Yescarta (axicabtagene ciloleucel)

WARNING

CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES

• Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving Yescarta. Do not administer Yescarta to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS withtocilizumabor tocilizumab andcorticosteroids.
• Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving Yescarta, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with Yescarta. Provide supportive care and/or corticosteroids as needed.
• Yescarta is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta REMS.

Common side effects of Yescarta include:

• cytokine release syndrome,
• fever,
• low blood pressure(hypotension),
• brain disease (encephalopathy),
• fastheartrate,fatigue,
• headache,
• decreased appetite,
• chills,
• diarrhea,
• low white blood cell count withfever,
• infections,
• nausea,
• low blood oxygen,
• tremor,
• cough,
• vomiting,
• dizziness,
• constipation,
• and irregular heartbeats

For autologous use only. For intravenous use only.

Dose

Each single infusion bag of Yescarta contains a suspension of chimeric antigen receptor (CAR)-positive T cells in approximately 68 mL. The target dose is 2 × 10⁶CAR-positive viable T cells per kg body weight, with a maximum of 2 × 10⁸CAR-positive viable T cells.

• There are no available data with Yescarta use inpregnantwomen. No animal reproductive and developmental toxicity studies have been conducted with Yescarta to assess whether it can cause fetal harm when administered to apregnantwoman.
• 我t is not known if Yescarta 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-celllymphocytopenia. Therefore, Yescarta is not recommended for women who are pregnant, andpregnancyafter Yescarta infusion should be discussed with the treating physician.
• There is no information regarding the presence of Yescarta inhuman milk, the effect on thebreastfedinfant, and the effects on milk production.
• The developmental and health benefits ofbreastfeedingshould be considered along with the mother's clinical need for Yescarta and any potential adverse effects on the breastfed infant from Yescarta or from the underlying maternal condition.