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How to Respond to Changes in Symptoms

If the person you are caring for starts exhibiting changes in symptoms, alert his or her doctor immediately. In some cases, changes in symptoms can indicate relapse.

Changes in Positive Symptoms

When a person living with schizophrenia experiences a positive symptom, it may be a sign that the person is having a psychotic episode or relapse. If you notice a change in symptoms, alert a healthcare professional and get help. Positive symptoms include:

Delusions – when a person with schizophrenia has a delusion, they strongly believe in something that is clearly not real or true. Don’t try to prove the person wrong or reason with them.

Hallucinations – with hallucinations, a person is hearing, seeing, feeling, tasting, or smelling something that you will not experience. A common hallucination for people with schizophrenia is hearing voices tell them what to do. Don’t try and discuss whether or not a hallucination exists or go along with them.

Disorganized speech – this speech with ongoing, rambling talk and incomplete thoughts often doesn’t make any sense. Words seem tossed around randomly. Don’t try to unravel what the person is saying or ask questions, as that can increase frustration.

Approved for the treatment of schizophrenia.Please discuss your symptoms with your healthcare professional. He or she will review your symptoms and may consult the established guidelines, which are available in the Diagnostic and Statistical Manual of Mental Disorders, where applicable.

Changes in Negative Symptoms

People living with schizophrenia who experience negative symptoms have emotions or feelings that they would not normally have. If you notice a change in symptoms, alert a healthcare professional and get help. Negative symptoms include:

Affective flattening – this is when a person doesn't have any emotional response—or has a completely inappropriate response—to what's going on around them.

Alogia – with alogia, the patient isn’t talking a lot and is not able to think clearly. Your loved one may have difficulty speaking or may give very short answers.

Avolition – if a person living with schizophrenia experiences avolition, he or she won’t feel like doing anything at all. He or she may sit for long periods of time and show little interest in participating in work or everyday activities, like bathing or getting dressed.

Approved for the treatment of schizophrenia.Please discuss your symptoms with your healthcare professional. He or she will review your symptoms and may consult the established guidelines, which are available in the Diagnostic and Statistical Manual of Mental Disorders, where applicable.

NOTE: Many people with schizophrenia seem to lack motivation. They may stay in bed too long, stop bathing or neglect their appearance. As a caregiver, it’s important to understand that this behavior is part of the disease and it’s not your loved one’s fault. However, any changes in these behaviors or signs of the symptoms above are reason to call the doctor immediately. If you have any questions, discuss them with a member of the Treatment Team.

INDICATION

INDICATION

INVEGA TRINZA® (3-month paliperidone palmitate) is a prescription medicine given by injection every 3 months by a healthcare professional and used to treat schizophrenia. INVEGA TRINZA® is used in people who have been treated with INVEGA SUSTENNA® (1-month paliperidone palmitate) for at least 4 months.

INVEGA SUSTENNA® (In-VEY-guh Suss-TEN-uh) (paliperidone palmitate) is a prescription medicine given by injection by a healthcare professional. INVEGA SUSTENNA® is used to treat schizophrenia in adults. 

 

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about INVEGA TRINZA® and INVEGA SUSTENNA®?
INVEGA TRINZA® and INVEGA SUSTENNA® can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss, and have lost touch with reality (dementia-related psychosis). INVEGA TRINZA® and INVEGA SUSTENNA® are not for treating dementia-related psychosis.

Do not receive INVEGA TRINZA® or INVEGA SUSTENNA® if you are allergic to paliperidone, paliperidone palmitate, risperidone, or any of the ingredients in INVEGA TRINZA® or INVEGA SUSTENNA® . See the end of the Patient Information leaflet in the full Prescribing Information for a complete list of INVEGA TRINZA® and INVEGA SUSTENNA® ingredients.

Before you receive INVEGA TRINZA®  or INVEGA SUSTENNA®, tell your healthcare professional about all your medical conditions, including if you:

  • have had Neuroleptic Malignant Syndrome (NMS)
  • have or have had heart problems, including a heart attack, heart failure, abnormal heart rhythm, or long QT syndrome
  • have or have had low levels of potassium or magnesium in your blood
  • have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
  • have or have had kidney or liver problems
  • have diabetes or have a family history of diabetes
  • have had a low white blood cell count
  • have had problems with dizziness or fainting or are being treated for high blood pressure
  • have or have had seizures or epilepsy
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if INVEGA TRINZA® or INVEGA SUSTENNA® will harm your unborn baby
    • If you become pregnant while taking INVEGA TRINZA®  or INVEGA SUSTENNA®, talk to your healthcare professional about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry.
    • Infants born to women who are treated with INVEGA TRINZA® or INVEGA SUSTENNA® may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare professional know if these symptoms occur.
  • are breastfeeding or plan to breastfeed. INVEGA TRINZA® and INVEGA SUSTENNA® can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you receive INVEGA TRINZA® or INVEGA SUSTENNA®.

Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show to your healthcare professional or pharmacist when you get a new medicine.

Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare professional for the potential risk of falls.

What should I avoid while receiving INVEGA TRINZA® or INVEGA SUSTENNA®?

  • INVEGA TRINZA® and INVEGA SUSTENNA® may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how INVEGA TRINZA® or INVEGA SUSTENNA® affects you.
  • avoid getting overheated or dehydrated.

INVEGA TRINZA® and INVEGA SUSTENNA® may cause serious side effects, including:

  • See “What is the most important information I should know about INVEGA TRINZA® and INVEGA SUSTENNA®?”
  • 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 TRINZA® or INVEGA SUSTENNA®. NMS can cause death and must be treated in a hospital. Call your healthcare professional 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 professional right away if you have any of these symptoms: passing out or feeling like you will pass out, dizziness, or 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 TRINZA® or 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 professional 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 TRINZA®  include: injection site reactions, weight gain, headache, upper respiratory tract infections, feeling restlessness or difficulty sitting still, slow movements, tremors, stiffness and shuffling walk.

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

Tell your healthcare professional 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® or INVEGA SUSTENNA®. For more information, ask your healthcare professional or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects of prescription drugs to the FDA at 1‑800‑FDA‑1088.

General information about the safe and effective use of INVEGA TRINZA® or INVEGA SUSTENNA®

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INVEGA TRINZA® or INVEGA SUSTENNA® for a condition for which it was not prescribed. Do not give INVEGA TRINZA® or INVEGA SUSTENNA® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare professional for information about INVEGA TRINZA® or INVEGA SUSTENNA® that is written for healthcare professionals.

This Patient Information leaflet summarizes the most important information about INVEGA TRINZA® and INVEGA SUSTENNA® . If you would like more information, talk with your healthcare professional.

You can ask your healthcare professional or pharmacist for more information that is written for healthcare professionals. For more information, go to www.invegatrinza.com or www.invegasustenna.com or call 1‑800‑526‑7736.

Please click to read the full Prescribing Information, for INVEGA TRINZA® and INVEGA SUSTENNA® and discuss any questions you have with your healthcare professional.

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