Byannli (Previously Paliperidone Janssen-Cilag International)

Posology Patients who are adequately treated with 1-monthly paliperidone palmitate injection at doses of 100 mg or 150 mg (preferably for four months or more) or 3-monthly paliperidone palmitate injection at doses of 350 mg or 525 mg (for at least one injection cycle) and do not require dose adjustment may be transitioned to 6-monthly paliperidone palmitate injection.

BYANNLI for patients adequately treated with 1-monthly paliperidone palmitate injection BYANNLI should be initiated in place of the next scheduled dose of 1-monthly paliperidone palmitate injection (± 7 days). To establish a consistent maintenance dose, it is recommended that the last two doses of 1-monthly paliperidone palmitate injection be the same dose strength before starting BYANNLI.

The BYANNLI dose should be based on the previous 1-monthly paliperidone palmitate injectable dose shown in the following table: Transitioning to BYANNLI for patients adequately treated with 1-monthly paliperidone palmitate injection If the last dose of 1-monthly paliperidone injection is Initiate BYANNLI at the following dose* 100 mg 700 mg 150 mg 1 000 mg 3 * There are no equivalent doses of BYANNLI for the 25 mg, 50 mg or 75 mg doses of 1-monthly paliperidone palmitate injection, which were not studied.

BYANNLI for patients adequately treated with 3-monthly paliperidone palmitate injection BYANNLI should be initiated in place of the next scheduled dose of 3-monthly paliperidone palmitate injection (± 14 days). The BYANNLI dose should be based on the previous 3-monthly paliperidone palmitate injectable dose shown in the following table: Transitioning to BYANNLI for patients adequately treated with 3-monthly paliperidone palmitate injection If the last dose of 3-monthly paliperidone injection is Initiate BYANNLI at the following dose* 350 mg 700 mg 525 mg 1 000 mg * There are no equivalent doses of BYANNLI for the 175 mg or 263 mg doses of 3-monthly paliperidone palmitate injection, which were not studied.

Following the initial BYANNLI dose, BYANNLI should be administered once every 6 months. If necessary, patients may be given the injection up to 2 weeks before or up to 3 weeks after the 6-month scheduled timepoint (see also Missed dose section).

If needed, dose adjustment of BYANNLI can be made every 6 months between the dose levels of 700 mg and 1 000 mg based on individual patient tolerability and/or efficacy. 2). If the patient remains symptomatic, they should be managed according to clinical practice.

Summary of the safety profile The most frequently observed adverse reactions reported in ≥ 5% of patients in the randomised double-blind active controlled clinical trial of BYANNLI were upper respiratory tract infection, injection site reaction, weight increased, headache and Parkinsonism.

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).

Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. 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 BYANNLI 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.

7 Neuroleptic malignant syndrome (NMS) 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 BYANNLI.

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 BYANNLI. , 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 (WBC) count or a drug-induced leucopenia/neutropenia should be monitored during the first few months of therapy and discontinuation of BYANNLI should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.

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