Invega Trinza

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

IM Use only after 1-mth paliperidone palmitate inj has been established as adequate treatment for at least 4 mth. To establish consistent maintenance dose, the last 2 doses of 1-mth paliperidone palmitate inj should be the same dosage strength before starting Invega Trinza. Initiate Invega Trinza when next 1-mth paliperidone palmitate dose is scheduled w/ an Invega Trinza dose based on the previous 1-mth inj using 3.5 as multiplier (eg, if last dose of 1-mth paliperidone palmitate inj is 50 mg, initiate Invega Trinza at 175-mg dose; if last dose of 1-mth paliperidone palmitate inj is 75 mg, initiate Invega Trinza at 263-mg dose; if last dose of 1-mth paliperidone palmitate inj is 100 mg, initiate Invega Trinza at 350-mg dose; if last dose of 1-mth paliperidone palmitate inj is 150 mg, initiate Invega Trinza at 525-mg dose). Invega Trinza may be administered up to 7 days before or after the mthly time point of the next scheduled paliperidone palmitate 1-mth dose. Following initial Invega Trinza dose, administer Invega Trinza every 3 mth. Adjust dose every 3 mth if needed in increments w/in range of 175-525 mg. Re-initiation regimen after missing >4 mth up to 9 mth of Invega Trinza If last Invega Trinza dose is 175 mg, administer paliperidone palmitate 1-mth inj 2 doses 1 wk apart (50 mg in days 1 & 8) into deltoid muscle, then administer Invega Trinza 3-mth inj 175 mg 1 mth after day 8 into deltoid or gluteal muscle. If last Invega Trinza dose is 263 mg, administer paliperidone palmitate 1-mth inj 2 doses 1 wk apart (75 mg in days 1 & 8) into deltoid muscle, then administer Invega Trinza 3-mth inj 263 mg 1 mth after day 8 into deltoid or gluteal muscle. If last Invega Trinza dose is 350 mg, administer paliperidone palmitate 1-mth inj 2 doses 1 wk apart (100 mg in days 1 & 8) into deltoid muscle, then administer Invega Trinza 3-mth inj 350 mg 1 mth after day 8 into deltoid or gluteal muscle. If last Invega Trinza dose is 525 mg, administer paliperidone palmitate 1-mth inj 2 doses 1 wk apart (100 mg in days 1 & 8) into deltoid muscle, then administer Invega Trinza 3-mth inj 525 mg 1 mth after day 8 into deltoid or gluteal muscle. Patient w/ mild renal impairment (CrCl ≥50-<80 mL/min) Transition to Invega Trinza is w/ a dose in a 3.5:1 ratio to the previous stabilized 1-mth paliperidone palmitate inj. Max: 350 mg.

Hypersensitivity to paliperidone or risperidone.

Discontinue use if hypersensitivity reactions occur; if signs or symptoms indicative of NMS or tardive dyskinesia develop; in case of severe neutropenia (ANC <1 x 10⁹/L). Do not administer dose intravascularly or SC; in divided inj. 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/ psychostimulants eg, methylphenidate; drugs prolonging QT interval; other antipsychotics. 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, UTI; hyperglycemia, hyperinsulinemia, increased wt; anxiety; akathisia, dyskinesia, dystonia, headache, Parkinsonism, somnolence; tachycardia; orthostatic hypotension; nausea, vomiting; amenorrhea, galactorrhea; inj site reaction.

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