Generic drug: axicabtagene ciloleucel

Brand name: Yescarta

What is Yescarta (axicabtagene ciloleucel), and how does it work?

Yescarta (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

What are the side effects of Yescarta?

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 with tocilizumab or tocilizumab and corticosteroids.
  • 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:

What is the dosage for Yescarta?

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 × 106 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 108 CAR-positive viable T cells.

What drugs interact with Yescarta?

No information provided.

Is Yescarta safe to use while pregnant or breastfeeding?

  • There are no available data with Yescarta use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with Yescarta to assess whether it can cause fetal harm when administered to a pregnant woman.
  • It 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-cell lymphocytopenia. Therefore, Yescarta is not recommended for women who are pregnant, and pregnancy after Yescarta infusion should be discussed with the treating physician.
  • There is no information regarding the presence of Yescarta 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 Yescarta and any potential adverse effects on the breastfed infant from Yescarta or from the underlying maternal condition.

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Summary

Yescarta (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma. Serious side effects of Yescarta include Cytokine Release Syndrome (CRS) and neurologic toxicities, both of which can be fatal.

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Medically Reviewed on 7/2/2021
References
All sections courtesy of the U.S. Food and Drug Administration