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.
More about lifileucel
- Check interactions
- Compare alternatives
- Side effects
- During pregnancy
- Drug class: miscellaneous antineoplastics
- En español
Patient resources
Other brands
Professional resources
Other brands
Related treatment guides
See also:
Opdivo
Opdivo is used to treat many cancers, such as melanoma, non-small cell lung cancer, malignant ...
Keytruda
Keytruda is used to treat multiple types of cancer such as melanoma, non-small cell lung cancer ...
Opdivo Qvantig
Opdivo Qvantig is used to treat adults with melanoma, non-small cell lung cancer, renal cell ...
Tecentriq
Tecentriq (atezolizumab) is a monoclonal antibody used to treat non-small cell lung cancer, small ...
Yervoy
Yervoy (ipilimumab) is a cancer treatment used for lung cancer, melanoma, renal cell carcinoma ...
Interferon alfa-2b
Interferon alfa-2b systemic is used for angioblastoma, condylomata acuminata, conjunctival ...
Dacarbazine
Dacarbazine systemic is used for hodgkin's lymphoma, melanoma, melanoma, metastatic
Ipilimumab
ipilimumab (Yervoy) is an immunotherapy used for melanoma, renal cell carcinoma, non-small cell ...
Atezolizumab
Atezolizumab (Tecentriq) is a type of immunotherapy drug that helps the body's immune system to ...
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.