For your patients with treatment-resistant schizophrenia…

After schizophrenia treatment failures,
change course—consider Versacloz¹

Versacloz is indicated for:

• Treatment-resistant schizophrenia in severely ill patients. Because of the significant risk of agranulocytosis and 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 was established in a 6-week, randomized, double-blind, active-controlled study comparing clozapine and chlorpromazine in patients who had failed other antipsychotics.
• Reduction in the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state. The effectiveness of clozapine was demonstrated over a 2-year treatment period in the InterSePT^TM trial.

Dosing/Delivery:

• Highly concentrated oral, low-volume suspension: 1 mL = 50 mg¹
• Offers a tasteless choice of clozapine therapy²
  • Measured and administered using an oral syringe—no need to mix or match clozapine tablets
• When restarting VERSACOLOZ in patients who have had even a brief interruption in treatment with VERSACLOZ dosage must be reduced. This is necessary to minimize the risk of hypotension, bradycardia and syncope If one days dosing has been missed, resume treatment at 40% to 50% of the established dose. If two days dosing has been missed, resume dosage at approx. 25% of the established dosage. For longer interruptions, re-initiate with a dosage of 12.5 mg once daily or twice daily.

Dedicated Clinical Compliance Liaisons (CCLs):

• 24/7 support services to support healthcare practitioners and pharmacies

Important Safety Information

Contraindications include:

• VERSACLOZ is contraindicated in patients with a history of serious hypersensitivity to clozapine (e.g., photosensitivity, vasculitis, erythema multiforme, or Stevens-Johnson Syndrome) or any other component of VERSACLOZ [see Adverse Reactions (6.2) of the Prescribing Information].

Warnings and Precautions

• Versacloz may cause somnolence, postural hypotension, and motor and sensory instability, which may lead to falls and consequently, fractures or other injuries. For patients with diseases, or conditions that could exacerbate these effects, fall risk assessments should be completed intestinal ulceration, perforation or necrosis.
• Gastrointestinal hypomotility can range from constipation to paralytic ileus. Severe complications of gastrointestinal hypomotility can result in intestinal obstruction, fecal impaction, megacolon and intestinal ischemia or infarction. These reactions have resulted in hospitalization, surgery and death. Reassess bowel function frequently with careful attention to any changes in the frequency or character of bowel movements or symptoms of hypomotility (nausea, vomiting, abdominal distension or abdominal pain) and treat promptly with laxatives as necessary.
• Eosinophilia has occurred, usually during the first month of treatment with clozapine. In clinical trials, approximately 1% of patients developed eosinophilia. Discontinue VERSACLOZ if organ involvement (e.g., myocarditis, pancreatitis, hepatitis, colitis, nephritis) occurs.
• QT interval prolongation, sometimes life-threatening, has occurred with clozapine. Consider additional risk factors for prolonged QT interval (disorders and drugs) including patient or family history, treatment with other medications that cause QT prolongation or inhibit the metabolism of VERSACLOZ, and electrolyte abnormalities. Discontinue use if the QTc interval exceeds 500 msec or if the patient experiences symptoms consistent with Torsades de Pointes or other arrhythmias (e.g., syncope, presyncope, dizziness, or palpitations).
• Atypical antipsychotics including clozapine have been associated with metabolic changes, including:
  • Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis and hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including clozapine. Monitor for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with or at risk for diabetes.
  • Dyslipidemia: Undesirable alterations in lipids have occurred in patients treated with atypical antipsychotics. Baseline and periodic follow-up lipid evaluations are recommended.
  • Weight Gain: Weight gain has occurred in clinical trials with clozapine. Monitor weight during treatment.
• Hepatotoxicity: Severe, life threatening, and in some cases fatal hepatotoxicity including hepatic failure, hepatic necrosis and hepatitis have been reported. Monitor for signs and symptoms of hepatotoxicity such as fatigue, malaise, anorexia, nausea, jaundice, coagulopathy and hepatic encephalopathy and perform serum tests for liver injury.
• Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex, has been reported with administration of antipsychotics, including clozapine. Clinical manifestations include hyperpyrexia, muscle rigidity, altered mental status, and autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria, rhabdomyolysis, and acute renal failure. If NMS occurs, immediately discontinue VERSACLOZ, manage with intensive symptomatic treatment, monitor closely, and assess for comorbidities.
• Patients have experienced transient, clozapine-related fever during therapy, often within the first 3 weeks of treatment. Evaluate patients with fever for agranulocytosis, infection, or NMS.
• Consider pulmonary embolism (PE) if respiratory distress, chest pain, or deep vein thrombosis occur.
• Versacloz has potent anticholinergic effects. Treatment with Versacloz can result in CNS and peripheral anticholinergic toxicity especially at higher dosages or in overdose situations. Use with caution in patients with constipation, urinary retention, clinically significant prostatic hypertrophy or other conditions in which anticholinergic effects can lead to significant adverse reactions. When possible avoid concomitant use with other anticholinergic medications because the risk for anticholinergic toxicity or severe gastrointestinal adverse reactions is increased.
• VERSACLOZ can cause sedation and impairment of cognitive and motor performance. Advise caution when operating machinery, including automobiles. Consider reducing the dose if cognitive or motor interference occurs.
• Tardive dyskinesia (TD) has occurred in patients treated with antipsychotic drugs including clozapine. The risk and likelihood that it will become irreversible are believed to increase with greater durations of treatment and higher total cumulative doses, although it can occur after short periods and at low doses. Use the lowest effective dose and the shortest duration necessary to control symptoms. Periodically assess the need for continued treatment. Consider discontinuing VERSACLOZ if TD occurs.
• Cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities, have occurred in elderly patients with dementia-related psychosis who were treated with some atypical antipsychotics. Use VERSACLOZ 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.
• Most common adverse reactions (≥5%) were: CNS reactions (sedation, dizziness/vertigo, headache, and tremor); cardiovascular reactions (tachycardia, hypotension, and syncope); autonomic nervous system reactions (hypersalivation, sweating, dry mouth, and visual disturbances); gastrointestinal reactions (constipation and nausea); and fever.

You may contact the Clozapine REMS Program
at Phone: 1-888-586-0758 or Fax: 1-800-878-5927 or https://www.newclozapinerems.com.

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

Click here for additional safety information.

References: 1. Versacloz^® Prescribing Information, Warminister, PA: Tasman Pharma Inc. 2021 2. Data on file. Warminster, PA: Tasman Pharma, INC.; 2017.