93 - References

References

Schizophrenia and related psychoses CHAPTER 1 Dose adjustments should not be needed but can be made every 6 months based on patient response and tolerability. Any dose change may not be apparent in respect to clinical effects for several months owing to the long-­acting nature of PP6M and the time needed for a new steady-state level to be reached.23 Points to note ■ ■PP6M is suitable for patients who are stable in their mental state and do not require any dose adjustments. ■ ■PP6M should be given only into the upper-­outer quadrant of the gluteal muscle. ■ ■Before IM administration, the vial requires extensive and rapid shaking for a ­minimum of 30 seconds. ■ ■The median half-­life is 148–159 days or longer.23,24 See the manufacturer’s information for full information on missed doses and ­re-­initiation regimens. References

1. Cleton A, et al. A single-­dose, open-­label, parallel, randomized, dose-­proportionality study of paliperidone after intramuscular injections of paliperidone palmitate in the deltoid or gluteal muscle in patients with schizophrenia. J Clin Pharmacol 2014; 54:1048–1057.
2. Lopez A, et al. Role of paliperidone palmitate 3-­monthly in the management of schizophrenia: insights from clinical practice. Neuropsychiatr Dis Treat 2019; 15:449–456.
3. Janssen-­Cilag Ltd. Summary of Product Characteristics. Xeplion (paliperidone) 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg prolonged-­release suspension for injection. 2023 (last accessed May 2024); https://www.medicines.org.uk/emc/product/7652/smpc.
4. Pappa S, et al. Partial compliance with long-­acting paliperidone palmitate and impact on hospitalization: a 6-­year mirror-­image study. Ther Adv Psychopharmacol 2020; 10:2045125320924789.
5. Laing E, et al. Relapse and frequency of injection of monthly paliperidone palmitate—a retrospective case-­control study. Eur Psychiatry 2021; 64:e11. PP6M is generally well tolerated and has a tolerability profile similar to PP3M and PP1M.24 The most common adverse effect in one phase 3 trial was the injection site pain (which can be attributed to the large injection volume: 3.5mL or 5mL), followed by weight gain.24 Patients and clinicians seem to prefer PP6M over PP3M.25 Table 1.22 gives the regimen for switching to PP6M. Table 1.22  Switching to paliperidone 6-­monthly.23 Switching from Recommended method of switching Comments 100mg PP1M Give 700mg of PP6M in place of the next scheduled dose of 100mg PP1M PP6M can be initiated ±7 days of the PP1M due date 150mg PP1M Give 1000mg of PP6M in place of the next scheduled dose of 150mg PP1M 350mg PP3M Give 700mg of PP6M in place of the next scheduled dose of 350mg PP3M PP6M can be initiated ±14 days of the PP3M due date 525mg PP3M Give 1000mg of PP6M in place of the next scheduled dose of 525mg PP3M

98 The Maudsley® Prescribing Guidelines in Psychiatry CHAPTER 1 6. Russu A, et al. Maintenance dose conversion between oral risperidone and paliperidone palmitate 1 month: practical guidance based on pharmacokinetic simulations. Int J Clin Pract 2018; 72:e13089. 7. Dexcel Pharma Ltd. Summary of Product Characteristics. Risperidone 1mg Film-­Coated Tablets. 2023 (last checked May 2024); https:// www.medicines.org.uk/emc/product/8207/smpc. 8. Janssen-­Cilag Limited. Summary of Product Characteristics. Invega (paliperidone) 3 mg prolonged-­release tablets. 2021 (last checked May 2024); https://www.medicines.org.uk/emc/product/6816. 9. McEvoy JP, et al. Effectiveness of paliperidone palmitate vs haloperidol decanoate for maintenance treatment of schizophrenia: a randomized clinical trial. JAMA 2014; 311:1978–1987. 10. Naber D, et al. Qualify: a randomized head-­to-­head study of aripiprazole once-­monthly and paliperidone palmitate in the treatment of schizophrenia. Schizophr Res 2015; 168:498–504. 11. Cuomo I, et al. Head-­to-­head comparison of 1-­year aripiprazole long-­acting injectable (LAI) versus paliperidone LAI in comorbid psychosis and substance use disorder: impact on clinical status, substance craving, and quality of life. Neuropsychiatr Dis Treat 2018; 14:1645–1656. 12. Janssen Pharmaceuticals Inc. Highlights of Prescribing Information. INVEGA SUSTENNA (paliperidone palmitate) extended-­release injectable suspension, for intramuscular use. 2022 (last accessed May 2024); http://www.janssenlabels.com/package-­insert/product-­monograph/ prescribing-­information/INVEGA+SUSTENNA-­pi.pdf. 13. Taylor DM, et al. Paliperidone palmitate: factors predicting continuation with treatment at 2 years. Eur Neuropsychopharmacol 2016; 26:2011–2017. 14. Clark I, et al. Clinical outcomes with paliperidone palmitate 3-­monthly injection as monotherapy: observational 3-­year follow-­up of patients with schizophrenia. Eur Psychiatry 2024; 67:e15. 15. Janssen-­Cilag Limited. Summary of Product Characteristics. TREVICTA (paliperidone) 175mg, 263mg, 350mg, 525mg prolonged release suspension for injection. 2023 (last accessed May 2024); https://www.medicines.org.uk/cmc/medicine/32050. 16. Ravenstijn P, et al. Pharmacokinetics, safety, and tolerability of paliperidone palmitate 3-­month formulation in patients with schizophrenia: a phase-­1, single-­dose, randomized, open-­label study. J Clin Pharmacol 2016; 56:330–339. 17. Cicala G, et al. Tolerability profile of paliperidone palmitate formulations: a pharmacovigilance analysis of the EUDRAVigilance database. Front Psychiatry 2023; 14:1130636. 18. Gutiérrez-­Rojas L, et al. Impact of 3-­monthly long-­acting injectable paliperidone palmitate in schizophrenia: a retrospective, real-­world analysis of population-­based health records in Spain. CNS Drugs 2022; 36:517–527. 19. Spoelstra SK, et al. One-­month versus three-­month formulation of paliperidone palmitate treatment in psychotic disorders: patients’, relatives’, and mental health professionals’ perspectives. Patient Prefer Adherence 2022; 16:615–624. 20. Clark I, et al. Long term impact of 3-­monthly paliperidone palmitate on hospitalisation in patients with schizophrenia: six-­year mirror image study. Acta Psychiatr Scand 2024; 150:48–50. 21. Turkoz I, et al. Comparing relapse rates in real-­world patients with schizophrenia who were adequately versus not adequately treated with paliperidone palmitate once-­monthly injections before transitioning to once-­every-­3-­months injections. Neuropsychiatr Dis Treat 2022; 18:1927–1937. 22. O’Donnell A, et al. Defining ’adequately treated’: a post hoc analysis examining characteristics of patients with schizophrenia successfully transitioned from once-­monthly paliperidone palmitate to once-­every-­3-­months paliperidone palmitate. Neuropsychiatr Dis Treat 2021; 17:1–9. 23. Janssen-­Cilag Ltd. Summary of Product Characteristics. Byannli 700mg prolonged-­release suspension for injection in pre-­filled syringe ­(paliperidone). 2023 (last accessed February 2025); https://www.medicines.org.uk/emc/product/13307/smpc. 24. Cirnigliaro G, et al. Evaluating the 6-­month formulation of paliperidone palmitate: a twice-­yearly injectable treatment for schizophrenia in adults. Expert Rev Neurother 2024; 24:325–332. 25. García-­Carmona JA, et al. Preliminary data from a 4-­year mirror-­image and multicentre study of patients initiating paliperidone palmitate 6-­monthly long-­acting injectable antipsychotic: the Paliperidone 2 per Year study. Ther Adv Psychopharmacol 2023; 13:20451253231220907.