Axicabtagene Ciloleucel

Axicabtagene Ciloleucel is a prescription medication used for the treatment of large B-cell lymphoma and follicular lymphoma. 

• Axicabtagene Ciloleucel is available under the following different brand names: Yescarta.

Common side effects of Axicabtagene Ciloleucel include:

• Nausea,
• Diarrhea,
• Low blood cells,
• Confusion, and
• Fast heartbeats

Serious side effects of Axicabtagene Ciloleucel include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Fever,
• Chills,
• Confusion,
• Severe vomiting or diarrhea,
• Fast or irregular heartbeats,
• Lightheadedness,
• Weakness,
• Tiredness,
• Problems with speech,
• Problems with thinking or memory,
• Confusion,
• Seizure,
• Headaches,
• Dizziness,
• Tremors,
• Anxiety,
• Trouble sleeping,
• Unusual thoughts or behavior,
• Trouble speaking or understanding speech,
• Flu-like symptoms,
• Mouth sores,
• Skin sores,
• Easy bruising,
• Unusual bleeding,
• Pale skin,
• Cold hands and feet, and
• Shortness of breath

Rare side effects of Axicabtagene Ciloleucel 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 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

• Single-dose units contain specific amounts of T cells depending on the patient’s body weight that is 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 approximately 68 mL

Large B-Cell Lymphoma

Adult dosage

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 intravenous once a day for 3 days  
• Cyclophosphamide 500 mg/m2 intravenous once a day for 3 days starting with the first dose of fludarabine.

Axicabtagene Ciloleucel intravenous 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 intravenous infusion for the individual patient within 30 minutes by either gravity or peristaltic pump.
• Do not use a leukocyte-depleting filter.

Follicular Lymphoma

Adult dosage

Lymphodepleting chemotherapy

• 3 doses of fludarabine and cyclophosphamide infused intravenously on the fifth, fourth, and third day before infusion of axicabtagene Ciloleucel.
• Fludarabine 30 mg/m2 intravenous once a day for 3 days  
• Cyclophosphamide 500 mg/m2 intravenous once a day for 3 days starting with the first dose of fludarabine.

Axicabtagene Ciloleucel intravenous 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 intravenous infusion for the individual patient within 30 minutes by either gravity or peristaltic pump.
• Do not use a leukocyte-depleting filter.

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, health care provider, or pharmacist first.

• Aaxicabtagene Ciloleucel has severe interactions with no other drugs.
• Axicabtagene Ciloleucel has serious interactions with at least 196 other drugs.
• Axicabtagene Ciloleucel has moderate interactions with no other drugs.
• Axicabtagene Ciloleucel 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 your products. 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 Axicabtagene Ciloleucel?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Axicabtagene Ciloleucel?”

Cautions

• Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment in most patients (see Black Box Warnings)
• Neurological toxicities, which may be severe or life-threatening, can occur following treatment (see Black Box Warnings)
• Prophylactic corticosteroids for CRS and neurologic toxicities may result in a higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay onset, and decrease the duration of CRS; consider the risk and benefits of prophylactic corticosteroids in patients with pre-existing comorbidities and the potential for the risk of Grade 4 and prolonged neurologic toxicities.
• 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 by 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 the 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 before the start of lymphodepleting chemotherapy, during axicabtagene Ciloleucel treatment, and until immune recovery afterward.

Pregnancy and Lactation

• Data are not available on 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 before starting treatment.
• 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 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 the underlying maternal condition.