About Versacloz^® (clozapine, USP) Oral Suspension

Versacloz is a prescription antipsychotic medicine used to treat people with certain types of schizophrenia including people who¹:

• Are not helped by other schizophrenia medicines
• Have been suicidal and may be at risk of suicidal behavior again

This video is provided as a guide to help demonstrate the dosing and administration of Versacloz. Please review this video, as well as the directions available in the Patient Instructions for Use, prior to administration of Versacloz.

This video does not replace having a conversation with your doctor. Be sure to talk to your doctor if you have any questions or concerns about Versacloz.

This video is only a guide. It is important that you follow your doctor's exact instructions while taking Versacloz.

Important Safety Information

Who Should Not Take VERSACLOZ?

Do not take VERSACLOZ if you:

• have blood problems called neutropenia
• are allergic to clozapine or any of the ingredients in VERSACLOZ

Are There Any Other Serious Side Effects with VERSACLOZ?

Patients taking VERSACLOZ may have:

• High count of a certain white blood cell (eosinophilia). Your doctor will monitor you and may need to stop VERSACLOZ until your white blood cell count improves.
• Problems with your heartbeat. These heart problems can cause death. Call your healthcare provider right away if you have any of these symptoms:
  • passing out or feeling like you will pass out
  • dizziness
  • feeling as if your heart is pounding or missing beats
• Constipation resulting in serious bowel complications. Know the risk of clozapine-induced constipation, including medications to avoid when possible (drugs with anticholinergic activity). Constipation can lead to intestinal obstruction or fecal impaction. Contact your health care provider if you experience symptoms of constipation such as difficulty passing stools, incomplete passage of stools, decreased bowel movement frequency, vomiting, bloating, belly swelling or belly pain.
• High blood sugar (diabetes). VERSACLOZ may cause increases in your blood sugar levels. Your doctor may check your blood sugar level before you start treatment and during your treatment with VERSACLOZ. Tell your doctor right away if you have any of the following symptoms while taking VERSACLOZ: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. Tell your doctor if you have diabetes or if you are at risk for diabetes (because of obesity or a family history of diabetes). Your doctor may perform tests to check your blood sugar levels before and during treatment with VERSACLOZ to check for increases (or worsening) in your blood sugar levels.
• Neuroleptic malignant syndrome (NMS). This is a disease that can be life-threatening. Tell your doctor if you have high fever, stiff muscles, confusion, sweating, or changes in your pulse, heart rate, or blood pressure.
• Falls. This may lead to fractures or other injuries.
• Liver problems. Call your healthcare provider right away if you have nausea, vomiting, loss of appetite, pain on the right side of your stomach (abdomen), yellowing of your skin or the whites of your eyes, or if you feel tired.
• Fever. Some people may have a fever that comes and goes while they take VERSACLOZ. This happens more often in the first 3 weeks you take VERSACLOZ. Talk to your healthcare provider if you have a fever.
• Blood clot in the lung (pulmonary embolism) or in the veins of your legs (deep vein thrombosis). Contact your doctor right away if you have chest pain and shortness of breath; swelling or pain in your leg, ankle or foot; warm feeling in the skin of your affected leg; or changes in your skin color such as turning pale or blue.
• A problem that includes dry mouth, increased sweating, increased pulse rate, and constipation (anticholinergic toxicity)
• Problems thinking clearly and moving your body. Be careful not to do any activities, such as driving, where you need to be alert until you know you can do them safely.
• Uncontrolled movements of the tongue, face, mouth or jaw (tardive dyskinesia).
• Stroke in elderly people (cerebrovascular problems).

What other important information should I know about VERSACLOZ?

• Always take VERSACLOZ exactly as your doctor tells you to take it. Do not change your dose or stop taking VERSACLOZ without asking your doctor first. If you miss taking VERSACLOZ for more than 2 days, do not restart your VERSACLOZ at the same dose. You should contact your doctor for instructions.
• You should not drink alcohol while taking VERSACLOZ. It can increase your chances of getting serious side effects.

Tell your doctor if:

• You are taking prescription or non-prescription/over-the-counter medicines, alcohol, vitamins, herbal supplements or if you smoke tobacco. Talk to your doctor before starting or stopping any other medicine while taking VERSACLOZ
• You become pregnant or plan to become pregnant during VERSACLOZ treatment. Breastfeeding while taking VERSACLOZ is not recommended.

The most common side effects of VERSACLOZ include:

These are not all the possible side effects of VERSACLOZ. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about any side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Customer Service at 1-855-279-0626.*

* Customer Service is provided by TruPharma, exclusive distributor of Versacloz.

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