Yescarta (axicabtagene ciloleucel): Cancer Drug Side Effects & Dosage

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:

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

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.