The REMS for clozapine products of which Clozaril is a member was originally approved on September 15, 2015, and the most recent REMS modification was approved on February 18, 2021.
Is the clozapine REMS still suspended?
Because of these issues, FDA is temporarily suspending certain clozapine REMS program requirements, allowing pharmacists to dispense clozapine without a REMS dispense authorization. Abrupt discontinuation of clozapine can result in significant complications for patient treatment.
What are the restrictions for dispensing clozapine?
Treatment should not be initiated if WBC
Can you dispense clozapine without REMS?
The agency confirmed that pharmacists can dispense clozapine without a REMS dispense authorization and wholesalers can continue to ship clozapine to pharmacies and other health care settings.
How do I enroll a patient in clozapine REMS?
Prescribers can certify and enroll their patients on the Clozapine REMS website under Important Program Update and follow the link to the revised REMS website. This website has the materials that prescribers and their designees will need to certify and enroll patients.
Does clozapine require blood monitoring?
In the United States, the Food and Drug Administration requires regular blood count monitoring of all patients taking clozapine. An uncommon but serious side effect of clozapine is severe neutropenia, defined as an absolute neutrophil count (ANC) less than 500/μL.
Why is there a new clozapine REMS?
“The purpose of this new Clozapine REMS Program is to ensure that the benefits of a patient taking clozapine are greater than the potential life threatening risk of severe neutropenia, a well established rare adverse event,” said John J.
What is a REMS program?
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.
When did clozapine REMS start?
FDA first required a REMS for clozapine in September 2015. The REMS applies to all clozapine medicines on the market and requires patient monitoring via a centralized system to monitor and manage clozapine-induced neutropenia. Prior to 2015, individual manufacturers operated their own clozapine patient registries.
Is clozapine a Schedule 4?
In the HDPR, clozapine is classed as a Schedule 4, regulated restricted drug.
What is RDA for clozapine REMS?
An RDA is an electronic code that indicates the Clozapine REMS has verified that all safe use conditions have been met. dashboard. identify the patient in the REMS system.
Can you get a 90 day supply of clozapine?
In a recent international consensus statement, recommendations were made to consider a reduced hematologic monitoring frequentcy of every 3 months with the dispensing of a 90 day clozapine supply (if safe).
How do you monitor clozapine?
Monitoring clozapine patients
Baseline blood tests should check white cell count, troponins, CRP and possibly BNP3. Patients with a history of cardiac disease or abnormal cardiac findings on examination (such as QT prolongation) should be referred to a cardiologist7.
