INVEGA SUSTENNA ® 100 MG / ML ( PALIPERIDONE PALMITATE ) IM PRE-FILLED SYRINGE

Invega Sustenna Overview & Usage

IMPORTANT:
HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PALIPERIDONE - INJECTION

(PAL-ee-PER-i-done)

COMMON BRAND NAME(S): Invega Sustenna

WARNING:
There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.

USES:
This medication is used to treat certain mental/mood disorders (such as schizophrenia, schizoaffective disorder). Paliperidone is an antipsychotic drug (atypical type). It works by helping to restore the balance of certain natural chemicals (neurotransmitters) in the brain.

This medication can decrease hallucinations and help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life.

HOW TO USE:
Read the Patient Information Leaflet provided by your pharmacist before you start using paliperidone and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

This medication is given by injection into a muscle (upper arm or buttocks) by a health care professional. The first 2 doses are usually given 1 week apart, in the upper arm. After the first 2 doses, the medication is usually given into the upper arm or buttocks every month or as directed by your doctor.

Dosage is based on your medical condition and response to treatment.

Use this medication regularly in order to get the most benefit from it. To help you remember, mark the days on the calendar when you need to receive the medication.

Continue using this medication exactly as prescribed, even if you are feeling better and thinking more clearly. Do not stop using this medication without first consulting your doctor.

Tell your doctor if your condition persists or worsens.

Invega Sustenna Side Effects & Precautions
SIDE EFFECTS:
Drowsiness, dizziness, lightheadedness, weight gain, or pain/redness/swelling at the injection site may occur. If any of these side effects persist or worsen, tell your doctor promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: difficulty swallowing, restlessness, muscle spasms, signs of infection (such as fever, persistent sore throat).

Get medical help right away if any of these rare but serious side effects occur: fainting, severe dizziness, slow heartbeat, seizures.

Paliperidone may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any unusual/uncontrolled movements (especially of the face, lips, mouth, tongue, arms, or legs).

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, change in the amount of urine.

This drug may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugar level regularly.

This drug may also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor. (See also Notes section.)

Rarely, this medication may increase your blood level of a certain hormone (prolactin). In females, an increase in prolactin levels may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. In males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.

For males, in the very unlikely event you have a painful or prolonged erection (lasting more than 4 hours), stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS:
See also Warnings section.

Before using paliperidone, tell your doctor or pharmacist if you are allergic to it; or to risperidone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, low white blood cell count (leukopenia), seizures, Parkinson's disease, dementia, certain eye problems (cataracts, glaucoma).

Also tell your doctor or pharmacist if you or a family member has a history of the following: high blood cholesterol/triglyceride levels, heart disease (such heart attack), high blood pressure, diabetes, obesity.

Paliperidone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using paliperidone, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using paliperidone safely.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. These effects are more likely to occur in the first few days after starting/restarting the drug or after your dose increases.

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

Before having surgery (including cataract/glaucoma eye surgery), tell your doctor or dentist if you are using or have ever used this medication, and about all the other products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away.

Since untreated mental/mood problems (such as schizophrenia, schizoaffective disorders) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Invega Sustenna Missed Dose
DRUG INTERACTIONS:
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
A product that may interact with this drug is: metoclopramide.

Many drugs besides paliperidone may affect the heart rhythm (QT prolongation), including amiodarone, chlorpromazine, moxifloxacin, quinidine, sotalol, procainamide, thioridazine, among others.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).

Check the labels on all your medicines (such as cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Paliperidone is very similar to risperidone. Do not use medications containing risperidone while using paliperidone.

OVERDOSE:
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness/dizziness, fast/irregular heartbeat, muscle stiffness/spasms, restlessness, unusual/uncontrolled movements.

NOTES: Laboratory and/or medical tests (such as fasting blood sugar, kidney function, cholesterol/triglyceride levels, blood pressure, weight) may be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE:
For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.

STORAGE:
Not applicable. This medication is given in a clinic or doctor's office and will not be stored at home.

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