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Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Multiple Myeloma, Date of authorisation: 25/05/2022, Revision: 4, Status: Authorised

The most common side effects with Carvykti (which may affect more than 1 in 5 people) are neutropenia (low levels of neutrophils), lymphopenia and leucopenia (low levels of lymphocytes or other white blood cells), anaemia (low levels of red blood cells), thrombocytopenia (low levels of blood platelets), hypotension (low blood pressure), pain of the muscles and bones, high level of liver enzymes, upper respiratory tract infection (nose and throat infection), diarrhoea, hypokalaemia (low level of potassium), hypocalcaemia (low levels of calcium), hypophosphataemia (low levels of phosphate in the blood), nausea, headache, cough, tachycardia (rapid heartbeat), encephalopathy (a brain disorder), oedema (fluid retention), decreased appetite, chills, fever, tiredness, as well as cytokine release syndrome (a potentially life-threatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure).

The most common serious side effects (which may affect more than 1 in 100 people) are cytokine release syndrome, thrombocytopenia, febrile neutropenia (low blood levels of neutrophils with fever), pneumonia (infections of the lungs), sepsis (blood poisoning) and a neurological disorder called ICANS (immune effector cell-associated neurotoxicity syndrome) which may include problems with speech and writing, confusion and depressed level of consciousness.

People who cannot have chemotherapy to clear away their existing white blood cells must not receive Carvykti.

For the full list of side effects and restrictions of Carvykti, see the package leaflet.