About Versacloz^® (clozapine, USP) Oral Suspension

VERSACLOZ is a prescription antipsychotic medicine used to treat people:

• Who are severely ill with schizophrenia not helped by other schizophrenia medicines
• With schizophrenia or schizoaffective disorder who have been suicidal and may be at risk of suicidal behavior again

It is not known if VERSACLOZ is safe and effective in children.

Important Safety Information

Who Should Not Take VERSACLOZ?

Do not take VERSACLOZ if you: 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:

• falls. VERSACLOZ may make you sleepy, dizzy, may cause a decrease in your blood pressure when changing positions, and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.

• slow emptying of your stomach and intestines (decreased gastric motility). Severe constipation and bowel problems can happen and can lead to hospitalization, surgery, and death. You may not feel or be aware of constipation symptoms. Your healthcare provider will examine you for possible bowel problems. Tell your healthcare provider if you get any signs and symptoms of decreased gastrointestinal motility during treatment during treatment with VERSACLOZ, including:

  • having bowel movements less than normal
  • hard or dry stools
  • difficulty in passing gas
  • stomach bloating or pain
  • nausea or vomiting

  Staying well hydrated, increasing physical activity, and taking fiber during treatment with VERSACLOZ can help prevent constipation and other bowel problems. Your healthcare provider may prescribe medicines to prevent severe problems.

• high count of a certain white blood cell (eosinophilia). VERSACLOZ can cause a high count of eosinophils in some people and can be serious. This is a different risk than the risk of VERSACLOZ causing an abnormally low white blood cell count (neutropenia). Your healthcare provider may send you to see an internal medicine specialist (internist) or blood specialist (hematologist). Tell your healthcare provider right away if you have any of these symptoms:

  • feeling very tired or weak
  • fever
  • rash
  • swelling
  • joint pain
  • coughing and wheezing
  • nausea, vomiting, or diarrhea
  • night sweats
  • confusion
  • difficulty swallowing

• serious heart rhythm problems (QTc Interval Prolongation) that can cause death. Your healthcare provider will do a physical exam and may obtain blood tests and an electrocardiogram before starting you on treatment with VERSACLOZ. Tell 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

• problems with your metabolism such as:

  • high blood sugar (hyperglycemia) or diabetes. Increases in blood sugar can happen in some people who take VERSACLOZ. Extremely high blood sugar can lead to coma and death. If you have diabetes or risk factors for diabetes (such as being overweight), your healthcare provider should check your blood sugar before you start VERSACLOZ and during treatment. Tell your healthcare provider if you have any of these symptoms of high blood sugar while taking VERSACLOZ:

    • feel very thirsty
    • need to urinate more than usual
    • feel very hungry
    • feel weak or tired
    • feel sick to your stomach
    • feel confused, or your breath smells fruity

  • increased fat levels (cholesterol and triglycerides) in your blood (dyslipidemia). Your healthcare provider should check the fat levels in your blood before you start and during treatment with VERSACLOZ.

  • weight gain. You and your healthcare provider should check your weight regularly.

• neuroleptic malignant syndrome (NMS). NMS is a rare but serious condition that can lead to death and must be treated in a hospital. Tell your healthcare provider right away if you become severely ill and have any of these symptoms:

  • high fever
  • stiff muscles
  • confusion
  • changes in breathing, heartbeat, and blood pressure
  • increased sweating

• liver problems. VERSACLOZ can cause serious life-threatening liver problems that can lead to death. Tell your healthcare provider right away if you have any of these symptoms:

  • feeling tired
  • loss of appetite
  • nausea and vomiting
  • yellowing of your skin or whites of your eyes
  • pain on the right side of your stomach (abdomen)
  • elevated bilirubin levels

• fever. Some people may have a fever while they take VERSACLOZ. If you have a fever, your healthcare provider will do blood tests to check for neutropenia or an infection. Your healthcare provider may also send you to see a blood specialist (hematologist). Tell your healthcare provider if you have a fever

• blood clot in your lung (pulmonary embolism) or in the veins of your legs (deep vein thrombosis). Get emergency help right away if you have symptoms of a blood clot including:

  • chest pain and shortness of breath
  • swelling or pain in your leg, ankle or foot
  • warm feeling in the skin of your affected leg
  • changes in your skin color such as turning pale or blue

• a problem that includes dry mouth, increased sweating, increased pulse rate, constipation, and urinary retention (anticholinergic toxicity).

• problems thinking clearly and moving your body.

• uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia). Tardive dyskinesia may not go away, even if you stop VERSACLOZ. Tardive dyskinesia may also start after you stop taking VERSACLOZ.

• stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.

What other important information should I know about VERSACLOZ?

• Take VERSACLOZ exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking VERSACLOZ unless your healthcare provider tells you to. Talk to your healthcare provider or pharmacist if you are not sure how to take VERSACLOZ.
• Take VERSACLOZ with or without food.
• If your healthcare provider decides that you can take VERSACLOZ at home, you should receive training on the correct way to take VERSACLOZ. Do not try to take VERSACLOZ yourself until you have been shown how to take VERSACLOZ.
• If you miss taking VERSACLOZ for 1 day or more, call your healthcare provider right away. Do not take 2 doses at the same time unless your healthcare provider tells you to.
• If you take too much (overdose) VERSACLOZ, call your healthcare provider or the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

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.

Your healthcare provider may lower your dose or temporarily or permanently stop treatment with VERSACLOZ if you have certain symptoms or if your WBC count is low.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. 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 TruPharma, LLC at 1-877-541-5504.*

* TruPharma, LLC is the exclusive distributor of Versacloz.

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