Selfemra

Generic name:

pimavanserin

Drug class:

Atypical antipsychotic; selective serotonin 5-HT2A receptor inverse agonist

Dosage form:

Delayed-release film-coated tablets: 34 mg

Root of administration:

Oral

Dose:

Standard: 34 mg once daily. In patients taking strong CYP3A4 inhibitors: reduce to 17 mg once daily. Varies by indication; consult label.

Mechanism of action:

Pimavanserin acts as an inverse agonist and antagonist at central serotonin 5-HT2A receptors, with lesser activity at 5-HT2C receptors, without direct dopaminergic, adrenergic, histaminergic, or muscarinic receptor binding.

Drug usage cases:

• Parkinson’s disease psychosis (approved)
• Alzheimer’s disease psychosis (off-label; investigational)
• Schizophrenia-related psychosis (off-label; investigational)
• Major depressive disorder with psychotic features (off-label; investigational)
• Other psychotic disorders (off-label; investigational)

Drug contra indications:

• Hypersensitivity to pimavanserin or any component of the formulation
• Concurrent use with other drugs known to prolong QT interval
• History of torsades de pointes or congenital long QT syndrome

Side effects:

• Peripheral edema
• Confusional state
• Hallucinations
• Constipation
• Urinary tract infection
• Somnolence
• Nausea
• Dizziness
• Headache
• QT interval prolongation
• Fall-related injuries

Warnings:

• Increased mortality in elderly patients with dementia-related psychosis
• QT interval prolongation; use with caution in patients with congenital long QT, electrolyte abnormalities, or on other QT-prolonging drugs
• Risk of orthostatic hypotension and falls, particularly in elderly
• CYP3A4 interactions may alter plasma levels; adjust dose when administered with strong inhibitors or inducers
• Abrupt discontinuation may lead to exacerbation of psychotic symptoms; taper gradually if discontinuing
• Monitor for worsening psychosis, suicidal ideation, or unusual behavior

Use during pregnancy or breastfeeding:

Pregnancy: Animal studies have shown adverse fetal effects; no adequate, well-controlled studies in pregnant women. Use only if potential benefit justifies potential risk to fetus.

Breastfeeding: It is unknown if pimavanserin is excreted in human milk. Consider benefits of breastfeeding against potential adverse effects on the infant; monitor infant for sedation and feeding difficulties.