Fosaprepitant dimeglumine(EMEND) powder video
Fosaprepitant dimeglumine(EMEND) powder basic Characters
|Name:||Fosaprepitant dimeglumine (EMEND) powder|
|Storage Temp:||-20°C Freezer|
|Color:||white to off-white amorphous powder|
Fosaprepitant dimeglumine (EMEND) Powder usage
Fosaprepitant dimeglumine powder (CAS 265121-04-8)
Fosaprepitant dimeglumine Powder usage
In combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly and moderately emetogenic cancer chemotherapy, including high-dose cisplatin.
Warning on EMEND powder (CAS 265121-04-8)
- Fosaprepitant should be used with caution in patients receiving concomitant medications that are primarily metabolized through CYP3A4.
- Immediate hypersensitivity reactions may occur during infusion. Patients have generally responded to discontinuation. It is not recommended to reinitiate the infusion. (B)
- Coadministration of fosaprepitant or aprepitant with warfarin (a CYP2C9 substrate) may result in a clinically significant decrease in International Normalized Ratio (INR) of prothrombin time. (C)
- The efficacy of hormonal contraceptives during and for 28 days following the last dose of fosaprepitant or aprepitant may be reduced. Alternative or back-up methods of contraception should be used. (D)
A: CYP3A4 Interactions Fosaprepitant is rapidly converted to aprepitant, which is a moderate inhibitor of CYP3A4 when administered as a 3-day antiemetic dosing regimen for CINV. Fosaprepitant should be used with caution in patients receiving concomitant medications that are primarily metabolized through CYP3A4. Inhibition of CYP3A4 by aprepitant or fosaprepitant could result in elevated plasma concentrations of these concomitant medications. When fosaprepitant is used concomitantly with another CYP3A4 inhibitor, aprepitant plasma concentrations could be elevated. When aprepitant is used concomitantly with medications that induce CYP3A4 activity, aprepitant plasma concentrations could be reduced, and this may result in decreased efficacy of aprepitant. Chemotherapy agents that are known to be metabolized by CYP3A4 include docetaxel, paclitaxel, etoposide, irinotecan, ifosfamide, imatinib, vinorelbine, vinblastine and vincristine. In clinical studies, the oral aprepitant regimen was administered commonly with etoposide, vinorelbine, or paclitaxel. The doses of these agents were not adjusted to account for potential drug interactions. In separate pharmacokinetic studies, no clinically significant change in docetaxel or vinorelbine pharmacokinetics was observed when the oral aprepitant regimen was coadministered. Due to the small number of patients in clinical studies who received the CYP3A4 substrates vinblastine, vincristine, or ifosfamide, particular caution and careful monitoring are advised in patients receiving these agents or other chemotherapy agents metabolized primarily by CYP3A4 that were not studied.
B: Hypersensitivity Reactions Isolated reports of immediate hypersensitivity reactions including flushing, erythema, dyspnea, and anaphylaxis have occurred during infusion of fosaprepitant. These hypersensitivity reactions have generally responded to discontinuation of the infusion and administration of appropriate therapy. Reinitiation of the infusion is not recommended in patients who experience these symptoms during first-time use.
C: Coadministration with Warfarin Coadministration of fosaprepitant or aprepitant with warfarin may result in a clinically significant decrease in International Normalized Ratio (INR) of prothrombin time. In patients on chronic warfarin therapy, the INR should be closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of fosaprepitant with each chemotherapy cycle.
D. Coadministration with Hormonal Contraceptives Upon coadministration with fosaprepitant or aprepitant, the efficacy of hormonal contraceptives may be reduced during and for 28 days following the last dose of either fosaprepitant or aprepitant. Alternative or back-up methods of contraception should be used during treatment with and for 1 month following the last dose of fosaprepitant or aprepitant [see Drug Interactions ]. 5.5 Chronic Continuous Use Chronic continuous use of EMEND powder for Injection for prevention of nausea and vomiting is not recommended because it has not been studied; and because the drug interaction profile may change during chronic continuous use.
Fosaprepitant dimeglumine powder for injection 150 mg is now indicated in adults in combination with other antiemetic agents for the prevention of delayed nausea and vomiting associated with initial and repeat courses of MEC. The approved dosage in adults is a single 150-mg intravenous (IV) infusion over 20 to 30 minutes approximately 30 minutes prior to chemotherapy on Day 1. The FDA approval of this new indication was based in part on findings from a randomized, parallel, doubleblind, active comparator-controlled study that evaluated fosaprepitant for injection as a single intravenous infusion in combination with ondansetron and dexamethasone (referred to as the EMEND powder regimen) (N=502) compared with ondansetron and dexamethasone alone (control regimen) (N=498) in patients receiving MEC. The primary endpoint was complete response (defined as no vomiting and no use of rescue therapy) in the delayed phase (25 to 120 hours following initiation of chemotherapy) of chemotherapy-induced nausea and vomiting. A 78.9% complete response rate was observed with the Fosaprepitant dimeglumine powder regimen compared to 68.5% with the control regimen (P<0.001). The most common adverse reactions reported in the EMEND powder regimen versus control regimen were fatigue (15% vs 13%), diarrhea (13% vs 11%), neutropenia (8% vs 7%), asthenia (4% vs 3%), anemia (3% vs 2%), peripheral neuropathy (3% vs 2%), leukopenia (2% vs 1%), dyspepsia (2% vs 1%), urinary tract infection (2% vs 1%), and pain in extremity (2% vs 1%).
Indication Fosaprepitant dimeglumine powder for injection, in combination with other antiemetic agents, is indicated in adults for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin; and for prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
Fosaprepitant dimeglumine powder for injection has not been studied for the treatment of established nausea and vomiting.
Fosaprepitant dimeglumine Raw Powder(CAS 265121-04-8)
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