Kit components for Versacloz

Each Versacloz prescription contains these items:

• The Versacloz oral suspension bottle
• 9 mL and 1 mL oral syringes
• Full Prescribing Information with Medication Guide
• Bottle neck adaptor*

* The bottle neck adaptor may already be inserted in the bottle.

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

Additional components are available free of charge for use with Versacloz. The Versacloz component kit is considered part of the Versacloz product and is for use only with Versacloz.

To order additional components, contact the TruPharma, LLC Customer Service number at 1-855-279-0626 or request via the sales email at Sales@trupharma.com.

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 self- limited, 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 [see Warnings and Precautions (5.1) of the Full Prescribing Information]. Consider the possibility of NMS [see Warnings and Precautions (5.11) of the Full 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, especially at higher dosages or in overdose situations [see Overdosage (10) of the Full Prescribing Information]. Use with caution in patients with a current diagnosis or prior history of constipation, urinary retention, clinically significant prostatic hypertrophy, or other conditions in which anticholinergic effects can lead to significant adverse reactions.

When possible, avoid use with other anticholinergic drugs and use with caution in patients with a current diagnosis or prior history of constipation, urinary retention, clinically significant prostatic hypertrophy, or other conditions in which anticholinergic effects can lead to significant adverse reactions [see Anticholinergic Toxicity (5.15) and Potential for Other Drugs to Affect VERSACLOZ (7.1) of the Full Prescribing Information].

Treatment with VERSACLOZ can result in gastrointestinal adverse reactions, including constipation, paralytic ileus, fecal impactions, megacolon, intestinal obstruction, ischemia, infraction, perforation, ulceration, or necrosis. Such reactions can be fatal. Constipation should be initially treated by ensuring adequate hydration, physical activity, and fiber intake. Consultation with a healthcare provider 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, Douglas Pharmaceuticals America Ltd. 2025