Warnings & precautions

• INVEGA SUSTENNA can cause increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). INVEGA SUSTENNA is not for treating dementia-related psychosis.¹

summary

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

What are the possible side effects of INVEGA SUSTENNA?

INVEGA SUSTENNA may cause serious side effects, including¹:

• increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). INVEGA SUSTENNA is not for treating dementia-related psychosis.
• stroke in elderly people (cerebrovascular problems) that can lead to death
• Neuroleptic Malignant Syndrome (NMS). NMS is a rare but very serious problem that can happen in people who receive INVEGA SUSTENNA. NMS can cause death and must be treated in a hospital. Call your healthcare provider right away if you become severely ill and have any of these symptoms:
  • high fever
  • severe muscle stiffness
  • confusion
  • loss of consciousness
  • changes in your breathing, heartbeat 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 movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
• metabolic changes. Metabolic changes may include high blood sugar (hyperglycemia), diabetes mellitus and changes in the fat levels in your blood (dyslipidemia), and weight gain.
• low blood pressure and fainting
• changes in your blood cell counts
• high level of prolactin in your blood (hyperprolactinemia). INVEGA SUSTENNA may cause a rise in the blood levels of a hormone called prolactin (hyperprolactinemia) that may cause side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection.
• problems thinking clearly and moving your body
• seizures
• difficulty swallowing that can cause food or liquid to get into your lungs
• prolonged or painful erection lasting more than 4 hours. 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 with control of your body temperature especially when you exercise a lot or spend time doing things that make you warm. It is important for you to drink water to avoid dehydration.

The most common side effects of INVEGA SUSTENNA include: injection site reactions, sleepiness or drowsiness, dizziness, feeling restlessness or needing to be constantly moving, abnormal muscle movements including tremors (shaking), shuffling, uncontrolled involuntary movements, and abnormal movement of eyes.¹

Tell your healthcare provider if you have any side effect that bothers you or does not go away.¹

These are not all the possible side effects of INVEGA SUSTENNA. For more information, ask your healthcare provider or pharmacist.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 SUSTENNA.¹