Prescriber
All prescribers of clozapine products must certify in the Clozapine REMS Program. Certification requires prescribers to:
  • Enroll: Complete the Enrollment form (name, address, NPI, DEA)
  • Educate: Review Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers
  • Assess: Successfully complete the Clozapine REMS Knowledge Assessment for Healthcare Providers


The 02/2019 Clozapine REMS Program Modification went live on 02/28/2019. Prescribers are required to certify in the Clozapine REMS Program as soon as possible to continue patient therapy. If prescribers are not certified at the time of the 02/2019 Clozapine REMS Program Modification, a dispense of clozapine will not be authorized for patients under their care. Click on the Important Program Update (IPU) button for more information.

Pharmacy
All pharmacies dispensing clozapine products must certify in the Clozapine REMS Program. Certification requires pharmacies to:
  • Enroll: Complete the Enrollment form (name, address, NPI, DEA)
  • Educate: Review Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers
  • Assess: Successfully complete the Clozapine REMS Knowledge Assessment for Healthcare Providers
  • Implement: Implement the necessary staff training and processes to comply with the Clozapine REMS Program requirements

The 02/2019 Clozapine REMS Program Modification went live on 02/28/2019. Pharmacies are required to certify in the Clozapine REMS Program. If pharmacies are not certified at the time of the 02/2019 Clozapine REMS Program Modification, a dispense of clozapine will not be authorized for patients under their care. Click on the Important Program Update (IPU) button for more information.



What is the Clozapine REMS Program?

Clozapine is associated with severe neutropenia (absolute neutrophil count (ANC) less than 500/μL), which can lead to serious and fatal infections. The requirements to prescribe, dispense, and receive clozapine are incorporated into a single shared program called the Clozapine Risk Evaluation and Mitigation Strategy (REMS). A REMS is a strategy to manage known or potential risks associated with a drug or group of drugs, and is required by the Food and Drug Administration (FDA) for clozapine to ensure that the benefits of the drug outweigh the risk of severe neutropenia. The Clozapine REMS Program replaces the individual clozapine patient registries and the National Non-Rechallenge Master File (NNRMF).

***Important Program Update (as of 02/28/2019)*** X
The following Clozapine REMS Program and Website Changes will be effective beginning 02/28/2019.
Program Requirement Changes:

Prescriber and Pharmacy Certification Requirements
  • Only prescribers certified in the Clozapine REMS Program will be able to prescribe clozapine to patients for outpatient use.
    • Prescribing clozapine for patients receiving inpatient care does not require prescriber certification in the Clozapine REMS Program if the patient is already enrolled in the program.
    • If the patient is to be initiated on clozapine while admitted to an inpatient setting, a certified prescriber must enroll the patient in the Clozapine REMS Program prior to receiving the first dose of clozapine.
  • Only pharmacies certified in the Clozapine REMS Program will be able to receive and dispense clozapine.
For more information on the 02/2019 Clozapine REMS Program changes, please click on the links below.


Program Document Changes:

The following Clozapine REMS Program Materials have been updated and can be found on the program website:

Program Requirements that are NOT Changing

Patient Requirements

Patients who meet the following requirements can receive clozapine. Patients must:
  • Be enrolled in the Clozapine REMS Program;
  • Have an Absolute Neutrophil Count (ANC) lab on file with the Clozapine REMS Program; and
  • The ANC lab must be within the acceptable range or a "Treatment Rationale" must be provided by the prescriber for a patient to receive clozapine.
Patients that do not meet the requirements cannot receive clozapine.
ANC Current Lab Requirements

Absolute Neutrophil Count not current (i.e., within 7, 15, or 31 days of the lab draw date) based on the patient's monitoring frequency (MF) will not prevent a patient from receiving clozapine from the pharmacy.

Although 'ANC not current' will not prevent a patient from receiving clozapine from the pharmacy, pharmacies are encouraged to submit the ANC to the Clozapine REMS Program when the pharmacist is made aware of a more current ANC than the most recent lab value reported in the PDA response.

Pharmacies may submit ANCs to the Clozapine REMS Program at www.clozapinerems.com, by calling the Clozapine REMS Program Contact Center at 844-267-8678 or faxing a completed Clozapine REMS ANC Lab Reporting Form (available from the website) to the Clozapine REMS Program at 844-404-8876.

If the most recent ANC indicates moderate or severe neutropenia the prescriber must provide a Treatment Rationale to the Clozapine REMS Program to allow the pharmacy to receive a PDA and dispense clozapine to the patient. The pharmacy may contact the prescriber to remind them of the need for a Treatment Rationale.

If the last ANC result on file with the Clozapine REMS Program is not current according to the patient's MF (within 7 days of the PDA/Eligibility Check transaction date for weekly monitoring, 15 days for every two weeks monitoring, and 31 days for monthly monitoring), a PDA/Eligibility Check will still be issued, but the pharmacist will receive a warning message regarding the need to ensure that the ANC is current.

In the future, patients who do not have a current ANC on file may not be allowed to receive clozapine.


Privacy Policy and Terms of Use

The Clozapine REMS Program has updated the Privacy Policy and Terms of Use documents on the program website.

If you have any questions or need additional information about the Clozapine REMS Program, please call the Clozapine REMS Program Contact Center at 844-267-8678.
For additional information about the Clozapine REMS Program, please call 844-267-8678.