Invega Hafyera (injection)

Paliperidone is used in adults to treat schizophrenia.

Paliperidone may also be used in adults, either alone or with other medicines, to treat schizoaffective disorder.

Paliperidone may also be used for reasons that are not mentioned in this medication guide.

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

You should not use this medicine if you are allergic to paliperidone, risperidone, or any of its ingredients.

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

Tell your doctor if you have or have ever had:

• heart problems including heart failure, heart attack, irregular heartbeats, and long QT syndrome (in you or a family member);
• a stroke, a TIA, or "mini-stroke";
• trouble swallowing;
• dizziness, fainting, high or low blood pressure;
• low white blood cell (WBC) counts;
• abnormal prolactin levels;
• high cholesterol or triglycerides;
• a nervous system reaction associated with antipsychotic medication use;
• Parkinson's disease or a type of dementia called Lewy body dementia;
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• seizures or epilepsy;
• an electrolyte imbalance (such as low blood levels of potassium or magnesium);
• diabetes (in you or a family member);
• breast cancer;
• dehydration;
• any other medical condition or take any other medicine; or
• liver or kidney disease.

Using antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine 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.

If you are breastfeeding, tell your doctor if you notice drowsiness, irregular growth, tremors, and abnormal muscle movements in the nursing baby.

It may be harder for you to get pregnant while you are using this medicine.

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

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

Invega Hafyera may cause serious side effects. Call your doctor immediately if you have:

• low blood pressure, fast or pounding heartbeats, fluttering in your chest, shortness of breath, sudden dizziness (like you might pass out);
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• problems with thinking or moving your body;
• trouble swallowing;
• issues controlling your body temperature (feeling too warm), feeling unusually hot or cold;
• seizures (convulsions);
• breast swelling and tenderness, nipple discharge, loss of interest in sex, impotence, erectile dysfunction, difficulty having an orgasm, missed menstrual periods;
• high cholesterol, weight gain;
• low white blood cell counts—fever, mouth sores, skin sores, sore throat, cough;
• signs of infection—fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
• high blood sugar—increased thirst, increased urination, dry mouth, fruity breath odor;
• severe nervous system reaction—very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out; or
• a painful or prolonged erection (lasting more than 4 hours).

Common side effects of Invega Hafyera may include:

• pain, bruising, swelling, or irritation where the medicine was injected;
• headache, dizziness, drowsiness;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• feeling restless;
• muscle stiffness;
• uncontrolled muscle movements, tremors or shaking;
• problems with balance or eye movement; or
• weight gain.

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.

Paliperidone is injected into a muscle. A healthcare provider will give you this injection if you are unable to take the medicine by mouth.

You may need to take paliperidone or risperidone by mouth (in tablet or liquid form) before you receive your first injection. Follow your doctor's dosing instructions very carefully.

Your dose schedule may change if you switch to a different brand form or strength of this medicine. Follow your doctor's instructions about your dosing schedule.

Your doctor will need to check your progress on a regular basis, and you may need other medical tests.

Call your doctor for instructions if you miss an appointment for your paliperidone (injection).

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

• Avoid drinking alcohol. Dangerous side effects could occur.

• Avoid becoming overheated or dehydrated during exercise and in hot weather. Paliperidone can decrease sweating and you may be more prone to heat stroke. Drink plenty of liquids while you are receiving paliperidone.

• Avoid driving or hazardous activity until you know how this medicine will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

When you start or stop taking paliperidone, your doctor may need to change the doses of other medicines you take regularly.

Paliperidone can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using paliperidone with other drugs that make you sleepy or lower your blood pressure can make this effect worse. Ask your doctor before using blood pressure medication, opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can affect paliperidone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you take.