Approved Risk Evaluation and Mitigation Strategies (REMS)

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Clozapine
Shared System REMS
REMS last update: 09/15/2015

What are Clozapine products?

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The Clozapine REMS Program includes the following products:

Product Name Application Number Application Holder Added to REMS
Clozaril (clozapine) ( PI at DailyMed , Info at Drugs@FDA ) NDA 019758 HLS Therapeutics 09/15/2015
Fazaclo ODT (clozapine) ( PI at DailyMed , Info at Drugs@FDA ) NDA 021590 Jazz Pharmaceuticals 09/15/2015
Versacloz (clozapine) ( PI at DailyMed , Info at Drugs@FDA ) NDA 203479 Jazz Pharmaceuticals 09/15/2015
clozapine ( Info at Drugs@FDA ) ANDA 203807 Actavis 09/17/2015
clozapine ( Info at Drugs@FDA ) ANDA 090308 Barr Laboratories, Inc. 11/25/2015
clozapine ( Info at Drugs@FDA ) ANDA 203039 Barr Laboratories, Inc. 11/25/2015
clozapine ( Info at Drugs@FDA ) ANDA 202873 Accord Healthcare Inc. 11/25/2015
clozapine ( PI at DailyMed , Info at Drugs@FDA ) ANDA 075713 Caraco/Sun Pharmaceutical Industries 09/15/2015
clozapine ( PI at DailyMed , Info at Drugs@FDA ) ANDA 201824 Mylan Pharmaceuticals 09/15/2015
clozapine ( PI at DailyMed , Info at Drugs@FDA ) ANDA 075417 Mylan Pharmaceuticals 09/15/2015
clozapine ( PI at DailyMed , Info at Drugs@FDA ) ANDA 074949 Teva Pharmaceuticals 09/15/2015
clozapine ( Info at Drugs@FDA ) ANDA 076809 Teva 09/15/2015

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the product-specific REMS website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare Providers who prescribe clozapine products must

To be able to prescribe
  • Review the drug’s prescribing information.
  • Review Clozapine and Risk of Neutropenia: A Guide for Healthcare Providers.
  • Complete the Knowledge Assessment for Healthcare Providers and submit the successfully completed knowledge assessment to the application holder.
  • Enroll in the REMS by completing and submitting the Prescriber Enrollment Form.
Before the first prescription
  • Counsel the patient on the risks associated with clozapine including severe neutropenia and the REMS program requirements using What You Need to Know about Clozapine and Neutropenia: A Guide for Patients and Caregivers.
  • Unless clinical judgment indicates that the patient’s adherence to the treatment regimen will be negatively impacted: provide the patient with What You Need to Know about Clozapine and Neutropenia: A Guide for Patients and Caregivers.
  • Assess the patient’s absolute neutrophil count (ANC). Document and submit the results to the REMS program via the online system, by fax, or calling the contact center.
  • Enroll the patient by completing and submitting the Patient Enrollment Form. Retain a completed copy in the patient’s record.
At specified intervals, according to the Prescribing Information for a clozapine product, during treatment
  • Assess the patient’s ANC. Document and submit the results to the REMS program via the online system, by fax, or calling the contact center.
  • For patients with an ANC that falls below the acceptable range described in the Prescribing Information: assess the patient’s benefits of continuing treatment with the risks of developing severe neutropenia.
  • For patients whose continuing treatment benefit exceeds the risk of developing severe neutropenia: document and submit the authorization to continue treatment to the REMS program.

Patients who are prescribed clozapine shared system products

Before the first prescription
  • Get a blood test.
  • Receive counseling from the prescriber on the risks of clozapine and the REMS program requirements using What You Need to Know about Clozapine and Neutropenia: A Guide for Patients and Caregivers.
At specified intervals, according to the prescriber, during treatment
  • Get a blood test.

Outpatient pharmacies that support electronic telecommunication verification and that dispense clozapine shared system products must

To be able to dispense
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Have the authorized representative review Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers.
  • Have the authorized representative complete the Knowledge Assessment for Healthcare Providers and submit the successfully completed knowledge assessment to the application holder.
  • Train all relevant staff involved in the dispensing of clozapine on the REMS program requirements using Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers.
  • Establish processes and procedures to verify the prescriber is certified and the patient is enrolled.
  • Establish processes and procedures to verify the patient’s absolute neutrophil count (ANC) is current (within 7 calendar days of the blood draw).
  • Establish processes and procedures to verify the patient’s ANC is within an acceptable range described in the Prescribing Information or the prescriber has authorized the continuation of clozapine treatment for patients with an ANC that falls below the acceptable range when the prescriber determines the benefits exceed the risks of developing severe neutropenia prior to dispensing.
  • Establish processes and procedures to report dosing information for each clozapine prescription/fill to the REMS program.
  • Verify the pharmacy enables its pharmacy management system to support communication with the REMS Program system using established telecommunication standards and runs the standardized validation test transaction(s) to validate the system enhancements.
  • Have the authorized representative enroll in the REMS by completing and submitting the appropriate enrollment form: Clozapine REMS Pharmacy Enrollment Form or Clozapine REMS Chain Headquarters Pharmacy Enrollment Form.
Before dispensing
  • Obtain authorization to dispense by processing the prescription through the pharmacy management system.
At all times
  • Maintain records of staff training.
  • Maintain records of all processes and procedures are in place and are being followed. Maintain records of all processes and procedures are in place and are being followed.
  • Cooperate with audits carried out by the application holder to ensure that all processes and procedures are in place and are being followed.

Outpatient pharmacies that do NOT support electronic telecommunication verification and that dispense clozapine shared system products must

To be able to dispense
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Have the authorized representative review Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers.
  • Have the authorized representative complete the Knowledge Assessment for Healthcare Providers and submit the successfully completed knowledge assessment to the application holder.
  • Train all relevant staff involved in the dispensing of clozapine on the REMS program requirements using Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers.
  • All pharmacists: review Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers.
  • All pharmacists: complete the Knowledge Assessment for Healthcare Providers and submit the successfully completed knowledge assessment to the authorized representative.
  • Establish processes and procedures to verify the prescriber is certified and the patient is enrolled.
  • Establish processes and procedures to verify the patient’s absolute neutrophil count (ANC) is current (within 7 calendar days of the blood draw).
  • Establish processes and procedures to verify the patient’s ANC is within an acceptable range described in the Prescribing Information or the prescriber has authorized the continuation of clozapine treatment for patients with an ANC that falls below the acceptable range when the prescriber determines the benefits exceed the risks of developing severe neutropenia prior to dispensing.
  • Establish processes and procedures to report dosing information for each clozapine prescription/fill to the REMS program.
  • Have the authorized representative enroll in the REMS by completing and submitting the appropriate enrollment form: Clozapine REMS Pharmacy Enrollment Form or Clozapine REMS Chain Headquarters Pharmacy Enrollment Form.
Before dispensing
  • Obtain authorization to dispense using the Clozapine REMS Program website or by contacting the call center.
At all times
  • Maintain records of staff training.
  • Maintain records of all processes and procedures are in place and are being followed.
  • Cooperate with audits carried out by the application holder to ensure that all processes and procedures are in place and are being followed.

Inpatient pharmacies that dispense clozapine shared system products must

To be able to dispense
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Have the authorized representative review Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers.
  • Have the authorized representative complete the Knowledge Assessment for Healthcare Providers and submit the successfully completed knowledge assessment to the application holder.
  • Train all relevant staff involved in the dispensing of clozapine on the REMS program requirements using Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers.
  • All pharmacists: review the Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers.
  • All pharmacists: complete the Knowledge Assessment for Healthcare Providers and submit the successfully completed knowledge assessment to the authorized representative.
  • All pharmacists: complete the Knowledge Assessment for Healthcare Providers and submit the successfully completed knowledge assessment to the authorized representative.
  • Establish processes and procedures to verify the patient’s absolute neutrophil count (ANC) is current (within 7 calendar days of the blood draw).
  • Establish processes and procedures to verify the patient’s ANC is within an acceptable range described in the Prescribing Information or the prescriber has authorized the continuation of clozapine treatment for patients with an ANC that falls below the acceptable range when the prescriber determines the benefits exceed the risks of developing severe neutropenia prior to dispensing.
  • Establish processes and procedures to report dosing information for each clozapine prescription/fill to the REMS program.
  • Have the authorized representative enroll in the REMS by completing and submitting the Clozapine REMS Pharmacy Enrollment Form.
Before dispensing
  • Verify the prescriber is certified and the patient is enrolled by contacting the Clozapine REMS Program website or by contacting the call center.
  • Verify that ANC is current and within the acceptable range described in the Prescribing Information or the prescriber has authorized the continuation of clozapine treatment for patients with an ANC that falls below the acceptable range when the prescriber determines the benefits exceed the risks of developing severe neutropenia using the Clozapine REMS Program website, by contacting the call center, or checking the patient’s medical record.
At all times
  • Maintain records of staff training.
  • Maintain records of all processes and procedures are in place and are being followed.
  • Cooperate with audits carried out by the application holder to ensure that all processes and procedures are in place and are being followed.

Wholesalers that distribute clozapine shared system products must

To be able to distribute
  • Establish processes and procedures to verify that the drug is distributed only to certified pharmacies.
  • Train all relevant staff involved in on the REMS program requirements.
At all times
  • Maintain records of appropriate documentation.
  • Provide distribution data to the appropriate application holder.
  • Cooperate with audits carried out by the application holder to ensure that all processes and procedures are in place and are being followed.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers:


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Material Name
ANC Lab Reporting Form (PDF)
Chain Headquarters Pharmacy Enrollment Form (PDF)
Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers (PDF)
Knowledge Assessment for Healthcare Providers (PDF)
Patient Enrollment Form (PDF)
Pharmacy Enrollment Form (PDF)
Prescriber Designee Enrollment Form (PDF)
Prescriber Enrollment Form (PDF)
REMS document (PDF)
REMS full (PDF)
REMS Program website screenshot (PDF)
What You Need to Know about Clozapine and Neutropenia: A Guide for Patients and Caregivers (PDF)

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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