Lisocabtagene Maraleucel

Lisocabtagene Maraleucel is a prescription medication used for the treatment of B-cell lymphoma.

• Lisocabtagene Maraleucel is available under the following different brand names: Breyanzi

Common side effects of Lisocabtagene Maraleucel include:

• headache
• dizziness
• confusion
• problems with speech or thinking
• fever
• chills
• shaking
• nausea
• vomiting
• stomach pain
• diarrhea
• constipation
• fast or irregular heartbeats
• cough
• trouble breathing
• swelling
• pain in the bones, joints, or muscles

Serious side effects of Lisocabtagene Maraleucel include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• fever
• chills
• dizziness
• confusion
• vomiting
• diarrhea
• fast heartbeats
• weakness
• tiredness
• problems with the speech
• confusion
• trouble concentrating
• memory problems
• decreased consciousness
• tremors
• seizures
• mouth sores
• skin sores
• easy bruising
• unusual bleeding
• pale skin
• cold hands and feet
• light-headedness
• shortness of breath

Rare side effects of Lisocabtagene Maraleucel 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, coordination loss, 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, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because 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

• A single dose contains 50-110 × 106 CAR-positive viable T cells, consisting of CD8 and CD4 components, with each component supplied separately in single-dose vials
• More than 1 vial of each of the CD8 components and/or CD4 components may be needed to achieve the dose
• Each vial contains 6.9-322 × 106 CAR-positive viable T cells in 4.6 mL cell suspension (1.5-70 × 106 T cells/mL)
• Check Release for Infusion Certificate for specific content

B-Cell Lymphoma

Adult dosage

• Dose based on the number of CAR-positive viable T-cells per vial
• After 1 line of therapy: Single dose containing 90-110 × 106 CAR-positive viable T-cells
• After the above 2 lines of therapies: Single dose containing 50-110 × 106 CAR-positive viable T-cells
• Single dose consists of 1:1 CAR-positive viable T-cells of the CD8 and CD4 components.
• Each component is supplied separately in 1-4 single-dose vials

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.

• Lisocabtagene Maraleucel has severe interactions with no other drugs.
• Lisocabtagene Maraleucel has serious interactions with at least 187 other drugs.
• Lisocabtagene Maraleucel has moderate interactions with no other drugs.
• Lisocabtagene Maraleucel 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 Lisocabtagene Maraleucel?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Lisocabtagene Maraleucel?”

Cautions

• CRS, including fatal or life-threatening reactions, occurred (see Black Box Warnings and Adverse Effects)
• Available only through a restricted access program
• Allergic reactions may occur during infusion; serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide 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 manage infections with broad-spectrum antibiotics, fluids, and other supportive care
• 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, and HIV by clinical guidelines before collection of cells for manufacturing
• Prolonged cytopenias may occur and last for several weeks following lymphodepleting chemotherapy and CAR T-cell infusion; monitor blood cell counts before and after therapy administration
• 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 the patient life-long for secondary malignancies
• Neurological toxicities
  • Neurological toxicities, which may be severe or life-threatening, can occur following treatment
  • The most common neurologic toxicities include encephalopathy, tremor, aphasia, delirium, headache, ataxia, and dizziness
  • Serious events including cerebral edema and seizures occurred; fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, were reported
  • 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
  • Monitor daily during the first week following infusion for signs and symptoms of neurologic toxicities, then at least weekly for 4 weeks
  • HIV and the lentivirus used to make Lisocabtagene Maraleucel have limited, short spans of identical genetic material (RNA); therefore, some commercial HIV nucleic acid tests may yield false-positive results in patients who have received Lisocabtagene Maraleucel
• 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 before the start of lymphodepleting chemotherapy, during CAR T-cell treatment, and until immune recovery afterward

Pregnancy and Lactation

• 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 and hypogammaglobulinemia
• Not recommended during pregnancy, and pregnancy after infusion should be discussed with the treating physician
• Verify the pregnancy status of women with reproductive potential; sexually active women of reproductive potential should have a pregnancy test before starting treatment
• Infertility: Data are unavailable
• Contraception
  • See the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive lymphodepleting chemotherapy
  • Limited exposure data available concerning the duration of contraception following treatment
• Lactation
  • Unknown if distributed in human breast milk
  • Consider the developmental and health benefits of breastfeeding, the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition