Lifileucel

Lifileucel is a prescription medication indicated for unresectable or metastatic melanoma in adults previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation is positive, a BRAF inhibitor with or without a MEK inhibitor.

• Lifileucel is available under the following different brand names: Amtagvi.

Common side effects of Lifileucel include:

• chills
• fever 
• low white blood cell count 
• fatigue
• low red blood cell count 
• fast or irregular heartbeat
• rash
• low blood pressure (hypotension)
• fluid retention (edema)
• hair loss
• diarrhea
• low blood oxygen
• shortness of breath

Serious side effects of Lifileucel include:

• treatment-related mortality
• prolonged severe cytopenia
• internal organ hemorrhage
• severe infection
• cardiac disorder
• respiratory failure
• acute renal failure
• hypersensitivity reactions

Rare side effects of Lifileucel 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, 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

IV infusion bag

• A single dose contains 7.5-72 x 109 viable cells suspended in 1-4 patient-specific infusion bag(s)
• Each bag containing 100-125 mL of frozen suspension of tumor-derived T cells in 5% dimethyl sulfoxide (DMSO), 0.5% albumin (human), and 300 IU/mL interleukin-2 (Il-2; aldesleukin)
• Each bag is contained within a protective metal cassette

Melanoma

Adult dosage

• 7.5-72 x 109 viable cells as a single IV infusion

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.

• Lifileucel has no noted severe interactions with any other drugs
• Lifileucel has no noted serious interactions with any other drugs
• Lifileucel has no noted moderate interactions with any other drugs
• Lifileucel has no noted minor interactions with any 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 Lifileucel?”

Long-Term Effects

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

Cautions

• Severe cytopenia reported, monitor blood cell counts after infusion
• Patients may develop worsened respiratory function, which has been associated with deaths; monitor for respiratory failure before and after Lifileucel infusion; withhold or discontinue infusion if signs/symptoms of severe acute respiratory failure are found, or the patient is deemed ineligible for IL-2 (aldesleukin) infusion
• Treated patients may develop worsened kidney function, which has been associated with deaths; monitor for acute kidney injury before and after Lifileucel infusion; withhold or discontinue if signs/symptoms of severe acute kidney injury are found, or the patient is deemed ineligible for IL-2 (aldesleukin) infusion
• Treatment-related mortality
  • In clinical trials, the treatment-related mortality rate was 7.5%, including 2 deaths during the lymphodepleting period following Lifileucel administration
  • Adverse reactions associated with these deaths included severe infections (sepsis, pneumonia, and encephalitis), internal organ hemorrhage (abdominal hemorrhage and intracranial hemorrhage), acute kidney injury, acute respiratory failure, cardiac arrhythmia, extensive ascites, liver injury, and bone marrow failure
  • Owing to the varying conditions, treatment-related mortality rates observed may not reflect the rates observed in practice
• Internal organ hemorrhage
  • May exhibit internal organ hemorrhage
  • Intra-abdominal and intracranial hemorrhage can be life-threatening
  • Withhold or discontinue infusion if signs/symptoms of internal organ hemorrhage occur or the patient is deemed ineligible for IL-2 (aldesleukin) infusion
  • Patients with persistent or repeated thrombocytopenia after receiving Lifileucel should not use anticoagulants; if the patient must take anticoagulants, monitor closely
• Severe infections
  • Severe, life-threatening, or fatal infections occurred
  • Do not administer to patients with clinically significant systemic infections
  • Monitor for signs and symptoms of infection before and after Lifileucel infusion and treat appropriately.
  • Administer prophylactic antimicrobials according to institutional guidelines
  • Febrile neutropenia was also observed
  • In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated
• Cardiac disorders
  • Grade greater than 3 cardiac disorders (eg, tachycardia, atrial fibrillation, arrhythmia, acute myocardial infarction, cardiac ventricular thrombosis, cardiomyopathy, QT interval prolongation) related to Lifileucel regimen occurred
  • Monitor for cardiac disorders before and after Lifileucel infusion
  • Withhold or discontinue Lifileucel infusion if signs/symptoms of severe cardiac disorder are found, or the patient is deemed ineligible for IL-2 (aldesleukin) infusion
• Hypersensitivity reactions
  • Allergic reactions including serious hypersensitivity (eg, anaphylaxis) may occur
  • Acute infusion reactions (defined as occurring within 1 day of infusion) may occur and include fever, rigors or chills, tachycardia, rash, hypotension, dyspnea, cough, chest tightness, and wheezing
  • These events generally resolve on the same day of infusion
  • Monitor during and after infusion for signs and symptoms of a severe reaction, and treat promptly if found

Pregnancy and Lactation

• Data are unavailable regarding use in pregnant women
• No animal reproductive and developmental toxicity studies have been conducted
• Not recommended for women who are pregnant, and pregnancy after administration should be discussed with the treating physician
• Report pregnancies to Iovance Biotherapeutics, Inc. at 1-833-400-IOVA (1-833-400-4682)
• Pregnancy testing
  • Verify pregnancy status of women of childbearing potential
  • Perform pregnancy tests in sexually active women of reproductive potential before initiating treatment
• Infertility
  • Data are unavailable regarding the effect on fertility
• Lactation
  • Data are unavailable regarding the presence of Lifileucel in human milk, its effect on breastfed infants, or on milk production