Sarclisa

Sarclisa can only be obtained with a prescription and should be given by a healthcare professional in a clinic or hospital where severe reactions can be quickly treated. It is given by infusion (drip) into a vein and the dose depends on body weight. Treatment starts with one dose of Sarclisa a week and, after a month, continues with one dose every two weeks. Before the infusion of Sarclisa, patients may be given medicines to reduce the risk of infusion-related reactions. The doctor may slow down the infusion or stop treatment in case of infusion-related reactions.

For more information about using Sarclisa, see the package leaflet or contact your doctor or pharmacist.

The active substance in Sarclisa, isatuximab, is a monoclonal antibody (a type of protein) that has been designed to attach to the protein CD38, which is found in high amounts on multiple myeloma cells. By attaching to CD38 on the multiple myeloma cells, isatuximab activates the immune system (the body’s natural defences) to kill the cancer cells.

A main study in 307 patients with multiple myeloma that had not improved with previous treatments showed that adding Sarclisa to pomalidomide and dexamethasone can delay worsening of the disease. In this study, patients receiving Sarclisa and pomalidomide plus dexamethasone lived for 11.5 months without their disease getting worse compared with 6.5 months for patients receiving pomalidomide plus dexamethasone.

A second main study in 302 adults with multiple myeloma who had received one to three previous treatments showed that adding Sarclisa to carfilzomib and dexamethasone can delay worsening of the disease. In this study, over an average of 21 months, 48 out of 179 (26.8%) patients receiving Sarclisa with carfilzomib plus dexamethasone experienced worsening of their disease compared with 55 out of 123 (44.7%) of those receiving carfilzomib plus dexamethasone.

The most common side effects with Sarclisa used with pomalidomide and dexamethasone (which may affect more than 1 in 5 people) are neutropenia (low levels of neutrophils, a type of white blood cell), infusion reactions, pneumonia (infection of the lungs), upper respiratory tract infection (such as nose and throat infections), diarrhoea and bronchitis (inflammation of the airways in the lungs).

The most common serious side effects with Sarclisa when used with pomalidomide and dexamethasone are pneumonia and febrile neutropenia (low white blood cell counts with fever).

The most common side effects with Sarclisa used with carfilzomib and dexamethasone (which may affect more than 1 in 5 people) are infusion reactions, hypertension, diarrhoea, upper respiratory tract infection, pneumonia, tiredness, dyspnoea (difficulty breathing), insomnia (difficulty sleeping), bronchitis, and back pain. 

The most common serious side effect with Sarclisa used with carfilzomib and dexamethasone is pneumonia.

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

Sarclisa used together with dexamethasone plus either pomalidomide or carfilzomib extended the time patients with multiple myeloma lived without their disease getting worse. Sarclisa’s side effects are as expected for this type of medicine given with either pomalidomide plus dexamethasone or carfilzomib plus dexamethasone and are considered manageable. The European Medicines Agency therefore decided that Sarclisa’s benefits are greater than its risks and it can be authorised for use in the EU.

The company that markets Sarclisa will provide educational material to all blood banks as well as healthcare professionals expected to use the medicine to inform them that the medicine can affect the result of a blood test (indirect Coombs test) used to determine suitability for blood transfusions. Patients who are prescribed Sarclisa will be provided with a patient alert card with this information.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sarclisa have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Sarclisa are continuously monitored. Side effects reported with Sarclisa are carefully evaluated and any necessary action taken to protect patients.

Sarclisa received a marketing authorisation valid throughout the EU on 30 May 2020.