Patient information: uses, side effects, how to take - Invega Sustenna
What is the most important information I should know about INVEGA SUSTENNA?
INVEGA SUSTENNA 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 SUSTENNA is not for treating dementia-related psychosis.
What is INVEGA SUSTENNA?
INVEGA SUSTENNA is a prescription medicine given by injection by a healthcare professional and used to treat:
- schizophrenia in adults
- schizoaffective disorder in adults either alone or with other medicines such as mood stabilizers or antidepressants
It is not known if INVEGA SUSTENNA is safe and effective in children under 18 years of age.
Who should not receive INVEGA SUSTENNA?
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 this Patient Information leaflet for a complete list of ingredients in INVEGA SUSTENNA.
What should I tell my healthcare provider before receiving INVEGA SUSTENNA?
Before you receive INVEGA SUSTENNA, 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
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 provider 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 provider know if these symptoms occur.
- are breastfeeding or plan to breastfeed. INVEGA SUSTENNA can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive INVEGA SUSTENNA.
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.
How will I receive INVEGA SUSTENNA?
- Follow your INVEGA SUSTENNA treatment schedule exactly as your healthcare provider tells you to.
- Your healthcare provider will tell you how much INVEGA SUSTENNA you will receive and when you will receive it.
- INVEGA SUSTENNA is given as an injection by your healthcare provider into the muscle (intramuscularly) of your arm or your buttocks.
- When you receive your first dose of INVEGA SUSTENNA you will need to get a second dose 1 week later. After that you will only need to get a dose 1 time a month.
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.
What are the possible side effects of INVEGA SUSTENNA?
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 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 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 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 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 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 SUSTENNA. 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.
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 provider 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 provider.
You can ask your healthcare provider 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.
What are the ingredients in INVEGA SUSTENNA?
Active ingredient: paliperidone palmitate
Inactive ingredients: polysorbate 20, polyethylene glycol 4000, citric acid monohydrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide, and water for injection
Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560, USA
For patent information: www.janssenpatents.com
© Johnson & Johnson and its affiliates 2009
INSTRUCTIONS FOR USE
INVEGA SUSTENNA ®
(paliperidone palmitate)
extended-release injectable suspension
Rx only
Single use only
PLEASE READ COMPLETE INSTRUCTIONS PRIOR TO USE
For deltoid and gluteal intramuscular injection only
Please see accompanying full Package Insert.
IMPORTANT RESOURCES
For additional information, visit www.invegasustenna.com or call Janssen Pharmaceuticals, Inc. at 1-800-526-7736.
Kit contents
Each injection must be administered only by a health care professional. The kit contains a prefilled syringe and 2 safety needles (a 1 ½-inch 22 gauge needle and a 1-inch 23 gauge needle) for intramuscular injection. INVEGA SUSTENNA is for single use only.
INVEGA SUSTENNA is intended for intramuscular use only. Inject slowly, deep into the muscle. Care should be taken to avoid inadvertent injection into a blood vessel. Each injection should be administered by a health care professional. Administration should be in a single injection. Do not administer the dose in divided injections. Do not administer intravascularly or subcutaneously.
INSTRUCTIONS FOR USE
- Shake the syringe vigorously for a minimum of 10 seconds to ensure a homogeneous suspension.
Select the appropriate needle.
For DELTOID injection:
- If the patient weighs less than 90 kg, use the 1-inch 23 gauge needle (needle with blue colored hub).
- If the patient weighs 90 kg or more, use the 1 ½-inch 22 gauge needle (needle with gray colored hub).
For GLUTEAL injection:
Use the 1 ½-inch 22 gauge needle (needle with gray colored hub) regardless of patient's weight.
- Hold the syringe with the tip cap pointing up. Remove the rubber tip cap with a gentle twisting motion.
- Peel the safety needle pouch half way open. Grasp the needle sheath using the plastic peel pouch. Hold the syringe pointing up. Attach the safety needle to the syringe using a gentle twisting motion to avoid needle hub cracks or damage. Always check for signs of damage or leaking prior to administration.
- Pull the needle sheath away from the needle with a straight pull. Do not twist the sheath as the needle may be loosened from the syringe.
- Bring the syringe with the attached needle in upright position to de-aerate. De-aerate the syringe by moving the plunger rod carefully forward.
- Inject the entire contents intramuscularly slowly, deep into the selected deltoid or gluteal muscle of the patient. Do not administer by any other route.
- After the injection is complete, use either thumb or finger of one hand (h1, h2) or a flat surface (h3) to activate the needle protection system. The needle protection system is fully activated when a 'click' is heard. Discard the syringe with needle appropriately.
Keep out of reach of children.
| h1 | |
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| h2 | |
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| h3 | |
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Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560, USA
For patent information: www.janssenpatents.com
© Johnson & Johnson and its affiliates 2009
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 2/2025