Invega Sustenna is an extended-release antipsychotic medicine given by intramuscular injection.

Invega Sustenna is prescription medicine used to treat schizophrenia in adults.

Invega Sustenna is also used alone or with other medicines to treat schizoaffective disorder in adults.

When you receive your first dose of Invega Sustenna you will need to get a second dose one week later. After that you will only need to get one injection each month.

Invega Sustenna is not approved for use in older adults with dementia-related psychosis.

Dizziness, sleepiness, and feeling less stable may happen with Invega Sustenna. This may lead to falling, which can cause broken bones or other health problems. To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.

Some people may get a severe muscle problem called tardive dyskinesia. This problem may lessen or go away after stopping Invega Sustenna, but it may not go away. The risk is greater with diabetes and in older adults, especially older women. The risk is greater with longer use or higher doses, but it may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.

Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of infection. Rarely, infections have been deadly. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.

Invega Sustenna is injected into a muscle. A healthcare provider will give you this injection.

Invega Sustenna is usually given only once per month, but the first two doses are given 1 week apart. Invega Trinza is usually given once every 3 months, after you have used Invega Sustenna for at least 4 months in a row.

Follow your doctor's dosing instructions very carefully. Get your Invega Sustennas regularly to get the most benefit.

Your doctor will need to check your progress while you are using Invega Sustenna.

Usual Adult Dose of Invega Sustenna for Schizophrenia:

1-month extended-release injectable suspension:
-For patients who have never taken oral paliperidone or oral or injectable risperidone, tolerability should be established with oral paliperidone or oral risperidone prior to initiating treatment with paliperidone extended-release injectable suspension.
-Dosing in the US and Canada is the same; however, paliperidone extended-release injectable suspension is dosed as the salt (paliperidone palmitate) in the US and as the base (paliperidone) in Canada:

Paliperidone palmitate:
-Initial dose: 234 mg IM on day 1 followed by 156 mg IM one week later; administer IM into deltoid muscle
-Maintenance dose: 117 mg IM monthly; administer into deltoid or gluteal muscle
-Dose range: 39 to 234 mg based on patient tolerability and efficacy; dose adjustments may be made monthly, although full effect may not be evident for several months
-Maximum dose: 234 mg/month

Paliperidone (base):
-Initial dose: 150 mg IM on day 1 followed by 100 mg IM one week later; administer IM into deltoid muscle
-Maintenance dose: 75 mg IM monthly; administer into deltoid or gluteal muscle
-Dose range: 25 to 150 mg based on patient tolerability and efficacy; dose adjustments may be made monthly, although full effect may not be evident for several months

Comments:
-The dosing window for maintenance doses is 7 days before or after monthly time point.
-If a dose is missed during initial titration or maintenance dosing, see dosage adjustment section for guidance.

Usual Adult Dose od Invega Sustenna for Schizoaffective Disorder:

1-month extended-release injectable suspension::
-For patients who have never taken oral paliperidone or oral or injectable risperidone, tolerability should be established with oral paliperidone or oral risperidone prior to initiating treatment with paliperidone extended-release injectable suspension.
-Dosing in the US and Canada is the same; however, paliperidone extended-release injectable suspension is dosed as the salt (paliperidone palmitate) in the US and as the base (paliperidone) in Canada:

Paliperidone palmitate:
-Initial dose: 234 mg IM on day 1 followed by 156 mg IM one week later; administer IM into deltoid muscle
-Dose range: 78 to 234 mg based on patient tolerability and efficacy; dose adjustments may be made monthly, although full effect may not be evident for several months
-Maximum dose: 234 mg/month

Paliperidone (base):
-Initial dose: 150 mg IM on day 1 followed by 100 mg IM one week later; administer IM into deltoid muscle
-Dose range: 50 to 150 mg based on patient tolerability and efficacy; dose adjustments may be made monthly, although full effect may not be evident for several months

Comments:
-The dosing window for maintenance doses is 7 days before or after monthly time point.
-If a dose is missed during initial titration or maintenance dosing, see dosage adjustment section for guidance.

Use: Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants

You should not use Invega Sustenna if you are allergic to Invega Sustenna or to risperidone (Risperdal).

Invega Sustenna may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

High doses or long-term use of paliperidone can cause a serious movement disorder that may not be reversible. The longer you use Invega Sustenna, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Before you receive your first injection, tell your doctor if you have never taken oral (by mouth) Invega Sustenna or risperidone.

To make sure Invega Sustenna is safe for you, tell your doctor if you have ever had:

• heart problems, or a heart attack;

• long QT syndrome (in you or a family member);

• high or low blood pressure, or fainting spells;

• low white blood cell (WBC) counts;

• a serious neurologic disorder caused by taking an antipsychotic medicine;

• uncontrolled muscle movements in your face;

• liver or kidney disease;

• seizures or epilepsy;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• diabetes (paliperidone may raise your blood sugar); or

• breast cancer.

Tell your doctor if you are pregnant or plan to become pregnant while using Invega Sustenna.

Using antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. However, you may have withdrawal symptoms or other problems if you stop using your medicine during pregnancy. If you get pregnant, tell your doctor right away. Do not stop using Invega Sustenna without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of paliperidone on the baby.

It may not be safe to breastfeed while using Invega Sustenna. Ask your doctor about any risk.

Invega Sustenna is not approved for use by anyone younger than 18 years old.

Call your doctor for instructions if you miss an appointment for your Invega Sustenna.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include a headache with chest pain, fast or pounding heartbeats, and severe dizziness.

Avoid drinking alcohol. Dangerous side effects could occur.

While you are using Invega Sustenna, you may be more sensitive to very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

Avoid driving or hazardous activity until you know how Invega Sustenna will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Get emergency medical help if you have signs of an allergic reaction to Invega Sustenna: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have any of these signs of a serious movement disorder:

• tremors or shaking in your arms or legs;

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or

• any new or unusual muscle movements you cannot control.

Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• trouble swallowing;

• a seizure (convulsions);

• breast swelling (in women or men), nipple discharge;

• changes in menstrual periods;

• impotence, or penis erection that is painful or lasts 4 hours or longer;

• weight gain;

• fever, chills, sore throat, mouth sores, feeling light-headed;

• high blood sugar - increased thirst, increased urination, hunger, fruity breath odor; or

• severe nervous system reaction - very stiff (rigid) muscles, high fever, fast or pounding heartbeats, fainting.

Common Invega Sustenna side effects may include:

• dizziness, drowsiness;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• feeling restless or anxious;

• muscle stiffness, tremors or shaking;

• uncontrolled muscle movements, trouble with walking, balance, or speech;

• abnormal movements of your eyes;

• weight gain;

• upset stomach, constipation;

• fast heart rate; or

• pain or tenderness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect Invega Sustenna. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.