Is clozapine a REMS drug?
On July 29, 2021, FDA approved modifications to the Clozapine Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risk of severe neutropenia. The Clozapine REMS is a shared system REMS for all approved clozapine products.
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.
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. Miller, MD, Editor in Chief of Psychiatric TimesTM.
What is REMS number?
Call our toll free number 1-866-495-0654 to report any of the following: An Adverse Event: If you or someone you know has experienced an adverse event, please call 1-866-495-0654. A Pregnancy: If you are an activated prescriber, report pregnancy results by logging in and clicking on “Manage Patients.”
What class of drug is clozapine?
Clozapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
Can you get a 90 day supply of clozapine?
For many patients on long-term clozapine treatment, this may simply be an additional 30-day supply of clozapine, if an ANC can be obtained the next month. However, a 60- or 90-day supply may be prudent if patients remain at high risk due to the pandemic.
How many days supply of clozapine can be dispensed?
Note that even though blood tests are required daily, the pharmacy can dispense up to 7-day supply of medication.
How do I get REMS certification?
1. Complete and sign the Rosiglitazone REMS Prescriber Enrollment Form and submit it to the Rosiglitazone REMS Program. 2. Agree to complete and sign a Rosiglitazone REMS Patient Enrollment Form for each patient enrolled.
Why is clozapine a last resort?
Clozapine has unique and powerful side effects and risks, which often make it a drug of last resort.
Who runs clozapine REMS?
Generic Products
| Trade Name | Generic Name | Company |
|---|---|---|
| Clozapine | Clozapine Tablets, USP | Teva Pharmaceuticals USA Inc. |
| Clozapine | Clozapine, ODT | Teva Pharmaceuticals USA Inc. |
| Clozapine | Clozapine, ODT | Teva Pharmaceuticals USA Inc. |
| Clozapine | Clozapine, ODT | Teva Pharmaceuticals USA Inc. |
What is the REMS program for Revlimid?
WHAT IS LENALIDOMIDE REMS? To avoid serious risks to unborn babies, REVLIMID is only available through a restricted distribution program called Lenalidomide Risk Evaluation and Mitigation Strategy (REMS) program. You must be enrolled in the Lenalidomide REMS program before your doctor can prescribe REVLIMID.
Who can prescribe clozapine?
You will be prescribed clozapine by a specialist doctor who will keep a thorough and close check on your progress. Clozapine is prescribed to relieve the symptoms of psychosis. This is the name used by doctors to describe a disordered state of mind. Clozapine is prescribed in particular for people with schizophrenia.
What are the side effects of clozapine?
Seizures or convulsions: The higher the dosage,the greater the risk of seizures.
Is clozapine a prescription drug?
Clozapine (marketed as Clozaril, Fazaclo ODT, Versacloz and generics) is an antipsychotic medicine used to treat schizophrenia in patients whose symptoms are not controlled with standard antipsychotic drugs. Clozapine is also used in patients with recurrent suicidal behavior associated with schizophrenia or schizoaffective disorder.