Idecabtagene Vicleucel – Uses, Dosage,Side Effects, Interactions

Last updated: February 8, 2026Reviewed date: February 8, 2026Reading time: 19 min read
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Article Summary

Multiple myeloma is cancer where plasma cells rapidly divide out of control. These cancerous cells generally express the B-cell maturation antigen, while it is rarely expressed in non-cancerous cells.2 Multiple myeloma is typically treated with an immunomodulatory agent like lenalidomide,6 a proteasome inhibitor like bortezomib, or an anti-CD38 monoclonal antibody like isatuximab.8 Idecabtagene vicleucel, also known as bb2121, is a chimeric antigen receptor (CAR) T-cell therapy like axicabtagene ciloleucel and brexucabtagene autoleucel. These therapies...

Key Takeaways

  • This article explains Mechanism of action in simple medical language.
  • This article explains Indication in simple medical language.
  • This article explains Contraindications in simple medical language.
  • This article explains Dosage in simple medical language.
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  • Any symptom that feels urgent, unusual, or unsafe for the patient.
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Multiple myeloma is cancer where plasma cells rapidly divide out of control. These cancerous cells generally express the B-cell maturation antigen, while it is rarely expressed in non-cancerous cells.2 Multiple myeloma is typically treated with an immunomodulatory agent like lenalidomide,6 a proteasome inhibitor like bortezomib, or an anti-CD38 monoclonal antibody like isatuximab.8

Idecabtagene vicleucel, also known as bb2121, is a chimeric antigen receptor (CAR) T-cell therapy like axicabtagene ciloleucel and brexucabtagene autoleucel. These therapies involve extracting and genetically manipulating T-cells from a patient to express a CAR for a tumor specific antigen.1 The chimeric antigen receptor of idecabtagene vicleucel includes an anti-B-cell maturation antigen scFv-targeting domain, CD3ζ T-cell activation domain, and 4-1BB costimulatory domain.9 Idecabtagene vicleucel is indicated as a fifth-line treatment of adult patients with relapsed or refractory multiple myeloma.9

Idecabtagene vicleucel was granted FDA approval on 26 March 2021.10

Idecabtagene vicleucel injection may cause severe or life-threatening central nervous system reactions. These reactions can occur after treatment with idecabtagene vicleucel. Tell your doctor if you have or have ever had seizures, a stroke, or memory loss. If you experience any of the following symptoms, tell your doctor immediately: pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।" data-rx-term="headache" data-rx-definition="Headache means pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।">headache, dizziness, difficulty falling asleep or staying asleep, restlessness, confusion, anxiety, uncontrollable shaking of a part of the body, loss of consciousness, agitation, seizures, loss of balance, or difficulty speaking.

Idecabtagene vicleucel injection may cause a severe decrease in the number of certain types of blood cells in your blood. This may cause certain symptoms and may increase the risk that you will develop a serious infection or bleeding. If you experience any of the following symptoms after your treatment, tell your doctor immediately: fever, feeling tired, or have bruising or bleeding.

Mechanism of action

Multiple myeloma is cancer where plasma cells rapidly divide out of control.2 These cancerous cells generally express the B-cell maturation antigen, while it is rarely expressed on non-cancerous cells.2

The chimeric antigen receptor of idecabtagene vicleucel includes an anti-B-cell maturation antigen scFv-targeting domain, CD3ζ T-cell activation domain, and 4-1BB costimulatory domain.9 The single chain variable fragment (scFv) allows for B-cell maturation antigen specificity of the CAR.5,9 The CD23ζ cytoplasmic domain mediates T-cell activation by CD2, a T-cell surface adhesion molecule.3 4-1BB enhances cytotoxic T-cell activity as well as the production of interferon-γ.4

Idecabtagene violence binds to B-cell maturation antigen-expressing cells.9 Binding to the target leads to the proliferation of idecabtagene vicleucel, secretion of cytokines, and lysis of the targeted cells.9

Indication

Idecabtagene vicleucel is indicated to treat adult patients with relapsed or refractory multiple myeloma who have tried at least 4 other lines of therapy, including an immunomodulatory agent, proteasome inhibitor, and anti-CD38 monoclonal antibody.9

  • Refractory Multiple Myeloma
  • Relapsed Multiple Myeloma
  • Multiple myeloma that has relapsed (come back) or is refractory (does not respond to treatment). It is used in adults who have received at least four previous treatments that included an immunomodulating agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

    Idecabtagene vicleucel is only available as part of a special program called Abecma REMS (Risk Evaluation and Mitigation StrategiesExit Disclaimer).

    Contraindications

    The following conditions are contraindicated with this drug. Check with your physician if you have any of the following:

    • an unusual viral infection called cytomegalovirus infection
    • a bad infection
    • decreased blood platelets
    • low levels of a type of white blood cell called neutrophils
    • pregnancy
    • reactivation of hepatitis B infection

    Dosage

    Usual Adult Dose for Multiple Myeloma

    • This drug is provided as a single dose for infusion containing a suspension of chimeric antigen receptor (CAR)-positive T cells in one or more infusion bags; the recommended dose is 300 to 460 x 106 CAR-positive T cells.
    •  Administer the lymphodepleting chemotherapy regimen: cyclophosphamide 300 mg/m2 IV and fludarabine 30 mg/m2 IV for 3 days
    • Administer this drug 2 days after completion of lymphodepleting chemotherapy.

    Delay the infusion of this drug up to 7 days if a patient has any of the following conditions:

    • Unresolved adverse events (e.g., pulmonary events, cardiac events, hypotension), including those after preceding chemotherapies
    • Active infections or inflammatory disorders

    Premedication:

    • Administer acetaminophen (650 mg orally) and diphenhydramine (12.5 mg IV or 25 to 50 mg orally, or another H1-antihistamine) approximately 30 to 60 minutes before infusion of this drug NOTE: avoid prophylactic use of dexamethasone or other systemic corticosteroids, as the use may interfere with the activity of this drug.

    Receipt of the drug:

    • This drug is shipped directly to the cell laboratory or clinical pharmacy associated with the infusion center in the vapor phase of a liquid nitrogen shipper.
    • Confirm the patient’s identity with the patient identifiers on the shipper.
    • If the patient is not expected to be ready for same-day administration before the shipper expires and the infusion site is qualified for onsite storage, transfer this drug to onsite vapor phase of liquid nitrogen storage.
    • If the patient is not expected to be ready for same day administration before the shipper expires and the infusion site is not qualified for onsite storage, contact Bristol-Myers Squibb to arrange for return shipment.

    Preparation for Infusion:

    • 1) Confirm the infusion time in advance and adjust the start time of the thaw of this drug so it will be available for infusion when the patient is ready.
    • 2) Prior to thawing, confirm that tocilizumab and emergency equipment are available.
    • 3) Doses may be contained in one or more patient-specific infusion bag(s). Verify the number of bags received for the indicated dose prior to preparation.
    • 4) Match patient identity with identifiers on the cassette(s), infusion bag(s), and the RFI Certificate (the patient identifier number may be preceded by the letters DIN or Aph ID).
    • 5) Do not remove the infusion bag(s) from the cassette(s) if the information on the cassette label(s) does not match the intended patient. Contact Bristol-Myers Squibb at if there are any discrepancies between the labels and the patient identifiers.
    • 6) When patient identity is confirmed, remove the infusion bag(s) from the cassette(s) and check that the patient information on the cassette label(s) matches the patient information on the bag label(s).
    • 7) Inspect the infusion bag(s) for breaches of container integrity such as breaks or cracks.
    • 8) Thaw each infusion bag one at a time. Do not initiate thaw of the next bag until infusion of the previous bag is complete.
    • 9) Place infusion bag(s) inside a second sterile bag per local guidelines.
    • 10) Thaw infusion bag(s) at 37C using a thawing device or water bath until there is no ice in the infusion bag. Gently mix the contents to disperse clumps of cellular material. If visible clumps remain, continue to gently mix the contents. Small clumps of cellular material should disperse with gentle manual mixing. Do not wash, spin down, and/or resuspend in new media prior to infusion.
      11) Administer within 1 hour of the start of thaw (the drug is stable for 2 hours at room temperature when thawed).

    Administration:

    • For autologous use only.
    • Do not use a leukodepleting filter.
    • Ensure that a minimum of 2 doses of tocilizumab and emergency equipment are available.
    • Central venous access is recommended in patients with poor peripheral access.
    • Confirm the patient’s identity.
    • Prime tubing with normal saline.
    • Infuse contents of the bag within 1 hour after the start of thaw by gravity flow.
    • After infusion, rinse the tubing with 30 to 60 mL of normal saline at the same infusion rate to ensure all drug is delivered.
    • Follow the same steps for any subsequent infusion bags. Do not thaw the next bag until the infusion of the previous bag is complete.

    MANAGEMENT OF SEVERE ADVERSE REACTIONS:

    • Cytokine Release Syndrome (CRS): Evaluate for and treat other causes of fever, hypoxia, and hypotension. If CRS is suspected, manage it according.
    • Monitor patients who experience CRS for cardiac and organ function until the resolution of symptoms.
    • Consider antiseizure prophylaxis with levetiracetam in patients who experience CRS.
    • Patients who experience Grade 2 or higher CRS (e.g., hypotension not responsive to fluids, or hypoxia requiring supplemental oxygenation) should be monitored with continuous cardiac telemetry and pulse oximetry.
    • For severe or life-threatening CRS, consider intensive care unit-level monitoring and supportive therapy.
    • For CRS refractory to first-line interventions such as tocilizumab or tocilizumab and corticosteroids, consider alternate treatment options (i.e., higher corticosteroid dose, alternative anti-cytokine agents, anti-T cell therapies). NOTE: Refractory CRS is characterized by fevers, end-organ toxicity (e.g., hypoxia, hypotension) not improving within 12 hours of first line interventions or development of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).

    CRS GRADING AND MANAGEMENT GUIDANCE:
    GRADE 1 (requires symptomatic treatment only [e.g., fever, fatigue, pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।" data-rx-term="headache" data-rx-definition="Headache means pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।">headache, myalgia, malaise]):

    • Tocilizumab: If onset 72 hours or more after infusion, treat symptomatically; if onset less than 72 hours after infusion, consider tocilizumab 8 mg/kg IV over 1 hour (not to exceed 800 mg).
    • Corticosteroids (if corticosteroids are initiated, continue for at least 3 doses, and taper over a maximum of 7 days): Consider dexamethasone 10 mg IV every 24 hours.

    GRADE 2 (symptoms require moderate intervention; oxygen requirement less than 40% FiO2 or hypotension responsive to fluids, or low dose of one vasopressor, or Grade 2 organ toxicity):

    • Tocilizumab: Administer tocilizumab 8 mg/kg IV over 1 hour (not to exceed 800 mg); repeat tocilizumab every 8 hours as needed if not responsive to IV fluids or supplemental oxygen; limit to a maximum of 3 doses in a 24-hour period; maximum total of 4 doses.
    • Corticosteroids (if corticosteroids are initiated, continue for at least 3 doses, and taper over a maximum of 7 days): Consider dexamethasone 10 mg IV every 12 to 24 hours.
    • If no improvement of Grade 2 reaction within 24 hours or rapid progression, repeat tocilizumab and escalate dose and frequency of dexamethasone (20 mg IV every 6 to 12 hours); if no improvement within 24 hours or continued rapid progression, switch to methylprednisolone 2 mg/kg followed by 2 mg/kg divided 4 times per day; after 2 doses of tocilizumab, consider alternative anti-cytokine agents; do not exceed 3 doses of tocilizumab in 24 hours, or 4 doses total.

    GRADE 3:

    • Tocilizumab: Administer tocilizumab 8 mg/kg IV over 1 hour (not to exceed 800
    • Corticosteroids (if corticosteroids are initiated, continue for at least 3 doses, and taper over a maximum of 7 days): Administer dexamethasone 10 mg IV every 12 hours.
    • If no improvement within 24 hours or rapid progression, repeat tocilizumab and escalate dose and frequency of dexamethasone (20 mg IV every 6 to 12 hours); if no improvement within 24 hours or continued rapid progression, switch to methylprednisolone 2 mg/kg followed by 2 mg/kg divided 4 times per day; after 2 doses of tocilizumab, consider alternative anti-cytokine agents do not exceed 3 doses of tocilizumab in 24 hours, or 4 doses total.

    GRADE 4 (Life-threatening symptoms; requirement for ventilator support, continuous veno-venous hemodialysis (CVVHD), or Grade 4 organ toxicity (excluding transaminitis):

    • Tocilizumab: Administer tocilizumab 8 mg/kg IV over 1 hour (not to exceed 800
    • Corticosteroids (if corticosteroids are initiated, continue for at least 3 doses, and taper over a maximum of 7 days): Administer dexamethasone 20 mg IV every 6 hours.
    • After 2 doses of tocilizumab, consider alternative anti-cytokine agents; do not exceed 3 doses of tocilizumab in 24 hours, or 4 doses total if no improvement within 24 hours, consider methylprednisolone 1 to 2 g IV; repeat every 24 hours if needed with taper or other anti-T cell therapies.

    NEUROLOGIC TOXICITY:

    • Monitor for neurologic toxicities.
    • Rule out other causes of neurologic signs or symptoms; provide supportive therapy for severe or life-threatening toxicities; if neurologic toxicity is suspected, manage according to the recommendations in Table 2.

    If concurrent CRS is suspected during the neurologic toxicity, administer:

    • Corticosteroids according to the more aggressive intervention based on the CRS and neurologic toxicity grades in Tables 1 and 2.
    • Tocilizumab according to CRS grade in Table 1.
    • Antiseizure medication according to neurologic toxicity in Table 2.

    NEUROLOGIC TOXICITY GRADING AND MANAGEMENT GUIDANCE:

    • Grade 1: Start non-sedating, antiseizure medicines (e.g., levetiracetam) for seizure prophylaxis; if 72 hours or more after infusion, observe patient if less than 72 hours after infusion, consider dexamethasone 10 mg IV every 12 to 24 hours for 2 to 3 days.
    • Grade 2: Start non-sedating, antiseizure medicines (e.g., levetiracetam) for seizure prophylaxis; start dexamethasone 10 mg IV every 12 hours for 2 to 3 days, or longer for persistent symptoms; consider taper for a total corticosteroid exposure of greater than 3 days; corticosteroids are not recommended for isolated Grade 2 headaches if no improvement after 24 hours or worsening of neurologic toxicity, increase the dose and/or frequency of dexamethasone up to a maximum of 20 mg IV every 6 hours.
    • Grade 3: Start non-sedating, antiseizure medicines (e.g., levetiracetam) for seizure prophylaxis; start dexamethasone 10 to 20 mg IV every 6 to 12 hours; corticosteroids are not recommended for isolated Grade 3 headaches; if no improvement after 24 hours or worsening of neurologic toxicity, escalate to methylprednisolone (2 mg/kg loading dose, followed by 2 mg/kg divided into 4 times a day; taper within 7 days); if cerebral edema is suspected, consider hyperventilation and hyperosmolar therapy; give high-dose methylprednisolone (1 to 2 g IV, repeat every 24 hours if needed; taper as clinically indicated) and cyclophosphamide 1.5 g/m2.
    • Grade 4: Start non-sedating, antiseizure medicines (e.g., levetiracetam) for seizure prophylaxis; start dexamethasone 20 mg IV every 6 hours; if no improvement after 24 hours or worsening of neurologic toxicity, escalate to high-dose methylprednisolone (1 to 2 g IV, repeated every 24 hours if needed; taper as clinically indicated); if cerebral edema is suspected, consider hyperventilation and hyperosmolar therapy; give high-dose methylprednisolone (1 to 2 g IV, repeat every 24 hours if needed; taper as clinically indicated), and cyclophosphamide 1.5 g/m2.

    Side Effects

    Most common

    • Blemishes on the skin
    • blistering, crusting, irritation, itching, or reddening of the skin
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • constipation
    • cracked, dry, scaly skin
    • fear
    • the feeling of constant movement of self or surroundings
    • pain in the mouth
    • pimples
    • sensation of spinning
    • skin rash or blisters
    • toothache
    • trouble sleeping
    • unusually warm skin
    • trembling and shaking of hands
    • trouble in swallowing
    • ulcers, sores, or white spots in the mouth
    • unsteadiness or awkwardness
    • unusual bleeding or bruising
    • unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
    • unusual excitement, nervousness, or restlessness
    • unusual weight gain or loss

    More common

    • Agitation
    • pain: Back pain means pain in the spine, muscles, discs, joints, or nerves of the back. সহজ বাংলা: পিঠ/কোমরের ব্যথা।" data-rx-term="back pain" data-rx-definition="Back pain means pain in the spine, muscles, discs, joints, or nerves of the back. সহজ বাংলা: পিঠ/কোমরের ব্যথা।">back pain
    • black, tarry stools
    • being forgetful
    • bloating or swelling of the face, arms, hands, lower legs, or feet
    • body aches and pain
    • bone pain
    • bleeding gums
    • blood in the urine or stools
    • blue lips, fingernails, or skin
    • blurred vision
    • burning, crawling, itching, numbness, painful, prickling, “pins and needles”, or tingling feelings
    • burning, numbness, pain, or tingling in all the fingers except the smallest finger
    • changes in patterns and rhythms of speech
    • chest discomfort, pain, or tightness
    • chills
    • cold flu-like symptoms
    • cold sweats
    • coma
    • confusion
    • confusion as to time, place, or person
    • cough or hoarseness
    • decreased frequency or amount of urine

    Less common

    • Coughing that sometimes produces a pink frothy sputum
    • diarrhea
    • fainting
    • increased sweating
    • partial or slight paralysis
    • shakiness and unsteady walk
    • stomach pain
    • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins
    • unsteadiness, trembling, or other problems with muscle control or coordination
    • vomiting of blood or material that looks like coffee grounds

    Drug Interactions

    This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

    Pregnancy and lactation

    Pregnancy

    • US FDA pregnancy category: Not assigned.

    There are no data on the use of this drug in pregnancy. No animal reproductive and developmental toxicity studies have been conducted. It is not known if this drug is transferred to the fetus. Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including plasma cell aplasia or hypogammaglobulinemia.

    Breastfeeding

    Safety has not been established.

    Excreted into human milk: Unknown
    Excreted into animal milk: Data not available

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of idecabtagene vicleucel injection in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of idecabtagene vicleucel injection in the elderly.

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    Frequently Asked Questions

    Mechanism of actionMultiple myeloma is cancer where plasma cells rapidly divide out of control.2 These cancerous cells generally express the B-cell maturation antigen, while it is rarely expressed on non-cancerous cells.2The chimeric antigen receptor of idecabtagene vicleucel includes an anti-B-cell maturation antigen scFv-targeting domain, CD3ζ T-cell activation domain, and 4-1BB costimulatory domain.9 The single chain variable fragment (scFv) allows for B-cell maturation antigen specificity of the CAR.5,9 The CD23ζ cytoplasmic domain mediates T-cell activation by CD2, a T-cell surface adhesion molecule.3 4-1BB enhances cytotoxic T-cell activity as well as the production of interferon-γ.4Idecabtagene violence binds to B-cell maturation antigen-expressing cells.9 Binding to the target leads to the proliferation of idecabtagene vicleucel, secretion of cytokines, and lysis of the targeted cells.9IndicationIdecabtagene vicleucel is indicated to treat adult patients with relapsed or refractory multiple myeloma who have tried at least 4 other lines of therapy, including an immunomodulatory agent, proteasome inhibitor, and anti-CD38 monoclonal antibody.9Refractory Multiple Myeloma Relapsed Multiple Myeloma Multiple myeloma that has relapsed (come back) or is refractory (does not respond to treatment). It is used in adults who have received at least four previous treatments that included an immunomodulating agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.Idecabtagene vicleucel is only available as part of a special program called Abecma REMS (Risk Evaluation and Mitigation StrategiesExit Disclaimer).ContraindicationsThe following conditions are contraindicated with this drug. Check with your physician if you have any of the following:an unusual viral infection called cytomegalovirus infection a bad infection decreased blood platelets low levels of a type of white blood cell called neutrophils pregnancy reactivation of hepatitis B infectionDosageUsual Adult Dose for Multiple MyelomaThis drug is provided as a single dose for infusion containing a suspension of chimeric antigen receptor (CAR)-positive T cells in one or more infusion bags; the recommended dose is 300 to 460 x 106 CAR-positive T cells.  Administer the lymphodepleting chemotherapy regimen: cyclophosphamide 300 mg/m2 IV and fludarabine 30 mg/m2 IV for 3 days Administer this drug 2 days after completion of lymphodepleting chemotherapy.Delay the infusion of this drug up to 7 days if a patient has any of the following conditions:Unresolved adverse events (e.g., pulmonary events, cardiac events, hypotension), including those after preceding chemotherapies Active infections or inflammatory disordersPremedication:Administer acetaminophen (650 mg orally) and diphenhydramine (12.5 mg IV or 25 to 50 mg orally, or another H1-antihistamine) approximately 30 to 60 minutes before infusion of this drug NOTE: avoid prophylactic use of dexamethasone or other systemic corticosteroids, as the use may interfere with the activity of this drug.Receipt of the drug:This drug is shipped directly to the cell laboratory or clinical pharmacy associated with the infusion center in the vapor phase of a liquid nitrogen shipper. Confirm the patient's identity with the patient identifiers on the shipper. If the patient is not expected to be ready for same-day administration before the shipper expires and the infusion site is qualified for onsite storage, transfer this drug to onsite vapor phase of liquid nitrogen storage. If the patient is not expected to be ready for same day administration before the shipper expires and the infusion site is not qualified for onsite storage, contact Bristol-Myers Squibb to arrange for return shipment.Preparation for Infusion:1) Confirm the infusion time in advance and adjust the start time of the thaw of this drug so it will be available for infusion when the patient is ready. 2) Prior to thawing, confirm that tocilizumab and emergency equipment are available. 3) Doses may be contained in one or more patient-specific infusion bag(s). Verify the number of bags received for the indicated dose prior to preparation. 4) Match patient identity with identifiers on the cassette(s), infusion bag(s), and the RFI Certificate (the patient identifier number may be preceded by the letters DIN or Aph ID). 5) Do not remove the infusion bag(s) from the cassette(s) if the information on the cassette label(s) does not match the intended patient. Contact Bristol-Myers Squibb at if there are any discrepancies between the labels and the patient identifiers. 6) When patient identity is confirmed, remove the infusion bag(s) from the cassette(s) and check that the patient information on the cassette label(s) matches the patient information on the bag label(s). 7) Inspect the infusion bag(s) for breaches of container integrity such as breaks or cracks. 8) Thaw each infusion bag one at a time. Do not initiate thaw of the next bag until infusion of the previous bag is complete. 9) Place infusion bag(s) inside a second sterile bag per local guidelines. 10) Thaw infusion bag(s) at 37C using a thawing device or water bath until there is no ice in the infusion bag. Gently mix the contents to disperse clumps of cellular material. If visible clumps remain, continue to gently mix the contents. Small clumps of cellular material should disperse with gentle manual mixing. Do not wash, spin down, and/or resuspend in new media prior to infusion. 11) Administer within 1 hour of the start of thaw (the drug is stable for 2 hours at room temperature when thawed).Administration:For autologous use only. Do not use a leukodepleting filter. Ensure that a minimum of 2 doses of tocilizumab and emergency equipment are available. Central venous access is recommended in patients with poor peripheral access. Confirm the patient's identity. Prime tubing with normal saline. Infuse contents of the bag within 1 hour after the start of thaw by gravity flow. After infusion, rinse the tubing with 30 to 60 mL of normal saline at the same infusion rate to ensure all drug is delivered. Follow the same steps for any subsequent infusion bags. Do not thaw the next bag until the infusion of the previous bag is complete.MANAGEMENT OF SEVERE ADVERSE REACTIONS:Cytokine Release Syndrome (CRS): Evaluate for and treat other causes of fever, hypoxia, and hypotension. If CRS is suspected, manage it according. Monitor patients who experience CRS for cardiac and organ function until the resolution of symptoms. Consider antiseizure prophylaxis with levetiracetam in patients who experience CRS. Patients who experience Grade 2 or higher CRS (e.g., hypotension not responsive to fluids, or hypoxia requiring supplemental oxygenation) should be monitored with continuous cardiac telemetry and pulse oximetry. For severe or life-threatening CRS, consider intensive care unit-level monitoring and supportive therapy. For CRS refractory to first-line interventions such as tocilizumab or tocilizumab and corticosteroids, consider alternate treatment options (i.e., higher corticosteroid dose, alternative anti-cytokine agents, anti-T cell therapies). NOTE: Refractory CRS is characterized by fevers, end-organ toxicity (e.g., hypoxia, hypotension) not improving within 12 hours of first line interventions or development of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).CRS GRADING AND MANAGEMENT GUIDANCE: GRADE 1 (requires symptomatic treatment only [e.g., fever, fatigue, headache, myalgia, malaise]):Tocilizumab: If onset 72 hours or more after infusion, treat symptomatically; if onset less than 72 hours after infusion, consider tocilizumab 8 mg/kg IV over 1 hour (not to exceed 800 mg). Corticosteroids (if corticosteroids are initiated, continue for at least 3 doses, and taper over a maximum of 7 days): Consider dexamethasone 10 mg IV every 24 hours.GRADE 2 (symptoms require moderate intervention; oxygen requirement less than 40% FiO2 or hypotension responsive to fluids, or low dose of one vasopressor, or Grade 2 organ toxicity):Tocilizumab: Administer tocilizumab 8 mg/kg IV over 1 hour (not to exceed 800 mg); repeat tocilizumab every 8 hours as needed if not responsive to IV fluids or supplemental oxygen; limit to a maximum of 3 doses in a 24-hour period; maximum total of 4 doses. Corticosteroids (if corticosteroids are initiated, continue for at least 3 doses, and taper over a maximum of 7 days): Consider dexamethasone 10 mg IV every 12 to 24 hours. If no improvement of Grade 2 reaction within 24 hours or rapid progression, repeat tocilizumab and escalate dose and frequency of dexamethasone (20 mg IV every 6 to 12 hours); if no improvement within 24 hours or continued rapid progression, switch to methylprednisolone 2 mg/kg followed by 2 mg/kg divided 4 times per day; after 2 doses of tocilizumab, consider alternative anti-cytokine agents; do not exceed 3 doses of tocilizumab in 24 hours, or 4 doses total.GRADE 3:Tocilizumab: Administer tocilizumab 8 mg/kg IV over 1 hour (not to exceed 800 Corticosteroids (if corticosteroids are initiated, continue for at least 3 doses, and taper over a maximum of 7 days): Administer dexamethasone 10 mg IV every 12 hours. If no improvement within 24 hours or rapid progression, repeat tocilizumab and escalate dose and frequency of dexamethasone (20 mg IV every 6 to 12 hours); if no improvement within 24 hours or continued rapid progression, switch to methylprednisolone 2 mg/kg followed by 2 mg/kg divided 4 times per day; after 2 doses of tocilizumab, consider alternative anti-cytokine agents do not exceed 3 doses of tocilizumab in 24 hours, or 4 doses total.GRADE 4 (Life-threatening symptoms; requirement for ventilator support, continuous veno-venous hemodialysis (CVVHD), or Grade 4 organ toxicity (excluding transaminitis):Tocilizumab: Administer tocilizumab 8 mg/kg IV over 1 hour (not to exceed 800 Corticosteroids (if corticosteroids are initiated, continue for at least 3 doses, and taper over a maximum of 7 days): Administer dexamethasone 20 mg IV every 6 hours. After 2 doses of tocilizumab, consider alternative anti-cytokine agents; do not exceed 3 doses of tocilizumab in 24 hours, or 4 doses total if no improvement within 24 hours, consider methylprednisolone 1 to 2 g IV; repeat every 24 hours if needed with taper or other anti-T cell therapies.NEUROLOGIC TOXICITY:Monitor for neurologic toxicities. Rule out other causes of neurologic signs or symptoms; provide supportive therapy for severe or life-threatening toxicities; if neurologic toxicity is suspected, manage according to the recommendations in Table 2.If concurrent CRS is suspected during the neurologic toxicity, administer:Corticosteroids according to the more aggressive intervention based on the CRS and neurologic toxicity grades in Tables 1 and 2. Tocilizumab according to CRS grade in Table 1. Antiseizure medication according to neurologic toxicity in Table 2.NEUROLOGIC TOXICITY GRADING AND MANAGEMENT GUIDANCE:Grade 1: Start non-sedating, antiseizure medicines (e.g., levetiracetam) for seizure prophylaxis; if 72 hours or more after infusion, observe patient if less than 72 hours after infusion, consider dexamethasone 10 mg IV every 12 to 24 hours for 2 to 3 days. Grade 2: Start non-sedating, antiseizure medicines (e.g., levetiracetam) for seizure prophylaxis; start dexamethasone 10 mg IV every 12 hours for 2 to 3 days, or longer for persistent symptoms; consider taper for a total corticosteroid exposure of greater than 3 days; corticosteroids are not recommended for isolated Grade 2 headaches if no improvement after 24 hours or worsening of neurologic toxicity, increase the dose and/or frequency of dexamethasone up to a maximum of 20 mg IV every 6 hours. Grade 3: Start non-sedating, antiseizure medicines (e.g., levetiracetam) for seizure prophylaxis; start dexamethasone 10 to 20 mg IV every 6 to 12 hours; corticosteroids are not recommended for isolated Grade 3 headaches; if no improvement after 24 hours or worsening of neurologic toxicity, escalate to methylprednisolone (2 mg/kg loading dose, followed by 2 mg/kg divided into 4 times a day; taper within 7 days); if cerebral edema is suspected, consider hyperventilation and hyperosmolar therapy; give high-dose methylprednisolone (1 to 2 g IV, repeat every 24 hours if needed; taper as clinically indicated) and cyclophosphamide 1.5 g/m2. Grade 4: Start non-sedating, antiseizure medicines (e.g., levetiracetam) for seizure prophylaxis; start dexamethasone 20 mg IV every 6 hours; if no improvement after 24 hours or worsening of neurologic toxicity, escalate to high-dose methylprednisolone (1 to 2 g IV, repeated every 24 hours if needed; taper as clinically indicated); if cerebral edema is suspected, consider hyperventilation and hyperosmolar therapy; give high-dose methylprednisolone (1 to 2 g IV, repeat every 24 hours if needed; taper as clinically indicated), and cyclophosphamide 1.5 g/m2.Side EffectsMost commonBlemishes on the skin blistering, crusting, irritation, itching, or reddening of the skin dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position constipation cracked, dry, scaly skin fear the feeling of constant movement of self or surroundings pain in the mouth pimples sensation of spinning skin rash or blisters toothache trouble sleeping unusually warm skin trembling and shaking of hands trouble in swallowing ulcers, sores, or white spots in the mouth unsteadiness or awkwardness unusual bleeding or bruising unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness unusual excitement, nervousness, or restlessness unusual weight gain or lossMore commonAgitation back pain black, tarry stools being forgetful bloating or swelling of the face, arms, hands, lower legs, or feet body aches and pain bone pain bleeding gums blood in the urine or stools blue lips, fingernails, or skin blurred vision burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings burning, numbness, pain, or tingling in all the fingers except the smallest finger changes in patterns and rhythms of speech chest discomfort, pain, or tightness chills cold flu-like symptoms cold sweats coma confusion confusion as to time, place, or person cough or hoarseness decreased frequency or amount of urineLess commonCoughing that sometimes produces a pink frothy sputum diarrhea fainting increased sweating partial or slight paralysis shakiness and unsteady walk stomach pain tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins unsteadiness, trembling, or other problems with muscle control or coordination vomiting of blood or material that looks like coffee groundsDrug InteractionsThis information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.DRUG INTERACTIONArticaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Articaine.Benzocaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Benzocaine.Benzyl alcohol The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Benzyl alcohol.Bupivacaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Bupivacaine.Butacaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Butacaine.Butamben The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Butamben.Capsaicin The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Capsaicin.Chloroprocaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Chloroprocaine.Cinchocaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Cinchocaine.Cocaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Cocaine.Darbepoetin alfa The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Idecabtagene vicleucel.Diphenhydramine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Diphenhydramine.Dyclonine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Dyclonine.Erythropoietin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Idecabtagene vicleucel.Ethyl chloride The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Ethyl chloride.Etidocaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Etidocaine.Levobupivacaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Levobupivacaine.Lidocaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Lidocaine.Meloxicam The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Meloxicam.Mepivacaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Mepivacaine.Methoxy polyethylene glycol-epoetin beta The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Idecabtagene vicleucel.Oxetacaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Oxetacaine.Oxybuprocaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Oxybuprocaine.Peginesatide The risk or severity of Thrombosis can be increased when Peginesatide is combined with Idecabtagene vicleucel.Phenol The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Phenol.Pramocaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Pramocaine.Prilocaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Prilocaine.Procaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Procaine.Proparacaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Proparacaine.Propoxycaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Propoxycaine.Ropivacaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Ropivacaine.Tetracaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Tetracaine.Pregnancy and lactationPregnancyUS FDA pregnancy category: Not assigned.There are no data on the use of this drug in pregnancy. No animal reproductive and developmental toxicity studies have been conducted. It is not known if this drug is transferred to the fetus. Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including plasma cell aplasia or hypogammaglobulinemia.Breastfeeding Safety has not been established.Excreted into human milk: Unknown Excreted into animal milk: Data not available Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Pediatric Appropriate studies have not been performed on the relationship of age to the effects of idecabtagene vicleucel injection in the pediatric population. Safety and efficacy have not been established. Geriatric Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of idecabtagene vicleucel injection in the elderly.Why is this medication prescribed?

    Idecabtagene vicleucel injection is used to treat certain types of multiple myeloma (a type of cancer of the bone marrow) in adults whose cancer has returned or is unresponsive to at least four other treatments. Idecabtagene vicleucel injection is in a class of medications called autologous cellular immunotherapy, a type of medication prepared using cells from the patient's own blood. It works by causing the body's immune system (a group of cells, tissues, and organs that protects the body from…

    How should this medicine be used?

    Idecabtagene vicleucel injection comes as a suspension (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a doctor's office or infusion center. It is usually given over a total period of up to 30 minutes as a one-time dose. Before you receive your idecabtagene vicleucel dose, your doctor or nurse will administer other chemotherapy medications to prepare your body for idecabtagene vicleucel. Before your dose of idecabtagene vicleucel injection is to be given, a sample…

    Before receiving idecabtagene vicleucel injection,tell your doctor and pharmacist if you are allergic to idecabtagene vicleucel, any other medications, dimethyl sulfoxide (DMSO), or any of the ingredients in idecabtagene vicleucel injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: steroids such as dexamethasone, methylprednisolone (Medrol), prednisolone, and prednisone (Rayos). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor if you have ever had reactions from previous chemotherapy treatments such as breathing problems or irregular heartbeat. Also, tell your doctor if you have or have ever had lung, kidney, heart, or liver disease. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You will need to have a pregnancy test before you start idecabtagene vicleucel. If you become pregnant while receiving idecabtagene vicleucel, call your doctor immediately. Idecabtagene vicleucel may harm the fetus. you should know that idecabtagene vicleucel injection may make you drowsy and cause confusion, weakness, dizziness, seizures, and coordination problems. Do not drive a car or operate machinery for at least 8 weeks after your idecabtagene vicleucel dose. do not donate blood, organs, tissues, or cells for transplantation after you receive your idecabtagene vicleucel injection. check with your doctor to see if you need to receive any vaccinations. Do not have any vaccinations without talking to your doctor for at least 6 weeks before starting chemotherapy, during your idecabtagene vicleucel treatment, and until your doctor tells you that your immune system has recovered.What should I do if I forget a dose?

    If you miss the appointment to collect your cells, you must call your doctor and the collection center right away. If you miss the appointment to receive your idecabtagene vicleucel dose, you must call your doctor right away. References https://go.drugbank.com/drugs/DB16665 https://www.cancer.gov/about-cancer/treatment/drugs/idecabtagenevicleucel https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-idecabtagene-vicleucel-multiple-myeloma https://www.mayoclinic.org/drugs-supplements/idecabtagene-vicleucel-intravenous-route/before-using/drg-20512967 https://pubchem.ncbi.nlm.nih.gov/substance/384585532 https://chem.nlm.nih.gov/chemidplus/unii/8PX1X7UG4D https://medlineplus.gov/druginfo/meds/a621024.html https://www.drugs.com/mtm/idecabtagene-vicleucel.html

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