Fosnetupitant
- Generic Name
- Fosnetupitant
- Brand Names
- Akynzeo
- Drug Type
- Small Molecule
- Chemical Formula
- C31H35F6N4O5P
- CAS Number
- 1703748-89-3
- Unique Ingredient Identifier
- T672P80L2S
Overview
In April 2018, the U.S. Food and Drug Administration (FDA) and the Swiss company Helsinn approved the intravenous formulation of AKYNZEO® (NEPA, a fixed antiemetic combination of fosnetupitant, 235mg, and palonosetron, 0.25mg) as an alternative treatment option for patients experiencing chemotherapy-induced nausea and vomiting . Fosnetupitant is the pro-drug form of netupitant . Generally, 25% to 30% of patients with a diagnosis of cancer receive chemotherapy as a treatment modality and 70% to 80% of these patients undergoing chemotherapy treatment may experience nausea and vomiting as major side effects. Considered one of the most distressing side effects of chemotherapy, nausea and vomiting has an immense impact on the quality of life of patients receiving certain antineoplastic therapies .
Background
In April 2018, the U.S. Food and Drug Administration (FDA) and the Swiss company Helsinn approved the intravenous formulation of AKYNZEO® (NEPA, a fixed antiemetic combination of fosnetupitant, 235mg, and palonosetron, 0.25mg) as an alternative treatment option for patients experiencing chemotherapy-induced nausea and vomiting . Fosnetupitant is the pro-drug form of netupitant . Generally, 25% to 30% of patients with a diagnosis of cancer receive chemotherapy as a treatment modality and 70% to 80% of these patients undergoing chemotherapy treatment may experience nausea and vomiting as major side effects. Considered one of the most distressing side effects of chemotherapy, nausea and vomiting has an immense impact on the quality of life of patients receiving certain antineoplastic therapies .
Indication
Indicated in combination palonosetron (as the drug Akynzeo) and dexamethasone in adults 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 . The following are indications listed on the EMA label : Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy . Prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy .
Associated Conditions
- Acute delayed Nausea caused by cancer chemotherapy
- Acute delayed Nausea caused by highly emetogenic cancer chemotherapy
- Acute delayed Vomiting caused by cancer chemotherapy
- Acute delayed Vomiting caused by highly emetogenic cancer chemotherapy
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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No clinical trials found
No clinical trials found for this drug
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
INTRAVENOUS | 260 mg in 20 mL | 2023/02/10 | 69639-106 | ||
INTRAVENOUS | 260 mg in 20 mL | 2023/02/10 | 69639-105 | ||
INTRAVENOUS | 260 mg in 1 1 | 2023/02/10 | 69639-102 |
EMA Approved Products
Product Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
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No EMA products found
No EMA products found for this drug
HSA Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval Number |
|---|---|---|---|---|---|
INFUSION, SOLUTION CONCENTRATE | 235mg/vial | 2023/11/28 | SIN16899P |
NMPA Approved Products
Product Name | Approval Number | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
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No NMPA products found
No NMPA products found for this drug
PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Registration Date |
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No PPB products found
No PPB products found for this drug
TGA Approved Products
Product Name | ARTG ID | Sponsor | Status | Registration Date | Ingredient |
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No TGA products found
No TGA products found for this drug