Akynzeo

Product manufactured by Eisai Inc.

Application Nr Approved Date Route Status External Links
NDA205718 2014-10-10 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Akynzeo Is Indicated For The Prevention Of Acute And Delayed Nausea And Vomiting Associated With Initial And Repeat Courses Of Cancer Chemotherapy, Including, But Not Limited To, Highly Emetogenic Chemotherapy. Akynzeo Is An Oral Fixed Combination Of Palonosetron And Netupitant: Palonosetron Prevents Nausea And Vomiting During The Acute Phase And Netupitant Prevents Nausea And Vomiting During Both The Acute And Delayed Phase After Cancer Chemotherapy. Akynzeo Is A Fixed Combination Of Netupitant, A Substance P/neurokinin 1 (nk1) Receptor Antagonist, And Palonosetron, A Serotonin-3 (5-Ht3) Receptor Antagonist Indicated For The Prevention Of Acute And Delayed Nausea And Vomiting Associated With Initial And Repeat Courses Of Cancer Chemotherapy, Including, But Not Limited To, Highly Emetogenic Chemotherapy. Oral Palonosetron Prevents Nausea And Vomiting During The Acute Phase And Netupitant Prevents Nausea And Vomiting During Both The Acute And Delayed Phase After Cancer Chemotherapy. (1)

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Water WATER Molecular
3. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
4. Sodium Stearyl Fumarate SODIUM STEARYL FUMARATE Molecular MISC-Miscellaneous , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.
5. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Gelatin GELATIN Unresolved
8. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
10. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Netupitant NETUPITANT ZINC11681563
2. Palonosetron PALONOSETRON ZINC3795819

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