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Lifileucel Side Effects

Applies to lifileucel: intravenous suspension.

Important warnings This medicine can cause some serious health issues

Tell your doctor if you use other medicines or have other medical conditions or allergies.

You may be given another medication during treatment to help your body make white blood cells.

Call your doctor right away if you have signs of infection such as: fever, chills, sore throat, mouth sores, red or swollen gums, pale skin, easy bruising, unusual bleeding, or chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to lifileucel: intravenous suspension.

General adverse events

The most common adverse reactions occurring in 20% of patients or more included cytopenia, anemia, chills, pyrexia, fatigue, tachycardia, diarrhea, hypophosphatemia, febrile neutropenia, edema, rash, hypotension, alopecia, infection, hypoxia, and dyspnea.[Ref]

Cardiovascular

Tachycardia also includes sinus tachycardia, atrial fibrillation, and supraventricular tachycardia.

Hypotension also includes decreased blood pressure, decreased systolic blood pressure, decreased diastolic blood pressure diastolic, and orthostatic hypotension.

Hypertension also includes increased blood pressure, increased systolic blood pressure, and increased diastolic blood pressure.

Dermatologic

Rash also includes generalized rash, maculo-papular rash, papular rash, pruritic rash, erythematous rash, and macular rash.

Gastrointestinal

Hematologic

Hypersensitivity

Immunologic

Metabolic

Ocular

Other

Description of adverse reactions:

Adverse reactions associated with treatment-related mortality included severe infections (sepsis, pneumonia and encephalitis), internal organ hemorrhage (abdominal and intracranial hemorrhage), acute renal failure, acute respiratory failure, cardiac arrythmia, extensive ascites, liver injury, and bone marrow failure; 12 deaths were reported in clinical trials.

Fatigue also includes asthenia and malaise.

Edema also includes face edema, generalized edema, localized edema, edema peripheral, peripheral swelling, genital edema, scrotal edema, brain edema, catheter-site edema, conjunctival edema, eyelid edema, laryngeal edema, macular edema, periorbital edema, pulmonary edema, vasogenic cerebral edema, and lymphoedema.

Infection with an unspecified pathogen also includes cellulitis, conjunctivitis, cystitis, dermatitis infected, device related infection, infectious diarrhea, endocarditis, enterocolitis infectious, infection, meningitis, nasopharyngitis, neutropenic sepsis, pneumonia, pyuria, pustular rash, respiratory tract infection, rhinitis, sepsis, sinusitis, skin infection, and urinary tract infection.

Infection with a known pathogen also includes bacteremia, candida infection, clostridium difficile colitis, cytomegalovirus infection or reactivation, Epstein-Barr virus infection, escherichia bacteremia, fungal skin infection, herpes simplex, herpes zoster, metapneumovirus infection, oral herpes, oral candidiasis, pneumonia klebsiella, respiratory syncytial virus infection, skin candida, and tuberculosis.

Renal

Acute kidney injury also includes anuria, azotemia, renal failure, renal tubular dysfunction, renal tubular necrosis, oliguria, and increased blood creatinine.

Respiratory

Hypoxia also includes decreased oxygen saturation.

Dyspnea also includes acute respiratory failure, orthopnea, respiratory distress, respiratory failure, and exertional dyspnea.

Hepatic

Nervous system

Encephalopathy also includes automatism, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, hypersomnia, lethargy, leukoencephalopathy, memory impairment, mental status changes, paranoia, somnolence, and stupor.

References

1. (2024) "Product Information. Amtagvi (lifileucel)." Iovance Biotherapeutics Manufacturing LLC

Further information

Lifileucel side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.