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Clozapine
Overview
What is VERSACLOZ?
VERSACLOZ, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5-dibenzo[][1,4]diazepine.
The structural formula is:
VERSACLOZ is available as a free-flowing yellow suspension. Each mL contains 50 mg of clozapine.
The active component of VERSACLOZ is clozapine. The remaining components are glycerin, sorbitol (non-crystallizing), sodium dihydrogen phosphate dihydrate, xanthan gum, sodium methylparaben, sodium propylparaben, povidone, water, and sodium hydroxide to adjust to a pH range of 6.5 – 7.0.
What does VERSACLOZ look like?
What are the available doses of VERSACLOZ?
VERSACLOZ is available as a free-flowing yellow oral suspension. Each mL contains 50 mg of clozapine.
What should I talk to my health care provider before I take VERSACLOZ?
How should I use VERSACLOZ?
VERSACLOZ is indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, VERSACLOZ should be used only in patients who have failed to respond adequately to standard antipsychotic treatment
.
The effectiveness of clozapine in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing clozapine and chlorpromazine in patients who had failed other antipsychotics .
Prior to initiating treatment with VERSACLOZ, a baseline ANC must be obtained. The baseline ANC must be at least 1500/µL for the general population, and at least 1000/µL for patients with documented Benign Ethnic Neutropenia (BEN). To continue treatment, the ANC must be monitored regularly .
What interacts with VERSACLOZ?
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What are the warnings of VERSACLOZ?
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What are the precautions of VERSACLOZ?
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What are the side effects of VERSACLOZ?
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What should I look out for while using VERSACLOZ?
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4.1
What might happen if I take too much VERSACLOZ?
How should I store and handle VERSACLOZ?
Protect from light. Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [].5 mg Tablets NDC 68071-4251-6 BOTTLES OF 60NDC 68071-4251-9 BOTTLES OF 90 Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature), and dispense in tight, light resistant container (USP). Manufactured in India by: H.O.: ALKEM HOUSE, Senapati Bapat marg, Lower Parel, Mumbai - 400 013. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Revised Date: October, 2017 5 mg Tablets NDC 68071-4251-6 BOTTLES OF 60NDC 68071-4251-9 BOTTLES OF 90 Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature), and dispense in tight, light resistant container (USP). Manufactured in India by: H.O.: ALKEM HOUSE, Senapati Bapat marg, Lower Parel, Mumbai - 400 013. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Revised Date: October, 2017 5 mg Tablets NDC 68071-4251-6 BOTTLES OF 60NDC 68071-4251-9 BOTTLES OF 90 Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature), and dispense in tight, light resistant container (USP). Manufactured in India by: H.O.: ALKEM HOUSE, Senapati Bapat marg, Lower Parel, Mumbai - 400 013. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Revised Date: October, 2017
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of action of clozapine is unknown. However, it has been proposed that the therapeutic efficacy of clozapine in schizophrenia is mediated through antagonism of the dopamine type 2 (D) and the serotonin type 2A (5-HT) receptors. VERSACLOZ also acts as an antagonist at adrenergic, cholinergic, histaminergic and other dopaminergic and serotonergic receptors.
Non-Clinical Toxicology
•4.1
Ketorolac is highly bound to human plasma protein (mean 99.2%). There is no evidence in animal or human studies that ketorolac tromethamine induces or inhibits hepatic enzymes capable of metabolizing itself or other drugs.
Background
VERSACLOZ can cause neutropenia (a low absolute neutrophil count [ANC]), defined as a reduction below pre-treatment normal levels of blood neutrophils. The ANC is usually available as a component of the complete blood count (CBC), including differential, and is more relevant to drug-induced neutropenia than is the white blood cell (WBC) count. The ANC may also be calculated using the following formula: . Other granulocytes (basophils and eosinophils) contribute minimally to neutropenia and their measurement is not necessary . Neutropenia may be mild, moderate, or severe (see Tables 2 and 3). To improve and standardize understanding, “severe neutropenia” replaces the previous terms severe leukopenia, severe granulocytopenia, or agranulocytosis.
Severe neutropenia, ANC less than (<) 500/µL, occurs in a small percentage of patients taking VERSACLOZ and is associated with an increase in the risk of serious and potentially fatal infections. Risk of neutropenia appears greatest during the first 18 weeks on treatment and then declines. The mechanism by which VERSACLOZ causes neutropenia is unknown and is not dose-dependent.
Two separate management algorithms are provided below, the first for patients in the general population, and the second for patients identified to have baseline neutropenia.
VERSACLOZ Treatment and Monitoring in the General Patient Population (see Table 2)
Obtain a CBC, including the ANC value, prior to initiating treatment with VERSACLOZ to ensure the presence of a normal baseline neutrophil count (equal to or greater than 1500/µL) and to permit later comparisons. Patients in the general population with an ANC equal to or greater than (≥) 1500/µL are considered within normal range (Table 2) and are eligible to initiate treatment. Weekly ANC monitoring is required for all patients during the first 6 months of treatment. If a patient's ANC remains equal to or greater than 1500/µL for the first 6 months of treatment, monitoring frequency may be reduced to every 2 weeks for the next 6 months. If the ANC remains equal to or greater than 1500/µL for the second 6 months of continuous therapy, ANC monitoring frequency may be reduced to once every 4 weeks thereafter.
Table 2: VERSACLOZ Treatment Recommendations Based on Absolute Neutrophil Count (ANC) Monitoring for the General Patient Population
* Confirm all reports of ANC less than 1500/µL with a repeat ANC measurement within 24 hours** If clinically appropriate
VERSACLOZ Treatment and Monitoring in Patients with Benign Ethnic Neutropenia (see Table 3)
Benign ethnic neutropenia (BEN) is a condition observed in certain ethnic groups whose average ANC values are lower than “standard” laboratory ranges for neutrophils. It is most commonly observed in individuals of African descent (approximate prevalence of 25-50%), some Middle Eastern ethnic groups, and in other non-Caucasian ethnic groups with darker skin. BEN is more common in men. Patients with BEN have normal hematopoietic stem-cell number and myeloid maturation, are healthy, and do not suffer from repeated or severe infections. They are not at increased risk for developing VERSACLOZ-induced neutropenia. Additional evaluation may be needed to determine if baseline neutropenia is due to BEN. Consider hematology consultation before initiating or during VERSACLOZ treatment as necessary.
Patients with BEN require a different ANC algorithm for VERSACLOZ management due to their lower baseline ANC levels. Table 3 provides guidelines for managing VERSACLOZ treatment and ANC monitoring in patients with BEN.
Table 3: Patients with Benign Ethnic Neutropenia (BEN); VERSACLOZ Treatment Recommendations Based on Absolute Neutrophil Count (ANC) Monitoring
* Confirm all initial reports of ANC less than 1500/µL with a repeat ANC measurement within 24 hours** If clinically appropriate
General Guidelines for Management of All Patients with Fever or with Neutropenia
Rechallenge after an ANC less than 500/µL (severe neutropenia)
For some patients who experience severe VERSACLOZ-related neutropenia, the risk of serious psychiatric illness from discontinuing VERSACLOZ treatment may be greater than the risk of rechallenge (e.g., patients with severe schizophrenic illness who have no treatment options other than VERSACLOZ). A hematology consultation may be useful in deciding to rechallenge a patient. In general, however, do not rechallenge patients who develop severe neutropenia with VERSACLOZ or a clozapine product.
If a patient will be rechallenged, the clinician should consider thresholds provided in Tables 2 and 3, the patient's medical and psychiatric history, a discussion with the patient and his/her caregiver about the benefits and risks of VERSACLOZ rechallenge, and the severity and characteristics of the neutropenic episode.
Using VERSACLOZ with Other Drugs Associated with Neutropenia
It is unclear if concurrent use of other drugs known to cause neutropenia increases the risk or severity of VERSACLOZ-induced neutropenia. There is no strong scientific rationale to avoid VERSACLOZ treatment in patients concurrently treated with these drugs. If VERSACLOZ is used concurrently with an agent known to cause neutropenia (e.g., some chemotherapeutic agents), consider monitoring patients more closely than the treatment guidelines provided in Tables 2 and 3. Consult with the treating oncologist in patients receiving concomitant chemotherapy.
The following adverse reactions are discussed in more detail in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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