Overview
Fosaprepitant is an intravenously administered antiemetic drug. It is a prodrug of Aprepitant. It aids in the prevention of acute and delayed nausea and vomiting associated with chemotherapy treatment.
Background
Fosaprepitant is an intravenously administered antiemetic drug. It is a prodrug of Aprepitant. It aids in the prevention of acute and delayed nausea and vomiting associated with chemotherapy treatment.
Indication
Fosaprepitant is indicated in adult and pediatric patients ≥6 months of age, in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin. It is also indicated for the treatment of delayed nausea and vomiting with initial and repeat courses of moderately emetogenic cancer chemotherapy.
Associated Conditions
- Acute Chemotherapy-Induced Nausea and Vomiting (CINV) caused by highly emetogenic chemotherapy
- Delayed Chemotherapy-Induced Nausea and Vomiting (CINV) caused by highly emetogenic chemotherapy
- Delayed Chemotherapy-Induced Nausea and Vomiting (CINV) caused by moderately emetogenic chemotherapy
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/18 | Phase 2 | Not yet recruiting | |||
2024/05/24 | Early Phase 1 | Not yet recruiting | |||
2024/04/24 | Phase 2 | Recruiting | |||
2023/05/31 | Not Applicable | Not yet recruiting | |||
2023/05/03 | Phase 4 | Not yet recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2023/03/17 | Not Applicable | ENROLLING_BY_INVITATION | |||
2023/03/06 | Not Applicable | Recruiting | Xijing Hospital | ||
2022/10/03 | Phase 3 | Completed | Shantou University Medical College | ||
2022/08/22 | Phase 3 | Completed | |||
2022/02/09 | Not Applicable | UNKNOWN | Shanghai Children's Medical Center |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sandoz Inc | 0781-3484 | INTRAVENOUS | 150 mg in 5 mL | 12/1/2019 | |
| Cipla USA Inc. | 69097-830 | INTRAVENOUS | 150 mg in 5 mL | 1/1/2021 | |
| NorthStar RxLLC | 16714-929 | INTRAVENOUS | 150 mg in 5 mL | 12/21/2022 | |
| Dr. Reddy's Laboratories Inc., | 43598-859 | INTRAVENOUS | 150 mg in 5 mL | 9/6/2019 | |
| Fresenius Kabi USA, LLC | 63323-972 | INTRAVENOUS | 150 mg in 5 mL | 6/29/2020 | |
| NorthStar RxLLC | 16714-120 | INTRAVENOUS | 150 mg in 5 mL | 9/3/2019 | |
| Baxter Healthcare Corporation | 0338-0008 | INTRAVENOUS | 150 mg in 5 mL | 9/5/2019 | |
| Mylan Institutional LLC | 67457-888 | INTRAVENOUS | 115 mg in 5 mL | 9/4/2019 | |
| Qilu Pharmaceutical Co., Ltd. | 67184-0540 | INTRAVENOUS | 150 mg in 5 mL | 3/11/2022 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9384 | INTRAVENOUS | 150 mg in 5 mL | 10/27/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/11/2008 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Emend® I.V. Powder for Solution for Infusion 150mg | SIN14150P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 150.0 mg | 5/17/2012 | |
| FOSAPREPITANT-AFT POWDER FOR INJECTION 150MG/VIAL | SIN16419P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 150MG/VIAL | 1/24/2022 | |
| APRITANT IV powder for solution for injection 150mg/vial | SIN16996P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 150mg/vial | 5/6/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Fosaprepitant Dimeglumine for Injection | 国药准字H20213106 | 化学药品 | 注射剂 | 2/2/2021 | |
| Fosaprepitant Dimeglumine for Injection | 国药准字H20244661 | 化学药品 | 注射剂 | 8/20/2024 | |
| Fosaprepitant Dimeglumine for Injection | 国药准字H20244156 | 化学药品 | 注射剂 | 6/25/2024 | |
| Fosaprepitant Dimeglumine for Injection | 国药准字H20193289 | 化学药品 | 注射剂 | 8/1/2024 | |
| Fosaprepitant Dimeglumine for Injection | 国药准字H20234005 | 化学药品 | 注射剂 | 8/1/2023 | |
| Fosaprepitant Dimeglumine for Injection | 国药准字H20223351 | 化学药品 | 注射剂 | 5/31/2022 | |
| Fosaprepitant Dimeglumine for Injection | 国药准字H20190030 | 化学药品 | 注射剂 | 10/23/2019 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| FOSAPREPITANT-AFT fosaprepitant (as dimeglumine) 150 mg powder for injection vial | 378090 | Medicine | A | 10/4/2022 | |
| FOSAPREPITANT MEDICIANZ fosaprepitant (as dimeglumine) 150 mg powder for injection vial | 401533 | Medicine | A | 11/20/2023 | |
| FOSAPREPITANT JUNO fosaprepitant (as dimeglumine) 150 mg powder for injection vial | 401185 | Medicine | A | 12/6/2023 | |
| FOSAPREPITANT MSN fosaprepitant (as dimeglumine) 150 mg powder for injection vial | 372680 | Medicine | A | 10/19/2022 | |
| FOSAPREPITANT MEDSURGE fosaprepitant (as dimeglumine) 150 mg powder for injection vial | 401534 | Medicine | A | 11/20/2023 | |
| EMEND IV fosaprepitant 150mg (as fosaprepitant dimeglumine) powder for injection vial | 167061 | Medicine | A | 3/18/2011 |