Invega Trinza

Paliperidone palmitate

3-mth inj for schizophrenia in adults who have been adequately treated w/ the 1-mth paliperidone palmitate inj for at least 4 mth.

IM Use only after the 1-mth paliperidone palmitate inj has been established as adequate treatment for at least 4 mth. To establish a consistent maintenance dose, the last 2 doses of the 1-mth paliperidone palmitate inj be the same dosage strength before starting Invega Trinza. Initiate Invega Trinza when the next 1-mth paliperidone palmitate dose is scheduled w/ an Invega Trinza dose based on the previous 1-mth inj using 3.5 as a multiplier (eg, if last dose is 50 mg, initiate Invega Trinza at 175-mg dose; if last dose is 75 mg, initiate Invega Trinza at 263-mg dose; if last dose is 100 mg, initiate Invega Trinza at 350-mg dose; if last dose is 150 mg, initiate Invega Trinza at 525-mg dose). Following the initial Invega Trinza dose, Invega Trinza should be administered every 3 mth. If needed, dose adjustment can be made every 3 mth in increments w/in the range of 175-525 mg based on individual patient tolerability &/or efficacy. Re-initiation regimen after missing >4 mth up to 9 mth of Invega Trinza Last Invega Trinza dose: 175 mg: paliperidone palmitate 1-mth inj into deltoid muscle 2 doses (50 mg in day 1 & 8) 1 wk apart then Invega Trinza 175 mg into deltoid or gluteal muscle 1 mth after day 8; 263 mg: paliperidone palmitate 1-mth inj into deltoid muscle 2 doses (75 mg in day 1 & 8) 1 wk apart then Invega Trinza 263 mg into deltoid or gluteal muscle 1 mth after day 8; 350 mg: paliperidone palmitate 1-mth inj into deltoid muscle 2 doses (100 mg in day 1 & 8) 1 wk apart then Invega Trinza 350 mg into deltoid or gluteal muscle 1 mth after day 8; 525 mg: paliperidone palmitate 1-mth inj into deltoid muscle 2 doses (100 mg in day 1 & 8) 1 wk apart then Invega Trinza 525 mg into deltoid or gluteal muscle 1 mth after day 8. Mild renal impairment (CrCl ≥50-<80 mL/min) Transition to Invega Trinza is w/ a dose in a 3.5 to 1 ratio to the previous stabilized 1-mth paliperidone palmitate inj. Max: 350 mg.

Hypersensitivity to paliperidone or risperidone.

Discontinue use if hypersensitivity reactions occur; signs or symptoms of NMS or tardive dyskinesia develop. Not to be inj in divided doses, intravascularly or SC. Patients w/ history of cardiac arrhythmias, congenital long QT syndrome; known CV & cerebrovascular disease or conditions predisposing to hypotension; history of seizures or other conditions potentially lowering seizure threshold; history of clinically significant low WBC or drug-induced leukopenia/neutropenia; risk factors for VTE; Parkinson's disease & dementia w/ Lewy bodies. Hyperglycemia, DM & exacerbation of preexisting diabetes; wt gain; priapism; disruption of the body's ability to reduce core temp; antiemetic effect; intraoperative floppy iris syndrome. Concomitant use w/ 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). Severe hepatic impairment. Pregnancy. Not to be used during lactation. Childn <18 yr. Elderly w/ dementia.

Upper resp tract infection, UTI; hyperglycemia, hyperinsulinemia, increased wt; anxiety; akathisia, dyskinesia, dystonia, headache, Parkinsonism, somnolence; tachycardia; orthostatic hypotension; nausea, vomiting; amenorrhea, galactorrhea; inj site reaction.

Concomitant use w/ drugs prolonging QT interval; other centrally-acting drugs & alcohol; risperidone or oral paliperidone. May antagonize effect of levodopa & other dopamine agonists. Additive effect to other therapeutic agents w/ potential to induce orthostatic hypotension. 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