed 3 tocilizumab doses per 24 hours, and maximum total of 4 tocilizumab doses. If no improvement within 24 hours, consider methylprednisolone (1 to 2 g IV, repeat every 24 hours if needed; taper as clinically indicated) or other anti-T cell therapies. | ||
Neurotoxicity: Monitor for signs/symptoms of neurologic toxicities, including immune effector cell–associated neurotoxicity syndrome and other neurotoxicities. Evaluate neurologic symptoms and treat promptly; rule out other causes of neurologic symptoms. Provide intensive care supportive therapy for severe or life-threatening neurologic toxicities. If neurotoxicity is suspected, manage according to the neurotoxicity table. If concurrent CRS is suspected during neurotoxicity, administer more aggressive corticosteroid intervention (based on the CRS and neurotoxicity tables), tocilizumab (according to CRS table), and antiseizure medications (according to neurotoxicity table).
|
Neurotoxicity grade |
Corticosteroids and antiseizure medication |
|---|---|
|
Grade 1 |
Initiate seizure prophylaxis with nonsedating antiseizure medications (eg, levetiracetam). If ≥72 hours after infusion, observe patient. If <72 hours after infusion, consider dexamethasone 10 mg IV every 12 to 24 hours for 2 to 3 days. |
|
Grade 2 |
Initiate seizure prophylaxis with nonsedating antiseizure medications (eg, levetiracetam). Initiate dexamethasone 10 mg IV every 12 hours for 2 to 3 days (or longer for persistent symptoms). Consider taper for a total corticosteroid exposure of >3 days. Corticosteroids are not recommended for isolated grade 2 headache. If no improvement after 24 hours or worsening of neurologic toxicity, increase dexamethasone dose and/or frequency up to a maximum of 20 mg IV every 6 hours. |
|
Grade 3 |
Initiate seizure prophylaxis with nonsedating antiseizure medications (eg, levetiracetam). Initiate dexamethasone 10 to 20 mg IV every 6 to 12 hours. Corticosteroids are not recommended for isolated grade 3 headache. If no improvement after 24 hours, or worsening neurologic toxicity, escalate to methylprednisolone (2 mg/kg IV loading dose, followed by 0.5 mg/kg IV every 6 hours; taper within 7 days). If cerebral edema is suspected, consider hyperventilation and hyperosmolar therapy. Administer methylprednisolone 1 to 2 g IV, repeat every 24 hours if needed and taper as clinically indicated. Administer cyclophosphamide 1.5 g/m2 IV. |
|
Grade 4 |
Initiate seizure prophylaxis with nonsedating antiseizure medications (eg, levetiracetam). Initiate dexamethasone 20 mg IV every 6 hours. If no improvement after 24 hours, or worsening neurologic toxicity, administer methylprednisolone 1 to 2 g IV, repeat every 24 hours if needed and taper as clinically indicated. If cerebral edema is suspected, consider hyperventilation and hyperosmolar therapy. Administer methylprednisolone 1 to 2 g IV, repeat every 24 hours if needed and taper as clinically indicated. Administer cyclophosphamide 1.5 g/m2 IV. |
Other toxicities:
Cytomegalovirus reactivation: Manage as clinically appropriate.
Cytopenias: Manage cytopenia with myeloid growth factor and blood product transfusion support (according to local institutional guidelines).
Hemophagocytic lymphohistiocytosis/macrophage activation syndrome: Manage per institutional standards.
Hypogammaglobulinemia (IgG <400 mg/dL): Administer IV immune globulin and manage as indicated with infection precautions, and antibiotic and/or antiviral prophylaxis.
Infection: Administer prophylactic, preemptive, and/or therapeutic antimicrobials according to standard institutional guidelines.
Neutropenic fever: Evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as clinically indicated.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Edema (25%), hypertension (11%), hypotension (17%), tachycardia (19%)
Dermatologic: Skin rash (14%), xeroderma (11%)
Endocrine & metabolic: Hypophosphatemia (grades 3/4: 45%), weight loss (13%)
Gastrointestinal: Constipation (16%), decreased appetite (22%), diarrhea (35%), nausea (29%), vomiting (15%)
Hematologic & oncologic: Anemia (grades 3/4: 63%), febrile neutropenia (16%; grades ≥3: 16%), hypogammaglobulinemia (21% to 41%; grades ≥3: <1%), leukopenia (grades 3/4: 96%), lymphocytopenia (grades 3/4: 92%), neutropenia (grades 3/4: 96%), thrombocytopenia (grades 3/4: 63%)
Hypersensitivity: Cytokine release syndrome (85%)
Immunologic: Antibody development (47%)
Infection: Bacterial infection (15%), infection (51% to 70%; serious infection: 19%), viral infection (27%)
Nervous system: Anxiety (12%), chills (11%), dizziness (17%), encephalopathy (26%), fatigue (45%), headache (23%), insomnia (13%), motor dysfunction (11%), mouth pain (12%), neurotoxicity (28%), peripheral neuropathy (17%)
Neuromuscular & skeletal: Musculoskeletal pain (45%)
Respiratory: Cough (23%), dyspnea (13%), pneumonia (17%), upper respiratory tract infection (34%)
Miscellaneous: Fever (25%), physical health deterioration (11%)
1% to 10%:
Cardiovascular: Atrial fibrillation (5%), cardiomyopathy (2%), thrombosis (3%)
Endocrine & metabolic: Hyperglycemia (<10%), hypoalbuminemia (<10%), hypocalcemia (<10%), hypokalemia (<10%), hyponatremia (grades 3/4: 10%)
Gastrointestinal: Gastrointestinal hemorrhage (3%)
Hematologic & oncologic: Disorder of hemostatic components of blood (9%), elevated aPTT associated with bleeding (grades 3/4: 10%), hematologic disease (hemophagocytic lymphohistiocytosis/macrophage activation syndrome: ≤4%), hypofibrinogenemia (<10%)
Hepatic: Increased serum alanine aminotransferase (<10%), increased serum alkaline phosphatase (<10%), increased serum aspartate aminotransferase (<10%), increased serum bilirubin (<10%)
Infection: Fungal infection (8%), sepsis (9%)
Nervous system: Aphasia (7%), ataxia (3%), delirium (6%), paresis (2%), seizure (2%)
Neuromuscular & skeletal: Tremor (10%)
Renal: Renal failure syndrome (10%)
Respiratory: Hypoxia (2%), pulmonary edema (2%)
Frequency not defined:
Hematologic & oncologic: Hemorrhage
Infection: Cytomegalovirus disease, reactivation of HBV
Postmarketing: Hematologic & oncologic: Hematologic malignancy (T-cell) (FDA Safety Communication 2023)
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Cytokine release syndrome: Cytokine release syndrome (CRS) commonly occurred with idecabtagene vicleucel; grade 3, life-threatening, and fatal CRS events have occurred. The median time to onset of CRS (any grade) was 1 day (range: 1 to 23 days) and the median duration of CRS was 7 days (range: 1 to 63 days). The most common CRS manifestations included fever, chills, hypotension, tachycardia, hypoxia, fatigue, and headache. Serious events associated with CRS may include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, atrial fibrillation, acute respiratory distress syndrome, hepatocellular injury, metabolic acidosis, pulmonary edema, multiple organ dysfunction, and/or hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Identify CRS based on clinical presentation. CRS has been reported to be associated with findings of HLH/MAS (which is potentially life-threatening), as signs/symptoms may overlap. Evaluate for evidence of HLH/MAS in patients with progressive or refractory CRS symptoms (despite treatment). The rate and duration of CRS may be dose-related, with higher idecabtagene vicleucel doses associated with higher incidences of grade 2 CRS and a slightly longer CRS duration; higher idecabtagene vicleucel doses were also associated with a higher requirement for tocilizumab and corticosteroid utilization. Patients should seek immediate medical attention if signs/symptoms of CRS occur at any time.
• Cytomegalovirus reactivation: Cytomegalovirus infection resulting in pneumonia and death has occurred following idecabtagene vicleucel.
• Cytopenias: Prolonged cytopenias, including grades 3 and 4 neutropenia, thrombocytopenia, and anemia, may occur following lymphodepleting chemotherapy and idecabtagene vicleucel. The incidence of prolonged cytopenias may be related to the idecabtagene vicleucel dose. The median time to recovery following idecabtagene vicleucel infusion was 1.9 months for grade 3 or 4 neutropenia and 2.1 months for grade 3 or 4 thrombocytopenia. The median time to cytopenia recovery was similar among the idecabtagene vicleucel doses administered. Although rare, some patients required hematopoietic cell therapy (with autologous or allogeneic cells) for hematopoietic reconstitution due to prolonged cytopenia; fatal cases of complications (due to bleeding or infection) resulting from prolonged cytopenia occurred (in the setting of ongoing or prior CRS or HLH/MAS).
• Hemophagocytic lymphohistiocytosis/macrophage activation syndrome: HLH/MAS has occurred with idecabtagene vicleucel, including rare fatal cases of multiorgan HLH/MAS with CRS or with pulmonary fungal infection. HLH/MAS is a life-threatening condition with a high mortality rate if not recognized and managed early. Three cases of grade 2 HLH/MAS resolved. The incidence of HLH/MAS may be dose related. The median time to onset of HLH/MAS was 7 days (range: 4 to 9 days) and occurred in the setting of ongoing or worsening CRS. HLH/MAS with overlapping neurotoxicity has been observed. Manifestations of HLH/MAS include hypotension, hypoxia, multiple organ dysfunction, kidney dysfunction, and cytopenia.
• Hepatitis B virus reactivation: Hepatitis B virus reactivation (sometimes resulting in fulminant hepatitis, hepatic failure, and death) can occur in patients treated with medication directed against plasma cells.
• Hypersensitivity: Allergic reactions may occur with idecabtagene vicleucel; serious hypersensitivity, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) in idecabtagene vicleucel.
• Hypogammaglobulinemia: Hypogammaglobulinemia and plasma cell aplasia may occur in patients receiving idecabtagene vicleucel. Some patients required IV immunoglobulin following idecabtagene vicleucel, either for management of an adverse reaction or for prophylaxis.
• Infections: Infections have occurred commonly with idecabtagene vicleucel; severe, life-threatening, or fatal infections have occurred. Infections included bacterial, viral, and fungal infections, as well as infection with unspecified pathogens. Neutropenic fever has been observed and may be concurrent with CRS.
• Neurologic toxicities: Neurologic toxicities, including immune effector cell–associated neurotoxicity syndrome, which may be severe or life-threatening, have occurred with idecabtagene vicleucel; grade 3 neurotoxicity has been observed. Neurotoxicity may occur concurrently with CRS, after CRS resolution, or in the absence of CRS. The median time to onset of neurotoxicity was 2 days (range: 1 to 42 days). Neurotoxicity resolved in most patients, with a median duration of 6 days (range: up to ~1.5 years); cases of ongoing grade 2 neurotoxicity or tremor have occurred. For patients experiencing resolution, the median time to resolution was 5 days (range: 1 to 61 days). Grade 3 neurotoxicity may be dose related. Frequent manifestations of neurotoxicity include encephalopathy, tremor, aphasia, and delirium. Idecabtagene vicleucel has been associated with grade 3 parkinsonism, grade 3 myelitis, grade 4 neurotoxicity, and cerebral edema in multiple myeloma studies. Patients should seek immediate medical attention for signs/symptoms of neurologic toxicity. Due to the potential for neurologic events, including altered mental status or seizures, patients receiving idecabtagene vicleucel are at risk for altered or decreased consciousness or coordination in the 8 weeks following administration. Patients should refrain from driving and other hazardous activities for at least 8 weeks following idecabtagene vicleucel cell infusion.
• Secondary malignancies: Patients treated with idecabtagene vicleucel may develop secondary malignancies. If a secondary malignancy develops, contact the manufacturer (1-888-805-4555) for reporting and to obtain patient sampling instructions for origin testing.
Concurrent drug therapy issues:
• Immunizations: Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during idecabtagene vicleucel treatment, and until immune recovery following treatment with idecabtagene vicleucel. The safety of immunization with live viral vaccines during or following idecabtagene vicleucel has not been studied.
Special populations:
• Older adult: The incidence of grade 3 neurotoxicity was higher in patients ≥65 years of age.
Dosage form specific issues:
• Dimethyl sulfoxide: Idecabtagene vicleucel contains dimethyl sulfoxide (DMSO), which has been associated with serious hypersensitivity reactions (including anaphylaxis).
• Universal precautions: Idecabtagene vicleucel contains human blood cells that are genetically modified with replication incompetent, self-inactivating lentiviral vector. Follow universal precautions and local biosafety guidelines for handling and disposal.
Other warnings/precautions:
• REMS program: Idecabtagene vicleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS. Information is available at https://www.AbecmaREMS.com or at 1-888-423-5436.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Intravenous:
Abecma: 460 million cells (1 ea)
No
Suspension (Abecma Intravenous)
460000000CELLS (per each): $0.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
IV: For IV use only. Administer in a health care facility. Coordinate the timing of administration with thawing. Prime tubing set with NS prior to infusion. Infuse idecabtagene vicleucel by gravity infusion within 1 hour after the start of thaw. After the entire contents of infusion bag(s) have infused, rinse tubing with 30 to 60 mL of NS (at the same infusion rate) to ensure all product is delivered. Do not use a leukodepleting filter. A central line may be used for administration (and is encouraged in patients with poor peripheral access). If >1 infusion bag is required, administer all bags as instructed, and prime and rinse with all bags. Thaw 1 bag at a time and do not initiate thawing of the next bag until infusion of the previous bag is complete. Apply universal precautions for product handling.
Prior to administration: Ensure tocilizumab (at least 2 doses) and emergency equipment are available prior to infusion and during recovery period. Confirm patient identity and match to patient identifiers on the infusion bag. Premedicate with acetaminophen 650 mg orally and diphenhydramine 12.5 mg IV or 25 to 50 mg orally (or other H1 antihistamine) ~30 to 60 minutes prior to idecabtagene vicleucel infusion. Avoid prophylactic dexamethasone or other systemic corticosteroids as they may interfere with the idecabtagene vicleucel activity.
Monitor patient daily (for signs/symptoms of cytokine release syndrome and neurotoxicity) at the health care facility for at least 7 days after cell infusion; patient should remain within proximity of the facility for at least 4 weeks after infusion.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Abecma: https://packageinserts.bms.com/medguide/medguide_abecma.pdf
Multiple myeloma, relapsed or refractory: Treatment of relapsed or refractory multiple myeloma in adults after ≥4 prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Idecabtagene vicleucel may be confused with axicabtagene ciloleucel, betibeglogene autotemcel, brexucabtagene autoleucel, ciltacabtagene autoleucel, elivaldogene autotemcel, exagamglogene autotemcel, lisocabtagene maraleucel, lovotibeglogene autotemcel, sipuleucel-T, tisagenlecleucel.
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its lists of drug classes which have a heightened risk of causing significant patient harm when used in error.
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination
Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. 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 enhance the adverse/toxic effect of CAR-T Cell Immunotherapy. Specifically, the severity and duration of neurologic toxicities may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of CAR-T Cell Immunotherapy. 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 (Adenovirus Vector): CAR-T Cell Immunotherapy may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). 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 mRNA vaccine series at least 3 months (12 weeks) after CAR-T-cell therapy. Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): CAR-T Cell Immunotherapy may diminish the therapeutic effect 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 diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect 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 enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: May enhance the immunosuppressive effect 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 enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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 enhance the immunosuppressive effect 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
Mumps- Rubella- or Varicella-Containing Live Vaccines: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the potential for allergic or hypersensitivity reactions to 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 enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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 enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect 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 enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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 Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect 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 combination
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Verify pregnancy status prior to treatment initiation.
Refer to monographs of concomitant medications for contraception recommendations; recommendations specific to idecabtagene vicleucel are not available.
Animal reproduction studies have not been conducted. Based on the mechanism of action, fetal plasma cell aplasia or hypogammaglobulinemia may occur following in utero exposure. Monitor immunoglobulin levels in newborns.
It is not known if idecabtagene vicleucel is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Screen for cytomegalovirus, hepatitis B virus (HBV), hepatitis C virus, and HIV in accordance with clinical guidelines prior to collection of cells for manufacturing. Monitor CBC prior to and after idecabtagene vicleucel administration. Evaluate pregnancy status prior to use (in patients who may become pregnant). Monitor immunoglobulin levels (IgG) after idecabtagene vicleucel treatment.
Monitor for cytokine release syndrome (CRS) and signs/symptoms of neurologic toxicity (including immune effector cell-associated neurotoxicity syndrome) during therapy and for at least 4 weeks after infusion. For ≥ grade 2 CRS, perform continuous cardiac telemetry and pulse oximetry. Monitor patient daily at the health care facility for at least 7 days after cell infusion. Monitor for signs/symptoms of infection before and after idecabtagene vicleucel administration. Monitor for signs/symptoms of cytomegalovirus and HBV reactivation. Monitor for hypersensitivity. Evaluate for evidence of hemophagocytic lymphohistiocytosis/macrophage activation syndrome. Monitor (lifelong) for secondary malignancies.
The American Society of Clinical Oncology HBV screening and management provisional clinical opinion (ASCO [Hwang 2020]) 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.
Cardiovascular monitoring: Comprehensive assessment prior to treatment including a history and physical examination, screening for cardiovascular disease risk factors such as hypertension, diabetes, dyslipidemia, obesity, and smoking (ASCO [Armenian 2017]). Obtain baseline ECG, natriuretic peptides, and troponins; a baseline echocardiography is recommended in patients with preexisting cardiovascular disease; consider baseline echocardiography in all patients; for patients who develop ≥ grade 2 cytokine release syndrome, assess natriuretic peptides and troponins, and obtain echocardiography (ESC [Lyon 2022]). Refer to a cardiologist when clinically indicated.
Idecabtagene vicleucel is a B cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy in which a patient's T cells are reprogrammed via transduction with an anti-BCMA02 chimeric antigen receptor (CAR) lentiviral vector. The CAR construct includes an anti-BCMA single chain variable fragment-targeting domain for antigen specificity, a transmembrane domain, a CD3-zeta T cell activation domain, and a 4-1BB costimulatory domain. CD3-zeta signaling initiates activation and antitumor activity, while 4-1BB (CD137) signaling enhances T cell expansion. Antigen-specific activation of idecabtagene vicleucel results in CAR-positive T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells. Idecabtagene vicleucel is prepared from the patient's T cells, which are obtained via leukapheresis.
Note: Idecabtagene vicleucel exhibits an initial rapid expansion followed by a bi-exponential decline. Patients who received tocilizumab and/or corticosteroids to manage cytokine release syndrome (CRS) and/or neurologic toxicity experienced higher idecabtagene vicleucel expansion levels and higher AUC0 to 28d and Cmax compared to patients who did not receive tocilizumab or corticosteroids.
Duration: Idecabtagene can persist in peripheral blood for up to 1 year after infusion.
Time to peak: Median time to maximal expansion (in peripheral blood): 11 days after infusion.
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