Netupitant/palonosetron (original) (raw)

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Pharmaceutical drug

Netupitant/palonosetron

Combination of
Netupitant NK1 receptor antagonist
Palonosetron 5-HT3 receptor antagonist
Clinical data
Trade names Akynzeo
AHFS/Drugs.com Monograph
MedlinePlus a614053
License data US DailyMed: Netupitant
Pregnancy category AU: B3[1]
Routes of administration By mouth, intravenous
ATC code A04AA55 (WHO)
Legal status
Legal status AU: S4 (Prescription only)[2][3] CA: ℞-only[4][5] UK: POM (Prescription only)[6] US: ℞-only[7] EU: Rx-only[8] In general: ℞ (Prescription only)
Identifiers
CAS Number 2446322-17-2
KEGG D10572 checkY

Netupitant/palonosetron, sold under the brand name Akynzeo, is a fixed-dose combination medication used for the prevention of acute and delayed chemotherapy-induced nausea and vomiting.[7][9] It is marketed and distributed by Helsinn Therapeutics. Netupitant is an NK1 receptor antagonist and palonosetron is a 5-HT3 receptor antagonist.[10]

The capsules contain netupitant and palonosetron hydrochloride. The intravenous version is a combination of fosnetupitant chloride hydrochloride and palonosetron hydrochloride.[11][7][8]

Netupitant/palonosetron may be contraindicated during pregnancy.[12][1][13]

The most common side effects include headache, weakness, fatigue, upset stomach, constipation, and skin redness.[7] The overall profile of adverse effects is comparable to that of palonosetron (see Palonosetron#Adverse effects); no common adverse effects can be attributed to netupitant.[12]

Netupitant/palonosetron was approved for use in the United States in October 2014.[14] It was approved for use in the European Union in May 2015.[8] The intravenous version, which contains the prodrug fosnetupitant in place of netupitant, was approved in the United States in April 2018.[15][11]

  1. ^ a b "Netupitant / palonosetron (Akynzeo) Use During Pregnancy". Drugs.com. 22 October 2018. Archived from the original on 19 December 2019. Retrieved 19 March 2020.
  2. ^ AusPAR: Netupitant / Palonosetron (as hydrochloride). Therapeutic Goods Administration (TGA) (Report). October 2020. Archived from the original on 9 September 2017. Retrieved 10 June 2022.
  3. ^ "Prescription medicines: registration of new chemical entities in Australia, 2015". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 10 April 2023. Retrieved 10 April 2023.
  4. ^ "Archived copy" (PDF). Archived (PDF) from the original on 10 June 2022. Retrieved 10 June 2022.{{[cite web](/wiki/Template:Cite%5Fweb "Template:Cite web")}}: CS1 maint: archived copy as title (link)
  5. ^ "Cancer therapies". Health Canada. 8 May 2018. Archived from the original on 16 June 2024. Retrieved 13 April 2024.
  6. ^ "Akynzeo 300 mg/0.5 mg hard capsules - Summary of Product Characteristics (SmPC)". (emc). 11 February 2020. Archived from the original on 19 March 2020. Retrieved 19 March 2020.
  7. ^ a b c d "Akynzeo- netupitant and palonosetron capsule; Akynzeo- fosnetupitant and palonosetron injection". DailyMed. 28 May 2020. Archived from the original on 18 October 2020. Retrieved 18 July 2020.
  8. ^ a b c "Akynzeo EPAR". European Medicines Agency (EMA). 19 March 2020. Archived from the original on 19 March 2020. Retrieved 19 March 2020.
  9. ^ "FDA approves Akynzeo for nausea and vomiting associated with cancer chemotherapy" (Press release). U.S. Food and Drug Administration (FDA). 10 October 2014. Archived from the original on 1 February 2017. Retrieved 16 December 2019.
  10. ^ "Akynzeo: Summary of Product Characteristics" (PDF). European Medicines Agency. Archived (PDF) from the original on 26 June 2016. Retrieved 12 July 2016.
  11. ^ a b "Drug Trials Snapshots: Akynzeo". U.S. Food and Drug Administration (FDA). 11 May 2018. Archived from the original on 24 January 2020. Retrieved 19 March 2020.
  12. ^ a b Haberfeld H, ed. (2015). Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag. Akynzeo 300 mg / 0,5 mg Hartkapseln.
  13. ^ "Fosnetupitant / palonosetron (Akynzeo for Injection) Use During Pregnancy". Drugs.com. 22 October 2018. Archived from the original on 19 March 2020. Retrieved 19 March 2020.
  14. ^ "Drug Approval Package: Akynzeo (Netupitant and Palonosetron) Capsules NDA #205718". U.S. Food and Drug Administration (FDA). 7 November 2014. Archived from the original on 19 March 2020. Retrieved 19 March 2020.
  15. ^ "Drug Approval Package: Akynzeo (fosnetupitant and palonosetron) Injection". U.S. Food and Drug Administration (FDA). 31 May 2018. Archived from the original on 19 March 2020. Retrieved 19 March 2020.