Italian Medicines Agency Agenzia Italiana del Farmaco

Direct Healthcare Professional Communication (DHPC) - Clozapine and risk of neutropenia and agranulocytosis: PRAC updates recommendations for blood count monitoring - Direct Healthcare Professional Communication (DHPC) - Clozapine and risk of neutropenia and agranulocytosis: PRAC updates recommendations for blood count monitoring

Asset Publisher

Direct Healthcare Professional Communication (DHPC) - Clozapine and risk of neutropenia and agranulocytosis: PRAC updates recommendations for blood count monitoring

The PRAC has updated recommendations for blood monitoring in patients treated with clozapine. This medicine, indicated for treatment-resistant schizophrenia and psychotic disorders in Parkinson's disease, may increase the risk of neutropenia (reduction in neutrophils) and agranulocytosis.

To minimize this risk, regular blood count monitoring is recommended, now simplified and based exclusively on the absolute neutrophil count (ANC), considered the most reliable parameter.

In summary, the new recommendations include:

  • Treatment thresholds: ANC ≥ 1,500/mm³ in the general population; ANC ≥ 1,000/mm³ in patients with benign ethnic neutropenia (BEN).
  • Monitoring frequency: weekly during the first 18 weeks, monthly until the end of the first year, then every 12 weeks; after two years of stable treatment without episodes of neutropenia, monitoring may be performed annually.

The risk of neutropenia is highest during the first year of therapy and subsequently tends to decrease. The new indications will be updated in the product information of clozapine containing medicines.
The related document provides further information.


Published on: 08 September 2025

Asset Publisher

Galleria

Cookie Bar

cookie management module

Descrizione cookieBar

Questo sito utilizza cookie tecnici e analytics, necessari al suo funzionamento, per i quali non è richiesto il consenso. Per alcuni servizi aggiuntivi, le terze parti fornitrici, dettagliatamente sotto individuate, possono utilizzare cookies tecnici, analytics e di profilazione. Per saperne di più consulta la PRIVACY POLICY. Per proseguire nella navigazione devi effettuare la scelta sui cookie di terze parti dei quali eventualmente accetti l’utilizzo. Chiudendo il banner attraverso la X in alto a destra rifiuti tutti i cookie di terze parti. Puoi rivedere e modificare le tue scelte in qualsiasi momento attraverso il link "Gestione cookie" presente nel footer.

Social networks
go to beginning of content