Invega Trinza

Generic name: Paliperidone Palminate
Dosage form: extended-release suspension for intramuscular injection
Drug class: Atypical antipsychotics

Usage of Invega Trinza

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.

Invega Trinza side effects

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.

Before taking 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.

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How to use Invega Trinza

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.

Warnings

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.

What other drugs will affect Invega Trinza

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.

Disclaimer

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