Trevicta (Previously Paliperidone Janssen)

Posology Patients who are adequately treated with 1-monthly paliperidone palmitate injectable (preferably for four months or more) and do not require dose adjustment may be switched to 3-monthly paliperidone palmitate injection. 3 TREVICTA should be initiated in place of the next scheduled dose of 1-monthly paliperidone palmitate injectable (± 7 days).

5-fold higher dose shown in the following table: TREVICTA doses for patients adequately treated with 1-monthly paliperidone palmitate injectable If the last dose of 1-monthly paliperidone palmitate injectable is Initiate TREVICTA at the following dose 50 mg 175 mg 75 mg 263 mg 100 mg 350 mg 150 mg 525 mg There is no equivalent dose of TREVICTA for the 25 mg dose of 1-monthly paliperidone palmitate injectable which was not studied.

Following the initial TREVICTA dose, TREVICTA should be administered by intramuscular injection once every 3 months (± 2 weeks, see also Missed dose section). If needed, dose adjustment of TREVICTA can be made every 3 months in increments within the range of 175 mg to 525 mg based on individual patient tolerability and/or efficacy.

2). If the patient remains symptomatic, they should be managed according to clinical practice. Switching from other antipsychotic medicinal products Patients should not be switched directly from other antipsychotics as 3-monthly paliperidone palmitate injectable should only be initiated after the patient is stabilised on the 1-monthly paliperidone palmitate injectable.

Switching from TREVICTA to other antipsychotic medicinal products If TREVICTA is discontinued, its prolonged release characteristics must be considered. 5-fold lower dose shown in the following table. The initiation dosing as described in the prescribing information for 1-monthly paliperidone palmitate injectable is not required.

The 1-monthly paliperidone palmitate injectable should then continue to be dosed at monthly intervals as described within its prescribing information. Doses of 1-monthly paliperidone palmitate injectable for patients switching from TREVICTA If the last dose of TREVICTA is Initiate 1-monthly paliperidone palmitate injectable 3 months later at the following dose 175 mg 50 mg 263 mg 75 mg 350 mg 100 mg 525 mg 150 mg Switching from TREVICTA to oral daily paliperidone prolonged release tablets For switching from TREVICTA to paliperidone prolonged release tablets, the daily dosing of paliperidone prolonged release tablets should be started 3 months after the last TREVICTA dose and treatment continued with paliperidone prolonged release tablets as described in the table below.

Summary of the safety profile The most frequently observed adverse reactions reported in ≥ 5% of patients in two double-blind controlled clinical trials of TREVICTA were weight increased, upper respiratory tract infection, anxiety, headache, insomnia, and injection site reaction.

Tabulated list of adverse reactions The following are all adverse reactions that were reported with paliperidone by frequency category estimated from paliperidone palmitate clinical trials. The following terms and frequencies are applied: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10,000 to < 1/1 000); very rare (< 1/10 000); and not known (cannot be estimated from the available data).

6) Reproductive system and breast disorders amenorrhoea erectile dysfunction, ejaculation disorder, menstrual disordere, gynaecomastia, galactorrhoea, sexual dysfunction, breast pain priapism, breast discomfort, breast engorgement, breast enlargement, vaginal discharge General disorders and administration site conditions pyrexia, asthenia, fatigue, injection site reaction face oedema, oedemae, body temperature increased, gait abnormal, chest pain, chest discomfort, malaise, induration hypothermia, chills, thirst, drug withdrawal syndrome, injection site abscess, injection site cellulitis, injection site cyst, injection site haematoma body temperature decreased, injection site necrosis, injection site ulcer Injury, poisoning and procedural complications fall a The frequency of adverse reactions is qualified as “not known” because they were not observed in paliperidone palmitate clinical trials.

They were either derived from spontaneous post-marketing reports and frequency cannot be determined, or they were derived from risperidone (any formulation) or oral paliperidone clinical trials data and/or post-marketing reports. b Refer to ‘Hyperprolactinaemia’ below.

Use in patients who are in an acutely agitated or severely psychotic state TREVICTA should not be used to manage acutely agitated or severely psychotic states when immediate symptom control is warranted. QT interval Caution should be exercised when paliperidone is prescribed in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicinal products thought to prolong the QT interval.

Neuroleptic malignant syndrome Neuroleptic Malignant Syndrome (NMS), characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness, and elevated serum creatine phosphokinase levels has been reported to occur with paliperidone.

Additional clinical signs may include myoglobinuria (rhabdomyolysis) and acute renal failure. If a patient develops signs or symptoms indicative of NMS, paliperidone should be discontinued. Consideration should be given to the long-acting nature of TREVICTA.

Tardive dyskinesia/extrapyramidal symptoms Medicinal products with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical, involuntary movements, predominantly of the tongue and/or face.

If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including paliperidone, should be considered. Consideration should be given to the long-acting nature of TREVICTA. , methylphenidate) and paliperidone concomitantly, as extrapyramidal symptoms could emerge when adjusting one or both medicinal products.

5). Leucopenia, neutropenia, and agranulocytosis Events of leucopenia, neutropenia, and agranulocytosis have been reported with paliperidone. Patients with a history of a clinically significant low white blood cell count (WBC) or a drug-induced leucopenia/neutropenia should be monitored during the first few months of therapy and discontinuation of TREVICTA should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.

1.