YESCARTA (axicabtagene ciloleucel)

There are 0 contraindications.

There are 3 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Infection
Pregnancy
Viral hepatitis B

There are 0 moderate contraindications.

There are 35 severe adverse reactions.

More Frequent	Less Frequent
Cardiac arrhythmia Cytokine release syndrome Encephalopathy Hypoxia Infection Tachycardia	Anemia Hemorrhage Hypertension Hypogammaglobulinemia Increased alanine transaminase Kidney disease with reduction in glomerular filtration rate (GFr) Neutropenic disorder Seizure disorder Thrombocytopenic disorder Thrombotic disorder

Rare/Very Rare
Anaphylaxis Capillary leak syndrome Cardiac arrest Cerebral edema Dysphagia Fungal infection Heart failure Hemophagocytic lymphohistiocytosis Hypersensitivity drug reaction Immune effector cell-associated neurotoxicity syndrome Leukoencephalopathy Myelitis Peripheral t-cell lymphoma Pleural effusions Pulmonary edema Reactivation of hepatitis B Spinal cord edema Status epilepticus Thrombophilia

There are 35 less severe adverse reactions.

More Frequent	Less Frequent
Anorexia Chills Constipation Cough Diarrhea Dizziness Fatigue Fever Headache disorder Hypotension Musculoskeletal pain Nausea Tremor Vomiting	Aphasia Arthralgia Back pain Dehydration Delirium Dyspnea Edema Facial palsy Hemiparesis Injection site sequelae Insomnia Muscle spasm Muscle weakness Myalgia Pain Symptoms of anxiety Weight loss

Rare/Very Rare
Acalculia Ataxia Myoclonus Skin rash

There are no available data with axicabtagene ciloleucel use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with axicabtagene ciloleucel to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if axicabtagene ciloleucel has the potential to be transferred to the fetus.

Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia. Therefore, axicabtagene ciloleucel is not recommended for women who are pregnant, and pregnancy after axicabtagene ciloleucel infusion should be discussed with the treating physician. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively.

There is no information regarding the presence of axicabtagene ciloleucel 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 axicabtagene ciloleucel and any potential adverse effects on the breastfed infant from axicabtagene ciloleucel or from the underlying maternal condition.

Of the 422 patients with NHL who received axicabtagene ciloleucel in clinical trials, 127 patients (30%) were 65 years of age and older. No clinically important differences in safety or effectiveness were observed between patients 65 years of age and older and younger patients.