Invega Trinza

Invega Trinza

paliperidone

Manufacturer:

Janssen

Distributor:

Johnson & Johnson
Concise Prescribing Info
Contents
Paliperidone palmitate
Indications/Uses
3-mth inj for schizophrenia in adults who have been adequately treated w/ the 1-mth paliperidone palmitate inj for at least 4 mth.
Dosage/Direction for Use
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 to 175-mg dose; if last dose is 75 mg, initiate Invega Trinza to 263-mg dose; if last dose is 100 mg, initiate Invega Trinza to 350-mg dose; if last dose is 150 mg, initiate Invega Trinza to 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.
Contraindications
Hypersensitivity to paliperidone or risperidone.
Special Precautions
Do not administer intravascularly or SC. Avoid inadvertent inj into a blood vessel. Discontinue use if signs or symptoms indicative of neuroleptic malignant syndrome (NMS) develops; signs & symptoms of tardive dyskinesia appear; hypersensitivity reactions occur. Concomitant use w/ psychostimulants (eg, methylphenidate). History of cardiac arrhythmias, congenital long QT syndrome, & in concomitant use w/ drugs known to prolong the QT interval. Monitor for symptoms of hyperglycemia & DM. Clinical monitoring of wt is recommended. Known CV disease (eg, heart failure, MI or ischemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose to hypotension (eg, dehydration, hypovolemia, & treatment w/ antihypertensive medications). History of seizures or other conditions that potentially lower the seizure threshold. Monitor patients w/ history of clinically significant low WBC or drug-induced leukopenia/neutropenia during the 1st few mth of therapy & consider discontinuation of use at the 1st sign of a clinically significant decline in WBC in the absence of other causative factors. Carefully monitor patients w/ clinically significant neutropenia for fever or other symptoms or signs of infection. Discontinue use & follow WBC until recovery in patients w/ severe neutropenia. Identify all possible risk factors for venous thromboembolism before & during treatment. Increased risk of NMS & sensitivity to antipsychotic medications in patients w/ Parkinson's disease or dementia w/ Lewy bodies. Induced priapism. Conditions which may contribute to core body temp elevation. Antiemetic effect may mask signs & symptoms of overdosage w/ certain drugs or conditions eg, intestinal obstruction, Reye's syndrome, & brain tumor. Intraoperative floppy iris syndrome. May interfere w/ activities requiring mental alertness & may have visual effects; advise patients not to drive or operate machinery. 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.
Adverse Reactions
Upper resp tract infection, UTI; hyperglycemia, hyperinsulinemia, wt increased; anxiety; akathisia, dyskinesia, dystonia, headache, parkinsonism, somnolence; tachycardia; orthostatic hypotension; nausea, vomiting; amenorrhea, galactorrhea; inj site reaction.
Drug Interactions
Drugs known to prolong the QT interval; other centrally acting drugs & alcohol; risperidone or w/ oral paliperidone. May antagonize the effect of levodopa & other dopamine agonists. Additive effect w/ other therapeutic agents that have potential for inducing orthostatic hypotension. Decreased mean steady-state Cmax & AUC w/ carbamazepine. Emergence of extrapyramidal symptoms w/ psychostimulants (eg, methylphenidate).
MIMS Class
ATC Classification
N05AX13 - paliperidone ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
Invega Trinza PR susp for inj 175
Packing/Price
1's
Form
Invega Trinza PR susp for inj 263 mg
Packing/Price
1's
Form
Invega Trinza PR susp for inj 350 mg
Packing/Price
1's
Form
Invega Trinza PR susp for inj 525 mg
Packing/Price
1's
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