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Important Safety Information and Indication for NUPLAZID (pimavanserin) 17-mg Tablets

Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking antipsychotic drugs are at an increased risk of death. NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.

NUPLAZID may cause serious side effects including:

QT Interval Prolongation: NUPLAZID may increase the risk of changes to your heart rhythm. This risk may increase if NUPLAZID is taken with certain other medications known to change heart rhythm. Tell your healthcare provider about all the medicines you take or have recently taken.

It is important to talk to your healthcare provider about the possible side effect of changes to your heart rhythm. Call your healthcare provider right away if you feel a change in your heartbeat.

Do not take NUPLAZID if you have certain kinds of heart conditions such as:

  • An irregular heartbeat
  • A slow heart rate

Before taking NUPLAZID, tell your healthcare provider if you have:

  • Reduced kidney function. NUPLAZID is not recommended if you have severe kidney problems.
  • Reduced liver function. NUPLAZID is not recommended if you have liver problems.

Other medicines may affect how NUPLAZID works. Some medicines should not be taken with NUPLAZID. Your healthcare provider can tell you if it is safe to take NUPLAZID with your other medicines. Do not start or stop any medicines while taking NUPLAZID without talking to your healthcare provider first.

The most common side effects of NUPLAZID include swelling in the legs or arms, nausea, confusion, hallucination, constipation, and changes to normal walking. These are not all the possible side effects of NUPLAZID. For more information, ask your healthcare provider about this medicine.

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if NUPLAZID may harm your unborn baby.

It is not known if NUPlAZID is safe and effective in people under 18 years of age.

Dosage and Administration

The recommended dose of NUPLAZID is 34 mg once per day, taken as two 17-mg tablets.

Indication

NUPLAZID is a prescription medicine used to treat hallucinations and delusions associated with Parkinson's disease psychosis.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You can also call ACADIA Pharmaceuticals Inc. at 1-844-4ACADIA (1-844-422-2342).

This website is intended for use by US residents.

Important Safety Information and Indication for NUPLAZID (pimavanserin) 17-mg Tablets

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. NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.

QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics. NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.

Adverse Reactions: The most common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).

Drug Interactions: Strong CYP3A4 inhibitors (eg, ketoconazole) increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half. Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for reduced efficacy. Increase in NUPLAZID dosage may be needed.

Renal Impairment: No dosage adjustment for NUPLAZID is needed in patients with mild to moderate renal impairment. Use of NUPLAZID is not recommended in patients with severe renal impairment.

Hepatic Impairment: Use of NUPLAZID is not recommended in patients with hepatic impairment. NUPLAZID has not been evaluated in this patient population.

Pregnancy: Use of NUPLAZID in pregnant women has not been evaluated and should therefore be used in pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

Pediatric Use: Safety and efficacy have not been established in pediatric patients.

Dosage and Administration

Recommended dose: 34 mg per day, taken orally as two 17-mg tablets once daily, without titration.

Indication

NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You can also call ACADIA Pharmaceuticals Inc. at 1-844-4ACADIA (1-844-422-2342).

This website is intended for use by US healthcare professionals only.

+ See more - See less

Important Safety Information and Indication for NUPLAZID (pimavanserin) 17-mg Tablets

Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking antipsychotic drugs are at an increased risk of death. NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.

NUPLAZID may cause serious side effects including:

QT Interval Prolongation: NUPLAZID may increase the risk of changes to your heart rhythm. This risk may increase if NUPLAZID is taken with certain other medications known to change heart rhythm. Tell your healthcare provider about all the medicines you take or have recently taken.

It is important to talk to your healthcare provider about the possible side effect of changes to your heart rhythm. Call your healthcare provider right away if you feel a change in your heartbeat.

Do not take NUPLAZID if you have certain kinds of heart conditions such as:

  • An irregular heartbeat
  • A slow heart rate

Before taking NUPLAZID, tell your healthcare provider if you have:

  • Reduced kidney function. NUPLAZID is not recommended if you have severe kidney problems.
  • Reduced liver function. NUPLAZID is not recommended if you have liver problems.

Other medicines may affect how NUPLAZID works. Some medicines should not be taken with NUPLAZID. Your healthcare provider can tell you if it is safe to take NUPLAZID with your other medicines. Do not start or stop any medicines while taking NUPLAZID without talking to your healthcare provider first.

The most common side effects of NUPLAZID include swelling in the legs or arms, nausea, confusion, hallucination, constipation, and changes to normal walking. These are not all the possible side effects of NUPLAZID. For more information, ask your healthcare provider about this medicine.

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if NUPLAZID may harm your unborn baby.

It is not known if NUPlAZID is safe and effective in people under 18 years of age.

Dosage and Administration

The recommended dose of NUPLAZID is 34 mg once per day, taken as two 17-mg tablets.

Indication

NUPLAZID is a prescription medicine used to treat hallucinations and delusions associated with Parkinson's disease psychosis.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You can also call ACADIA Pharmaceuticals Inc. at 1-844-4ACADIA (1-844-422-2342).

This website is intended for use by US residents.

Important Safety Information and Indication for NUPLAZID (pimavanserin) 17-mg Tablets

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. NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.

QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics. NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.

Adverse Reactions: The most common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).

Drug Interactions: Strong CYP3A4 inhibitors (eg, ketoconazole) increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half. Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for reduced efficacy. Increase in NUPLAZID dosage may be needed.

Renal Impairment: No dosage adjustment for NUPLAZID is needed in patients with mild to moderate renal impairment. Use of NUPLAZID is not recommended in patients with severe renal impairment.

Hepatic Impairment: Use of NUPLAZID is not recommended in patients with hepatic impairment. NUPLAZID has not been evaluated in this patient population.

Pregnancy: Use of NUPLAZID in pregnant women has not been evaluated and should therefore be used in pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

Pediatric Use: Safety and efficacy have not been established in pediatric patients.

Dosage and Administration

Recommended dose: 34 mg per day, taken orally as two 17-mg tablets once daily, without titration.

Indication

NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You can also call ACADIA Pharmaceuticals Inc. at 1-844-4ACADIA (1-844-422-2342).

This website is intended for use by US healthcare professionals only.