CARVYKTI (ciltacabtagene autoleucel)

There are 0 contraindications.

There are 6 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Anemia
Infection
Neutropenic disorder
Pregnancy
Thrombocytopenic disorder
Viral hepatitis B

There are 0 moderate contraindications.

There are 34 severe adverse reactions.

More Frequent	Less Frequent
Abnormal hepatic function tests Anemia Cytokine release syndrome Encephalopathy Hypoalbuminemia Hypogammaglobulinemia Hypotension Infection Lymphopenia Neutropenic disorder Thrombocytopenic disorder Viral infection	Cardiac arrhythmia Cranial nerve disorder Hemorrhage Hypersensitivity drug reaction Hypertension Pneumonia Renal failure Sepsis Thrombotic disorder Tumor lysis syndrome

Rare/Very Rare
Acute myeloid leukemia Capillary leak syndrome Cerebrovascular accident Guillain-barre syndrome Hemophagocytic lymphohistiocytosis Immune effector cell-associated neurotoxicity syndrome Macrophage activation syndrome Myelitis Myelodysplastic syndrome Parkinsonism Peripheral t-cell lymphoma Seizure disorder

There are 29 less severe adverse reactions.

More Frequent	Less Frequent
Anorexia Chills Constipation Cough Diarrhea Dizziness Dyspnea Edema Fatigue Fever Headache disorder Musculoskeletal pain Nausea Tachycardia Upper respiratory infection Vomiting	Accidental fall Aphasia Bradykinesia Chest pain Delirium Depression Dysphagia Insomnia Peripheral motor neuropathy Peripheral sensory neuropathy Skin rash Urinary tract infection

Rare/Very Rare
Nystagmus

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

Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia and hypogammaglobulinemia. Therefore, ciltacabtagene autoleucel is not recommended for women who are pregnant, or for women of childbearing potential not using contraception. Pregnant women should be advised that there may be risks to the fetus.

Pregnancy after ciltacabtagene autoleucel therapy 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 ciltacabtagene 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 ciltacabtagene autoleucel and any potential adverse effects on the breastfed infant from ciltacabtagene autoleucel or from the underlying maternal condition.

Of the 97 patients in Study CARTITUDE-1 that received ciltacabtagene autoleucel, 28% were 65 to 75 years of age, and 8% were 75 years of age or older. CARTITUDE-1 did not include sufficient numbers of patients 65 years of age and older to determine whether the effectiveness differs compared with that of younger patients. In 62 patients less than 65 years of age, all grade and Grade 3 and higher neurologic toxicities occurred in 19% (12/62) and 6% (4/62) respectively. Of the 35 patients >=65 years of age, all grade and Grade 3 and higher neurologic toxicities occurred in 37% (13/35) and 20% (7/35) respectively.