Lifileucel Side Effects

Applies to lifileucel: intravenous suspension.

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:

• severe infections such as sepsis, pneumonia, encephalitis;

• breathing problems;

• easy bruising or bleeding, unusual weakness;

• sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, problems with vision or balance;

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• kidney problems--swelling, urinating less, feeling tired or short of breath; or

• heart problems--irregular heartbeats, swelling, rapid weight gain, feeling short of breath.

Common side effects may include:

• fever, chills;

• mouth sores, rash, skin sores, sore throat, cough;

• pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet;

• hair loss;

• swelling;

• fast or irregular heartbeats;

• low blood pressure; or

• 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.

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.

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