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Get answers to questions about prescribing, dosing, the registry
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Frequently Asked Questions

Below are answers to the most common questions concerning prescribing, dosing and dispensing clozapine, as well as registry information for you and your patients. Click on any of the links below to view the answer.

How do I obtain a user ID and password for the Teva Clozapine Registry website? How do I report WBC counts and ANC values to the Registry? How can I get additional forms? Are prescribers able to write standard orders for clozapine refills? Why does the medication need to be dispensed within 7 days of the blood draw? How long do I have to monitor my patient after clozapine is discontinued? Do I have to change my patient’s monitoring frequency if I change the dosage? Can I monitor my patient monthly? How long do I have to maintain lab records for my patients? Can an additional supply of medication be dispensed for patients who are traveling or in special situations? Which registry should I use for registering my patient? How do I register my patient? How do I start clozapine? How do I calculate an ANC? What happens if my patient skips a dose? What is an acceptable plasma concentration range for clozapine? What is an abnormal lab and what do I do? What is a substantial drop and what do I do? How do I register a pharmacy? I am a physician. How do I get registered? How is eligibility determined? What is an Eligibility code or an Authorization Code? What is the maximum recommended dose for clozapine? What are the side effects of clozapine? What happens if I forget to submit or obtain labs on my patient? How can I be sure my patients’ confidentiality is maintained? What is a Treatment Team? Will the Registry send me a notice if my patient experiences a low count or substantial drop? What is the Teva Clozapine Patient Registry? What is the goal of the program? Why was a clozapine patient registry created? What are the hours of operation of the registry? How do I contact the Registry?

How do I obtain a user ID and password for the Teva Clozapine Registry website?

Click here to apply for a website User ID. You will be asked to provide your contact information, make a user id and password selection, enter responses to a challenge question in case you need to retrieve log in information and you will need to agree to a set of responsibilities. You will also be asked to provide the DEA number of the physician (if not yourself) or the pharmacy you work for. Click here for additional details. Back to Top

How do I report WBC counts and ANC values to the Registry?

The preferred method is to use the website. Click here to sign up. Lab data can also be submitted via our phone, fax, or mail, whatever is easiest for you. The Teva Clozapine Registry accepts lab data on any form or report as long as we can identify the patient. Include your contact info on the submission with patient identifiers like patient initials, SSN, or birth date. Lab reporting forms are available in single patient or multiple patient formats. Click here to download forms. Blank or pre-filled 3-part NCR forms are also available by calling 800-507-8334. Back to Top

How can I get additional forms?

Forms are on the website. Click here. If you don’t see what you are looking for, call 800-507-8334 for help. Back to Top

Are prescribers able to write standard orders for clozapine refills?

Yes, standard orders and refills can be written for clozapine. The pharmacy must receive the current blood work (within 7 days of the blood draw) prior to dispensing clozapine. Back to Top

Why does the medication need to be dispensed within 7 days of the blood draw?

This is to ensure that clozapine is dispensed safely, appropriately and within a reasonable time from the date of the last blood test. Back to Top

How long do I have to monitor my patient after clozapine is discontinued?

Patients should be monitored weekly for four weeks after stopping clozapine regardless of the reason for discontinuation. If lab values are abnormal (WBC <3,500/mm3 and/or ANC < 2,000/mm3) the patient should be monitored weekly until the WBC is > 3,500/mm3 and/or ANC > 2,000/mm3. Back to Top

Do I have to change my patient’s monitoring frequency if I change the dosage?

No. Monitoring frequency changes are based on lab values and treatment duration (see the Clozapine Package Insert). Back to Top

Can I monitor my patient monthly?

Patients are monitored weekly for the first six months. If there are no low counts the patient can be monitored every two weeks for an additional six months. Afterwards, the patient may qualify for every 4 week monitoring. Transitions to reduce monitoring frequency to monthly permitted if there were no interruptions in therapy and all labs within the past year are acceptable (WBC >=3,500 / mm3 and ANC >= 2,000 / mm3) and physician authorization is on file with the Registry. Click here for a copy of the Monthly Monitoring Request Form. Back to Top

How long do I have to maintain lab records for my patients?

This is usually based on a facility’s record retention policy. Back to Top

Can an additional supply of medication be dispensed for patients who are traveling or in special situations?

Yes, an additional 1 week supply can be obtained. In addition, the Registry will help set up a new team in the new location for extended stays. Click here to see instructions on how to secure extra supplies for vacations, extended travel or other special situations. Call 800-507-8334 for assistance. Back to Top

Which registry should I use for registering my patient?

Each company that manufactures clozapine has its own registry. Patients should be registered with the manufacturer of the clozapine product that your facility dispenses. To ensure patient safety, please register your patient(s) with the appropriate registry. When in doubt call us: 800-507-8334. Back to Top

How do I register my patient?

Patients can be registered online, by phone or by submitting a registration form. The following information is required: Patient Initials, Social Security Number, Gender, Birth date, the name of the dispensing pharmacy and the responsible physician. Call 800-507-8334 for assistance. To register a patient online, you need a website User ID. Click her to obtain a User ID. Click here to download a patient registration form. Click here for additional instructions. Back to Top

How do I start clozapine?

First make sure you have a current and acceptable WBC count and ANC value. A current lab means within 7 days of the dispense date. An acceptable lab means WBC >= 3,500 / mm3 and ANC >=2,000 / mm3. Then confirm that the patient is registered. Then, according to the package insert you have titrate the dose. Click here for details. Back to Top

How do I calculate an ANC?

Click here to open the ANC Calculator. ANC equals the Total WBC count multiplied by the total percentage of neutrophils (segs plus bands). Refer to Mosby's Diagnostic and Laboratory Test Reference, 6th ed. 2003. White blood cell count and differential, page 942. Click here for additional information. WBC x Neutrophil % = ANC. Example: if WBC = 3.600 and Neutrophil = 30%, then ANC = 1,080. Back to Top

What happens if my patient skips a dose?

According to the package insert, if clozapine is interrupted for 2 or more days, the drug should be re-titrated at 12.5 mg once or twice daily. If the dose is tolerated, it may be feasible to titrate back to a therapeutic dose more quickly than the titration schedule for patient new to clozapine. Back to Top

What is an acceptable plasma concentration range for clozapine?

A clear relationship between clozapine plasma levels and efficacy/safety has not been established and a therapeutic range is not included in the prescribing information for clozapine. However, the following information may be useful: When monitoring clozapine plasma levels, a trough level should be drawn, usually before the first morning dose. Norclozapine is a metabolite of clozapine and this level should be ignored and only the total clozapine level evaluated. Clozapine blood levels should be about 400 ng/mL. Levels above 900 ng/mL are considered high and are associated with an increased risk of CNS side effects such as confusion, delirium, and seizure. Back to Top

What is an abnormal lab and what do I do?

A low lab is defined as a WBC less than 3,500/mm3 or ANC less than 2,000/mm3. Refer to the Clozapine Package Insert to determine actions associated with lab values. Click here for a copy.

If WBC < 2,000 and/or ANC < 1,000:
Permanently discontinue clozapine. Patient is non-rechallengeable and will be posted to the National Non-Rechallenge Masterfile. Repeat labs daily until WBC > 3,000 and ANC > 1,500. Then twice weekly until WBC > 3,500 and ANC > 2,000, then weekly for at least 4 weeks after WBC > 3,500. Notify the Registry at 800-507-8334. Back to Top

What is a substantial drop and what do I do?

A substantial drop in WBC or ANC is defined as single or cumulative decrease in lab values from one lab to the next over the past 3 weeks. For WBC counts, a single drop is defined as a decrease of 3,000 units or more when you compare the current lab to the last lab and a cumulative drop is a decrease of a total of 3,000 units or more over all labs within the past 3 weeks. For ANC values, a single drop is defined as a decrease of 1,500 units or more when you compare the current lab to the last lab and a cumulative drop is a decrease of a total of 1,500 units or more over all labs within the past 3 weeks. Refer to the Clozapine Package Insert to determine actions associated with lab values. Click here for a copy. Back to Top

How do I register a pharmacy?

Pharmacies can be registered online, by phone, or by submitting a registration form. Call 800-507-8334 for assistance. Click here for online registration of physicians and pharmacies. Click here to download a registration form. Click here for additional instructions. Back to Top

I am a physician. How do I get registered?

Physicians can be registered online, by phone, or by submitting a registration form. Call 800-507-8334 for assistance. Click here for online registration of physicians and pharmacies. Click here to download a registration form. Click here for additional instructions. Back to Top

How is eligibility determined?

Eligibility to treat is based on prior experience with the drug and WBC/ANC lab history. A current and acceptable WBC count and ANC value is not stand alone evidence of eligibility. A current lab means within 7 days of the dispense date. An acceptable lab means WBC >= 3,500 / mm3 and ANC >=2,000 / mm3.

For patients new to clozapine, restarting clozapine or if clozapine experience is unknown, a rechallenge status check with the Novartis Clozaril® National Registry Non Rechallenge Masterfile is conducted before eligibility is confirmed. Upon completing the registration process, the relevant providers are notified and an authorization number (also called eligibility code) is provided. Back to Top

What is an Eligibility code or an Authorization Code?

The Teva Eligibility code, also called an authorization code, is an ID number provided by Registry staff to the health care professional who requested registration of a patient. Treatment authorization is provided after verification of eligibility. Back to Top

What is the maximum recommended dose for clozapine?

According to the package insert, while many patients may respond adequately at doses between 300- 600mg daily, it may be necessary to raise the dose to the 600-900mg daily range to obtain an therapeutic response. Due to an increase risk of adverse effects, in particular seizures, the dose should not exceed 900mg daily and the patients should be re-evaluated to assess whether continued therapy is appropriate or whether a reduction in dose is possible. Back to Top

What are the side effects of clozapine?

Refer to the package insert for a full description of warnings and potential adverse effect. Click here for a copy. Black box warning include agranulocytosis, seizures, myocarditis, other cardiovascular and respiratory effects, increased mortality in elderly patients with dementia related psychosis. Back to Top

What happens if I forget to submit or obtain labs on my patient?

An automated reminder system will notify the healthcare providers of a patients’ current Treatment Team if labs have not been received by the Registry in a timely manner based on a patients monitoring frequency. Back to Top

How can I be sure my patients’ confidentiality is maintained?

The Teva Clozapine Patient Registry is committed to safeguarding your data. Click here for more details and scroll down to the section entitled "Security and Confidentiality of Clozapine Registry". All patient identifiers are protected in accordance with HIPAA. Click here for more information on HIPAA. Back to Top

What is a Treatment Team?

A Treatment Team is a term used by Registry staff to describe the relationship between a patient, the responsible physician and the dispensing pharmacy. Every time a patient is assigned to a different physician or a different pharmacy, a new Team is created. Back to Top

Will the Registry send me a notice if my patient experiences a low count or substantial drop?

Yes. The Teva Clozapine Registry uses an automated reminder system that will notify the healthcare providers of a patients’ current Treatment Team if a patient experiences a low count or substantial drop. Back to Top

What is the Teva Clozapine Patient Registry?

The Teva Clozapine Patient Registry is an FDA mandated risk management program for patients taking Teva Clozapine. The registry is required to register patients, physicians, and pharmacies; collect and monitor lab data and report adverse events. Back to Top

What is the goal of the program?

The goal of the program is to prevent clozapine induced agranulocytosis. This is accomplished by the early detection of leukopenia or granulocytopenia based on WBC counts and ANC values. Patients at risk of clozapine induced agranulocytosis are those who have a history of severe leukopenia or severe granulocytopenia (WBC < 2,000/mm3 or ANC < 1,000/mm3). Back to Top

Why was a clozapine patient registry created?

Clozapine is known to be associated with a risk of developing agranulocytosis, a potentially life threatening condition. The risk of developing agranulocytosis is minimized by regular hematological monitoring. Access to the drug requires results of a blood test and the quantity dispensed is limited to a patients monitoring frequency as defined in the package insert. Back to Top

What are the hours of operation of the registry?

Monday through Friday 8am to 5pm eastern time. To register patients after hours you can page a Case Manager 24 / 7 / 365 by calling 800-507-8334. Back to Top

How do I contact the Registry?

Teva Clozapine Patient Registry
74 NW 176th Street
Miami, Florida 33169
800-507-8334 (Phone)
800-507-8339 (fax)
Clozapine.Registry@TevaUSA.com
Clozapineregistry.com Back to Top