Risk management of CRS and neurological events

Treating hospital: haematologist, oncologist, and multidisciplinary team

Due to the risks associated with YESCARTA^®/TECARTUS^® use, a special risk management plan has been put in place.

Over nine out of 10 patients who receive YESCARTA^®/TECARTUS^® develop some degree of cytokine release syndrome (CRS), an inflammatory process with presentation ranging from flu-like symptoms to systemic shock and multiorgan failure.^1,2 Although most cases of CRS following YESCARTA^®/TECARTUS^® infusion are mild to moderate, 11% of patients develop severe, life-threatening, or fatal CRS, so safety precautions must be taken.¹

Severe neurological events are also very common after YESCARTA^®/TECARTUS^® infusion and could be life-threatening or fatal.¹

Prior to infusion and during monitoring, the CAR T treatment team ensures:¹

• At least 1 dose of the monoclonal antibody tocilizumab is available.
• Emergency equipment is on hand.
• Additional doses of tocilizumab are available within 8 hours of the previous dose.

An intensive care unit physician and neurologist are on call to provide advice and urgent care should the patient develop CRS or a neurological adverse reaction.

Please see the summary of product characteristics for all special warnings and precautions for use of YESCARTA^®/TECARTUS^®.

Checking patient health and providing information before infusion

Treating hospital: haematologist, oncologist, and nurse

Before preparations for YESCARTA^®/TECARTUS^® infusion begin, the treating physician will check the patient’s health, including ECOG performance status and organ function (see Patient Selection for more information on suitability for YESCARTA^®/TECARTUS^®).³ They will delay infusion if the patient has:¹

• unresolved serious adverse reactions, including from preceding chemotherapies
• active uncontrolled infection
• active graft-versus-host disease

The patient must be fully informed of risks and understand the steps they need to take to help reduce risks.¹ The CAR T treatment team explains:

• the risk of CRS and serious neurological events
• the requirement to immediately report related symptoms
• the need to remain close to the treating hospital (within 2 hours’ journey) for 4 weeks following infusion
• the need to carry a patient alert card at all times.¹

Please see the summary of product characteristics for all special warnings and precautions for use of YESCARTA^®/TECARTUS^®.

Pre-medicating the patient before infusion

Treating hospital: haematologist and oncologist

Pre-medication with paracetamol and the antihistamine diphenhydramine an hour before YESCARTA^®/TECARTUS^® infusion reduces the risk of infusion reactions and pyrexia.¹

As serious infections are very common with YESCARTA^®/TECARTUS^® treatment, prophylactic antimicrobials are given to the patient according to the treating hospital’s guidelines.¹

YESCARTA^®/TECARTUS^® treatment is occasionally associated with tumour lysis syndrome (TLS) caused by dying cancer cells.^1,4 To minimize risks of acute kidney injury associated with TLS, patients with elevated uric acid or high tumour burden are given allopurinol or an alternative prophylaxis prior to YESCARTA^®/TECARTUS^® infusion.¹

Checking and preparing the YESCARTA^®/TECARTUS^® infusion

Treating hospital: haematologist, oncologist, or nurse

YESCARTA^®/TECARTUS^® arrives at the treating hospital in a shipper and must be transported and stored at ≤150ºC. On delivery and when unpacking the treatment, the CAR T treatment team performs checks to ensure the product has been kept at the correct temperature, is undamaged, and is for the correct patient.

Unpacking and thawing is performed immediately before infusion and takes a few minutes.¹

Please see the summary of product characteristics for full instructions on the preparation of YESCARTA^®/TECARTUS^®.

Performing the infusion

Treating hospital: haematologist, oncologist, or nurse

The physician or nurse who administers the YESCARTA^®/TECARTUS^® infusion is specially trained. YESCARTA^®/TECARTUS^® is administered through central venous access without a leukodepletion filter.¹ Once the patient ID and product ID are cross-checked, the infusion is given within a 30-minute window.¹

Please see the summary of product characteristics for full instructions on the infusion of YESCARTA^®/TECARTUS^®.

References

1. Yescarta SmPC
2. Fesnak A, et al. CAR T cell therapies from the transfusion medicine perspective. Transfus Med Rev 2016;30(3):139-45.
3. Protocol for Neelapu SS, Locke FL, Bartlett NL, et al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med 2017;377:2531-44.
4. Alakel N, et al. Prevention and treatment of tumor lysis syndrome, and the efficacy and role of rasburicase. OncoTargets and Therapy 2017;10:597-605.

SE-YES-0024 | 09/2024