Lifileucel Dosage
Medically reviewed by Drugs.com. Last updated on Apr 9, 2024.
Usual Adult Dose for:
Additional dosage information:
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.
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- Drug class: miscellaneous antineoplastics
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