Clozapine REMS Program Modified
January 17, 2019 – The U.S. FDA has approved changes to the Risk Evaluation and Mitigation Strategy (REMS) program for clozapine, an antipsychotic associated with severe neutropenia [absolute neutrophil count (ANC) less than 500/μL]. Clozapine is marketed under the brand names Clozaril® (HLS Therapeutics), FazaClo® (Jazz Pharmaceuticals), and Versacloz® (Tasman Pharma). It is also available in generic forms from numerous manufacturers. All forms of clozapine are subject to the same REMS program.
Changes to the program are due to take effect on February 28, 2019. Prescribers and pharmacies must be certified under the clozapine REMS program by February 28, 2019, or they will be barred from prescribing or dispensing the medication. However, inpatient prescribers do not need to obtain certification as long as they are prescribing the medication to patients already enrolled in the REMS program. Other changes include:
- The absence of a current absolute neutrophil count (ANC) for a patient will not prevent clozapine from being dispensed; and
- The prescriber or the prescriber designee must complete a patient’s enrollment in the REMS program. Pharmacies may no longer enroll patients after February 28, 2019.
Clozapine is indicated to treat schizophrenia in patients who do not respond adequately to standard antipsychotic treatment. Although certain patients benefit from its use, the drug can cause a significant decrease in neutrophils, a type of white blood cell. This can interfere with the body’s immune system, and may lead to serious infection and even death. The clozapine REMS program is focused on managing the risks of severe neutropenia for patients receiving the medication.