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Paliperidone

Byannli (previously Paliperidone Janssen-Cilag International), Invega, Trevicta (previously Paliperidone Janssen), Xeplion · ATC code N05AX13

Also known as: Paliperidon, Palipéridone, Paliperidona · Brand names: Byannli, Invega, Trevicta, Xeplion, Paliperidon Abz, Paliperidon Al, Paliperidon Heumann, Paliperidon Zentiva, Paligis, Palveon

Key facts
Active substance
Paliperidone
Drug class
Antipsychotics
ATC code
N05AX13
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
BYANNLI 700 mg prolonged-release suspension for injection in pre-filled syringe / BYANNLI 1 000 mg prolonged-release suspension for injection in pre-filled syringe · INVEGA 3 mg prolonged-release tablets / INVEGA 6 mg prolonged-release tablets / INVEGA 9 mg prolonged-release tablets · TREVICTA 175 mg prolonged release suspension for injection / TREVICTA 263 mg prolonged release suspension for injection / TREVICTA 350 mg prolonged release suspension for injection · Xeplion 25 mg prolonged release suspension for injection / Xeplion 50 mg prolonged release suspension for injection / Xeplion 75 mg prolonged release suspension for injection · Xeplion 150 mg and Xeplion 100 mg prolonged release suspension for injection
Marketing authorisation holder
6526, Janssen-Cilag International NV, Janssen-Cilag International
Information as of
2026-11-04

Key facts

Paliperidone, the major active metabolite of risperidone, is an atypical antipsychotic. In the EU it is available as Invega prolonged-release tablets and as long-acting injectable paliperidone palmitate: Xeplion (monthly), Trevicta (3-monthly) and Byannli (6-monthly).

What it is used for

  • Invega tablets: schizophrenia in adults and adolescents 15 years and older; schizoaffective disorder in adults
  • Xeplion: maintenance treatment of schizophrenia in adults stabilised on paliperidone or risperidone; in selected adults with previous response to oral paliperidone or risperidone and mild to moderate symptoms, also without prior oral stabilisation
  • Trevicta: maintenance treatment of schizophrenia in adults clinically stable on 1-monthly paliperidone palmitate injection
  • Byannli: maintenance treatment of schizophrenia in adults clinically stable on 1-monthly or 3-monthly paliperidone palmitate injection

Dosing

  • Invega (adults): 6 mg once daily in the morning, no initial titration; range 3 mg to 12 mg (schizoaffective disorder 6 mg to 12 mg), increases in steps of 3 mg/day; swallow whole, always fasting or always with breakfast
  • Invega (adolescents 15 years and older, schizophrenia): start with 3 mg once daily; maximum 6 mg daily if < 51 kg, 12 mg daily if ≥ 51 kg
  • Invega in renal impairment: creatinine clearance ≥ 50 to < 80 mL/min start with 3 mg once daily (up to 6 mg); 10 to < 50 mL/min 3 mg every other day (up to 3 mg once daily); not recommended below 10 mL/min
  • Xeplion (monthly): 150 mg on day 1 and 100 mg on day 8, both into the deltoid; then monthly maintenance, recommended 75 mg (range 25 to 150 mg), deltoid or gluteal
  • Xeplion in mild renal impairment (creatinine clearance ≥ 50 to < 80 mL/min): 100 mg on day 1 and 75 mg one week later; maintenance 50 mg monthly (25 to 100 mg)
  • Trevicta (3-monthly): started in place of the next 1-monthly dose at a 3.5-fold higher dose (50 mg → 175 mg, 75 mg → 263 mg, 100 mg → 350 mg, 150 mg → 525 mg); then once every 3 months (± 2 weeks), deltoid or gluteal
  • Byannli (6-monthly): 1-monthly 100 mg or 150 mg, or 3-monthly 350 mg or 525 mg, is transitioned to 700 mg or 1,000 mg respectively; then once every 6 months, gluteal only
  • All injections: not recommended if creatinine clearance < 50 mL/min; Byannli in mild renal impairment only at 700 mg; given only by a healthcare professional, Trevicta and Byannli only with the needles in the pack

Contraindications

  • Hypersensitivity to paliperidone, risperidone or any excipient

Important warnings

  • Elderly patients with dementia: increased mortality and an approximately 3-fold risk of cerebrovascular adverse reactions with atypical antipsychotics
  • Neuroleptic malignant syndrome (discontinue paliperidone); tardive dyskinesia and extrapyramidal symptoms
  • Caution in cardiovascular disease, family history of QT prolongation or with other QT-prolonging medicines
  • Hyperglycaemia and diabetes, weight gain and hyperprolactinaemia; monitor weight and glucose control
  • Leucopenia, neutropenia and agranulocytosis; discontinue in severe neutropenia
  • Orthostatic hypotension, seizures, priapism, venous thromboembolism, intraoperative floppy iris syndrome at cataract surgery
  • Injections are not for acutely agitated or severely psychotic states needing immediate symptom control; Invega tablets should not ordinarily be used with severe gastrointestinal narrowing or difficulty swallowing

Side effects

  • Insomnia, headache, anxiety, agitation
  • Parkinsonism, akathisia, sedation/somnolence, dystonia, tremor, dizziness; akathisia and sedation appear dose-related
  • Weight increased, hyperprolactinaemia
  • Injection site reactions with the long-acting injections
  • Upper respiratory tract infection, nausea, constipation, vomiting, tachycardia

Interactions

  • Other QT-prolonging medicines (class IA and class III antiarrhythmics, some antihistamines, other antipsychotics, some antimalarials): caution
  • Centrally acting medicines and alcohol: caution; paliperidone may antagonise levodopa and other dopamine agonists
  • Carbamazepine decreased paliperidone exposure by approximately 37%; other inducers such as rifampicin and St John's wort may act similarly; valproate increased Invega exposure by approximately 50%
  • Risperidone or oral paliperidone with the injections: caution over extended periods; Invega with oral risperidone is not recommended (additive exposure)
  • Psychostimulants such as methylphenidate: extrapyramidal symptoms possible when either dose is changed; additive orthostatic hypotension with e.g. tricyclics

Pregnancy and breastfeeding

  • Should not be used during pregnancy unless clearly necessary; neonates exposed in the third trimester are at risk of extrapyramidal and/or withdrawal symptoms
  • Excreted into breast milk with likely effects on the infant: should not be used while breast-feeding

Summary of the official product information, written with AI on 2026-11-05. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Germany

  • Paliperidon AbzAbz-Pharma Gmbh · 1 register entry
  • Paliperidon AlAliud Pharma Gmbh · 2 register entries
  • Paliperidon HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
  • Paliperidon ZentivaZentiva Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-11-04

Austria

  • PaliperidonStada Arzneimittel Gmbh, Teva B.V · 3 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-11-04

Turkey

  • ByannliJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 2 register entries
  • InvegaJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 6 register entries
  • PaligisFARMA-TEK İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • PalveonGENVEON İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • TrevictaJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 4 register entries
  • XeplionJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 4 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-11-04

Brand names in 28 more European countries
Belgium
Paliperidon Eg, Paliperidon Krka, Paliperidon Sandoz, Paliperidone Eg, Paliperidone Teva
Bulgaria
Палиперидон Тева, Парнидо, Полтраксин
Croatia
Parnido, Pratyria
Cyprus
Paliperidon Tad, Paliperidone Palmitate Stada
Czechia
Balení Pro Zahájení Lécby Psylipax, Mopetia, Paliperidon Viatris, Parnido, Psylipax
Denmark
Paliperidon Krka, Paliperidon Zentiva, Paliperidone Stada, Palmeux
Estonia
Mopetia
Finland
Lodixeon, Paliperidone Stada, Palmeux
France
Paliperidone Bgr, Paliperidone Biogaran, Paliperidone Eg, Paliperidone Viatris, Paliperidone Zentiva
Greece
Paliperidone Palmitate Stada, Paliperidone Teva, Palmeux, Parnido
Hungary
Paliperidon Actavis, Paliperidon Krka, Paliperidon Ratiopharm, Paliperidone Stada, Paliperidone Zentiva, Parnido, Psylipax
Iceland
Invega, Niapelf, Paliperidon Krka, Paliperidone Stada, Trevicta, Xeplion
Ireland
Paliperidone Clonmel, Paliperidone Krka, Paliperidone Teva
Italy
Paliperidone Eg, Paliperidone Krka, Paliperidone Sandoz, Paliperidone Teva, Paliperidone Viatris Pharma, Paliperidone Zentiva
Latvia
Mopetia, Pratyria
Liechtenstein
Invega, Niapelf, Trevicta, Xeplion
Lithuania
Parnido, Pratyria
Luxembourg
Paliperidon Ratiopharm, Paliperidone Eg
Malta
Paliperidone Clonmel
Netherlands
Paliperidon Cf, Paliperidon Krka, Paliperidon Retard Teva, Paliperidon Sandoz, Paliperidon Viatris, Palmeux
Norway
Invega, Niapelf, Paliperidon Zentiva, Paliperidone Stada, Trevicta, Xeplion
Poland
Palifren Long, Parnido, Poltraxin, Pratyria, Psylipax
Portugal
Aldesven, Paliperidona Alter, Paliperidona Krka, Paliperidona Mylan, Paliperidona Pentafarma, Paliperidona Pharmakern, Paliperidona Ratiopharm, Paliperidona Sandoz, Paliperidona Stada, Paliperidona Teva, Paliperidona Zentiva
Romania
Mopetia, Paliperidonă Stada, Parnido
Slovakia
Paliperidón Stada, Paliperidón Teva, Parnido, Psylipax
Slovenia
Paliperidon Teva, Paliperidon Viatris, Paliperidone Viatris, Parnido
Spain
Inpalix, Lodixeon, Paliperidona Alter, Paliperidona Cinfa, Paliperidona Liconsa, Paliperidona Ratiopharm, Paliperidona Sandoz, Paliperidona Stada, Paliperidona Tad Tad Pharma, Paliperidona Teva, Parnido
Sweden
Mopetia, Paliperidon Heumann, Paliperidon Krka, Paliperidon Teva, Paliperidon Zentiva, Paliperidone Stada, Paliperidone Viatris, Poltraxin, Pratyria

EMA – Article 57 product data (EU/EEA), 2026-11-04

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Sources

  1. European Medicines Agency. Byannli (previously Paliperidone Janssen-Cilag International) – EPAR, Product Information. 2026-11-04. https://www.ema.europa.eu/en/documents/product-information/byannli-epar-product-information_en.pdf
  2. European Medicines Agency. Invega – EPAR, Product Information. 2026-11-04. https://www.ema.europa.eu/en/documents/product-information/invega-epar-product-information_en.pdf
  3. European Medicines Agency. Trevicta (previously Paliperidone Janssen) – EPAR, Product Information. 2026-11-04. https://www.ema.europa.eu/en/documents/product-information/trevicta-epar-product-information_en.pdf
  4. European Medicines Agency. Xeplion – EPAR, Product Information. 2026-11-04. https://www.ema.europa.eu/en/documents/product-information/xeplion-epar-product-information_en.pdf
  5. EMA – Article 57 product data (EU/EEA), 2026-11-04. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  6. EMA – Article 57 product data (EU/EEA), 2026-11-04. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  7. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-11-04. https://www.titck.gov.tr/dinamikmodul/85
  8. Wikidata (CC0): ATC N05AX.

Editorial: Medelix editorial team · last updated 2026-11-04 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.