what is the most important information I should Know about INVEGA TRINZA?

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

summary

Here is a passage from the INVEGA TRINZA MEDICATION GUIDE which may be helpful to address your question. Please see the PATIENT MEDICATION GUIDE for complete information on INVEGA TRINZA.

INVEGA TRINZA 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).
• Stroke in elderly people (cerebrovascular problems) that can lead to death.
• Neuroleptic malignant syndrome (NMS) is a rare but very serious problem that can happen in people who receive INVEGA TRINZA. NMS can cause death and must be treated in a hospital.
  • Call your healthcare provide right away if you become severely ill and have any symptoms of NMS including high fever, severe muscle stiffness, confusion, loss of consciousness, and change in breathing, heartbeat, and blood pressure.
• Problems with your heartbeat. These heartbeat problems may cause death.
  • Call your healthcare provider right away if you have any of the symptoms: passing out or feeling like you will pass out, dizziness, or feeling as if your heart is pounding or missing a beat.
• Uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia).
• Metabolic changes that may include high blood sugar (hyperglycemia), diabetes mellitus, 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 TRINZA may cause 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.
• Problem thinking clearly or moving your body.
• Seizures (convulsions).
• 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 the nearest emergency room right away if you have an erection that lasts more than 4 hours.
• Problems with control of your body temperature especially if 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 TRINZA include¹:

• Injection site reactions
• Weight gain
• Headache
• Upper respiratory tract infection
• Feeling restlessness or difficulty sitting still
• Slow movements
• Tremors
• Stiffness and shuffling walk.

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

• These are not all the possible side effects of INVEGA TRINZA. 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 Food and Drug Administration (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 MEDICATION GUIDE for INVEGA TRINZA.¹