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Precautions and Warnings With Paliperidone Palmitate

Specific Paliperidone Palmitate Warnings and Precautions

Some warnings and precautions to be aware of prior to receiving this medication include the following:
 
  • Antipsychotic medications, including paliperidone palmitate, have been associated with an increased risk for strokes or death when used to treat behavioral and mental health problems caused by dementia. Some reported deaths were due to strokes and infections. The potential benefits of using antipsychotics in people with dementia must be carefully weighed against the risks. No antipsychotic is approved to treat the behavioral symptoms of dementia.
 
  • Like other antipsychotic medications, paliperidone palmitate may cause a rare but life-threatening problem known as neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you develop signs of NMS, which may include:
 
    • A high fever or sweating
    • Confusion
    • Muscle stiffness
    • A fast or irregular heartbeat (pulse).
 
  • This medication may cause a change in the electrical activity of your heart known as QT prolongation, which could lead to life-threatening heart rhythm problems. Certain people may have an increased risk for QT prolongation, including those with long QT syndrome, a low heart rate, low blood levels of potassium or magnesium, or people who take other medicines that may cause QT prolongation (see Drug Interactions With Paliperidone Palmitate).
 
  • Antipsychotic medications, including paliperidone palmitate, can cause a potentially irreversible movement disorder known as tardive dyskinesia. This disorder involves uncontrollable facial, tongue, or body movements.

The risk for tardive dyskinesia increases with age and increasing dose and duration of antipsychotic use; however, it can happen in anyone and at any dose. There is no well-established treatment for this condition. Tell your healthcare provider if you experience any abnormal movements during paliperidone palmitate treatment.

  • Paliperidone palmitate may cause high blood glucose (blood sugar levels), high lipids, and weight gain. These side effects can increase your risk for other problems, including heart disease and strokes. Your healthcare provider will monitor your blood sugar levels, cholesterol, and weight during treatment. You may need to take other medicines to help control these problems if they occur.
 
  • This drug may increase the level of prolactin, a hormone in the body. Tell your healthcare provider if you have signs of high prolactin levels, such as breast enlargement, tenderness, or discharge.
 
  • Some people who use paliperidone palmitate may experience dizziness and lightheadedness, especially when rising from a seated or lying position. Dehydration, which can happen if you do not drink enough fluids or have extreme diarrhea or vomiting, can make this effect worse. Try to stay hydrated while using this medicine. Also, sit or stand slowly to help minimize this side effect.
 
  • Paliperidone palmitate may decrease white blood cell counts, which could increase your risk for developing an infection. If you already have low white blood cell counts, your healthcare provider will monitor your white blood cell counts frequently during the first few months of treatment. Tell your healthcare provider if you develop signs of infection, such as:
 
 
  • This medication can make you drowsy and dizzy, which could affect your thinking, judgment, and motor skills. Do not perform any activities that require mental alertness, such as driving, until you know how this medication affects you. Also, avoid drinking alcohol during paliperidone palmitate treatment, as alcohol can make these effects worse.
 
  • There have been rare reports of seizures occurring in clinical trials of paliperidone palmitate. Make sure your healthcare provider knows if you have a history of seizures before you receive this medicine.
 
  • Paliperidone palmitate may cause difficulty swallowing, which could cause you to inhale food (known as aspiration). Aspiration may increase the risk for pneumonia in certain people, especially older adults with advanced dementia.
 
  • In rare cases, this product may cause a prolonged and painful erection (known medically as priapism). If not treated quickly, priapism can lead to permanent problems, including impotence. Although it may seem embarrassing, it is important to seek immediate medical attention if you have a prolonged or painful erection lasting four hours or longer.
 
  • People who use this medication may become overheated more easily when exercising or exposed to high temperatures. Being dehydrated can make this effect more severe. Take care to stay hydrated and to avoid becoming overheated during paliperidone palmitate treatment.
 
 
  • This medication passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to receiving the drug (see Invega Sustenna and Breastfeeding).
 
  • Paliperidone palmitate is a pregnancy Category C medication. This means that it may not be safe for use during pregnancy, although the full risks are currently unknown (see Invega Sustenna and Pregnancy).
 
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