pimavanserin 34 mg/1
pimavanserin · CAPSULE · Novadoz Pharmaceuticals LLC
pimavanserin is a capsule containing pimavanserin at 34 mg/1, taken oral. Manufactured by Novadoz Pharmaceuticals LLC.
Key Facts
- Brand Name
- pimavanserin
- Generic Name
- pimavanserin
- NDC Code (Product)
72205-055- Manufacturer
- Novadoz Pharmaceuticals LLC
- Strength
- 34 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA214925
- Marketing Start
- 01/16/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Pimavanserin capsule is indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis [see Clinical Studies (14) ]. Pimavanserin capsule is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended dose is 34 mg taken orally once daily, without titration. ( 2.1 ) Can be taken with or without food. ( 2.2 ) Capsules may be swallowed whole or opened and entire contents sprinkled over a tablespoon of certain types of soft food. ( 2.2 ) 2.1 Recommended Dosage The recommended dose of pimavanserin capsule is 34 mg taken orally once daily, without titration. 2.2 Administration Information Pimavanserin capsule can be taken with or without food [see Clinical Pharmacology (12.3)]. Pimavanserin capsules can be taken whole, or opened and the entire contents sprinkled over a tablespoon (15 mL) of applesauce, yogurt, pudding, or a liquid nutritional supplement. Consume the drug/food mixture immediately without chewing; do not store for future use. 2.3 Dosage Modifications for Concomitant Use with CYP3A4 Inhibitors and Inducers Coadministration with Strong CYP3A4 Inhibitors The recommended dose of pimavanserin capsules when coadministered with strong CYP3A4 inhibitors is 10 mg, taken orally as one tablet once daily [see Drug interactions (7.1) ]. Coadministration with Strong or Moderate CYP3A4 Inducers Avoid concomitant use of strong or moderate CYP3A4…
Contraindications
4 CONTRAINDICATIONS Pimavanserin is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported [ see Adverse Reactions (6.2) ] . Known hypersensitivity to pimavanserin or any of its components. (4)
Drug Interactions
7 DRUG INTERACTIONS Strong CYP3A4 Inhibitors: Reduce pimavanserin dose to 10 mg once daily. ( 2.3 , 7.1 ) Strong or Moderate CYP3A4 Inducers: Avoid concomitant use of pimavanserin. ( 2.3 , 7.1 ) 7.1 Drugs Having Clinically Important Interactions with Pimavanserin Table 2 Clinically Important Drug Interactions with Pimavanserin QT Interval Prolongation Clinical Impact: Concomitant use of drugs that prolong the QT interval may add to the QT effects of pimavanserin and increase the risk of cardiac arrhythmia. Intervention: Avoid the use of pimavanserin in combination with other drugs known to prolong QT interval (e.g., Class 1A antiarrythmics, Class 3 antiarrythmics, certain antipsychotics or antibiotics) [see Warnings and Precautions (5.2)] . Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of pimavanserin with a strong CYP3A4 inhibitor increases pimavanserin exposure [see Clinical Pharmacology (12.3)] . Intervention: If pimavanserin is used with a strong CYP3A4 inhibitor, reduce the dosage of pimavanserin [see Dosage and Administration (2.3) ]. Strong or Moderate CYP3A4 Inducers Clinical Impact: Concomitant use of pimavanserin with strong or moderate CYP3A4 inducers reduces…
Adverse Reactions
6 ADVERSE REACTIONS 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 (5.1) ] QT Interval Prolongation [see Warnings and Precautions (5.2) ] Most common adverse reactions (≥5% and twice the rate of placebo): peripheral edema and confusional state. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 pimavanserin consists of over 1200 subjects and patients exposed to one or more doses of pimavanserin. 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 on…
Frequently Asked Questions
What is pimavanserin used for?
pimavanserin contains pimavanserin. It is a capsule taken oral. Consult your doctor for specific uses.
Is pimavanserin a controlled substance?
pimavanserin is not classified as a controlled substance by the DEA.
What is the generic name for pimavanserin?
The generic name for pimavanserin is pimavanserin. There are 2 other brand versions of pimavanserin.
What is the NDC code for pimavanserin 34 mg/1?
The NDC (National Drug Code) for pimavanserin 34 mg/1 is 72205-055, listed by Novadoz Pharmaceuticals LLC.