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INVEGA SUSTENNA® delays time to relapse vs a group of commonly prescribed daily pills

This finding is from a study designed to see how INVEGA SUSTENNA®, a once-monthly injection, compared to a group of 7 commonly prescribed daily oral pills in adults living with schizophrenia who had recently been in jail

The study wasn’t designed to compare INVEGA SUSTENNA® to each individual oral pill. However, it was intended to reflect the real-life issues that many adults living with schizophrenia may experience in their daily lives, by selecting participants who are often excluded from studies.

Read more about the relapse prevention benefits of INVEGA SUSTENNA® below, and talk with your doctor about whether this monthly product may be right for you.

How was the study set up?

A group of 444 adults living with schizophrenia were selected to participate in this 15-month study. These adults were often excluded from trials due to recent histories of arrest and jail time, prior self-reported substance or alcohol abuse, or who are currently homeless.

They were then divided into 2 treatment groups: 1 group took the once-monthly injection INVEGA SUSTENNA®, and the other group continued taking 1 of the 7 most common daily pills (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, or risperidone) prescribed by their doctor.

The rate of relapse was studied among these participants over 15 months. Relapse was defined as admission to a psychiatric hospital, arrests or jail time, suicide, quitting treatment due to safety or side effects, stopping or adding treatment because it wasn’t working, or seeking additional help to prevent hospitalization.

What was learned from the study?

At 15 months, patients in the INVEGA SUSTENNA® group experienced fewer relapses and a longer time to their first relapse compared to patients in the daily pills group.

INVEGA SUSTENNA®

39.8%

RATE OF RELAPSE

416DAYS

average time
to RELAPSE

MOST COMMONLY PRESCRIBED DAILY PILLS

53.7%

RATE OF RELAPSE

226DAYS

average time
to RELAPSE

What were the common side effects seen in this study?

INVEGA SUSTENNA®

Injection-site Pain Insomnia
Weight Increase

DAILY ORAL PILLS

Insomnia
Dry Mouth
Headache

 

Other common side effects seen in previous studies with INVEGA SUSTENNA® include:

  • Sleepiness/drowsiness
  • Dizziness
  • Restlessness/needing constant movement
  • Abnormal muscle movements including tremors (shaking), shuffling, uncontrolled involuntary movements, and abnormal eye movements

Please see Important Safety Information below for additional information.

Remember, your doctor is the best person to decide what treatment is appropriate for you, considering your medical and treatment history. Talk to your doctor about your options to treat schizophrenia.

References: 1. Alphs L, Benson C, Cheshire-Kinney K, et al. Real-world outcomes of paliperidone palmitate compared to daily oral antipsychotic therapy in schizophrenia: a randomized, open-label, review board–blinded 15-month study. J Clin Psychiatry. 2015;76(5):554-561.
2. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ. IMS Real-World Data. May 2010-December 2013.
3. INVEGA SUSTENNA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; January 2019

INDICATIONS

INVEGA SUSTENNA® (In-VEY-guh Suss-TEN-uh) (paliperidone palmitate) Extended-Release Injectable Suspension is a prescription medicine given by injection by a healthcare professional. INVEGA SUSTENNA® is used for schizoaffective disorder in adults, either alone or in combination with other medicines such as mood stabilizers or antidepressants, and is used to treat schizophrenia in adults.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about INVEGA SUSTENNA®?
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 SUSTENNA® is not for treating dementia-related psychosis.

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

Before you receive 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 SUSTENNA® will harm your unborn baby
    • If you become pregnant while taking 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 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 SUSTENNA® can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you receive 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 SUSTENNA®?

  • 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 SUSTENNA® affects you
  • avoid getting overheated or dehydrated

INVEGA SUSTENNA® may cause serious side effects, including:

  • See “What is the most important information I should know about 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 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 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 SUSTENNA® include: injection site reactions; sleepiness or drowsiness; dizziness; feeling 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 SUSTENNA®. For more information, ask your healthcare professional or pharmacist.

Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‑800‑FDA‑1088.

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

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INVEGA SUSTENNA® for a condition for which it was not prescribed. Do not give 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 SUSTENNA® that is written for healthcare professionals.

This Patient Information leaflet summarizes the most important information about 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.invegasustenna.com or call 1‑800‑526‑7736.

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

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