axicabtagene ciloleucel (Rx)

Brand and Other Names:Yescarta
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, suspension

  • 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
  • 2 x 106 CAR-positive viable T cells/kg of body weight, with a maximum of 2 x 108 CAR-positive viable T cells in ~68 mL

Large B-Cell Lymphoma

Indicated for adults with relapsed or refractory large B-cell lymphoma after ≥2 lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma

One treatment course consists of fludarabine- and cyclophosphamide-lymphodepleting chemotherapy followed by IV infusion of axicabtagene ciloleucel

Confirm availability of axicabtagene ciloleucel prior to starting lymphodepleting chemotherapy

Lymphodepleting chemotherapy

  • 3 doses of fludarabine and cyclophosphamide infused IV on the fifth, fourth, and third day before infusion of axicabtagene ciloleucel
  • Fludarabine 30 mg/m2 IV qDay for 3 days  
  • Cyclophosphamide 500 mg/m2 IV qDay for 3 days starting with the first dose of fludarabine

Axicabtagene ciloleucel IV infusion

  • Administer after completing lymphodepleting chemotherapy
  • Dosing of axicabtagene is based on the number of chimeric antigen receptor (CAR)-positive viable T cells
  • Target dose is 2 x 106 CAR-positive viable T cells/kg body weight, not to exceed 2 x 108 CAR-positive viable T cells  
  • Administer autologously prepared, weight-based IV infusion for individual patient within 30 minutes by either gravity or peristaltic pump
  • Do not use a leukocyte-depleting filter

Follicular Lymphoma

Indicated for adults with relapsed or refractory follicular lymphoma (FL) after ≥2 lines of systemic therapy

Lymphodepleting chemotherapy

  • 3 doses of fludarabine and cyclophosphamide infused IV on the fifth, fourth, and third day before infusion of axicabtagene ciloleucel
  • Fludarabine 30 mg/m2 IV qDay for 3 days  
  • Cyclophosphamide 500 mg/m2 IV qDay for 3 days starting with the first dose of fludarabine

Axicabtagene ciloleucel IV infusion

  • Administer after completing lymphodepleting chemotherapy
  • Dosing of axicabtagene is based on the number of chimeric antigen receptor (CAR)-positive viable T cells
  • Target dose is 2 x 106 CAR-positive viable T cells/kg body weight, not to exceed 2 x 108 CAR-positive viable T cells  
  • Administer autologously prepared, weight-based IV infusion for individual patient within 30 minutes by either gravity or peristaltic pump
  • Do not use a leukocyte-depleting filter

Dosage Modifications

Cytokine release syndrome (CRS) management

  • Grade 1
    • Symptoms: Fever, nausea, fatigue, headache, myalgia, malaise
    • Symptomatic treatment only
  • Grade 2
    • 1 or more of the following: 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 in a 24-hr period or 4 doses in total
    • Manage per Grade 3 if no improvement within 24 hr after initiating tocilizumab
  • Grade 3
    • 1 or more of the following: 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
    • Administer tocilizumab (see doses in CRS Grade 2)
    • Administer methylprednisolone 1 mg/kg IV BID or equivalent dexamethasone (eg, 10 mg IV q6hr)
    • Continue corticosteroid use until event is ≤Grade 1, then taper over 3 days
  • Grade 4
    • 1 or more of the following: Life-threatening symptoms; requires ventilator support, continuous venovenous hemodialysis (CVVHD), or Grade 4 organ toxicity (excluding transaminitis)
    • Administer methylprednisolone 1000 mg/day IV for 3 days; if improvement, then manage as above

Neurologic toxicity grading and management

  • Grade 2 with concurrent CRS
    • Administer tocilizumab (see doses in CRS Grade 2)
    • If no improvement within 24 hr after starting tocilizumab, administer dexamethasone 10 mg IV q6hr if not already taking other corticosteroids; continue dexamethasone use until the event is ≤Grade 1, then taper over 3 days
    • Consider nonsedating, antiseizure medicines (eg, levetiracetam) for seizure prophylaxis
  • Grade 2 or 3 with NO concurrent CRS
    • Administer dexamethasone 10 mg IV q6hr if not already taking other corticosteroids
    • Continue until event is ≤Grade 1, then taper over 3 days
  • Grade 3 with concurrent CRS
    • Administer tocilizumab (see doses in CRS Grade 2) AND
    • Administer dexamethasone 10 mg IV q6hr if not already taking other corticosteroids; continue dexamethasone until event is ≤Grade 1, then taper over 3 days
    • Consider nonsedating, antiseizure medicines (eg, levetiracetam) for seizure prophylaxis
  • Grade 4 with concurrent CRS
    • Administer tocilizumab (see doses in CRS Grade 2)
    • Administer methylprednisolone 1000 mg/day for 3 days with first dose of tocilizumab; if improvement, then manage as above
  • Grade 4 with NO concurrent CRS
    • Administer methylprednisolone 1000 mg/day for 3 days; if improvement, then manage as above

Dosing Considerations

For autologous use only

Administer axicabtagene at a certified healthcare facility

Monitor signs/symptoms of CRS and neurologic toxicities for at least daily for 7 days following infusion

Instruct patients to remain within proximity of the certified healthcare facility for at least 4 weeks following infusion

Limitation of use

  • Not indicated for primary central nervous system lymphoma

Safety and efficacy not established

Next:

Interactions

Interaction Checker

and axicabtagene ciloleucel

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (21)

              • adenovirus types 4 and 7 live, oral

                axicabtagene ciloleucel decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during axicabtagene ciloleucel treatment, and after treatment until full immune recovery is achieved.

              • betamethasone

                betamethasone decreases effects of axicabtagene ciloleucel by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid prophylactic use of systemic corticosteroids as premedication before axicabtagene ciloleucel. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

              • corticotropin

                corticotropin decreases effects of axicabtagene ciloleucel by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid prophylactic use of systemic corticosteroids as premedication before axicabtagene ciloleucel. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

              • cortisone

                cortisone decreases effects of axicabtagene ciloleucel by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid prophylactic use of systemic corticosteroids as premedication before axicabtagene ciloleucel. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

              • deflazacort

                deflazacort decreases effects of axicabtagene ciloleucel by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid prophylactic use of systemic corticosteroids as premedication before axicabtagene ciloleucel. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

              • dexamethasone

                dexamethasone decreases effects of axicabtagene ciloleucel by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid prophylactic use of systemic corticosteroids as premedication before axicabtagene ciloleucel. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

              • fludrocortisone

                fludrocortisone decreases effects of axicabtagene ciloleucel by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid prophylactic use of systemic corticosteroids as premedication before axicabtagene ciloleucel. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

              • hydrocortisone

                hydrocortisone decreases effects of axicabtagene ciloleucel by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid prophylactic use of systemic corticosteroids as premedication before axicabtagene ciloleucel. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

              • measles mumps and rubella vaccine, live

                axicabtagene ciloleucel decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during axicabtagene ciloleucel treatment, and after treatment until full immune recovery is achieved.

              • measles, mumps, rubella and varicella vaccine, live

                axicabtagene ciloleucel decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during axicabtagene ciloleucel treatment, and after treatment until full immune recovery is achieved.

              • methylprednisolone

                methylprednisolone decreases effects of axicabtagene ciloleucel by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid prophylactic use of systemic corticosteroids as premedication before axicabtagene ciloleucel. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

              • mometasone sinus implant

                mometasone sinus implant decreases effects of axicabtagene ciloleucel by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid prophylactic use of systemic corticosteroids as premedication before axicabtagene ciloleucel. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

              • palifermin

                palifermin increases toxicity of axicabtagene ciloleucel by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              • prednisolone

                prednisolone decreases effects of axicabtagene ciloleucel by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid prophylactic use of systemic corticosteroids as premedication before axicabtagene ciloleucel. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

              • prednisone

                prednisone decreases effects of axicabtagene ciloleucel by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid prophylactic use of systemic corticosteroids as premedication before axicabtagene ciloleucel. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

              • rotavirus oral vaccine, live

                axicabtagene ciloleucel decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during axicabtagene ciloleucel treatment, and after treatment until full immune recovery is achieved.

              • smallpox (vaccinia) vaccine, live

                axicabtagene ciloleucel decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during axicabtagene ciloleucel treatment, and after treatment until full immune recovery is achieved.

              • triamcinolone acetonide injectable suspension

                triamcinolone acetonide injectable suspension decreases effects of axicabtagene ciloleucel by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid prophylactic use of systemic corticosteroids as premedication before axicabtagene ciloleucel. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

              • varicella virus vaccine live

                axicabtagene ciloleucel decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during axicabtagene ciloleucel treatment, and after treatment until full immune recovery is achieved.

              • yellow fever vaccine

                axicabtagene ciloleucel decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during axicabtagene ciloleucel treatment, and after treatment until full immune recovery is achieved.

              • zoster vaccine live

                axicabtagene ciloleucel decreases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during axicabtagene ciloleucel treatment, and after treatment until full immune recovery is achieved.

              Monitor Closely (0)

                Minor (0)

                  Previous
                  Next:

                  Adverse Effects

                  >10% Any Grade

                  Cytokine release syndrome (94%)

                  Fever (86%)

                  Tachycardia (57%)

                  Encephalopathy (57%)

                  Hypotension (57%)

                  Fatigue (46%)

                  Headache (45%)

                  Decreased appetite (44%)

                  Chills (40%)

                  Diarrhea (38%)

                  Nausea (34%)

                  Hypoxia (32%)

                  Tremor (31%)

                  Cough (30%)

                  Vomiting (26%)

                  Infections, pathogen unspecified (26%)

                  Constipation (23%)

                  Arrhythmia (23%)

                  Dizziness (21%)

                  Edema (19%)

                  Motor dysfunction (19%)

                  Dyspnea (19%)

                  Aphasia (18%)

                  Pain in extremity (17%)

                  Delirium (17%)

                  Weight decreased (16%)

                  Hypogammaglobulinemia (15%)

                  Back pain (15%)

                  Hypertension (15%)

                  Abdominal pain (14%)

                  Muscle pain (14%)

                  Pleural effusion (13%)

                  Renal insufficiency (12%)

                  Dry mouth (11%)

                  Dehydration (11%)

                  >10% Grades 3-4

                  Lymphopenia (100%)

                  Leukopenia (96%)

                  Neutropenia (93%)

                  Anemia (66%)

                  Thrombocytopenia (58%)

                  Hypophosphatemia (50%)

                  Encephalopathy (29%)

                  Hyponatremia (19%)

                  Fever (16%)

                  Infections, pathogen unspecified (16%)

                  Hypotension (15%)

                  Cytokine release syndrome (13%)

                  Hyperuricemia (13%)

                  Direct bilirubin increased (13%)

                  Hypoxia (11%)

                  1-10% Any Grade

                  Arthralgia (10%)

                  Thrombosis (10%)

                  Pulmonary edema (9%)

                  Rash (9%)

                  Cardiac failure (6%)

                  Ataxia (6%)

                  Fungal infections (5%)

                  Cardiac arrest (4%)

                  Seizure (4%)

                  Capillary leak syndrome (3%)

                  Coagulopathy (2%)

                  Dyscalculia (2%)

                  Myoclonus (2%)

                  Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) (1%)

                  Hypersensitivity (1%)

                  1-10% Grades 3-4

                  Hypokalemia (10%)

                  Increased ALT (10%)

                  Bacterial infections (9%)

                  Arrhythmia (7%)

                  Aphasia (6%)

                  Delirium (6%)

                  Hypertension (6%)

                  Renal insufficiency, grades 3-4 (5%)

                  Diarrhea, grades 3-4 (4%)

                  Viral infections (3%)

                  Fatigue (3%)

                  Dehydration (3%)

                  Dyspnea (3%)

                  Tachycardia (2%)

                  Decreased appetite (2%)

                  Pain in extremity (2%)

                  Tremor (2%)

                  Pleural effusion (2%)

                  Vomiting (1%)

                  Abdominal pain (1%)

                  Edema (1%)

                  Motor dysfunction (1%)

                  Back pain (1%)

                  Muscle pain (1%)

                  Headache (1%)

                  Dizziness (1%)

                  Thrombosis (1%)

                  Previous
                  Next:

                  Warnings

                  Black Box Warnings

                  Cytokine release syndrome

                  • Cytokine release syndrome (CRS), including fatal or life-threatening reactions, reported in a majority of patients (see Adverse Effects)
                  • Median time to CRS onset was 2 days (range: 1-12 days)
                  • Median duration of CRS was 7 days (range: 2-58 days)
                  • Key manifestations of CRS include high fever, hypotension, tachycardia, hypoxia, and chills
                  • Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)
                  • Do not administer to patients with active infection or inflammatory disorders
                  • Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids
                    • Ensure that 2 doses of tocilizumab are available on site prior to initiating axicabtagene ciloleucel (see Dosage Modifications)
                    • Monitor for CRS signs or symptoms daily for at least 7 days at the certified healthcare facility following treatment; continue monitoring for 4 weeks following the infusion
                    • Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time
                    • At the first sign of CRS, immediately evaluate patient for hospitalization and institute treatment with supportive care, tocilizumab, and/or corticosteroids as indicated

                  Neurological toxicities

                  • Neurological toxicities, which may be severe or life-threatening, can occur following treatment, including concurrently with CRS
                  • The majority of neurological toxicities occurred within 8 weeks after treatment
                  • The most common neurological toxicities were encephalopathy, headache, tremor, dizziness, aphasia, delirium, insomnia, and anxiety (also see Adverse Effects)
                  • Prolonged encephalopathy lasting up to 173 days was observed
                  • Serious events, including leukoencephalopathy and seizures, occurred in clinical trials
                  • Fatal and serious cases of cerebral edema also occurred
                  • Monitor for neurological events after treatment; provide supportive care as needed

                  Restricted access program

                  • Available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta REMS
                  • Further information is available at www.yescarta-rems.com or 1-844-454-KITE (5483)
                  • REMS requirements
                    • Healthcare facilities that dispense and administer axicabtagene ciloleucel must be enrolled and comply with the REMS requirements
                    • Certified healthcare facilities must have onsite immediate access to tocilizumab and ensure that a minimum of 2 doses of tocilizumab are available for each patient for administration within 2 hr after axicabtagene ciloleucel IV infusion, if needed for treatment of CRS
                    • Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer axicabtagene ciloleucel are trained about the management of CRS and neurological toxicities

                  Contraindications

                  None

                  Cautions

                  Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment in a majority of patients (see Black Box Warnings and Adverse Effects)

                  Neurological toxicities, which may be severe or life-threatening, can occur following treatment (see Black Box Warnings)

                  Available only through a restricted access program (see Black Box Warnings)

                  Allergic reactions may occur during infusion; serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide (DMSO) or residual gentamicin in the product

                  Serious infections, including life-threatening or fatal infections, reported; before administering, infection prophylaxis for neutropenia should follow local guidelines; monitor for signs and symptoms of infection after treatment and treat appropriately

                  Viral reactivation can occur; hepatitis B virus (HBV) reactivation can result in fulminant hepatitis, hepatic failure, and death; perform screening for HBV, hepatitis C virus (HCV), and HIV in accordance with clinical guidelines before collection of cells for manufacturing

                  Prolonged cytopenias may occur and last for several weeks following lymphodepleting chemotherapy and axicabtagene ciloleucel infusion; monitor blood cell counts

                  B-cell aplasia and hypogammaglobulinemia can occur; monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement standard guidelines

                  Secondary malignancies may develop; monitor patient life-long for secondary malignancies

                  Owing to the potential for neurological events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following treatment; advise patients to refrain from driving and engaging in hazardous occupations or activities

                  Immunization with live viral vaccines

                  • The 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 axicabtagene ciloleucel treatment, and until immune recovery afterwards
                  Previous
                  Next:

                  Pregnancy

                  Pregnancy

                  Data are not available in pregnant women

                  No animal reproductive and developmental toxicity studies have been conducted

                  Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia

                  Therefore, axicabtagene ciloleucel is not recommended for women who are pregnant, and pregnancy after infusion should be discussed with the treating physician

                  Pregnancy status of females with reproductive potential should be verified; sexually active females of reproductive potential should have a pregnancy test prior to starting treatment

                  Contraception: See the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy; limited exposure data available concerning the duration of contraception following treatment with axicabtagene ciloleucel

                  Lactation

                  Unknown if distributed in human breast milk

                  Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

                  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.

                  Previous
                  Next:

                  Pharmacology

                  Mechanism of Action

                  CD19-directed genetically modified autologous T cell immunotherapy that involves reengineering a patient’s own T cells to express a chimeric antigen receptor (CAR) to identify and bind to CD19-expressing malignant and normal B cells

                  Following anti-CD19 CAR T-cell engagement with CD19-expressing target cells, the CD28 and CD3-zeta costimulatory domains activate downstream signaling cascades that lead to T cell activation, proliferation, acquisition of effector functions and secretion of inflammatory cytokines and chemokines

                  This cascade of events leads to killing of CD19-expressing cells

                  Absorption

                  Peak plasma time: 7-14 days

                  Peak plasma concentration, median: 43.6 cells/mcL (responsive patients); 21.2 cells/mcL (nonresponsive [NR] patients)

                  AUC (0-28d): 557.1 days·cells/mcL (responsive patients); 222 days·cells/mcL (NR patients)

                  Cmax and AUC in responsive patients were, respectively, 205% and 251% higher compared with the corresponding level in NR patients

                  Concurrent use of tocilizumab: 262% and 232% higher anti-CD19 CAR T cells as measured by AUC (0-28d) and Cmax, respectively, as compared with patients without tocilizumab

                  Concurrent use of corticosteroids: 217% and 155% higher AUC (0-28d) and Cmax compared with patients who did not receive corticosteroids

                  Previous
                  Next:

                  Administration

                  IV Preparation

                  Confirm infusion time in advance, and adjust start time for thaw so that axicabtagene is available for infusion when recipient is ready

                  Confirm patient identity prior to preparation, and match the patient's identity with the patient identifiers on the axicabtagene infusion bag; axicabtagene is for autologous use only

                  Inspect the infusion bag for any breaks or cracks before thawing; if bag is compromised, do not infuse the contents; contact Kite at 1-844-454-KITE

                  Place infusion bag inside a second, sterile bag as 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 the infusion bag

                  Gently mix the contents of the bag to disperse clumps of cellular material; if visible cell clumps remain, continue to gently mix the contents of the bag

                  Do not wash, spin down, and/or resuspend axicabtagene ciloleucel in new media prior to infusion

                  Once thawed, stored at room temperature (20-25ºC) for up to 3 hr

                  Premedication

                  Premedicate with acetaminophen 650 mg PO and diphenhydramine 12.5 mg IV or PO ~1 hr before axicabtagene ciloleucel infusion

                  Avoid prophylactic use of systemic corticosteroids at all times (may interfere with axicabtagene ciloleucel activity), except in the case of a life-threatening emergency

                  IV Administration

                  For autologous use only

                  Ensure that tocilizumab and emergency equipment are available prior to infusion and during the recovery period

                  Do not use a leukodepleting filter

                  Central venous access is recommended for the infusion

                  Prime tubing with 0.9% NaCl prior to infusion

                  Infuse entire contents of the bag within 30 minutes by either gravity or a peristaltic pump

                  Thawed infusion bag is stable at room temperature for up to 3 hr

                  Gently agitate the product bag during infusion to prevent cell clumping

                  After completing infusion, rinse tubing with 0.9% NaCl at the same infusion rate to ensure all product is delivered

                  Follow local biosafety guidelines applicable for handling and disposal of such products

                  Storage

                  Frozen product

                  • Store infusion bag in the vapor phase of liquid nitrogen ≤-238ºF (≤-150°C) supplied in a liquid nitrogen dry shipper
                  • Use closed, break-proof, leak-proof containers when transporting infusion bags within the facility

                  Thawed infusion bag

                  • Stored at room temperature 68-77ºF (20-25ºC) for up to 3 hr
                  Previous
                  Next:

                  Images

                  No images available for this drug.
                  Previous
                  Next:

                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
                  Previous
                  Next:

                  Formulary

                  FormularyPatient Discounts

                  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.

                  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.
                  Additional Offers
                  Email to Patient

                  From:

                  To:

                  The recipient will receive more details and instructions to access this offer.

                  By clicking send, you acknowledge that you have permission to email the recipient with this information.

                  Email Forms to Patient

                  From:

                  To:

                  The recipient will receive more details and instructions to access this offer.

                  By clicking send, you acknowledge that you have permission to email the recipient with this information.

                  Previous
                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.