warnings & precautions

• INVEGA HAFYERA may cause increased risk of death in elderly people with dementia-related psychosis. INVEGA HAFYERA increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). INVEGA HAFYERA is not for the treatment of people with dementia-related psychosis.¹

summary

Here is a passage from the INVEGA HAFYERA PATIENT INFORMATION which may be helpful to address your question:

What are the possible side effects of INVEGA HAFYERA?

INVEGA HAFYERA may cause serious side effects, including¹:

• increased risk of death in elderly people with dementia-related psychosis. INVEGA HAFYERA increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). INVEGA HAFYERA is not for the treatment of people with dementia-related psychosis.
• Cerebrovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.
• Neuroleptic Malignant Syndrome (NMS), a serious condition that can lead to death. Call your healthcare provider or go to your nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:
  • high fever
  • stiff muscles
  • confusion
  • sweating
  • changes in your breathing, pulse, heart rate, and blood pressure
• 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
• Uncontrolled body movements (tardive dyskinesia). INVEGA HAFYERA may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving INVEGA HAFYERA. Tardive dyskinesia may also start after you stop receiving INVEGA HAFYERA.
• Problems with your metabolism such as:
  • high blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who receive INVEGA HAFYERA. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before you start and regularly during treatment with INVEGA HAFYERA.
    • Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with INVEGA HAFYERA:
      • 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. Your healthcare provider should check the fat levels in your blood before you start and regularly during treatment with INVEGA HAFYERA.
  • weight gain. You and your healthcare provider should check your weight before you start and often during treatment with INVEGA HAFYERA.
• Decreased blood pressure (orthostatic hypotension) and fainting. You may feel lightheaded or faint when you rise too quickly from a sitting or lying position, especially early in treatment or when the dose is changed.
• Falls. INVEGA HAFYERA may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.
• Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with INVEGA HAFYERA.
• Increased prolactin levels in your blood (hyperprolactinemia). INVEGA HAFYERA may cause a rise in the blood levels of a hormone called prolactin (hyperprolactinemia) that may cause side effects including missed menstrual periods, a reversible reduction in fertility in females who are able to become pregnant, leakage of milk from the breasts, development of breasts in men, or problems with erection.
• INVEGA HAFYERA can make you sleepy or dizzy, and can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how INVEGA HAFYERA affects you.
• Seizures (convulsions).
• Difficulty swallowing that can cause food or liquid to get into your lungs.
• Prolonged or painful erection lasting more than 4 hours (priapism). Call your healthcare provider or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours.
• Problems controlling your body temperature so that you feel too warm.
  • While receiving INVEGA HAFYERA, you should avoid getting too hot or dehydrated.
    • Do not exercise too much.
    • In hot weather, stay inside in a cool place if possible.
    • Stay out of the sun.
    • Do not wear too much clothing or heavy clothing.
    • Drink plenty of water.

The most common side effects of INVEGA HAFYERA include¹:

• upper respiratory tract infections
• weight gain
• feeling of restlessness or difficulty sitting still
• tremors
• shuffling walk
• injection site reactions
• headache
• slow movements
• stiffness

These are not all the possible side effects of INVEGA HAFYERA.¹

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.¹

additional information

This information is provided ONLY in response to your request and is not intended as medical advice, to promote the use of our product, or suggest use in any manner other than as described in the PRESCRIBING INFORMATION. All decisions regarding your medical treatment should be made with your healthcare professional(s). Please contact your healthcare professional(s) to discuss the information in this response.

Please refer to the attached full PRESCRIBING INFORMATION and the PATIENT INFORMATION for INVEGA HAFYERA.¹