TM Owner Kite Pharma
Yescarta 2E6cell Injection
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Indications & Clinical Uses
- Yescarta (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T-cell immunotherapy, made from your own T cells and given once as an intravenous infusion of 2 x 10^6 CAR-positive viable T cells per kg body weight (maximum 2 x 10^8 cells) in about 68 mL.
- It is given only in specialist treatment centres.
- In the US label it is used for adults with large B-cell lymphoma that is refractory to first-line therapy or relapses within 12 months, or relapsed or refractory after two or more systemic therapies, and for follicular lymphoma after two or more lines of systemic therapy (accelerated approval).
- The EU (Kite Pharma EU B.V.) approval covers similar large B-cell lymphoma uses and follicular lymphoma after three or more prior therapies.
Side Effects
- BOXED WARNING (US): cytokine release syndrome (CRS), neurologic toxicities and secondary haematological malignancies, including T-cell malignancies.
- CRS and neurologic reactions can be fatal or life-threatening.
- The most common reactions (30% or more) are CRS, fever, low blood pressure, encephalopathy, fatigue, fast heartbeat, headache, nausea, febrile neutropenia, diarrhoea, muscle and bone pain, infections, chills and reduced appetite.
- Other serious risks include hypersensitivity reactions, serious infections (about 45%), prolonged low blood counts, low antibody levels (hypogammaglobulinaemia, about 14%) and hepatitis B reactivation.
- Tell your care team immediately about fever, chills, confusion, difficulty speaking, tremor, seizures, severe headache or trouble breathing; you are monitored closely after infusion.
Precautions & Warnings
- Yescarta must not be given to patients with active infections or inflammatory disorders (US boxed warning), and the EU label contraindicates allergy to gentamicin.
- Lymphodepleting chemotherapy (cyclophosphamide and fludarabine) is given first, and you are premedicated with paracetamol (acetaminophen) and an antihistamine.
- Tocilizumab must be available before infusion, central venous access is recommended, and a leukocyte-depleting filter must not be used.
- Screening for hepatitis B, hepatitis C and HIV is needed before cell collection.
- Avoid driving for at least 2 weeks after infusion (US label), and stay near a treatment centre; the EU label advises staying close to a specialist hospital for at least 4 weeks.
- Pregnancy testing is needed and use in pregnancy is not recommended.
Avoid Interactions
- Increase risk: the US label has no separate interaction section, and no formal interaction studies are described.
- Live virus vaccines are not recommended for at least 6 weeks before lymphodepleting chemotherapy, during Yescarta treatment, and until your immune system recovers.
- Reduce efficacy: the sections reviewed do not name a specific medicine, but your team will advise on when to stop or avoid immunosuppressive medicines before cell collection and infusion.
- Do not use a leukocyte-depleting filter during infusion.
- Tell your treatment team about every medicine and supplement you take, including steroids.
References
Frequently Asked Questions
Yescarta (axicabtagene ciloleucel) is a CAR T-cell therapy for adults with certain relapsed or hard-to-treat large B-cell lymphomas and, after prior treatments, follicular lymphoma. It is made from your own T cells and given once as an infusion in a specialist hospital centre.
Yescarta (axicabtagene ciloleucel) is a single intravenous infusion given by a specialist team, after your T cells are collected and modified. You first receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine). The infusion takes about 30 minutes, and you are watched closely afterwards.
Common Yescarta side effects include cytokine release syndrome, fever, low blood pressure, confusion, tiredness, fast heartbeat, headache, nausea and infections. Tell your team straight away about fever, chills, trouble speaking, seizures or breathing problems, because CRS and neurologic effects can be life-threatening.
The US boxed warning for Yescarta (axicabtagene ciloleucel) covers cytokine release syndrome, neurologic toxicities and secondary blood cancers including T-cell malignancies. CRS and neurologic reactions can be fatal. Yescarta must not be given to patients with active infections or inflammatory disorders.
After Yescarta (axicabtagene ciloleucel), you are monitored daily at first and must stay near the treatment centre; the US label says at least 2 weeks and the EU label at least 4 weeks. Avoid driving for at least 2 weeks. Avoid live vaccines until your immune system recovers.
Live virus vaccines are not recommended for at least 6 weeks before lymphodepleting chemotherapy, during Yescarta treatment and until immune recovery. Yescarta (axicabtagene ciloleucel) is not recommended in pregnancy, and a pregnancy test is needed before treatment. Ask your team about contraception.
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