Dosing & Uses
Dosage Forms & Strengths
Single-dose units contain specific amounts of T cells depending on the patient’s body weight that are suspended in a patient-specific infusion bag
See the certificate of analysis (CoA) for actual cell count following individual preparation
injection, suspension
- 300-460 x 106 CAR-positive viable T cells in 1 or more infusion bags
Multiple Myeloma
Indicated for relapsed or refractory multiple myeloma after ≥4 prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody
Confirm availability of idecabtagene vicleucel before starting lymphodepleting chemotherapy
One treatment course consists of fludarabine- and cyclophosphamide-lymphodepleting chemotherapy followed by IV infusion of idecabtagene vicleucel
Lymphodepleting chemotherapy
- Fludarabine 30 mg/m2 IV qDay for 3 days
- Cyclophosphamide 300 mg/m2 IV qDay for 3 days starting with the first dose of fludarabine
Idecabtagene vicleucel IV infusion
- Administer 2 days after completing lymphodepleting chemotherapy
- Premedicate with acetaminophen and diphenhydramine (see Administration)
- Dose based on the number of chimeric antigen receptor (CAR)–positive viable T cells
- Recommended dose range: 300-460 x 106 CAR-positive viable T cells
- Administer autologously prepared, IV infusion for individual patient within 30 minutes by either gravity or peristaltic pump
Dosage Modifications
Cytokine release syndrome (CRS) management
- Grade ≥2 CRS (eg, hypotension not responsive to fluids, or hypoxia requiring supplemental oxygenation): Monitor with continuous cardiac telemetry and pulse oximetry
- For severe or life-threatening CRS, consider intensive care unit level monitoring and supportive therapy
- Refractory CRS is characterized by fevers, end-organ toxicity (eg, hypoxia, hypotension) not improving within 12 hr of first-line interventions or development of hemophagocytic lymphohistiocytosis/macrophage activation syndrome
-
Grade 1
- Symptoms: Fever, nausea, fatigue, headache, myalgia, malaise
- Onset ≥72 hr after infusion: Treat symptomatically
- Onset <72 hr after infusion: Consider tocilizumab 8 mg/kg IV over 1 hr; not to exceed 800 mg
- Consider dexamethasone 10 mg IV q24hr
-
Grade 2
- Symptoms require moderate intervention; oxygen requirement <40% FiO2 or hypotension responsive to fluids or low dose of one vasopressor or Grade 2 organ toxicity
- Administer tocilizumab 8 mg/kg IV infused over 1 hr; not to exceed 800 mg
- Repeat tocilizumab q8hr as needed if not responsive to IV fluids or increasing supplemental oxygen; not to exceed 3 doses/24 hr or 4 doses in total
- Consider dexamethasone 10 mg IV q12-24hr
- If no improvement within 24 hr or rapid progression, repeat tocilizumab and escalate dose and frequency of dexamethasone 20 mg IV q6-12 hr
- If no improvement within 24 hr or continued rapid progression, switch to methylprednisolone 2 mg/kg followed by 2 mg/kg divided QID
- After 2 doses of tocilizumab, consider alternative anticytokine agents; do not exceed 3 doses of tocilizumab in 24 hr or 4 doses in total
-
Grade 3
- Symptoms require aggressive intervention; oxygen requirement ≥40% FiO2 or hypotension requiring high-dose or multiple vasopressors or Grade 3 organ toxicity or Grade 4 transaminitis
- Tocilizumab administration per Grade 2; if improving, discontinue
- Administer dexamethasone 10 mg IV q12hr
- If no improvement within 24 hr, follow Grade 2 recommendations
-
Grade 4
- Life-threatening symptoms; requires ventilator support, continuous venovenous hemodialysis, or Grade 4 organ toxicity (excluding transaminitis)
- Tocilizumab administration per Grade 2; if improving, discontinue
- Administer dexamethasone 20 mg IV q6hr
- After 2 doses of tocilizumab, consider alternative anticytokine agents; do not exceed 3 doses of tocilizumab in 24 hr or 4 doses in total
- If no improvement within 24 hr, consider methylprednisolone (1-2 g, repeat q24hr if needed; taper as clinically indicated) or other anti–T-cell therapies
Neurologic toxicity grading and management
- Grades 1-4: Start nonsedating, antiseizure medicines (eg, levetiracetam) for seizure prophylaxis
-
Grade 1
- ≥72 hr after infusion: Observe
- <72 hr after infusion: Consider dexamethasone 10 mg IV q12-24hr for 2-3 days
-
Grade 2
- Start dexamethasone 10 mg IV q12hr for 2-3 days, or longer for persistent symptoms
- Consider taper for a total corticosteroid exposure >3 days; not recommended for isolated Grade 2 headaches
- If no improvement after 24 hr or worsening of neurologic toxicity, increase dose and/or frequency of dexamethasone; not to exceed 20 mg IV q6hr
-
Grade 3 or 4
- Grade 3: Start dexamethasone 10-20 mg IV q6-12 hr
- Grade 4: Start dexamethasone 20 mg IV q6hr
- Corticosteroids are not recommended for isolated Grade 3 headaches
- If no improvement after 24 hr or worsening of neurologic toxicity, escalate to methylprednisolone (2 mg/kg loading dose, followed by 2 mg/kg divided into QID; taper within 7 days)
- If cerebral edema is suspected, consider hyperventilation and hyperosmolar therapy
- Give high-dose methylprednisolone (1-2 g, repeat q24hr if needed; taper as clinically indicated) and cyclophosphamide 1.5 g/m2
-
Renal or hepatic impairment
- Not studied
Dosing Considerations
Administer at a certified healthcare facility
Monitor for signs/symptoms of CRS and neurologic toxicities at least daily for 7 days following infusion
Instruct patients to remain within proximity of the certified healthcare facility at least 4 weeks following infusion
Verify pregnancy status in females of reproductive potential
Delay idecabtagene vicleucel infusion up to 7 days for the following conditions
- Unresolved serious adverse events (especially pulmonary events, cardiac events, or hypotension), including those after preceding chemotherapies
- Active infections or inflammatory disorders
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (202)
- abatacept
abatacept, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- abrocitinib
abrocitinib, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- adalimumab
adalimumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- adenovirus types 4 and 7 live, oral
idecabtagene vicleucel decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- ado-trastuzumab emtansine
ado-trastuzumab emtansine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- alefacept
alefacept, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- alemtuzumab
alemtuzumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- anakinra
anakinra, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ansuvimab
ansuvimab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- antithymocyte globulin equine
antithymocyte globulin equine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- antithymocyte globulin rabbit
antithymocyte globulin rabbit, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- apaziquone
apaziquone, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- atoltivimab/maftivimab/odesivimab
atoltivimab/maftivimab/odesivimab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- azathioprine
azathioprine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- balstilimab
balstilimab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- baricitinib
baricitinib, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- basiliximab
basiliximab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- belatacept
belatacept, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- bendamustine
bendamustine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- benralizumab
benralizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- benznidazole
benznidazole, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- betamethasone
betamethasone, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- bevacizumab
bevacizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- bezlotoxumab
bezlotoxumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- bimekizumab
bimekizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- botulism immune globulin IV
botulism immune globulin IV, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- brodalumab
brodalumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- busulfan
busulfan, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- C1 esterase inhibitor recombinant
C1 esterase inhibitor recombinant, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- C1 inhibitor human
C1 inhibitor human, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- canakinumab
canakinumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- capecitabine
capecitabine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- caplacizumab
caplacizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- carboplatin
carboplatin, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- carmustine
carmustine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- certolizumab pegol
certolizumab pegol, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cetuximab
cetuximab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- chlorambucil
chlorambucil, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cisplatin
cisplatin, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cladribine
cladribine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- clofarabine
clofarabine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- corticotropin
corticotropin, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- cortisone
cortisone, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- cyclophosphamide
cyclophosphamide, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cyclosporine
cyclosporine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cytarabine
cytarabine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cytomegalovirus immune globulin (CMV IG)
cytomegalovirus immune globulin (CMV IG), idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- dacarbazine
dacarbazine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- daclizumab
daclizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- daratumumab
daratumumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- deflazacort
deflazacort, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- dengue vaccine
idecabtagene vicleucel decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- denosumab
denosumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- dexamethasone
dexamethasone, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
idecabtagene vicleucel, dexamethasone. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity. - dimethyl fumarate
dimethyl fumarate, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- dinutuximab
dinutuximab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- diroximel fumarate
diroximel fumarate, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- dupilumab
dupilumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- Ebola Zaire vaccine
idecabtagene vicleucel decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- ecallantide
ecallantide, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- eculizumab
eculizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- elotuzumab
elotuzumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- emapalumab
emapalumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- emicizumab
emicizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- etanercept
etanercept, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- fexinidazole
fexinidazole, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- filgotinib
filgotinib, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- fingolimod
fingolimod, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- floxuridine
floxuridine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- fludarabine
fludarabine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- fludrocortisone
fludrocortisone, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- fluorouracil
fluorouracil, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- gemcitabine
gemcitabine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- gemtuzumab
gemtuzumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- glatiramer
glatiramer, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- golimumab
golimumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- guselkumab
guselkumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- hepatitis B immune globulin (HBIG)
hepatitis B immune globulin (HBIG), idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- hydrocortisone
hydrocortisone, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- hydroxychloroquine sulfate
hydroxychloroquine sulfate, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- hydroxyurea
hydroxyurea, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ibritumomab tiuxetan
ibritumomab tiuxetan, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- icatibant
icatibant, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ifosfamide
ifosfamide, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- immune globulin IM (IGIM)
immune globulin IM (IGIM), idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- immune globulin IV (IGIV)
immune globulin IV (IGIV), idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- immune globulin SC
immune globulin SC, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- inebilizumab
inebilizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- infliximab
infliximab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- influenza virus vaccine quadrivalent, intranasal
idecabtagene vicleucel decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- interferon alfa n3
interferon alfa n3, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- interferon alfacon 1
interferon alfacon 1, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- interferon beta 1a
interferon beta 1a, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- interferon beta 1b
interferon beta 1b, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- iodoquinol
iodoquinol, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ipilimumab
ipilimumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- isotretinoin
isotretinoin, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ixekizumab
ixekizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- leflunomide
leflunomide, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lomustine
lomustine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lurbinectedin
lurbinectedin, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- measles (rubeola) vaccine
idecabtagene vicleucel decreases effects of measles (rubeola) vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- measles mumps and rubella vaccine, live
idecabtagene vicleucel decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- measles, mumps, rubella and varicella vaccine, live
idecabtagene vicleucel decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- mechlorethamine
mechlorethamine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mechlorethamine topical
mechlorethamine topical, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- melphalan
melphalan, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- melphalan flufenamide
melphalan flufenamide, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mepolizumab
mepolizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mercaptopurine
mercaptopurine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- methotrexate
methotrexate, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- methylprednisolone
methylprednisolone, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
idecabtagene vicleucel, methylprednisolone. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity. - mineral oil topical
mineral oil topical, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mitoxantrone
mitoxantrone, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mogamulizumab
mogamulizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mometasone sinus implant
mometasone sinus implant, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- monomethyl fumarate
monomethyl fumarate, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- moxetumomab pasudotox
moxetumomab pasudotox, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- muromonab CD3
muromonab CD3, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mycophenolate
mycophenolate, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- narsoplimab
narsoplimab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- natalizumab
natalizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
idecabtagene vicleucel, natalizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. - nelarabine
nelarabine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- nitazoxanide
nitazoxanide, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- nivolumab
nivolumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- obinutuzumab
obinutuzumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ocrelizumab
ocrelizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ofatumumab
ofatumumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ofatumumab SC
ofatumumab SC, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- olaratumab
olaratumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- omalizumab
omalizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- oportuzumab monatox
oportuzumab monatox, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- oxaliplatin
oxaliplatin, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- panitumumab
panitumumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- paromomycin
paromomycin, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- peginterferon beta-1a
peginterferon beta-1a, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- pembrolizumab
pembrolizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- pemetrexed
pemetrexed, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- pentostatin
pentostatin, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- pimecrolimus
pimecrolimus, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- poliovirus vaccine live oral trivalent
idecabtagene vicleucel decreases effects of poliovirus vaccine live oral trivalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- pralatrexate
pralatrexate, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- prednisolone
prednisolone, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- prednisone
prednisone, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- procarbazine
procarbazine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- rabies immune globulin, human (RIG)
rabies immune globulin, human (RIG), idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ravulizumab
ravulizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- raxibacumab
raxibacumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- reltecimod
reltecimod, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
idecabtagene vicleucel, reltecimod. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. - remestemcel-L
remestemcel-L, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- reslizumab
reslizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- Rho(D) immune globulin
Rho(D) immune globulin, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- rilonacept
rilonacept, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- risankizumab
risankizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- rituximab
rituximab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
idecabtagene vicleucel, rituximab. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. - rituximab-hyaluronidase
rituximab-hyaluronidase, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- rotavirus oral vaccine, live
idecabtagene vicleucel decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- rubella vaccine
idecabtagene vicleucel decreases effects of rubella vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- ruxolitinib topical
ruxolitinib topical, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- sarilumab
sarilumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- secukinumab
secukinumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- siltuximab
siltuximab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- sintilimab
sintilimab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- sirolimus
sirolimus, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- sirolimus intravitreal
sirolimus intravitreal, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- sirukumab
sirukumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- smallpox (vaccinia) and monkeypox vaccine, live, nonreplicating
idecabtagene vicleucel decreases effects of smallpox (vaccinia) vaccine, attenuated by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- smallpox (vaccinia) vaccine, attenuated
idecabtagene vicleucel decreases effects of smallpox (vaccinia) vaccine, attenuated by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- smallpox (vaccinia) vaccine, live
idecabtagene vicleucel decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- spesolimab
spesolimab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- streptozocin
streptozocin, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- sulfasalazine
sulfasalazine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
idecabtagene vicleucel, sulfasalazine. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. - sutimlimab
sutimlimab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tacrolimus
tacrolimus, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tacrolimus ointment
tacrolimus ointment, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- temozolomide
temozolomide, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- teplizumab
teplizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- teriflunomide
teriflunomide, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tetanus immune globulin (TIG)
tetanus immune globulin (TIG), idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- thioguanine
thioguanine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- thiotepa
thiotepa, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tinidazole
tinidazole, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tocilizumab
tocilizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tofacitinib
tofacitinib, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tositumomab
tositumomab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- trabectedin
trabectedin, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tralokinumab
tralokinumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- trastuzumab
trastuzumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- trastuzumab deruxtecan
trastuzumab deruxtecan, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- treosulfan
treosulfan, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- triamcinolone acetonide extended-release injectable suspension
triamcinolone acetonide extended-release injectable suspension, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- triamcinolone acetonide injectable suspension
triamcinolone acetonide injectable suspension, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- ublituximab
ublituximab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- upadacitinib
upadacitinib, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ustekinumab
ustekinumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- vaccinia immune globulin intravenous
vaccinia immune globulin intravenous, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- varicella virus vaccine live
idecabtagene vicleucel decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- varicella zoster immune globulin, human
varicella zoster immune globulin, human, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- vedolizumab
vedolizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
idecabtagene vicleucel, vedolizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. - voclosporin
voclosporin, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- yellow fever vaccine
idecabtagene vicleucel decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
Monitor Closely (0)
Minor (0)
Adverse Effects
>10%
Any grade
- Cytokine release syndrome (85%)
- Infections, unspecified pathogen (51%)
- Fatigue (45%)
- Musculoskeletal pain (45%)
- Hypogammaglobulinemia (41%)
- Diarrhea (35%)
- Upper respiratory tract infection (34%)
- Nausea (29%)
- Viral infections (27%)
- Encephalopathy (26%)
- Pyrexia (25%)
- Edema (25%)
- Headache (23%)
- Cough (23%)
- Decreased appetite (22%)
- Tachycardia (19%)
- Dizziness (17%)
- Peripheral neuropathy (17%)
- Hypotension (17%)
- Pneumonia (17%)
- Constipation (16%)
- Febrile neutropenia (16%)
- Bacterial infections (15%)
- Vomiting (15%)
- Rash (14%)
- Weight decreased (13%)
- Insomnia (13%)
- Dyspnea (13%)
- Anxiety (12%)
- Oral pain (12%)
- General physical health deterioration (11%)
- Chills (11%)
- Motor dysfunction (11%)
- Xerosis (11%)
- Hypertension (11%)
Grade ≥3
- Neutropenia (96%)
- Leukopenia (96%)
- Lymphopenia (92%)
- Thrombocytopenia (63%)
- Anemia (63%)
- Hypophosphatemia (45%)
- Febrile neutropenia (16%)
- Infections, unspecified pathogen (15%)
1-10%
Any grade
- Tremor (10%)
- Renal failure (10%)
- Coagulopathy (9%)
- Sepsis (9%)
- Fungal infections (8%)
- Aphasia (7%)
- Delirium (6%)
- Atrial fibrillation (4.7%)
- Gastrointestinal hemorrhage (3.1%)
- Hemophagocytic lymphohistiocytosis (3.1%)
- Thrombosis (3.1%)
- Ataxia (3.1%)
- Paresis (2.4%)
- Hypoxia (2.4%)
- Pulmonary edema (2.4%)
- Cardiomyopathy (1.6%)
- Seizure (1.6%)
Grade ≥3
- General physical health deterioration (10%)
- Hyponatremia (10%)
- Activated partial thromboplastin time increased (10%)
- ALT increased (<10%)
- AST increased (<10%)
- Hypoalbuminemia (<10%)
- Alkaline phosphatase increased (<10%)
- Hyperglycemia (<10%)
- Hypokalemia (<10%)
- Bilirubin increased (<10%)
- Hypofibrinogenemia (<10%)
- Hypocalcemia (<10%)
- Cytokines release syndrome (9%)
- Viral infections (9%)
- Pneumonia (9%)
- Encephalopathy (6%)
- Bacterial infections (3.9%)
- Musculoskeletal pain (3.1%)
- Fatigue (3.1%)
- Hypertension (3.1%)
- Renal failure (2.4%)
- Dyspnea (2.4%)
- Pyrexia (1.6%)
- Diarrhea (1.6%)
- Weight decreased (1.6%)
- Upper respiratory tract infection (1.6%)
<1%
Grade ≥3
- Hypogammaglobulinemia (0.8%)
- Decreased appetite (0.8%)
- Dizziness (0.8%)
- Peripheral neuropathy (0.8%)
- Anxiety (0.8%)
- Rash (0.8%)
Warnings
Black Box Warnings
Cytokine release syndrome
- Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment
- Do not administer to patients with active infection or inflammatory disorders
- Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids
Neurological toxicities
- Neurologic toxicities, including severe or life-threatening reactions, reported; these may occur concurrently with CRS, after CRS resolution, or in absence of CRS; monitor and provide supportive care and/or corticosteroids as needed
- Most common neurological toxicities were encephalopathy, headache, tremor, aphasia, and delirium
- Monitor for neurological events for at least 7 days at the certified healthcare facility following infusion for signs and symptoms of neurologic toxicities
Hemophagocytic lymphohistiocytosis/macrophage activation syndrome
- Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment
- HLH/MAS can occur with CRS or neurologic toxicities
Prolonged cytopenia
- Prolonged cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment
Restricted access program
- Available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Abecma REMS program
- Further information is available at www.AbecmaREMS.com [insert link] or contact Bristol-Myers Squibb at 1-888-423-5436
-
REMS requirements
- Healthcare facilities that dispense and administer idecabtagene vicleucel must be enrolled and comply with the REMS requirements
- Certified healthcare facilities must have onsite immediate access to tocilizumab
- Ensure that a minimum of 2 doses of tocilizumab are available for each patient for administration within 2 hr after idecabtagene vicleucel IV infusion, if needed for treatment of CRS
- Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer idecabtagene vicleucel are trained about the management of CRS and neurological toxicities
Contraindications
None
Cautions
Neurological toxicities, which may be severe or life-threatening, can occur following treatment; monitor for signs and symptoms of neurologic toxicity at least daily for 7 days following after idecabtagene vicleucel infusion at REMS-certified healthcare facility; continue monitoring for at least 4 weeks further; rule out other causes of neurologic symptoms; treat promptly and manage with supportive care and/or corticosteroids as needed
Hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) reported: it is a potentially life-threatening condition with a high mortality rate if left undetected and untreated; in clinical trials, the median onset was 7 days (range: 4-9 days) and occurred in the setting of ongoing or worsening CRS; manifestations of HLH/MAS include: hypotension, hypoxia, multiple organ dysfunction, renal dysfunction, and cytopenia; treat HLH/MAS per institutional standards
Available only through a restricted access program owing to CRS and neurologic toxicities
Allergic reactions may occur during infusion; serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide in the product
Prolonged cytopenias may occur following lymphodepleting chemotherapy and idecabtagene vicleucel infusion; monitor blood cell counts before and after idecabtagene vicleucel infusion; manage cytopenia with myeloid growth factor and blood product transfusion support according to local institutional guidelines
Hypogammaglobulinemia and plasma cell aplasia can occur; monitor immunoglobulin levels after treatment and administer IV immunoglobulin for IgG<400 mg/dL; manage per local institutional guidelines
Secondary malignancies or recurrence of leukemia may occur; monitor life-long for secondary malignancies; if secondary malignancy occurs, contact Bristol-Myers Squibb at 1-888-805-4555
Owing to potential neurological events (eg, altered mental status, seizures), patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following treatment; advise patients to refrain from driving or engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period
Cytokine release syndrome
- CRS, including fatal or life-threatening reactions, occurred following treatment
- Median time to CRS onset was 1 day (range: 1-23 days)
- Most common manifestations of CRS included pyrexia, hypotension, tachycardia, chills, hypoxia, fatigue, and headache
- Grade ≥3 events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, acute respiratory distress syndrome, atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, multiple organ dysfunction syndrome, and HLH/MAS
- Identify CRS based on clinical presentation; evaluate for and treat other causes of fever, hypoxia, and hypotension
- CRS has been associated with findings of HLH/MAS, and physiology of syndromes may overlap
- In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS
- Treat severe or life-threatening CRS with tocilizumab
- At first sign of CRS, institute treatment with supportive care, tocilizumab, and/or corticosteroids as indicated
- Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time
Infections
- Serious infections, including life-threatening or fatal infections, reported
- Do not administer to patients with active infections or inflammatory disorders
- Monitor for signs and symptoms of infection before and after idecabtagene vicleucel infusion
- Administer prophylactic, empiric, and/or therapeutic antimicrobials according to standard institutional guidelines
- Febrile neutropenia observed after idecabtagene vicleucel infusion and may be concurrent with CRS; if febrile neutropenia occurs, manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated
-
Viral reactivation
- Cytomegalovirus (CMV) infection resulting in pneumonia and death occurred; monitor and treat for CMV reactivation in accordance with clinical guidelines
- Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against plasma cells
- Perform screening for CMV, HBV, hepatitis C virus, and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing
- Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice
Drug interaction overview
-
Immunization with live viral vaccines
- Safety of immunization with live viral vaccines during or following treatment has not been studied
- Vaccination with live-virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during idecabtagene vicleucel treatment, and until immune recovery afterwards
-
HIV nucleic acid tests
- HIV and the lentivirus used to make idecabtagene vicleucel have limited, short spans of identical genetic material (RNA)
- Therefore, some commercial HIV nucleic acid tests may yield false-positive results in patients receiving idecabtagene vicleucel
Pregnancy & Lactation
Pregnancy
Data are not available in pregnant women
No animal reproductive and developmental toxicity studies have been conducted
Unknown if idecabtagene vicleucel may potentially transfer to fetus; based on the mechanism of action, if transduced cells cross placenta, fetal toxicity, including B-cell lymphocytopenia, may occur; not recommended for females who are pregnant, and consult with treating physician on pregnancy after infusion
Treated patients may have hypogammaglobulinemia; assess immunoglobulin levels in newborns of treated mothers
Verify pregnancy status of females with reproductive potential before initiating treatment
There are no data on effects on fertility
Contraception
- See prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy
- Insufficient exposure data are available to provide recommendations on duration of contraception following treatment
Lactation
There is no information regarding presence in human milk, effects on the 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
B-cell maturation antigen (BCMA)–directed genetically modified autologous T-cell immunotherapy consisting of a patient’s own T cells that are harvested and genetically modified ex vivo through transduction with an anti-BCMA02 CAR lentiviral vector
CAR-positive T-cell therapy targeting BCMA, which is expressed on the surface of normal and malignant plasma cells
Antigen-specific activation of idecabtagene vicleucel results in CAR-positive T-cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells
Absorption
Peak plasma concentration: 256,333 copies/mcg
Peak plasma time: 11 days
AUC: 3,088,455 copies⋅days/mcg
Median peak plasma levels in responders were ~4.6-fold higher than corresponding levels in nonresponders
Median AUC in responding patients was ~5.6-fold higher than nonresponders
Administration
IV Preparation
Confirm availability of idecabtagene vicleucel before starting lymphodepleting chemotherapy regimen
Confirm infusion time in advance, and adjust start time for thaw so that idecabtagene vicleucel is available for infusion when recipient is ready
Before thawing, confirm tocilizumab and emergency equipment are available before infusion and during recovery period
Verify number of bags received for indicated dose before preparation of idecabtagene vicleucel
Confirm patient identity: Match patient's identity with patient identifiers on idecabtagene vicleucel cassette(s) and infusion bag(s); and eRlease for Infusion Certificate
Note: Patient identifier number may be preceded by letters DIN or Aph ID
Once patient identity is confirmed, remove infusion bag(s) from cassette(s) and check patient information on the cassette label(s) matches with bag label(s); do not remove from cassette(s) if patients-specific cassette label(s) do not match; contact Bristol-Myers Squibb at 1-888-805- 4555 if there are any discrepancies between labels and patient identifiers
Inspect infusion bag for any breaks or cracks before thawing; if bag is compromised, do not infuse the contents; contact Bristol-Myers Squibb at 1-888-805- 4555
If >1 infusion bag is needed, thaw each infusion bag one at a time; do not thaw the next bag until previous infusion bag is complete; place infusion bag(s) inside a second sterile bag per local guidelines
Thaw infusion bag at 37°C using either a water bath or dry thaw method until there is no visible ice in infusion bag; gently mix contents of bag to disperse clumps of cellular material
If visible cell clumps remain, continue to gently mix contents of bag; disperse small clumps of cellular material with gentle manual mixing; do not wash, spin down, and/or resuspend idecabtagene vicleucel in new media before infusion
Administer within 1 hr of the start of thaw; stable for 2 hr at room temperature once thawed
Premedication
Administer ~30-60 minutes before idecabtagene vicleucel infusion
- Acetaminophen 650 mg PO
- Diphenhydramine 12.5 mg IV or 25-50 mg PO, or another H1-antihistamine
- Always avoid prophylactic use of systemic corticosteroids (may interfere with idecabtagene vicleucel activity), except in the case of a life-threatening emergency
IV Administration
- For autologous use only
- Ensure a minimum of 2 doses of tocilizumab and emergency equipment are available before infusion and during recovery period
- May use central venous access for infusion and is recommended in patients with poor peripheral access
- Do not use a leukocyte-depleting filter; prime tubing of infusion set with 0.9% NaCl before infusion
- Administer entire contents of infusion bag within 1 hr after start of thaw by gravity flow
- Once infused, rinse tubing with 30-60 mL of 0.9% NaCl at same infusion rate to ensure all product is delivered
- If >1 infusion bag is needed, administer all bags as directed, following steps above for all subsequent infusion bags; do not initiate thaw of next bag until infusion of the previous bag is complete
- Follow local biosafety guidelines applicable for handling and disposal of such products
Storage
Refer to prescribing information for details on shipment
Frozen cassettes and infusion bags
- Store frozen in vapor phase of liquid nitrogen ≤-266°F (≤-130°C) in a temperature-monitored system
- Use closed, break-proof, leak-proof containers when transporting infusion bags within the facility
Thawed infusion bag
- Stored at room temperature 68-77°F (20-25°C) for up to 1 hr
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Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
