Invega (Paliperidone)

Invega is not recommended:

• If you are allergic to paliperidone or risperidone (Rispersdal) or have had an allergic reaction to Invega or ingredients in Invega
• If you suffer from dementia or dementia-related psychosis
• If you are pregnant or breastfeeding
• For patients under 12 years of age

Indications

Invega is approved for the treatment of schizophrenia in adults and adolescents who are at least 12 years old.

How is Invega used?

Storage

Invega should be stored at room temperature in the original package between 68°F and 77°F (20°C and 25°C) away from moisture and light. Do not store it in the bathroom.

Keep out of reach of children.

Instructions

Take Invega by mouth, as directed by your doctor, with or without food in the mornings. Swallow the tablet whole with liquid. Do not chew, split, or crush the tablet. Do not take any broken Invega tablets.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, only take one dose. Do not catch up by taking two doses at once.

Do not change your dosage, take more than what is prescribed, or stop using Invega without consulting with your doctor. If you took more than prescribed, contact your doctor immediately or seek emergency medical care.

Dosage

Invega is available in extended-release tablet form in the following strength: 1.5 mg, 3 mg, 6 mg and 9 mg. For adults, the usual starting dose is 6 mg once a day. The maximum recommended dose is 12 mg per day.

For adolescents, the recommended starting dose is 3 mg once a day. A higher dosage is not recommended.

Side Effects

It’s important to understand that although Invega is FDA-approved, it comes with side effects that may or may not affect you.

Before starting Invega, you should discuss possible side effects with your doctor or pharmacist.

Common Side Effects

Not all side effects require medical attention. As your body adjusts to Invega, side effects may go away. Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own.

• Drowsiness, fatigue or weakness
• Dizziness
• Anxiety
• Muscle stiffness, tremors or shaking
• Uncontrolled muscle movements, trouble with walking, balance or speech
• Upset stomach, stomach ache or constipation
• Weight gain
• Increased cholesterol
• Irregular heart rate
• Stuffy nose
• Sore throat
• Dry mouth
• Excess saliva/drooling
• Headache
• Empty tablet shell in your stool, but this is harmless

Serious Side Effects

Severe adverse reactions while taking Invega may occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:

• Serious movement disorders: tremors or shaking in arms or legs, uncontrolled muscle movement in face (chewing, frowning, blinking, etc.), any new, unusual or uncontrolled muscle movements.
• Fast/pounding heartbeats: fluttering, shortness of breath and sudden dizziness.
• Breast swelling: can occur in men and woman, nipple discharge.
• Change in menstrual periods.
• Impotence, painful erection or lasting more than 4 hours.
• Kidney or liver problems: change in the amount of urine or it’s very dark.
• Low white blood cell counts: fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing.
• High blood sugar: increased thirst, increased urination, hunger, fruity breath odour.
• Severe nervous system reaction: very stiff muscles, high fever, fast/pounding heartbeats, fainting.
• Serious allergic reaction: fever, swollen lymph nodes, itching, swelling, severe dizziness, trouble breathing.

The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.

Warnings & Precautions

Before using Invega, tell your doctor or pharmacist:

• If you are allergic to Invega or any ingredients in Invega
• If you are allergic to Rispersdal (risperidone) or any ingredients in Rispersdal
• If you suffer from dementia or dementia-related psychosis
• If you have ever experienced a serious neurological disorder caused by antipsychotic medicines
• If you are pregnant or plan to become pregnant
• If you are breastfeeding or plan to breastfeed
• If you have ever had any heart problems, high/low blood pressure, low white blood cell counts, suffered seizures or epilepsy, diabetes or breast cancer

Body temperature

While taking Invega, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, overheated or dehydrated. Drink lots of fluids, especially when it is hot and during exercise.

Dizziness

Avoid getting up too fast from a sitting or lying position to reduce your chance of feeling dizzy.

Alcohol

If you drink alcohol while taking Invega, you may have an increased risk of developing dangerous side effects.

Pregnant or Planning to Become Pregnant

Taking Invega during the last 3 months of pregnancy can cause the newborn baby to suffer from breathing difficulties, feeding problems or withdrawal symptoms.

If you are pregnant or plan to become pregnant, do not stop using Invega without speaking to your doctor. It can cause withdrawal symptoms or other problems.

In female patients, Invega can cause missed periods, it can completely stop or you can struggle to fall pregnant.

Male patients may experience a decreased sexual ability, inability to produce sperm or develop enlarged breasts.

Breastfeeding or Planning to Breastfeed

Invega can pass into human milk, Please speak to your doctor about the risks and benefits of breastfeeding while using Invega, and any potential adverse effects on the breastfed child.

Interactions & Contraindications

Before using Invega, tell your doctor or pharmacist if you take any medications, herbal supplements, or vitamins.

Dementia

Invega should not be used if you suffer from psychotic conditions related to dementia. It may cause sudden death, heart failure or pneumonia in older adults with dementia-related psychosis.

Risperidone (Rispersdal)

The active ingredient of Invega, paliperidone is a metabolite of risperidone. If you take Invega with risperidone, it can increase your risk of developing an irregular heart rhythm. This may be serious and potentially life-threatening.

Metoclopramide

Invega may interact with metoclopramide, a medication used to treat stomach and intestinal conditions. You may develop tardive dyskinesia, a potentially permanent condition that causes uncontrolled facial movements.

Frequently Asked Questions