Netupitant/palonosetron explained

Type:combo
Component1:Netupitant
Class1:NK1 receptor antagonist
Component2:Palonosetron
Class2:5-HT3 receptor antagonist
Tradename:Akynzeo
Dailymedid:Netupitant
Pregnancy Au:B3
Pregnancy Au Comment:[1]
Routes Of Administration:By mouth, intravenous
Atc Prefix:A04
Atc Suffix:AA55
Legal Au:S4
Legal Au Comment:[2] [3]
Legal Ca:Rx-only
Legal Ca Comment:[4] [5]
Legal Uk:POM
Legal Uk Comment:[6]
Legal Us:Rx-only
Legal Eu:Rx-only
Legal Status:Rx-only
Cas Number:2446322-17-2
Kegg:D10572

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] It is marketed and distributed by Helsinn Therapeutics. Netupitant is an NK1 receptor antagonist and palonosetron is a 5-HT3 receptor antagonist.[8]

The capsules contain netupitant and palonosetron hydrochloride. The intravenous version is a combination of fosnetupitant chloride hydrochloride and palonosetron hydrochloride.[9]

Contraindications

Netupitant/palonosetron may be contraindicated during pregnancy.[10] [11]

Adverse effects

The most common side effects include headache, weakness, fatigue, upset stomach, constipation, and skin redness. 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.

History

Netupitant/palonosetron was approved for use in the United States in October 2014.[12] It was approved for use in the European Union in May 2015.[13] The intravenous version, which contains the prodrug fosnetupitant in place of netupitant, was approved in the United States in April 2018.[14] [15]

Notes and References

  1. Web site: Netupitant / palonosetron (Akynzeo) Use During Pregnancy . Drugs.com . 22 October 2018 . 19 March 2020 . 19 December 2019 . https://web.archive.org/web/20191219051923/https://www.drugs.com/pregnancy/netupitant-palonosetron.html . live .
  2. AusPAR: Netupitant / Palonosetron (as hydrochloride) . Therapeutic Goods Administration (TGA) . October 2020 . 10 June 2022 . 9 September 2017 . https://web.archive.org/web/20170909221136/https://www.tga.gov.au/auspar/auspar-netupitant-palonosetron-hydrochloride . live .
  3. Web site: Prescription medicines: registration of new chemical entities in Australia, 2015 . Therapeutic Goods Administration (TGA) . 21 June 2022 . 10 April 2023 . 10 April 2023 . https://web.archive.org/web/20230410065829/https://www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia-2015 . live .
  4. Web site: Archived copy . 10 June 2022 . 10 June 2022 . https://web.archive.org/web/20220610022830/https://pdf.hres.ca/dpd_pm/00057864.PDF . live .
  5. Web site: Cancer therapies . . 8 May 2018 . 13 April 2024 . 16 June 2024 . https://web.archive.org/web/20240616160905/https://www.canada.ca/en/services/health/drug-health-products/drug-medical-device-highlights-2017/approved-drugs/cancer-therapies.html . live .
  6. Web site: Akynzeo 300 mg/0.5 mg hard capsules - Summary of Product Characteristics (SmPC) . (emc) . 11 February 2020 . 19 March 2020 . 19 March 2020 . https://web.archive.org/web/20200319201956/https://www.medicines.org.uk/emc/product/6993/smpc . live .
  7. FDA approves Akynzeo for nausea and vomiting associated with cancer chemotherapy . U.S. Food and Drug Administration (FDA) . 10 October 2014 . 16 December 2019 . https://web.archive.org/web/20170201191145/http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm418375.htm . 1 February 2017 . dead .
  8. Web site: Akynzeo: Summary of Product Characteristics. European Medicines Agency. 12 July 2016. 26 June 2016. https://web.archive.org/web/20160626122835/http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003728/WC500188432.pdf. live.
  9. Web site: Akynzeo- netupitant and palonosetron capsule; Akynzeo- fosnetupitant and palonosetron injection . DailyMed . 28 May 2020 . 18 July 2020 . 18 October 2020 . https://web.archive.org/web/20201018154534/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e47618e-af46-4d82-94e8-1507c042252d . live .
  10. Book: Austria-Codex. Haberfeld H. Akynzeo 300 mg / 0,5 mg Hartkapseln. Österreichischer Apothekerverlag. Vienna. 2015. German.
  11. Web site: Fosnetupitant / palonosetron (Akynzeo for Injection) Use During Pregnancy . Drugs.com . 22 October 2018 . 19 March 2020 . 19 March 2020 . https://web.archive.org/web/20200319201955/https://www.drugs.com/pregnancy/fosnetupitant-palonosetron.html . live .
  12. Web site: Drug Approval Package: Akynzeo (Netupitant and Palonosetron) Capsules NDA #205718 . U.S. Food and Drug Administration (FDA) . 7 November 2014 . 19 March 2020 . 19 March 2020 . https://web.archive.org/web/20200319201956/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205718Orig1s000TOC.cfm . live .
  13. Web site: Akynzeo EPAR . European Medicines Agency (EMA) . 19 March 2020 . 19 March 2020 . 19 March 2020 . https://web.archive.org/web/20200319201955/https://www.ema.europa.eu/en/medicines/human/EPAR/akynzeo . live .
  14. Web site: Drug Approval Package: Akynzeo (fosnetupitant and palonosetron) Injection . U.S. Food and Drug Administration (FDA) . 31 May 2018 . 19 March 2020 . 19 March 2020 . https://web.archive.org/web/20200319201957/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210493Orig1s000ApprovTOC.cfm . live .
  15. Web site: Drug Trials Snapshots: Akynzeo . U.S. Food and Drug Administration (FDA) . 11 May 2018 . 19 March 2020 . 24 January 2020 . https://web.archive.org/web/20200124193904/https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-akynzeo . live .

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