elivaldogene autotemcel (Rx)

Brand and Other Names:Skysona
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Dosing & Uses

AdultPediatric

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
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Interactions

Interaction Checker

and elivaldogene autotemcel

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              • 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)

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                  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%)
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                  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
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                  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.

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                  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

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                  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
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                  Images

                  No images available for this drug.
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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
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                  QL Quantity Limits
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                  ST Step Therapy
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                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.