Perseris

Perseris is a prescription medication used to treat schizophrenia in adults.

Perseris belongs to a group of drugs called atypical antipsychotics. The exact way Perseris works is not understood but is believed to be related to its ability to bind to and block certain dopamine and serotonin receptors. 

This medication comes in an injectable form to be given directly under the skin in the stomach by a healthcare professional.

Common side effects of Perseris include weight gain, constipation, and bone and muscle pain. Perseris can also cause drowsiness. Do not drive or operate heavy machinery until you know how Perseris affects you.

Perseris is a prescription medication used to treat schizophrenia in adults.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Perseris. See the “Perseris Precautions” section.

Common side effects of Perseris include the following:

• Weight gain
• Constipation
• Drowsiness
• Pain in arms, leg, back or muscles
• Restlessness
• Feeling excessive worry or nervousness
• Pain or redness at the injection site

This is not a complete list of Perseris side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort
• medications that block a protein in the body (CYP2D6) such as quinidine (Qualaquin), fluoxetine (Prozac, Sarafem), amitriptyline (Elavil, Amitril, Amitid), and paroxetine (Paxil)
• medications that increase activity of dopamine such as carbidopa and levidopa.
• alcohol. This may increase nervous system disorders.
• medications that treat high blood pressure.

This is not a complete list of Perseris drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Perseris including the following:

• Stroke in elderly people (cerebrovascular problems) that can lead to death.
• Neuroleptic Malignant Syndrome (NMS). NMS is a rare but very serious problem that can lead to death. Seek medical attention right away if you have any of these symptoms: high fever, severe muscle stiffness, confusion, sweating, irregular heartbeat, fast heart rate, or changes in your blood pressure.
• Uncontrolled facial or body movements (tardive dyskinesia) that may not go away, even if you stop receiving Perseris. Tardive dyskinesia may also start after you stop receiving Perseris.
• Problems with your metabolism that may include high blood sugar (hyperglycemia), diabetes mellitus, changes in the fat levels in your blood (dyslipidemia), and weight gain. Extremely high blood sugar can lead to coma or death. If you have diabetes or are at risk for diabetes (e.g., obesity, family history of diabetes), your healthcare provider should check your blood sugar before you start and during treatment with Perseris. Call your healthcare provider if you have symptoms of high blood sugar including: feeling very thirsty, hungry, sick to your stomach, weak or tired, or confused; needing to urinate more than usual; or your breath smells fruity.
• High level of prolactin in your blood. Perseris may cause a rise in the blood levels of a hormone called prolactin that may cause side effects including missed menstrual periods, decreased fertility in women, leakage of milk from the breasts, development of breasts in men, or problems with erection.
• Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
• Falls. Antipsychotic medicines like Perseris may cause drowsiness or dizziness when you are standing, which could increase your risk for falls and related injuries.
• Low white blood cell count.
• Problems thinking clearly and moving your body. Do not drive, operate machinery, or do other dangerous activities until you know how Perseris affects you.
• Seizures (convulsions).
• Difficulty swallowing that can cause food or liquid to get into your lungs.
• Prolonged or painful erection lasting more than 4 hours. Call your healthcare provider or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours.
• Problems with control of your body temperature (too high or too low). Avoid getting overheated or dehydrated.

Perseris can cause drowsiness. Do not drive or operate heavy machinery until you know how Perseris affects you.

Do not drink alcohol during treatment with Perseris.

Do not take Perseris if you:

• are allergic to Perseris or to any of its ingredients
• are allergic to paliperidone
• have dementia-related psychosis

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Perseris, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Perseris, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have had Neuroleptic Malignant Syndrome.
• have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia).
• have diabetes or have a family history of diabetes.
• have had dizziness or fainting or are being treated for high blood pressure.
• have had a low white blood cell count.
• have or have had seizures or epilepsy.
• are pregnant or plan to become pregnant during treatment with Perseris. It is not known if Perseris will harm your unborn baby. Use of Perseris during the third trimester of pregnancy may cause side effects in the newborn infant, including agitation, abnormal muscle tone, tremor, drowsiness, difficulty feeding, and difficulty breathing. Seek medical attention if you notice these signs. If you become pregnant during treatment with Perseris, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics.
• are breastfeeding or plan to breastfeed. If you are receiving Perseris and are breastfeeding, monitor your infant for sleepiness, inadequate weight gain, jitteriness, tremors, and abnormal muscle movements. Seek medical care if you notice these signs.
• have or have had kidney or liver problems.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

It is not known if Perseris will harm your unborn baby. Use of Perseris during the third trimester of pregnancy may cause side effects in the newborn infant, including agitation, abnormal muscle tone, tremor, drowsiness, difficulty feeding, and difficulty breathing. Seek medical attention if you notice these signs. If you become pregnant during treatment with Perseris, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics, or call 1-866-961-2388.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Perseris has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Perseris, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered. If you are receiving Perseris and are breastfeeding, monitor your infant for sleepiness, inadequate weight gain, jitteriness, tremors, and abnormal muscle movements. Seek medical care if you notice these signs.

Receive Perseris exactly as prescribed.

Perseris comes in an injectable form to be given directly under the skin in the stomach area by healthcare professional once per month.

If you miss a dose, receive the next dose as soon as possible.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• Your previous oral risperidone dose (the active ingredient of Perseris)

The recommended dose of Perseris for the treatment of schizophrenia in adults is either 90 mg or 120 mg once monthly.

Patients who have never taken risperidone must establish tolerability with oral risperidone before starting Perseris.

If Perseris is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Do not rub or massage the injection site. Do not place belts or clothing waistbands on the injection site.

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. PERSERISTM is not approved for the treatment of patients with dementia-related psychosis and has not been studied in this population.