AMTAGVI (lifileucel)

There are 0 contraindications.

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Hemorrhage
Infection

There are 5 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Acute myocardial infarction
Acute renal failure
Acute respiratory failure
Cardiac arrhythmia
Chronic heart failure

There are 18 severe adverse reactions.

More Frequent	Less Frequent
Acute kidney injury Anemia Capillary leak syndrome Encephalopathy Hematuria Infection Leukopenia Lymphopenia Neutropenic disorder Tachycardia Thrombocytopenic disorder	Anaphylaxis Cytokine release syndrome Hypersensitivity drug reaction Retinal detachment

Rare/Very Rare
Acute respiratory failure Cardiac arrhythmia Sepsis

There are 22 less severe adverse reactions.

More Frequent	Less Frequent
Alopecia Anorexia Chills Diarrhea Dyspnea Edema Fatigue Fever Headache disorder Hypertension Hypophosphatemia Hypotension Hypoxia Nausea Pruritus of skin Skin rash Vomiting Weight gain	Blurred vision Uveitis Visual changes Vitiligo

Rare/Very Rare
None.

There are no available data with lifileucel use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with lifileucel. Therefore, lifileucel is not recommended for women who are pregnant, and pregnancy after lifileucel administration should be discussed with the treating physician.

Report pregnancies to Iovance Biotherapeutics, Inc. at 1-833-400-IOVA. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

There is no information regarding the presence of lifileucel in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for lifileucel and any potential adverse effects on the breastfed infant from lifileucel or from the underlying maternal condition.

Of 156 patients with unresectable or metastatic melanoma who were treated with lifileucel in clinical studies, 37 patients (23.7%) were 65 years of age or older. No differences in safety or effectiveness were observed between elderly patients and younger patients.