Invega Sustenna

Treatment of schizophrenia & prevention of recurrence of symptoms of schizophrenia. Schizoaffective disorder as monotherapy & adjunct to mood stabilizers or antidepressants.

IM Schizophrenia Initially 150 mg on day 1 & 100 mg 1 wk later, both administered in deltoid muscle. Mthly maintenance dose: 75 mg; some patients may benefit from lower or higher doses w/in range of 25-150 mg. Following 2nd initiation dose, mthly maintenance doses can be administered in either deltoid or gluteal muscle. Schizoaffective disorder Initially 150 mg on day 1 & 100 mg 1 wk later, both administered in deltoid muscle. Mthly maintenance dose: W/in range of 50-150 mg. Following 2nd initiation dose, mthly maintenance doses can be administered in either deltoid or gluteal muscle. Patient w/ mild renal impairment (CrCl ≥50 to <80 mL/min) Initially 100 mg on day 1 & 75 mg 1 wk later, both administered in deltoid muscle. Thereafter, followed w/ mthly inj of 50 mg adjusted w/in range of 25-100 mg, administered in either deltoid or gluteal muscle.

Hypersensitivity to paliperidone or risperidone.

Discontinue use if hypersensitivity reactions occur; signs or symptoms of NMS or tardive dyskinesia develop; in case of severe neutropenia (ANC <1 x 10⁹/L). Do not administer dose in divided inj; intravascularly or SC. Avoid inadvertent inj into a blood vessel. Hyperglycemia, DM & exacerbation of pre-existing diabetes; wt gain; priapism; disruption of the body's ability to reduce core temp; antiemetic effect; intraoperative floppy iris syndrome. Patients w/ history of cardiac arrhythmias, congenital long QT syndrome; known CV disease (eg, heart failure, MI or ischemia, conduction abnormalities), cerebrovascular disease, or conditions predisposing to hypotension (eg, dehydration, hypovolemia, & treatment w/ antihypertensives); history of seizures or other conditions potentially lowering seizure threshold; risk factors for VTE; Parkinson's disease & dementia w/ Lewy bodies. Monitor patients w/ history of clinically significant low WBC or drug-induced leukopenia/neutropenia during 1st few mth of therapy. Concomitant use w/ other antipsychotics; psychostimulants eg, methylphenidate; drugs prolonging QT interval. May interfere w/ activities requiring mental alertness (eg, driving or operating machinery) & may have visual effects. Not recommended in moderate or severe renal impairment (CrCl <50 mL/min). Has not been studied in patients w/ severe hepatic impairment. Should only be used during pregnancy if benefits outweigh the risks. Not to be used during lactation. Safety & effectiveness have not been studied in childn <18 yr. Increased overall mortality & cerebrovascular adverse events in elderly w/ dementia treated w/ some atypical antipsychotics (eg, risperidone, aripiprazole, olanzapine).

URTI; agitation, insomnia, nightmare; akathisia, dizziness, extrapyramidal disorder, headache, somnolence/sedation; HTN; upper abdominal pain, constipation, diarrhea, dry mouth, nausea, toothache, vomiting; pain in extremity; asthenia, fatigue, inj site pain; increased wt.

Additive effect w/ drugs prolonging QT interval; other centrally-acting drugs & alcohol; other agents w/ potential to induce orthostatic hypotension; risperidone or oral paliperidone. May antagonize effect of levodopa & other dopamine agonists. Decreased mean steady-state C_max & AUC w/ carbamazepine. Emergence of extrapyramidal symptoms w/ psychostimulants eg, methylphenidate.

Antipsychotics

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

Rx