Nuplazid

What Is Nuplazid?

Nuplazid (pimavanserin) is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

What Are Side Effects of Nuplazid?

Common side effects of Nuplazid include:

• nausea
• constipation
• swelling of the extremities
• walking abnormally (gait disturbance)
• hallucinations
• confusion

Dosage for Nuplazid

The recommended dose of Nuplazid is 34 mg, taken orally as two 17 mg strength tablets once daily, without titration.

What Drugs, Substances, or Supplements Interact with Nuplazid?

Nuplazid may interact with antiarrhythmics, azole antifungals, clarithromycin, indinavir, rifampin, carbamazepine, phenytoin, and St. John's wort. Tell your doctor all medications and supplements you use.

Nuplazid During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant during treatment with Nuplazid; it is unknown if it would harm a fetus. It is unknown if Nuplazid passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Nuplazid (pimavanserin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Nuplazid Consumer Information

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

Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest;
• shortness of breath; or
• sudden dizziness (like you might pass out).

Common side effects may include:

• confusion; or
• swelling in your hands or feet.

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.

Read the entire detailed patient monograph for Nuplazid (Pimavanserin Tablets)

 

Nuplazid Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

• Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
• QT Interval Prolongation [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The clinical trial database for NUPLAZID consists of over 1200 subjects and patients exposed to one or more doses of NUPLAZID. Of these, 616 were patients with hallucinations and delusions associated with Parkinson's disease psychosis (PDP). In the placebo-controlled setting, the majority of experience in patients comes from studies evaluating once-daily NUPLAZID doses of 34 mg (N=202) compared to placebo (N=231) for up to 6 weeks. In the controlled trial setting, the study population was approximately 64% male and 91% Caucasian, and the mean age was about 71 years at study entry.  Additional clinical trial experience in patients with hallucinations and delusions associated with PDP comes from two open-label, safety extension studies (total N=497). The majority of patients receiving long-term treatment received 34 mg once-daily (N=459). Over 300 patients have been treated for more than 6 months; over 270 have been treated for at least 12 months; and over 150 have been treated for at least 24 months.

The following adverse reactions are based on the 6-week, placebo-controlled studies in which NUPLAZID was administered once daily to patients with hallucinations and delusions associated with PDP.

Common Adverse Reactions (incidence ≥5% and at least twice the rate of placebo): peripheral edema (7% NUPLAZID 34 mg vs. 2% placebo) and confusional state (6% NUPLAZID 34 mg vs. 3% placebo).

Adverse Reactions Leading To Discontinuation Of Treatment

A total of 8% (16/202) of NUPLAZID 34 mg-treated patients and 4% (10/231) of placebo-treated patients discontinued because of adverse reactions. The adverse reactions that occurred in more than one patient and with an incidence at least twice that of placebo were hallucination (2% NUPLAZID vs. <1% placebo), urinary tract infection (1% NUPLAZID vs. <1% placebo), and fatigue (1% NUPLAZID vs. 0% placebo).

Adverse reactions that occurred in 6-week, placebo-controlled studies and that were reported at an incidence of ≥2% and >placebo are presented in Table 1.

Table 1 : Adverse Reactions in Placebo-Controlled Studies of 6-Week Treatment Duration and Reported in ≥2% and >Placebo

Percentage of Patients Reporting Adverse Reaction
	NUPLAZID 34 mg N=202	Placebo N=231
Gastrointestinal disorders
Nausea	7%	4%
Constipation	4%	3%
General disorders
Peripheral edema	7%	2%
Gait disturbance	2%	<1%
Psychiatric disorders
Hallucination	5%	3%
Confusional state	6%	3%

Adverse Reactions In Demographic Subgroups

Examination of population subgroups in the 6-week, placebo-controlled studies did not reveal any differences in safety on the basis of age (≤75 vs. >75 years) or sex. Because the study population was predominantly Caucasian (91%; consistent with reported demographics for PD/PDP), racial or ethnic differences in the safety profile of NUPLAZID could not be assessed. In addition, in the 6-week, placebo-controlled studies, no clinically relevant differences in the incidence of adverse reactions were observed among those with a Mini-Mental State Examination (MMSE) score at entry of <25 versus those with scores ≥25.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of NUPLAZID. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include rash, urticaria, reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea), somnolence, falls, agitation, and aggression.

Read the entire FDA prescribing information for Nuplazid (Pimavanserin Tablets)