Invega Sustenna

DRUG DESCRIPTION

INVEGA® SUSTENNA® contains paliperidone palmitate. The active ingredient, paliperidone palmitate, is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. INVEGA® SUSTENNA® contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C39H57FN4O4 and its molecular weight is 664.89. The structural formula is:

INVEGA® SUSTENNA® (paliperidone palmitate) Structural Formula Illustration

Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate.

INVEGA® SUSTENNA® is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in dose strengths of 39 mg, 78 mg, 117 mg, 156 mg, and 234 mg paliperidone palmitate. The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive ingredients are polysorbate 20, polyethylene glycol 4000, citric acid monohydrate, disodium hydrogen phosphate anhydrous, sodium dihydrogen phosphate monohydrate, sodium hydroxide, and water for injection.

INVEGA® SUSTENNA® is provided in a prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains 2 safety needles (a 1 ?-inch 22 gauge safety needle and a 1-inch 23 gauge safety needle).

What are the precautions when taking paliperidone palmitate extended-release injectable suspension (Invega Sustenna)?

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, a severe loss of body water (dehydration), low white blood cell count (leukopenia), seizures, Parkinson's disease, Alzheimer's disease, heart/blood vessel disease (such as stroke, heart attack), breast cancer.

Also tell your doctor or pharmacist if you or a family member has a history of the following: diabetes, obesity.

Paliperidone may cause...

Read All Potential Precautions of Invega Sustenna »


Invega Sustenna Consumer (continued)

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, fast/slow/irregular 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 drug may infrequently cause a serious (rarely fatal) nervous system disorder (neuroleptic malignant syndrome). Get medical help right away if you notice any of the following rare but very serious side effects: muscle stiffness/pain, high fever, increased sweating, mental/mood changes, 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.

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, a severe loss of body water (dehydration), low white blood cell count (leukopenia), seizures, Parkinson's disease, Alzheimer's disease, heart/blood vessel disease (such as stroke, heart attack), breast cancer.

Also tell your doctor or pharmacist if you or a family member has a history of the following: 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 require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using paliperidone, tell your doctor or pharmacist 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 drug can make you more likely to get heat stroke. Avoid activities that may cause you to overheat (such as strenuous work, exercising in hot weather, using hot tubs). Drink plenty of fluids, dress lightly, and stay in cool/air-conditioned areas when the weather is hot.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking this medication unless directed by your doctor. 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 anytime during their first month, tell the doctor right away.

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



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