Idecabtagene Vicleucel

Idecabtagene Vicleucel is a prescription medication indicated for the treatment of relapsed or refractory multiple myeloma after more than four prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

• Idecabtagene Vicleucel is available under the following different brand names: Abecma

Common side effects of Idecabtagene Vicleucel include:

• cytokine release syndrome (CRS)
• infections
• fatigue
• musculoskeletal pain
• hypogammaglobulinemia
• diarrhea
• upper respiratory tract infection
• nausea
• viral infections
• encephalopathy
• fluid retention (edema)
• fever
• cough
• headache
• decreased appetite
• low white blood cells (neutropenia, leukopenia, lymphopenia)
• low platelets (thrombocytopenia)
• anemia

Serious side effects of Idecabtagene Vicleucel include:

• general physical health deterioration
• pneumonia
• infections, unspecified pathogen
• viral infections
• sepsis
• febrile neutropenia

Rare side effects of Idecabtagene Vicleucel include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, suspension

• 300-460 x 106 CAR-positive viable T cells in 1 or more infusion bags

Multiple Myeloma

Adult dosage

• Lymphodepleting chemotherapy
  • Fludarabine 30 mg/m2 IV every day for 3 days
  • Cyclophosphamide 300 mg/m2 IV every day for 3 days starting with the first dose of fludarabine
• Idecabtagene Vicleucel IV infusion
  • Administer the drug 2 days after completing lymphodepleting chemotherapy
  • Premedicate with acetaminophen and diphenhydramine
  • 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 patients within 30 minutes by either gravity or peristaltic pump

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Idecabtagene Vicleucel has severe interactions with no other drugs.
• Idecabtagene Vicleucel has serious interactions with at least 202 other drugs.
• Idecabtagene Vicleucel has moderate interactions with no other drugs.
• Idecabtagene Vicleucel has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Idecabtagene Vicleucel?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Idecabtagene Vicleucel?”

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  vicleucel infusion at a REMS-certified healthcare facility; continue monitoring for at least 4 weeks following infusion; 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 it 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 as 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 immunoglobulins for IgG less than 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)
  • CRS, including fatal or life-threatening reactions, reported 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 and moreevents 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 the 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 the 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; monitor and treat for CMV reactivation as per 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 afterward
  • HIV nucleic acid tests
    • HIV and the lentivirus used to make Idecabtagene Vicleucel have limited, short spans of identical genetic material (RNA)
    • Therefore, some commercial HIV nucleic acid tests may yield false-positive results in patients receiving Idecabtagene Vicleucel 

Pregnancy and Lactation

• Data are not available in pregnant women
• No animal reproductive and developmental toxicity studies have been conducted
• It is unknown if vicleucel may potentially transfer to the fetus; based on the mechanism of action, if transduced cells cross the placenta, fetal toxicity, including B-cell lymphocytopenia, may occur; not recommended for women who are pregnant; consult with treating physician on pregnancy after infusion
• Treated patients may have hypogammaglobulinemia; assess immunoglobulin levels in newborns of treated mothers
• Verify the pregnancy status of women with reproductive potential before initiating treatment
• There are no data on the effects on fertility
• Contraception
  • See prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive lymphodepleting chemotherapy
  • The data available on the drug’s exposure are insufficient to provide recommendations on the duration of contraception following treatment
• Lactation
  • There is no information regarding the presence in human milk, its effects on breastfed infants, and milk production