Paliperidone

DEA Class;  Rx

Common Brand Names; Invega, Invega Sustenna, Invega Trinza, Invega Hafyera

Documented hypersensitivity to paliperidone or risperidone

Invega Hafyera

• Upper respiratory tract infection (12%)

• Injection site reactions (11%)

Invega Sustenna

• Injection site reaction (12%)

Oral (adults)

• Extrapyramidal symptoms (7-20%)

• Akathisia (4-17%)

• Tachycardia (12-14%)

• Headache (11-14%)

• Somnolence (6-11%)

Oral (children and adolescents)

• Somnolence (9-26%)

• Extrapyramidal symptoms (4-23%)

• Akathisia (4-17%)

• Vomiting (6-11%)

Increased incidence of cerebrovascular adverse reactions (eg, stroke, transient ischemic attack, including fatalities) reported

Neuroleptic malignant syndrome (NMS) reported in association with antipsychotic drugs; if NMS is suspected, discontinue treatment and provide symptomatic treatment and monitoring

May induce orthostatic hypotension; use with caution in patients with known cardiovascular or cerebrovascular disease and patients predisposed to hypotension

Motor instability, somnolence, and orthostatic hypotension reported, which may lead to falls and, consequently, fractures or other fall-related injuries; assess risk of falls when initiating treatment and recurrently for patients receiving repeated doses, particularly the elderly, with diseases, conditions, or medications that could exacerbate these effects

Hyperprolactinemia reported; may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotrophin secretion and gonadal steroidogenesis in female and male patients; galactorrhea, amenorrhea, gynecomastia, and impotence reported; long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density in both female and male subjects

May cause CNS depression (somnolence, sedation, dizziness), which may impair abilities to perform tasks requiring mental alertness, including operating heavy machinery

Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold

Antipsychotic use has been associated with esophageal dysmotility and aspiration; use with caution in patients at risk of aspiration pneumonia

Rare cases of priapism reported

Neonates exposed to antipsychotic drugs during third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery

Limited data from published literature report presence of paliperidone in human breast milk

There is no information on effects on breastfed infant, or on milk production