Severe Neutropenia/Agranulocytosis is a possible serious adverse event during treatment with the IMP. As agranulocytosis is a sudden and idiosyncratic adverse event, we suggest you to keep your centre supplied with supportive therapy (antibiotic therapy and granulocyte colony stimulating factor) and make sure the prompt administration to the patients if necessary.
In case of agranulocytosis:
- treatment must be interrupted immediately and the patient must be withdrawn from the study andmonitored until resolution of the event;
- provide protective isolation; if clinically indicated, admit patient to hospital, obtain regular vital signsand administer appropriate therapy such as antibiotic therapy and granulocyte colony stimulating factor, beginning the same day that the event is identified;
- the patient will be examined the same day, if possible, collecting drug history and physical examination;
- if possible, hemocolture, viral studies (CMV, parvovirus, hepatitis A/B/C), serum ALT, BUN, creatininewill be collected.
- the patient will be monitored daily or more frequently until two successive ANCs are ≥ 1500/mm3.
Furthermore, we remind you that the study protocol requires to monitor neutrophil count weekly for the whole study period. In case of neutropenia, neutrophil count has to be monitored more frequently, even every day, in order to guarantee patients’ safety.
