Important Safety Information and Indication for
NUPLAZID (pimavanserin) 17-mg Tablets
Increased risk of death in elderly patients with dementia-related psychosis. Medicines like NUPLAZID can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). 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. Continues below
Do not take NUPLAZID if you have had an allergic reaction to any of the ingredients in NUPLAZID. Allergic reactions have included rash, hives, throat tightness, and swelling of the tongue, mouth, lips, or face.
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 prolong the QT interval. Tell your healthcare provider about all the medicines you take or have recently taken.
Do not take NUPLAZID if you have certain heart conditions that change your heart rhythm. It is important to talk to your healthcare provider about the possible side effect of changes to your heart rhythm. Call your healthcare provider if you feel a change in your heartbeat.
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).
Please see full Prescribing Information including Boxed WARNING.
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