About INVEGA TRINZA® (paliperidone palmitate)

GET RESULTS

In a long-term study, 93% of patients treated with INVEGA TRINZA^® did not experience a significant return of schizophrenia symptoms vs those not treated.

Take INVEGA TRINZA^® 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 a prescription medicine given by injection by a healthcare professional and used to treat schizophrenia after being adequately treated with INVEGA SUSTENNA^®, a once-monthly version of the same medication for at least four months.
Do not receive INVEGA TRINZA^® if you are allergic to paliperidone palmitate, risperidone, or any of the ingredients in INVEGA TRINZA^®. You can find a full list of the ingredients in the Patient Information Pamphlet in the Important Safety Information for INVEGA TRINZA^®.
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.

You can find a list of ingredients in the Patient Information Pamphlet in the Important Safety Information for INVEGA TRINZA^®

TREATMENT PLAN

INVEGA TRINZA^® is the only schizophrenia treatment to help control symptoms for 3 months with one dose. Your doctor will start you on INVEGA SUSTENNA^®, the once-monthly version of the active medication contained in INVEGA TRINZA^®. After being adequately treated for at least four months, you and your doctor can discuss a transition to INVEGA TRINZA^®.

Month 1

1. Starting Doses

Your doctor may give you a test dose of an oral version of INVEGA SUSTENNA^® to determine if you can tolerate the ingredients in INVEGA SUSTENNA^®. Then you will receive your first starting dose of INVEGA SUSTENNA^®, followed by a second starting dose one week later. Starting doses are not necessary if you are currently taking INVEGA SUSTENNA^®.

Month 2
Month 3
Month 4

2. Adjusting

You will get injections of INVEGA SUSTENNA^® for a minimum of four months in a row (including starting doses) until your doctor determines the right dose for you.

Month 5
Month 6
Month 7

3. Maintenance

Once you and your doctor have determined the INVEGA SUSTENNA^® dosage is effectively treating your schizophrenia symptoms, you can be transitioned to INVEGA TRINZA^®. You will then get a dose of INVEGA TRINZA^® once every 3 months.

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.

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.

Please see the Patient Information Pamphlet for full Prescribing Information for INVEGA TRINZA^® and INVEGA SUSTENNA^®.

HELP WITH COST

Your Partner for Cost Support

At Janssen, we don’t want cost to get in the way of treatment you need.

We can help you explore options to lower your out-of-pocket medication cost for INVEGA TRINZA^®.

Scroll for more information.

Government insurance or no insurance

If you are on Medicare Part D and eligible for Low-Income Subsidy (LIS), you should pay no more than $8.25.

The information provided is not a guarantee of coverage (partial or full). Actual benefits are determined by each plan according to its policies and procedures. It is strongly recommended that you review your plan’s list of covered drugs (formulary) and call your plan if needed to ensure you understand your coverage. All information is subject to change.

For more information about other financial assistance if you have government insurance or no insurance, visit JanssenPrescriptionAssistance.com.

Prescription savings with commercial or private insurance

If you have insurance, there are other financial assistance programs for those who qualify.

You may be eligible for the Instant Savings Program, which is an insurance co-pay support program that helps reduce the out-of-pocket cost of INVEGA SUSTENNA^® and/or INVEGA TRINZA^® prescriptions. Private or commercially insured patients who qualify will:

Pay no more than $10 on each out-of-pocket drug expense for INVEGA SUSTENNA^® or INVEGA TRINZA^® at either the pharmacy or for medication purchased at the physician's office.
Program exhausts after 13 doses of INVEGA SUSTENNA^®, 4 doses of INVEGA TRINZA^®, or $8000, whichever comes first.

This program is only available to individuals using private or commercial health insurance to cover a portion of medication costs. This program is not available to individuals who use any state or federal government subsidized healthcare program to cover a portion of medication costs, such as Medicare, Medicaid, TRICARE, Department of Defense, or Veterans Administration. Patients confirm that they will not seek reimbursement from any of these programs or from pharmaceutical patient assistance foundations and accounts such as a Flexible Spending Account (FSA), Healthcare Savings Account (HSA) or Health Reimbursement Account (HRA).

This offer may not be combined with any other coupon, discount, prescription savings card, free trial, or other offer.

The selling, purchasing, trading, or counterfeiting of this card is prohibited. Offer good only in the U.S. and Puerto Rico. For Massachusetts residents only, this offer is subject to change per state legislation. Janssen Pharmaceuticals, Inc., reserves the right to rescind, revoke, or amend this offer without notice at any time. Void where prohibited, taxed, or otherwise restricted by law.

Program expires December 31, 2018.

As a condition of participating in this program, you must ensure that you comply with any co-payment disclosure requirements of your insurance carrier or third-party payer, including disclosing to your insurer the amount of co-payment support you receive from this program.

Find out if you qualify for this insurance co-pay support program by calling 1-888-535-2850.

Janssen Pharmaceuticals, Inc., reserves the right to rescind, revoke, or amend this offer without notice at any time.

IMPORTANT SAFETY INFORMATION and INDICATION for INVEGA TRINZA^® (paliperidone palmitate) and INVEGA SUSTENNA^® (paliperidone palmitate)

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

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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