Amtagvi Side Effects
Generic name: lifileucel
Note: This document contains side effect information about lifileucel. Some dosage forms listed on this page may not apply to the brand name Amtagvi.
Applies to lifileucel: intravenous suspension.
Warning
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:
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severe infections such as sepsis, pneumonia, encephalitis;
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breathing problems;
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easy bruising or bleeding, unusual weakness;
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sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, problems with vision or balance;
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signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
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kidney problems--swelling, urinating less, feeling tired or short of breath; or
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heart problems--irregular heartbeats, swelling, rapid weight gain, feeling short of breath.
Common side effects may include:
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fever, chills;
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mouth sores, rash, skin sores, sore throat, cough;
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pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet;
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hair loss;
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swelling;
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fast or irregular heartbeats;
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diarrhea.
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
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.
Very common (10% or more): Tachycardia (47.4%), hypotension (37.2%), capillary leak syndrome (13.5%), hypertension (13.5%)
Frequency not reported: Cardiac arrhythmia
Dermatologic
Very common (10% or more): Rash (37.2%), alopecia (30.8%), pruritus (13.5%)
Common (1% to 10%): Vitiligo
Rash also includes generalized rash, maculo-papular rash, papular rash, pruritic rash, erythematous rash, and macular rash.
Gastrointestinal
Very common (10% or more): Nausea (68.6%), diarrhea (46.8%), vomiting (43.6%)
Frequency not reported: Intraabdominal hemorrhage, extensive ascites
Hematologic
Very common (10% or more): Thrombocytopenia (78.2%), neutropenia (69.2%), anemia (58.3%), leukopenia (46.8%), febrile neutropenia (46.8%), lymphopenia (42.3%)
Frequency not reported: Internal organ hemorrhage, bone marrow failure
Hypersensitivity
Common (1% to 10%): Anaphylactic reaction
Immunologic
Common (1% to 10%): Infusion-related reaction, cytokine release syndrome
Metabolic
Very common (10% or more): Decreased appetite (30.8), hypophosphatemia (25.6%)
Ocular
Common (1% to 10%): Uveitis
Frequency not reported: Grade 1 or 2 retinal detachment, blurred vision, visual impairment, periorbital edema, reduced visual acuity, retinal hemorrhage
Other
Very common (10% or more): Chills (75.6%), pyrexia (60.9), fatigue (55.8%), edema (42.3%), infection with unspecified pathogen (19.2%), infection with known pathogen (12.2%), increased weight (19.2%)
Common (1% to 10%): Treatment-related mortality
Frequency not reported: Sepsis
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
Very common (10% or more): Acute kidney injury (13.9%), hematuria (14.1%)
Frequency not reported: Acute renal failure
Acute kidney injury also includes anuria, azotemia, renal failure, renal tubular dysfunction, renal tubular necrosis, oliguria, and increased blood creatinine.
Respiratory
Very common (10% or more): Hypoxia (23.7%), dyspnea (21.8%)
Frequency not reported: Pneumonia, acute respiratory failure
Hypoxia also includes decreased oxygen saturation.
Dyspnea also includes acute respiratory failure, orthopnea, respiratory distress, respiratory failure, and exertional dyspnea.
Hepatic
Frequency not reported: Liver injury
Nervous system
Very common (10% or more): Headache (21.2%), encephalopathy (17.3%)
Frequency not reported: Intracranial hemorrhage, encephalitis
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.
More about Amtagvi (lifileucel)
- Check interactions
- Compare alternatives
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: miscellaneous antineoplastics
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Patient resources
Professional resources
Related treatment guides
References
1. (2024) "Product Information. Amtagvi (lifileucel)." Iovance Biotherapeutics Manufacturing LLC
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.