Kit components for Versacloz

Each Versacloz prescription contains these items:

• The Versacloz oral suspension bottle
• 9 mL and 1 mL oral syringes
• Prescribing Information
• Patient use instructions
• Bottle neck adaptor*

* The bottle neck adaptor may already be inserted in the bottle. If you have any questions, contact the Clozapine REMS Program at 1-888-586-0758.

Versacloz provides a highly concentrated, low-volume suspension— 1 mL is equivalent to a 50 mg clozapine dose¹

Additional preparation and administration components in three combinations, or kits, available upon request free of charge. Versacloz component kits are considered part of the Versacloz product and are for use only with Versacloz.

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Important Safety Information

Fever

During clozapine therapy, patients have experienced transient, clozapine-related fever. The peak incidence is within the first 3 weeks of treatment. While this fever is generally benign and selflimited, it may necessitate discontinuing treatment. The fever can be associated with an increase or decrease in WBC count. Carefully evaluate patients with fever to rule out severe neutropenia or infection. Consider the possibility of NMS [see Warnings and Precautions (5.12) of the Prescribing Information].

Pulmonary Embolism

Pulmonary embolism and deep vein thrombosis have occurred in patients treated with clozapine. Consider the possibility of pulmonary embolism in patients who present with deep vein thrombosis, acute dyspnea, chest pain, or with other respiratory signs and symptoms. Whether pulmonary embolus and deep vein thrombosis can be attributed to clozapine or some characteristic(s) of patients is not clear.

Anticholinergic Toxicity

VERSACLOZ has potent anticholinergic effects. Treatment with VERSACLOZ can result in CNS and peripheral anticholinergic toxicity. Use with caution in the presence of narrow-angle glaucoma, concomitant anticholinergic medications, prostatic hypertrophy, or other conditions in which anticholinergic effects can lead to significant adverse reactions.

Treatment with VERSACLOZ can result in gastrointestinal adverse reactions, including constipation, intestinal obstruction, fecal impaction, and paralytic ileus. Such reactions can be fatal. Constipation should be initially treated by ensuring adequate hydration and use of ancillary therapy such as bulk laxatives. Consultation with a gastroenterologist is advisable in more serious cases.

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