Storage and Handling¹:

Store Versacloz between 68°F-77°F.

Do not refrigerate or freeze.

Protect from light. Shake well for 10 seconds before use.

The suspension is stable for 100 days after initial bottle opening.

Keep out of reach of children.

Important Safety Information

WARNINGS AND PRECAUTIONS

Advise caution when operating machinery, including automobiles, and consider reducing the VERSACLOZ dose if cognitive or motor interference occurs. Use with caution in patients with risk factors for cerebrovascular adverse reactions. If abrupt discontinuation is necessary, monitor carefully for the recurrence of psychotic symptoms and adverse reactions related to cholinergic rebound.

Please see the full Prescribing Information for Important Safety Information, including
BOXED Warning.

Click here for additional safety information.

Reference: 1. Versacloz^® Prescribing Information, Warminister, PA: Tasman Pharma Inc. 2021

The information on this website is intended for use only by residents of the
United States.

Administration Clozapine REMS Program Ordering information

VERSACLOZ Full
Prescribing Information

WARNING:
SEVERE NEUTROPENIA; ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; MYOCARDITIS AND CARDIOMYOPATHY; INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Severe Neutropenia

Clozapine treatment has caused severe neutropenia, defined as an absolute neutrophil count (ANC) less than 500/µL. Severe neutropenia can lead to serious infection and death. Prior to initiating treatment with VERSACLOZ a baseline ANC must be at least 1500/µL for the general population, and must be at least 1000/µL for patients with documented Benign Ethnic Neutropenia (BEN). During treatment, patients must have regular ANC monitoring. Advise patients to immediately report symptoms consistent with severe neutropenia or infection (e.g., fever, weakness, lethargy, or sore throat). Because of the risk of severe neutropenia, VERSACLOZ is available only through a restricted program under a Risk Evaluation Mitigation Strategy (REMS) called the Clozapine REMS Program.

Orthostatic Hypotension, Bradycardia, Syncope

Orthostatic hypotension, bradycardia, syncope, and cardiac arrest have occurred with clozapine treatment. The risk is highest during the initial titration period, particularly with rapid dose escalation. These reactions can occur with the first dose, with doses as low as 12.5 mg per day. Initiate treatment at 12.5 mg once or twice daily; titrate slowly; and use divided dosages. Use VERSACLOZ cautiously in patients with cardiovascular/cerebrovascular disease or conditions predisposing to hypotension (e.g., dehydration, use of antihypertensive medications).

Seizures

Seizures have occurred with clozapine treatment. The risk is dose-related. Initiate treatment at 12.5 mg, titrate gradually, and use divided dosing. Use caution when administering VERSACLOZ to patients with a history of seizures or other predisposing risk factors for seizure (CNS pathology, medications that lower the seizure threshold, alcohol abuse). Caution patients about engaging in any activity where sudden loss of consciousness could cause serious risk to themselves or others.

Myocarditis, Cardiomyopathy and Mitral Valve Incompetence

Fatal myocarditis and cardiomyopathy have occurred with clozapine treatment. Discontinue VERSACLOZ and obtain a cardiac evaluation upon suspicion of these reactions. Generally, patients with VERSACLOZ-related myocarditis or cardiomyopathy should not be rechallenged with VERSACLOZ. Consider the possibility of myocarditis or cardiomyopathy if chest pain, tachycardia, palpitations, dyspnea, fever, flu-like symptoms, hypotension, or ECG changes occur.

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with
dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. VERSACLOZ is not approved for use in patients with dementia-related psychosis.