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  • Trevicta
    / Janssen


    Active Ingredient
    Paliperidone 175, 263, 350, 525 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Syringe

    1 X 175 mg

    partial basket chart 73576

    Pre-filled Syringe

    1 X 263 mg

    partial basket chart 73578

    Pre-filled Syringe

    1 X 350 mg

    partial basket chart 73580

    Pre-filled Syringe

    1 X 525 mg

    partial basket chart 73582

    Dosage

    If the last dose of 1-monthly paliperidone palmitate injectable is 50 mg: Initiate this formulation at the following dose 175 mg.
    If the last dose of 1-monthly paliperidone palmitate injectable is 75 mg: Initiate this formulation at the following dose 263 mg.
    If the last dose of 1-monthly paliperidone palmitate injectable is 100 mg: Initiate this formulation at the following dose 350 mg.
    If the last dose of 1-monthly paliperidone palmitate injectable is 150 mg: Initiate this formulation at the following dose 525 mg.


    Indications

    3-monthly injection is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1-monthly paliperidone palmitate injectable product.


    Contra-Indications

    Hypersensitivity to the active substance, to risperidone or to any of the excipients.


    Special Precautions

    Use in patients who are in an acutely agitated or severely psychotic state: This drug 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.
    Weight gain: Significant weight gain has been reported with this drug  use. Weight should be monitored regularly.
    Renal impairment: The plasma concentrations of paliperidone are increased in patients with renal impairment. For patients with mild renal impairment (creatinine clearance ≥ 50 ml/min to < 80 ml/min), dose should be adjusted and the patient stabilised using 1‑monthly paliperidone palmitate injectable, then transitioned to this drug. The drug is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min).
    Hepatic impairment: No data are available in patients with severe hepatic impairment (Child‑Pugh class C). Caution is recommended if paliperidone is used in such patients.
    Elderly patients with dementia: The drug has not been studied in elderly patients with dementia, it is not recommended to treat elderly patients with dementia due to increased risk of overall mortality and cerebrovascular adverse reactions.


    Side Effects

    Difficulty falling or staying asleep.
    See prescribing information for full details.


    Drug interactions

    Caution is advised when prescribing this drug with medicinal products known to prolong the QT interval, e.g., class IA antiarrhythmics (e.g., quinidine, disopyramide) and class III antiarrhythmics (e.g., amiodarone, sotalol), some antihistaminics, some antibiotics (e.g., fluoroquinolones), some other antipsychotics and some antimalarials (e.g., mefloquine). This list is indicative and not exhaustive. Potential for this drug to affect other medicines. Paliperidone is not expected to cause clinically important pharmacokinetic interactions with medicinal products that are metabolised by cytochrome P450 isozymes. Given the primary central nervous system (CNS) effects of paliperidone this drug should be used with caution in combination with other centrally acting medicinal products, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are no adequate data from the use of paliperidone during pregnancy.
    Lactation: Paliperidone is excreted in the breast milk to such an extent that effects on the breast-fed infant are likely if therapeutic doses are administered to breast-feeding women.
    See prescribing information for full details.


    Overdose

    Symptoms: In general, expected signs and symptoms are those resulting from an exaggeration of paliperidone’s known pharmacological effects, i.e., drowsiness and sedation, tachycardia and hypotension, QT prolongation, and extrapyramidal symptoms. Torsade de pointes and ventricular fibrillation have been reported in a patient in the setting of overdose with oral paliperidone. In the case of acute overdose, the possibility of multiple drug involvement should be considered.
    Management: Consideration should be given to the long-acting nature of the medicinal product and the long elimination half-life of paliperidone when assessing treatment needs and recovery. There is no specific antidote to paliperidone. General supportive measures should be employed. Establish and maintain a clear airway and ensure adequate oxygenation and ventilation.


    Important notes

    Storage: Do not store above 30 °C, Store in the original package.
    Compatibility: This medicinal product must not be mixed with other medicinal products.


    Manufacturer
    Janssen Pharmaceutica, Beerse, Belgium
    Licence holder
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