idecabtagene vicleucel (Rx)

Brand and Other Names:Abecma
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and idecabtagene vicleucel

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              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)

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                  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%)
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                  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
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                  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.

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                  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

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                  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

                  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
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  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.