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Palonosetron

Aloxi · ATC code A04AA05

Brand names: Aloxi, Palonosetron Kalceks, Palonosetron Beta, Palonosetron Fresenius Kabi, Palonosetron Hikma, Palonosetron Juta Pharma, Palonosetron Onkovis Qilu Pharma Spain, Palonosetron Stada, Cinvex, Dekol, Emtron, Genolax, Palodin, Paloject, Palondem …

Key facts
Active substance
Palonosetron
ATC code
A04AA05
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Aloxi 250 micrograms solution for injection. · Aloxi 500 micrograms soft capsules
Marketing authorisation holder
Helsinn Birex Pharmaceuticals Ltd.
Information as of
2026-10-28

Key facts

Palonosetron is a 5-HT3 receptor antagonist. It is given before cancer chemotherapy to prevent nausea and vomiting.

What it is used for

  • Aloxi solution for injection: prevention of acute nausea and vomiting with highly emetogenic, and of nausea and vomiting with moderately emetogenic chemotherapy in adults and children from 1 month of age.
  • Aloxi soft capsules: prevention of nausea and vomiting associated with moderately emetogenic chemotherapy in adults.

Dosing

  • Aloxi injection, adults: 250 micrograms as a single intravenous bolus approximately 30 minutes before chemotherapy, injected over 30 seconds; with highly emetogenic chemotherapy a corticosteroid may enhance efficacy.
  • Aloxi injection, children and adolescents (1 month to 17 years): 20 micrograms/kg (maximum total dose 1500 micrograms) as a single 15 minute intravenous infusion approximately 30 minutes before chemotherapy.
  • Aloxi soft capsules, adults: 500 micrograms orally approximately one hour before chemotherapy; no posology recommendation in children.
  • No dose adjustment for the elderly or in hepatic or renal impairment; no data in haemodialysis.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients.

Important warnings

  • May increase large bowel transit time; monitor patients with a history of constipation or signs of subacute intestinal obstruction.
  • Caution with existing or likely QT prolongation (e.g. heart failure, bradyarrhythmias, anti-arrhythmics); correct hypokalaemia and hypomagnesaemia beforehand.
  • Serotonin syndrome has been reported with 5-HT3 antagonists, particularly with SSRIs or SNRIs.
  • Not for preventing or treating nausea and vomiting in the days after chemotherapy if not associated with another chemotherapy administration.

Side effects

  • Injection (adults): most frequent headache (9 %) and constipation (5 %); dizziness also common.
  • Soft capsules: most frequent headache (3.7 %).
  • Very rare: hypersensitivity, anaphylaxis and shock.

Interactions

  • Serotonergic medicines (SSRIs, SNRIs): risk of serotonin syndrome.
  • Palonosetron does not inhibit or induce CYP450 at clinically relevant concentrations; administered safely with corticosteroids.

Pregnancy and breastfeeding

  • Should not be used in pregnancy unless considered essential by the physician.
  • Breast-feeding should be discontinued during therapy.

Summary of the official product information, written with AI on 2026-10-29. 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)

  • AloxiHelsinn Birex Pharmaceuticals Ltd. · EMEA/H/C/000563
  • Palonosetron Accord · genericAccord Healthcare S.L.U. · EMEA/H/C/004129

Source: European Medicines Agency (EMA), product information

Austria

  • Palonosetron KalceksKalceks · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Palonosetron BetaBetapharm Arzneimittel Gmbh · 1 register entry
  • Palonosetron Fresenius KabiFresenius Kabi Deutschland Gmbh · 1 register entry
  • Palonosetron HikmaRafarm Sa. · 1 register entry
  • Palonosetron Juta PharmaJuta Pharma Gmbh · 1 register entry
  • Palonosetron KalceksKalceks · 1 register entry
  • Palonosetron Onkovis Qilu Pharma SpainQilu Pharma Spain S.L. · 1 register entry
  • Palonosetron StadaStadapharm Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • CinvexER-KİM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • DekolLEDAPHARMA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
  • EmtronMONEMFARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • GenolaxMENTA PHARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • PalodinKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
  • PalojectTÜM-EKİP İLAÇ A.Ş. · 1 register entry
  • PalondemFARMA-TEK İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • PalonexHAVER TRAKYA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • PaloxitronPHARMADA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • PalselHAVER FARMA İLAÇ A.Ş. · 1 register entry
  • PelatosSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • PlaronPLATİN KİMYA MÜMESSİLLİK VE DIŞ TİC. A.Ş. · 1 register entry
Show all 16 brand names
  • VomisetRECORDATİ İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • VonaxiVEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • VotronBİEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • ZiaxePOLİFARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 26 more European countries
Belgium
Palonosetron Fresenius Kabi, Palonosetron Juta, Palonosétron Juta
Bulgaria
Ферант
Croatia
Ferant, Palonozetron Kalceks
Cyprus
Ferant, Injosetron, Palonan
Czechia
Ferant, Palonosetron Fresenius Kabi, Palonosetron Kalceks, Pominol
Denmark
Palonosetron Kalceks, Palonosetron Macure, Palonosetron Reig Jofre, Palonosetron Stada, Palonosetronhydrochlorid Qilu
Estonia
Ferant, Palonosetron Kalceks
Finland
Palonosetron Fresenius Kabi, Palonosetron Macure, Palonosetron Reig Jofre, Palonosetron Stada
France
Palonosetron Kalceks, Palonosetron Reig Jofre
Greece
Ferant, Injosetron, Palonan, Palonosetron/Kalceks, Pominol
Hungary
Palonosetron Kalceks, Palonosetron Onkogen
Iceland
Aloxi, Palonosetron Accord
Ireland
Palonosetron
Italy
Palonosetron Dr. Reddy’s, Palonosetron Fresenius Kabi, Palonosetron Kalceks, Palonosetron Reig Jofre
Latvia
Ferant, Palonosetron Kalceks
Liechtenstein
Aloxi, Palonosetron Accord
Lithuania
Ferant
Malta
Ferant, Palonosetron Anfarm
Netherlands
Palonosetron Fresenius Kabi
Norway
Aloxi, Palonosetron Accord, Palonosetron Fresenius Kabi, Palonosetron Reig Jofre
Portugal
Ferant, Palanossetrom Fresenius Kabi, Palonossetrom Fresenius Kabi, Palonossetrom Hikma, Palonossetrom Kalceks, Palonossetrom Pharmamatch
Romania
Ferant, Palonosetron Dr. Reddy’s, Palonosetron Fresenius Kabi, Palonosetron Kalceks, Palonosetron Stada
Slovakia
Ferant, Palonosetron Fresenius Kabi
Slovenia
Ferant, Palonosetron Fresenius Kabi
Spain
Ferant, Palonosetron Sala, Palonosetrón Qilu
Sweden
Ferant, Palonosetron Fresenius Kabi, Palonosetron Kalceks, Palonosetron Macure, Palonosetron Reig Jofre, Palonosetron Stada

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Aloxi – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/aloxi-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-28 · 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.