Invega Trinza is an atypical antipsychotic that is given once every 3 months. It is used to treat a mental disorder called schizophrenia.

Invega Trinza contains paliperidone. Another well-known antipsychotic drug called Risperdal (risperidone) is converted into paliperidone once it is in the body. Invega Trinza is an extended-release version of paliperidone that helps to overcome the fluctuations in blood levels of the drug that are seen after it is taken by mouth as an immediate-release formulation such as Risperdal. It also helps to avoid the problem of remembering to take a medication everyday.

It is not fully understood how Invega Trinza works, but it helps to adjust the levels of chemicals in the brain called dopamine and serotonin. These chemicals are called neurotransmitters and it's thought that an imbalance in these chemicals plays a role in schizophrenia.

Invega Trinza was approved by the US Food and Drug Administration (FDA) in 2015.

What is Invega Trinza used for?

Invega Trinza is a prescription medicine given by injection by a healthcare professional and used to treat schizophrenia.

Invega Trinza is used in people who have been treated with Invega Sustenna 1 time a month injections for at least 4 months.

It is not known if Invega Trinza is safe and effective in children under 18 years of age.

Invega Trinza can cause serious side effects, including:

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

Who should not receive Invega Trinza?

Do not receive Invega Trinza if you:

• are allergic to paliperidone palmitate, risperidone, or any of the ingredients in Invega Trinza. See below for a complete list of ingredients in Invega Trinza.

• Follow your Invega Trinza treatment schedule exactly as your healthcare provider tells you to.
• Your healthcare provider will tell you how much Invega Trinza you will receive and when you will receive it.
• Invega Trinza is given as an injection by your healthcare provider into the muscle (intramuscularly) of your arm or your buttocks, 1 time every 3 months.

• Invega Trinza is only used after you have been adequately treated with the 1-month paliperidone palmitate extended-release injectable suspension (Invega Sustenna) for at least four months.
• Invega Trinza should be administered once every 3 months.
• For intramuscular injection only.
• Each injection must be administered only by a healthcare professional.
• For deltoid injection: For patients weighing less than 90 kg, use the 1-inch 22 gauge thin wall needle. For patients weighing 90 kg or more, use the 1½-inch 22 gauge thin wall needle.
• For gluteal injection: Regardless of patient weight, use the1½-inch 22 gauge thin wall needle.
• Prior to administration, shake the prefilled syringe vigorously for at least 15 seconds within 5 minutes prior to administration to ensure a homogeneous suspension.
• Initiate Invega Trinza when the next 1-month paliperidone palmitate dose is scheduled with an Invega Trinza dose based on the previous 1-month injection dose as shown in the table below.
  
  Invega Trinza dose for adults adequately treated with Invega Sustenna.

  Last dose of Invega Sustenna was:	Start Invega Trinza at this dose:
  78mg	273mg
  117mg	410mg
  156mg	546mg
  234mg	819mg

  *Conversion from the Invega Sustenna 39 mg dose was not studied.

Do not receive Invega Trinza if you:

• are allergic to paliperidone palmitate, risperidone, or any of the ingredients in Invega Trinza. See below for a complete list of ingredients in Invega Trinza.

What should I tell my doctor before receiving Invega Trinza?

Before you receive Invega Trinza, tell your healthcare provider 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

Missing doses of Invega Trinza should be avoided. To manage missed doses on exceptional occasions, refer to the Full Prescribing Information.

Invega Trinza 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 affects you.

Avoid getting overheated or dehydrated.

Invega Trinza may cause serious side effects, including:

• See "Important information"
• 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. 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 Trinza 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 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.

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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider 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 provider or pharmacist when you get a new medicine.