Changes Announced for Monitoring Clozapine to Improve Delivery of Treatment, Increase Access

By Ken Duckworth, M.D. | Sep. 25, 2015

What makes clozapine a unique and effective antipsychotic? As I detailed in my recent Advocate piece, Clozapine is the only FDA-approved medicine for treatment resistant schizophrenia. It’s been found to be effective in treatment resistant schizophrenia and in reducing the risk of suicide in people who have schizoaffective disorder or schizophrenia. I feel it is underutilized, and have seen many good outcomes on this medication. The one caveat of this medication is that it requires vigilance to monitoring of medical side effects.

A recent announcement by the FDA stated that beginning October 15 it will change the approach to monitoring clozapine. There are two key areas that are being changed, which both strike me as substantial improvements. The changes address a rare but serious side effect of clozapine, which is the reduction of a specific type of white cells called neutrophils. For those taking clozapine, having their blood drawn on a structured schedule monitors their neutrophil counts (the schedule is not changing as a result of these changes). Greatly reduced neutrophil counts can lead to risk of infection or death, which is why monitoring for this risk is incredibly important. This is especially true during the first six months of treatment when the risk is greatest.

Here are the announced changes to monitoring clozapine:

  1. There will only be one centralized clozapine registry, called the Risk Evaluation and Mitigation Strategies (REMS). REMS will keep track of a person’s neutrophil counts to be sure no one who has too low of a count gets the medicine. Currently there are six different registries, and this can cause delays as well as increasing the chance for error. This change to one registry will streamline the monitoring component of clozapine. If you have any questions, ask your local pharmacy or staffer who runs your clozapine clinic.
  1. Clinically, the new changes will allow for more physician and patient discretion in some situations that involve a low neutrophil count.  Some individuals have low counts even before they start the treatment, which has shown to be more common in some ethnic groups. This is called Benign Ethic Neutropenia or BEN. The FDA is allowing these individuals to review the risks and benefits of taking the medicine with their doctor. In short, it allows for more clinical flexibility and shared decision making than the more absolute structure of the older system. Questions? Ask your prescribing doctor.

 

Comments
Gwemdolyn Love
My son is 37 and was on Clozaril for 6+ years. The side effects were so bad I had to have him taken off. It's been 15 mos since he stopped taking this and his condition has worsen. He's been on Haldol, Abilify, and is now on Invega injection 300mg(?) and 800 mg Seroquil. He has gained 100 lbs over the last year and is now diabetic. I've mentioned to his doctor on several visits that he should take him off of the Seroquil due to it's not helping my son at all and taking this has caused his weight gain and diabetes. He still refuses to change the medication.
My son is also being treated by the Act team
1/25/2017 10:02:52 PM

ROSEANNE CHIRICO
My son is not doing well at all lately. He is being treated by Act Team II - I feel the doctor is not giving him the care and treatment he should be having. He stopped smoking for 9 mos and was doing alright, not perfect but now he resumed cigarette smoking which I know makes the medication not as effective, and he's acting indecisive, very, very unhappy, was a brilliant person, wants to work so badly, etc. etc. He is trying to stop the smoking but I don't see a happy side of all this. I've been speaking to his treatment people hoping for help my son needs. Very sad situation.
12/2/2016 4:32:53 PM

mike m
Great drug
11/26/2016 10:26:27 PM

mike m
Great drug
11/26/2016 10:26:03 PM

roseanne chirico
My son is on 400 mgs of clozapine daily - it has helped him enormously although he still makes some ridiculous statements about the CIA, etc. at times - but on the whole, he's much better, has good habits, lives with me - he's 53 yrs old, very intelligent - was a stock broker at one time. He does not have a lot of side effects in fact he asked the doctor about a month ago if he could stop the medicine for the side effects (forgot the name) but he would like to work and he always worries about what will happen if his dad (we're divorced) and I are not here as we're still very vital and active but he worries about when he's not here, etc. Just wondering if another med could be added for the thoughts he has at times that don't make sense.
8/11/2016 1:02:25 PM

Vickie
I am having problems understanding when to have blood drawn, she has been on the medication for some time now we do monthly draws levels are good had her labs done on 11/30/15, pick up medication today she goes every month but I was told today, she not having them done on time we been doing this for years I really don't understand
12/2/2015 9:34:52 PM

Paula
My son has been on clozaril for a year and a half. Prior to that he went through hell. He is doing so well. He had been on everything and had so many side effects he would stop taking meds. Even he can see how far he has come.
10/17/2015 9:52:52 PM

James Pinkerton
Generic Name: clozapine (KLOE za peen)
Brand Names: Clozaril, FazaClo, Versacloz, Clopine, CloZAPine Synthon, Denzapine, Zaponex
10/2/2015 11:34:25 AM

Tuto
This madicine has been a life saver for my Son, so kufis to the FDA!
10/1/2015 10:48:44 PM

Linda
I take Klonopin for anxiety, and Seroquel as an anti-psychotic.
I thought this information from a website may help you.

Clozaril: Uses, Dosage, Side Effects & Warnings - Drugs.com
www.drugs.com/clozaril.html
Clozaril (clozapine) is an antipsychotic medication. It works by changing the actions of chemicals in the brain. Clozaril is used to treat severe schizophrenia, or to reduce the risk of suicidal behavior in people with schizophrenia or similar disorders.
‎Side Effects - ‎Dosage - ‎Clozaril Drug Interactions - ‎Generic Availability

Klonopin
Generic Name: clonazepam (kloe NAZ e pam)
Brand Names: Klonopin, Klonopin Wafer
Klonopin (clonazepam) is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Clonazepam affects chemicals in the brain that may become unbalanced and cause anxiety.

Klonopin is used to treat seizure disorders or panic disorder.

I hope this helps,
Linda
10/1/2015 8:15:06 PM

david allen palmer
for me clozapine is the most effective antipsychotic available.
10/1/2015 6:59:38 PM

Tonisha M. Pinckney, Ph.D. (I AM MORE, LLC)
This is an excellent set of changes. My teenage son has been on clozapine for just under a year. He is doing great. This is the first time in years that he has been home for 4 straight months. Unfortunately, his ANC can vary. It took two years to get him on the the drug for that reason. It is great to know that a psychologist (with the advice of a hematologist in our case) has more latitude. He does not have any physical illnesses. The changes in ANC just happen - on or off clozapine. Thrilled!
9/30/2015 10:30:19 PM

Michelle Shepard-Gates
I'm getting this article confused with klonopin and Clozaril..I know for sure the latter is used to treat schizophrenia and the patient must go thru blood draws often to check the levels. Some of the side effects are drooling. Bed wetting, and weight gain. Could someone tell me if this art is about the medication for panic attacks (clonopine) or for the other med used to treat schizophrenia? I have seen patients on colozeral(sp) and know it is effective, but the side effects and blood draws are difficult.
9/26/2015 1:25:52 AM