TECELRA (afamitresgene autoleucel)

There are 0 contraindications.

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

Severe List
Infection
Viral hepatitis B

There are 0 moderate contraindications.

There are 11 severe adverse reactions.

More Frequent	Less Frequent
Anemia Cytokine release syndrome Infection Leukopenia Lymphopenia Neutropenic disorder Thrombocytopenic disorder	Hypertension

Rare/Very Rare
Hypersensitivity drug reaction Immune effector cell-associated neurotoxicity syndrome Pleural effusions

There are 19 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Anorexia Back pain Constipation Diarrhea Dyspnea Edema Fatigue Fever Hypotension Nausea Non-cardiac chest pain Tachycardia Vomiting	Alopecia Cough Dizziness Pain in extremities Weight loss

Rare/Very Rare
None.

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

Therefore, afamitresgene autoleucel is not recommended for women who are pregnant, and pregnancy after afamitresgene autoleucel administration should be discussed with the treating physician. Report all pregnancies following treatment with afamitresgene autoleucel to Adaptimmune at 1-855-24MYADAP (1-855-246-9232). 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 afamitresgene autoleucel 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 afamitresgene autoleucel and any potential adverse effects on the breastfed infant from afamitresgene autoleucel or from the underlying maternal condition.

Of the 44 patients with synovial sarcoma in the SPEARHEAD-1 study that received afamitresgene autoleucel, 6.8% were 65 years of age or older. Clinical studies of afamitresgene autoleucel did not include sufficient numbers of patients 65 years of age and over to conclude whether they respond differently from younger patients.