Lifileucel Dosage

Medically reviewed by Drugs.com. Last updated on Apr 9, 2024.

Usual Adult Dose for Melanoma - Metastatic

7.5 x 10(9) to 72 x 10(9) viable cells IV once as a single dose

• Infuse an initial rate of 1 mL/min for the first 5 minutes, then at a rate of 5 to 10 mL/min thereafter.

Comments:

• A single dose of this drug is provided in 1 to 4 patient-specific IV infusion bag(s) containing a suspension of tumor-derived T cells; multiple infusions may be required to deliver a single dose.
• Administer under the supervision of a physician experienced in the use of anticancer agents in the inpatient hospital setting with access to an intensive care facility and skilled cardiopulmonary/intensive care specialists.

Use: As a tumor-derived autologous T cell immunotherapy for the treatment of unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:

• DRUG ADMINISTRATION: Administer this drug in an inpatient hospital setting. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available
• TREATMENT-RELATED MORTALITY:
• Prolonged Severe Cytopenia: Monitor patients for prolonged severe cytopenia and for internal organ hemorrhage. Administer filgrastim or a biosimilar product to patients beginning Day 1 after initiating therapy with this drug and continue daily until the absolute neutrophil count (ANC) is greater than 1000/mm3 for 3 consecutive days, or per institutional standard.
• Severe Infection: Treat severe infections.
• Cardiopulmonary/Renal Impairment: Monitor cardiopulmonary and renal functions throughout the treatment course.

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For IV use only
• For autologous use only: Ensure patient identity matches patient identifiers on the drug infusion bag(s).
• General advice is provided below; consult the manufacturer product information for detailed instructions on the receipt, preparation, and administration of this drug.
• Administer this drug in an inpatient hospital setting with access to an intensive care facility and specialists.
• Confirm the availability of this drug and IL-2 (aldesleukin) prior to preparing the patient for infusion.
• Reassess the health status of the patient before infusion; do not administer to patients with clinically significant systemic infections.
• PRETREATMENT (with lymphodepleting chemotherapy): Administer cyclophosphamide 60 mg/kg IV (with mesna) once a day for 2 days, followed by administration of fludarabine 25 mg/m2 IV once a day for 5 days before infusion of this drug.
• PREMEDICATION: Administer acetaminophen and diphenhydramine (or another H1-antihistamine) about 30 to 60 min before starting the infusion of this drug; avoid use of prophylactic systemic corticosteroids.
• POST-INFUSION (3 to 24 hours after): Administer IL-2 (aldesleukin) 600,000 international units/kg IV every 8 to 12 hours for a maximum of 6 doses to support cell expansion in vivo.

Drug Infusion:

• Initiate infusion of this drug 24 hours (but no later than 4 days) after the last dose of fludarabine.
• Administer 1 thawed infusion bag IV at an initial rate of 1 mL/min for the first 5 minutes, and then at a rate of 5 to 10 mL/min thereafter.
• Do NOT use a leukocyte-depleting filter.
• Administer in an environment at room temperature (18C to 25C).
• Complete the infusion of each bag within 3 hours of thawing.

Storage requirements:

• This product is stored in the vapor phase of liquid nitrogen (within a liquid nitrogen cryoshipper) and delivered directly to the treatment center; appropriate on-site storage is required.
• Store frozen at or below 150C (in the vapor phase of liquid nitrogen).
• Thawed product: Use as soon as possible; if required, maintain at room temperature (18C to 25C) for up to 3 hours. Do not re-freeze or refrigerate.

Reconstitution/preparation techniques:

• Do not thaw product until it is ready to be infused.
• Thaw at about 35C to 39C using a water bath or a dry thaw method (approximately 10 minutes).
• Gently invert or massage infusion bag if cell clumps are visible after thawing; then, infuse as soon as possible (or within 3 hours).
• Do not thaw the next infusion bag (if provided) until the previous infusion bag has been fully administered; coordinate the timing of thawing and infusion.
• The manufacturer product information should be consulted.

General:

• This drug contains human cells. Follow universal and local biosafety guidelines applicable for the handling and disposal of this drug to avoid potential transmission of infectious diseases.
• Review the manufacturer product information for cyclophosphamide, mesna, fludarabine, acetaminophen, diphenhydramine, and aldesleukin for additional information about pretreatment, premedication, and post-infusion regimens.

Monitoring:

• Cardiovascular: For signs/symptoms of cardiac disorders (before and after infusion)
• Hematologic: Blood counts (after infusion)
• Hypersensitivity: For signs/symptoms of hypersensitivity reactions (during infusion)
• Infections: For signs/symptoms of infection (before and after infusion)
• Renal: Signs/symptoms of acute renal failure (before and after infusion)
• Respiratory: For respiratory failure (before and after infusion)

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Understand that this drug must be administered in the hospital setting, including pre- and post-treatments.
• It is recommended to remain within 2 hours of the location you received your treatment for several weeks in order to ensure proper follow-up and/or side effect management.
• Tell your doctor about all of your medical conditions, any recent/active infections or inflammatory conditions, or if you had a vaccination in the past 28 days or plan to be vaccinated within a few months.
• Discuss all medications, vitamins, and over-the-counter products you take with your medical provider.
• Women of childbearing potential: Notify your health care provider of a known/suspected pregnancy.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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