Invega Hafyera

Paliperidone (as palmitate)

Every-6-mth inj for schizophrenia in adults after adequate treatment w/ once-a-mth paliperidone palmitate PR susp for inj (PP1M product eg, Invega Sustenna) for at least 4 mth, or every-3-mth paliperidone palmitate PR susp for inj (PP3M product eg, Invega Trinza) for at least one 3-mth cycle.

IM (gluteal) Following initial dose, administer Invega Hafyera once every 6 mth. Adjust dose, if needed, every 6 mth between dose of 700-1,000 mg based on individual response & tolerability. Switching from a PP1M product Initially 700 mg if last PP1M dose is 100 mg, or 1,000 mg if last PP1M dose is 150 mg. Initiate Invega Hafyera when the next PP1M dose is scheduled; may be administered up to 1 wk before or 1 wk after the next scheduled PP1M dose. Switching from a PP3M product Initially 700 mg if last PP3M dose is 350 mg, or 1,000 mg if last PP3M dose is 525 mg. Initiate Invega Hafyera when the next PP3M dose is scheduled; may be administered up to 2 wk before or 2 wk after the next scheduled PP3M dose.

Hypersensitivity to paliperidone or risperidone.

Avoid inadvertent inj into a blood vessel. Not approved for treatment of patients w/ dementia-related psychosis. Cerebrovascular adverse reactions (including stroke) & increased mortality in elderly patients w/ dementia-related psychosis. Discontinue treatment if NMS is suspected. Modest increase in QTc interval. Consider treatment discontinuation if signs & symptoms of tardive dyskinesia appear. Associated w/ metabolic changes including hyperglycemia, dyslipidemia, & body wt gain. Can induce orthostatic hypotension & syncope. Reports of somnolence, postural hypotension, motor & sensory instability which may lead to falls, & consequently, fractures or other fall-related injuries; leukopenia, neutropenia, & agranulocytosis; priapism. Discontinue treatment in patients w/ severe neutropenia (ANC <1,000/mm³). Hyperprolactinemia. Disruption of body temp regulation. Risk of intraoperative floppy iris syndrome during cataract surgery. Avoid in combination w/ other drugs that are known to prolong QTc. Avoid in patients w/ congenital long QT syndrome & history of cardiac arrhythmias. Caution in patients w/ known CV disease, cerebrovascular disease, or conditions that predispose the patient to hypotension; w/ history of seizures or other conditions that potentially lower the seizure threshold; at risk for aspiration pneumonia. Potential for cognitive & motor impairment. Not recommended for use in patients w/ mild, moderate, or severe renal impairment (CrCl <90 mL/min). Has not been studied in patients w/ hepatic impairment. Pregnancy & lactation. Neonates exposed to antipsychotic drugs during the 3rd trimester of pregnancy are at risk for extrapyramidal &/or w/drawal symptoms following delivery. Not recommended in ped patients. Increased sensitivity to Invega Hafyera in patients w/ Parkinson's disease or dementia w/ Lewy bodies.

URTI, inj site reaction, increased wt, headache, parkinsonism.

Modulated CNS effects w/ centrally-acting drugs & alcohol. Additive effect w/ other therapeutic agents that have the potential for inducing orthostatic hypotension. Decreased exposure w/ strong CYP3A4 & P-gp inducers. Antagonized effect of levodopa & other dopamine agonists.

Antipsychotics

N05AX13 - paliperidone ; Belongs to the class of other antipsychotics.

P₁S₁S₃