Dosing & Uses
See Pediatric Dosing
Dosage Forms & Strengths
injection, suspension
- Each infusion bag contains 20 mL of elivaldogene autotemcel
- Single dose contains 5 x 106 CD34+ cells/kg of body weight, suspended in a solution containing 5% dimethyl sulfoxide (DMSO)
Cerebral Adrenoleukodystrophy
Indicated to slow the progression of neurologic dysfunction in boys aged 4-17 years with early, active cerebral adrenoleukodystrophy (CALD)
Early, active CALD is defined as asymptomatic or mildly symptomatic (neurologic function score [NFS] ≤1) boys who have gadolinium enhancement on brain magnetic resonance imaging (MRI) and Loes scores of 0.5-9
Confirm availability and storage of elivaldogene autotemcel and availability of back-up collection of CD34+ cells is confirmed before conditioning
Full myeloablative and lymphodepleting conditioning must be administered before infusion; consult prescribing information for conditioning agents before treatment
After completion of conditioning, allow at least 48 hr of washout before infusion
Elivaldogene autotemcel IV infusion
- A single dose for infusion containing a suspension of CD34+ cells in 1-2 infusion bags
- Minimum recommended dose: 5 x 106 CD34+ cells/kg
- Dose is calculated based on patient’s weight before first apheresis
- See the Lot Information Sheet provided with product shipment for additional information pertaining to dose
Dosage Modifications
Renal impairment
- Not studied
- Assess renal impairment to ensure hematopoietic stem cell (HSC) transplantation is appropriate
Hepatic impairment
- Not studied
- Assess for hepatic impairment to ensure HSC transplantation is appropriate
Dosing Considerations
Before therapy
- Screen for hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus 1 and 2 (HIV-1/HIV-2) and human T-lymphotropic virus 1 and 2 (HTLV-1/HTLV-2) in accordance with clinical guidelines before collecting cells for manufacturing
Mobilization and apheresis
- Confirm HSC transplantation is appropriate for patient
- Patients are required to undergo HSC mobilization followed by apheresis to obtain CD34+ cells for product manufacturing
- Weigh patient before first apheresis collection; collect a minimum target number of CD34+ cells of 12 x 106 CD34+ cells/kg
- A backup collection of CD34+ cells ≥1.5 x 106 CD34+ cells/kg (if collected by apheresis) or ≥1 x 108 TNC/kg (Total Nucleated Cells, if collected by bone marrow harvest) is required
- Backup collection may be needed for rescue treatment, if drug is compromised after initiation of conditioning and before its infusion, primary engraftment failure, or loss of engraftment after infusion with this drug
- Collect and cryopreserve these cells before initiating conditioning and infusion with this product
Limitations of use
- Does not treat or prevent adrenal insufficiency
- An immune response to therapy may cause rapid loss of efficacy in patients with full deletions of the human adenosine triphosphate binding cassette, sub family D, member 1 (ABCD1) gene
- Not studied in CALD secondary to head trauma
- Owing to the risk of hematologic malignancy, and unclear long-term durability of therapy and human adrenoleukodystrophy protein (ALDP) expression, carefully consider the appropriateness and timing of treatment for each boy, especially for boys with isolated pyramidal tract disease, based on available treatment options since their clinical symptoms do not usually occur until adulthood
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (99)
- abacavir
elivaldogene autotemcel, abacavir. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- adenovirus types 4 and 7 live, oral
elivaldogene autotemcel, adenovirus types 4 and 7 live, oral. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- anthrax vaccine adsorbed
elivaldogene autotemcel, anthrax vaccine adsorbed. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- anthrax vaccine adsorbed, adjuvanted
elivaldogene autotemcel, anthrax vaccine adsorbed, adjuvanted. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- atazanavir
elivaldogene autotemcel, atazanavir. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- BCG vaccine live
elivaldogene autotemcel, BCG vaccine live. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- bictegravir
elivaldogene autotemcel, bictegravir. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- cabotegravir
elivaldogene autotemcel, cabotegravir. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- cholera vaccine
elivaldogene autotemcel, cholera vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- COVID-19 vaccine, adjuvanted-Novavax
elivaldogene autotemcel, COVID-19 vaccine, adjuvanted-Novavax. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- COVID-19 vaccine, mRNA-Moderna
elivaldogene autotemcel, COVID-19 vaccine, mRNA-Moderna. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- COVID-19 vaccine, mRNA-Pfizer
elivaldogene autotemcel, COVID-19 vaccine, mRNA-Pfizer. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- COVID-19 vaccine, viral vector-Janssen
elivaldogene autotemcel, COVID-19 vaccine, viral vector-Janssen. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- dapivirine intravaginal
elivaldogene autotemcel, dapivirine intravaginal. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- darunavir
elivaldogene autotemcel, darunavir. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- delavirdine
elivaldogene autotemcel, delavirdine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- dengue vaccine
elivaldogene autotemcel, dengue vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- didanosine
elivaldogene autotemcel, didanosine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- diphtheria & tetanus toxoids
elivaldogene autotemcel, diphtheria & tetanus toxoids. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- diphtheria & tetanus toxoids/ acellular pertussis vaccine
elivaldogene autotemcel, diphtheria & tetanus toxoids/ acellular pertussis vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine
elivaldogene autotemcel, diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- dolutegravir
elivaldogene autotemcel, dolutegravir. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- doravirine
elivaldogene autotemcel, doravirine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- Ebola Zaire vaccine
elivaldogene autotemcel, Ebola Zaire vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- efavirenz
elivaldogene autotemcel, efavirenz. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- elvitegravir
elivaldogene autotemcel, elvitegravir. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
elivaldogene autotemcel, elvitegravir/cobicistat/emtricitabine/tenofovir DF. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- emtricitabine
elivaldogene autotemcel, emtricitabine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- enfuvirtide
elivaldogene autotemcel, enfuvirtide. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- etravirine
elivaldogene autotemcel, etravirine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- fosamprenavir
elivaldogene autotemcel, fosamprenavir. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- fostemsavir
elivaldogene autotemcel, fostemsavir. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- haemophilus influenzae type b vaccine
elivaldogene autotemcel, haemophilus influenzae type b vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- hepatitis A vaccine inactivated
elivaldogene autotemcel, hepatitis A vaccine inactivated. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- hepatitis a/b vaccine
elivaldogene autotemcel, hepatitis a/b vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- hepatitis b vaccine
elivaldogene autotemcel, hepatitis b vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- HIV vaccine
elivaldogene autotemcel, HIV vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- human papillomavirus vaccine, bivalent
elivaldogene autotemcel, human papillomavirus vaccine, bivalent. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- human papillomavirus vaccine, nonavalent
elivaldogene autotemcel, human papillomavirus vaccine, nonavalent. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- human papillomavirus vaccine, quadrivalent
elivaldogene autotemcel, human papillomavirus vaccine, quadrivalent. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- ibalizumab
elivaldogene autotemcel, ibalizumab. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- indinavir
elivaldogene autotemcel, indinavir. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- influenza A (H5N1) vaccine
elivaldogene autotemcel, influenza A (H5N1) vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- influenza virus vaccine (H5N1), adjuvanted
elivaldogene autotemcel, influenza virus vaccine (H5N1), adjuvanted. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- influenza virus vaccine quadrivalent
elivaldogene autotemcel, influenza virus vaccine quadrivalent. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- influenza virus vaccine quadrivalent, adjuvanted
elivaldogene autotemcel, influenza virus vaccine quadrivalent, adjuvanted. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- influenza virus vaccine quadrivalent, cell-cultured
elivaldogene autotemcel, influenza virus vaccine quadrivalent, cell-cultured. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- influenza virus vaccine quadrivalent, intranasal
elivaldogene autotemcel, influenza virus vaccine quadrivalent, intranasal. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- influenza virus vaccine quadrivalent, recombinant
elivaldogene autotemcel, influenza virus vaccine quadrivalent, recombinant. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- influenza virus vaccine trivalent
elivaldogene autotemcel, influenza virus vaccine trivalent. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- influenza virus vaccine trivalent, adjuvanted
elivaldogene autotemcel, influenza virus vaccine trivalent, adjuvanted. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- influenza virus vaccine trivalent, recombinant
elivaldogene autotemcel, influenza virus vaccine trivalent, recombinant. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- Japanese encephalitis virus vaccine
elivaldogene autotemcel, Japanese encephalitis virus vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- lamivudine
elivaldogene autotemcel, lamivudine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- maraviroc
elivaldogene autotemcel, maraviroc. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- measles (rubeola) vaccine
elivaldogene autotemcel, measles (rubeola) vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- measles mumps and rubella vaccine, live
elivaldogene autotemcel, measles mumps and rubella vaccine, live. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- measles, mumps, rubella and varicella vaccine, live
elivaldogene autotemcel, measles, mumps, rubella and varicella vaccine, live. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine
elivaldogene autotemcel, meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- meningococcal A C Y and W-135 diphtheria conjugate vaccine
elivaldogene autotemcel, meningococcal A C Y and W-135 diphtheria conjugate vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- meningococcal A C Y and W-135 polysaccharide vaccine combined
elivaldogene autotemcel, meningococcal A C Y and W-135 polysaccharide vaccine combined. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- meningococcal C and Y/haemophilus influenza type B vaccine
elivaldogene autotemcel, meningococcal C and Y/haemophilus influenza type B vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- meningococcal group B vaccine
elivaldogene autotemcel, meningococcal group B vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- modified ragweed tyrosine adsorbate
elivaldogene autotemcel, modified ragweed tyrosine adsorbate. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- nelfinavir
elivaldogene autotemcel, nelfinavir. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- nevirapine
elivaldogene autotemcel, nevirapine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- pneumococcal vaccine 13-valent
elivaldogene autotemcel, pneumococcal vaccine 13-valent. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- pneumococcal vaccine 15-valent
elivaldogene autotemcel, pneumococcal vaccine 15-valent. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- pneumococcal vaccine 20-valent
elivaldogene autotemcel, pneumococcal vaccine 20-valent. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- pneumococcal vaccine heptavalent
elivaldogene autotemcel, pneumococcal vaccine heptavalent. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- pneumococcal vaccine polyvalent
elivaldogene autotemcel, pneumococcal vaccine polyvalent. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- poliovirus vaccine inactivated
elivaldogene autotemcel, poliovirus vaccine inactivated. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- poliovirus vaccine live oral trivalent
elivaldogene autotemcel, poliovirus vaccine live oral trivalent. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- rabies vaccine
elivaldogene autotemcel, rabies vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- rabies vaccine chick embryo cell derived
elivaldogene autotemcel, rabies vaccine chick embryo cell derived. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- raltegravir
elivaldogene autotemcel, raltegravir. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- rilpivirine
elivaldogene autotemcel, rilpivirine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- ritonavir
elivaldogene autotemcel, ritonavir. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- rotavirus oral vaccine, live
elivaldogene autotemcel, rotavirus oral vaccine, live. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- rubella vaccine
elivaldogene autotemcel, rubella vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- saquinavir
elivaldogene autotemcel, saquinavir. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- SARS-CoV-2 vaccine, inactivated
elivaldogene autotemcel, SARS-CoV-2 vaccine, inactivated. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- smallpox (vaccinia) and monkeypox vaccine, live, nonreplicating
elivaldogene autotemcel, smallpox (vaccinia) vaccine, attenuated. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- smallpox (vaccinia) vaccine, attenuated
elivaldogene autotemcel, smallpox (vaccinia) vaccine, attenuated. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- smallpox (vaccinia) vaccine, live
elivaldogene autotemcel, smallpox (vaccinia) vaccine, live. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- stavudine
elivaldogene autotemcel, stavudine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- tenofovir DF
elivaldogene autotemcel, tenofovir DF. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine
elivaldogene autotemcel, tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- tetanus toxoid adsorbed or fluid
elivaldogene autotemcel, tetanus toxoid adsorbed or fluid. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- tick-borne encephalitis vaccine
elivaldogene autotemcel, tick-borne encephalitis vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- tipranavir
elivaldogene autotemcel, tipranavir. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- travelers diarrhea and cholera vaccine inactivated
elivaldogene autotemcel, travelers diarrhea and cholera vaccine inactivated. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- typhoid polysaccharide vaccine
elivaldogene autotemcel, typhoid polysaccharide vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- typhoid vaccine live
elivaldogene autotemcel, typhoid vaccine live. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- varicella virus vaccine live
elivaldogene autotemcel, varicella virus vaccine live. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- yellow fever vaccine
elivaldogene autotemcel, yellow fever vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- zidovudine
elivaldogene autotemcel, zidovudine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- zoster vaccine live
elivaldogene autotemcel, zoster vaccine live. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- zoster vaccine recombinant
elivaldogene autotemcel, zoster vaccine recombinant. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
Monitor Closely (0)
Minor (0)
Adverse Effects
All grades of severity listed unless otherwise indicated
>10%
During mobilization and conditioning
- Nausea (79%)
- Vomiting (72%)
- Decreased appetite (42%)
- Catheter site pain (39%)
- Constipation (30%)
- Headache (24%)
- Abdominal pain (21%)
- Rash (13%)
- First 60 days after treatment H4
- Mucositis (88%)
- Febrile neutropenia (73%)
- Alopecia (72%)
- Abdominal pain (33%)
- Vomiting (31%)
- Decreased appetite (31%)
- Pyrexia (27%)
- Nausea (27%)
- Constipation (21%)
- Diarrhea (21%)
- Epistaxis (19%)
- Pruritus (18%)
- Headache (16%)
- Oropharyngeal pain (16%)
- Skin hyperpigmentation (16%)
- Anxiety (15%)
1 year after treatment
- Seizure (15%)
Between start of conditioning and 24 months after treatment
- Leukopenia (100%)
- Lymphopenia (100%)
- Thrombocytopenia (100%)
- Neutropenia (96%)
- Mucositis (92%)
- Nausea (84%)
- Anemia (84%)
- Vomiting (76%)
- Febrile neutropenia (73%)
- Febrile neutropenia, Grade 3 or more (73%)
- Alopecia (72%)
- Decreased appetite (64%)
- Mucositis, Grade 3 or more (51%)
- Abdominal pain (45%)
- Constipation (42%)
- Hypokalemia (42%)
- Decreased appetite, Grade 3 or more (40%)
- Diarrhea (28%)
- Headache (28%)
- Nausea, Grade 3 or more (25%)
- Rash (21%)
- Epistaxis (19%)
- Pruritus (19%)
- Vomiting, Grade 3 or more (18%)
- Oropharyngeal pain (18%)
- Skin hyperpigmentation (18%)
- Tachycardia (15%)
- Anxiety (15%)
- Transfusion reaction (12%)
- Hypertension (12%)
1-10%
Between 60 days and 1 year after treatment
- Pyrexia (9%)
- Vomiting (6%)
Between start of conditioning and 24 months after treatment
- Vision blurred (10%)
- Cough (10%)
- Epistaxis, Grade 3 or more (7%)
- Oropharyngeal pain, Grade 3 or more (4%)
- Abdominal pain, Grade 3 or more (3%)
- Transfusion reaction, Grade 3 or more (3%)
- Diarrhea, Grade 3 or more (1%)
- Alopecia, Grade 3 or more (1%)
- Hypertension, Grade 3 or more (1%)
Warnings
Black Box Warnings
Hematologic malignancy
- Hematologic malignancy, including life-threatening cases of myelodysplastic syndrome, has occurred
- Diagnosis was between 14 months and 7.5 years after elivaldogene autotemcel, and cancers appear to be the result of lentiviral vector, Lenti-D, integration in proto-oncogenes
- Closely monitor for evidence of malignancy through complete blood counts at least every 6 months and through assessments for evidence of clonal expansion or predominance at least twice in the first year and annually thereafter; consider bone marrow evaluations as clinically indicated
Contraindications
None
Cautions
May exhibit cytopenias, including pancytopenia, for >1 year following conditioning and infusion; monitor blood cell counts until normalization and assess for signs and symptoms of bleeding and/or infection before and after administration
Delayed platelet engraftment has been reported; bleeding risk is increased before platelet engraftment and may continue after engraftment in patients with prolonged thrombocytopenia; monitor for thrombocytopenia and bleeding according to standard guidelines; conduct frequent platelet counts until platelet engraftment and platelet recovery are achieved
There is a potential risk of neutrophil engraftment failure after treatment; neutrophil engraftment failure was defined as failure to achieve 3 consecutive absolute neutrophil counts (ANC) ≥0.5 x109 cells/L obtained on different days by Day 43 after infusion; monitor neutrophil counts until engraftment has been achieved; if neutrophil engraftment failure occurs, provide rescue treatment with back-up collection of CD34+ cells
Dimethyl sulfoxide (DMSO) may cause hypersensitivity reactions, including anaphylaxis, which is potentially life threatening and requires immediate intervention
May affect polymerase chain reaction (PCR) assays for HIV due to LVV provirus insertion; do not use PCR-based assay to screen for HIV infection in treated patients as a false-positive test result is likely
Myelodysplastic syndrome (MDS)
- MDS, a hematologic malignancy, has developed in treated patients
- Carefully consider alternative therapies before treating
- Consider consultation with hematology experts before treatment to inform benefit-risk treatment decision and to ensure adequate monitoring for hematologic malignancy
- Monitor patients treated with lifelong therapy for hematologic malignancy
- For the first 15 years after treatment, monitor via complete blood count (with differential) at least twice per year and via integration site analysis or other testing for evidence of clonal expansion and predominance at least twice in the first year and then annually thereafter
- If hematologic malignancy is detected, contact bluebird bio at 1-833-999-6378 for reporting and to obtain instructions on collection of samples for further testing
-
Consider appropriate expert consultation and additional testing in the following:
- Delayed or failed engraftment of platelets or other cell lines (patients who do not achieve unsupported platelet counts ≥20 x 109/L on or after Day 60 appear to be at particularly high risk for developing malignancy), or
- New or prolonged cytopenias, or
- Presence of clonal expansion or predominance (eg, increasing relative frequency of an integration site, especially if ≥10% and present in MECOM or another proto-oncogene known to be involved in hematologic malignancy)
Serious infections
- Severe infections, including life-threatening or fatal infections, have occurred
- Opportunistic infections (eg, BK cystitis, cytomegalovirus reactivation, human herpesvirus-6 viremia, candidiasis, bacteremias) that have been diagnosed within the first 3 months after treatment
- Opportunistic infections after the first 3 months include an atypical mycobacterium vascular device infection, pseudomonas bacteremia, and Epstein-Barr virus reactivations diagnosed as late as 18 months after treatment
- If patient has febrile neutropenia, evaluate for infection, and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated
- Monitor for signs and symptoms of infection before and after administration and treat appropriately
- Administer prophylactic antimicrobials according to best clinical practices and clinical guidelines
- Avoid administration in patients with active infections
Use of antiretroviral therapy (ART)
- Patients should not take ART for at least 1 month before mobilization or expected duration for elimination of the medications, and until all cycles of apheresis are completed
- ART may interfere with manufacturing of the apheresed cells
- If a patient requires ART for HIV prophylaxis, delay mobilization and apheresis of CD34+ cells until HIV infection is adequately ruled out
Vaccines
- Safety and effectiveness of vaccination during or following treatment not studied
- Vaccination is not recommended for 6 weeks preceding the start of myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel
- Where feasible, administer childhood vaccinations before myeloablative conditioning
Pregnancy & Lactation
Pregnancy
There are no available data with administration in pregnant females
Consider risks associated with mobilization and conditioning agents on pregnancy and fertility
No animal reproductive and developmental toxicity studies have been conducted to assess whether fetal harm may occur when administered
No nonclinical germline transmission studies have been conducted
Contraception
- Consult prescribing information of mobilization and conditioning agents for information on need for effective contraception
- There are insufficient exposure data to provide a precise recommendation on duration of contraception following treatment
- Males capable of fathering a child and their female partners of childbearing potential: Use effective method of contraception (intrauterine device or combination of hormonal and barrier contraception) from start of mobilization through at least 6 months after elivaldogene autotemcel
Infertility
- There are no data on effects on fertility
- Data are available on the risk of infertility with myeloablative conditioning
- Advise patients of option to cryopreserve semen before treatment if appropriate
Lactation
There is no information regarding the presence of elivaldogene autotemcel in human milk, effect on breastfed infants, and effects on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
CALD is a rare, X-linked metabolic disorder caused by mutations in the ABCD1 gene, which affects production of adrenoleukodystrophy protein (ALDP)
Elivaldogene autotemcel is administered as a one-time gene therapy designed to add functional copies of the ABCD1 gene into a patient’s own hematopoietic stem cells, resulting in the production of ALDP
Administration
IV Preparation
Coordinate timing of thawing and infusion; confirm infusion time in advance and adjust
start time of thawing such that it will be available for infusion when patient and healthcare providers are ready
Drug contains human blood cells that are genetically modified with replication-incompetent, self-inactivating Lenti-D lentiviral vector
Follow universal precautions and local biosafety guidelines for handling and disposal of elivaldogene autotemcel to avoid potential transmission of infectious diseases
Remove each metal cassette from liquid nitrogen storage
Confirm that elivaldogene autotemcel is printed on the infusion bag(s) label(s)
Confirm that patient identity matches the unique patient identification information located on infusion bag(s)
Do not infuse if information on patient-specific label on infusion bag does not match intended patient, and contact bluebird bio at 1-833-999-6378
Dose may be contained in 1 or 2 patient-specific infusion bags; ensure that the correct number of infusion bags are present
Use the accompanying Lot Information Sheet to confirm that each infusion bag is within the expiration date before preparation for infusion
Remove overwrap and inspect each infusion bag for any breaches of integrity before thawing and infusion
If a bag is compromised, follow the local guidelines and contact bluebird bio immediately at 1-833-999-6378
Thaw infusion bag at 37ºC (98.6ºF) in a water bath or dry bath, which may take ~2-4 minutes
Promptly remove infusion bag from bath once thawed
Do not leave bag unattended and do not submerge the infusion ports if thawed in a water bath
After thawing, massage infusion bag to gently mix and disperse clumps of cellular material until all the contents are uniform
If visible cell clumps remain, continue to gently mix the contents of the bag
Do not filter, wash, spin down and/or resuspend elivaldogene autotemcel in new media before infusing
Do not sample, alter, irradiate, or refreeze
IV Administration
Autologous use only
Patient’s identity must match patient identifiers on cassette(s) and infusion bag(s)
Do not infuse if information on patient-specific label does not match intended patient
Do NOT use an inline blood filter or an infusion pump
Prime tubing of infusion set with 0.9% NaCl before infusing
Tear off the protective wrap on infusion bag to expose sterile port
Access infusion bag and infuse per treatment center’s standard procedures for administration of cell therapy products
Complete infusion as soon as possible, and ≤4 hr after thawing
Administer each infusion bag of IV infusion (drip) by gravity flow over a period of less than 60 minutes
After the entire content of the infusion bag is infused, flush remnants in infusion bag and any associated tubing with at least 50 mL of 0.9% NaCl to ensure that as many cells as possible are infused into patient
If >1 infusion bag is provided, administer each infusion bag completely before proceeding to thaw and infuse next infusion bag like in the above steps
Maintain second infusion bag, if applicable, within cold-storage dewar to maintain temperature ≤-140ºC (-220ºF) until time to thaw
After administering elivaldogene autotemcel, standard procedures for patient management after HSC transplantation should be followed
Irradiate any blood products required within first 3 months after elivaldogene autotemcel
Treated patients should not donate blood, organs, tissues, or cells at any time in the future
Storage
Frozen product
- Store in vapor phase of liquid nitrogen at ≤-140ºC (-220ºF) until ready for thawing and administration
- Keep infusion bag(s) in metal cassette(s) and transfer the drug from vapor phase of liquid nitrogen shipper to treatment center vapor phase of liquid nitrogen storage at ≤-140ºC (-220ºF) until ready for thaw and administration
- Thaw before infusion
- Do not refreeze after thawing
- Do not irradiate as this could lead to inactivation
Thawed infusion bag
- Complete elivaldogene autotemcel as soon as possible, and ≤4 hr after thawing
Images
Formulary
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