Aprefos 150mg Injection

Aprepitant, in combination with other antiemetic agents, is indicated in adults for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen. nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. Aprepitant is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults, 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 (HEC) including high-dose cisplatin as a single-dose regimen. Limitations of Use: Aprepitant has not been studied for treatment of established nausea and vomiting. Limitations of Use Aprepitant has not been studied for the treatment of established nausea and vomiting.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

CYP3A4 Interactions: Aprepitant is a substrate, weak-to-moderate (dose-dependent) inhibitor and an inducer of CYP3A4; see Full Prescribing Information for recommendations regarding contraindications, risk of adverse reactions, and dosage adjustment of Aprepitant and concomitant drugs. Hypersensitivity Reactions (including anaphylaxis ): May occur during or soon after administration. If symptoms occur, discontinue Aprepitant and do not reinitiate it. Warfarin (a CYP2C9 substrate): Risk of decreased INR of prothrombin time; monitor INR in 2–week period, particularly at 7 to 10 days, following initiation of Aprepitant. Hormonal Contraceptives: Efficacy of contraceptives may be reduced during and for 28 days following administration of aprepitant. Use effective alternative or back-up methods of non-hormonal contraception. Clinically Significant CYP3A4 Drug Interactions Aprepitant is a substrate, weak-to-moderate (dose-dependent) inhibitor, and an inducer of CYP3A4. Use of Aprepitant with other drugs that are CYP3A4 substrates may result in increased plasma concentration of the concomitant drug. Use of pimozide with Aprepitant is contraindicated due to the risk of significantly increased plasma concentrations of pimozide, potentially resulting in prolongation of the QT interval, a known adverse reaction of pimozide. Use of Aprepitant with strong or moderate CYP3A4 inhibitors (e.g., ketoconazole, diltiazem) may increase plasma concentrations of aprepitant and result in an increased risk of adverse reactions related to Aprepitant. Use of Aprepitant with strong CYP3A4 inducers (e.g., rifampin) may result in a reduction in aprepitant plasma concentrations and decreased efficacy of Aprepitant. See Table 8 and Table 9 for a listing of potentially significant drug interactions. Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis during or soon after administration of Aprepitant have occurred. Symptoms including dyspnea, eye swelling, flushing, pruritus and wheezing have been reported. Monitor patients during and after administration. If hypersensitivity reactions occur, discontinue Aprepitant and administer appropriate medical therapy. Do not reinitiate Aprepitant in patients who experience these symptoms with previous use. Decrease in INR with Concomitant Warfarin Coadministration of Aprepitant with warfarin, a CYP2C9 substrate, may result in a clinically significant decrease in the International Normalized Ratio (INR) of prothrombin time. Monitor the INR in patients on chronic warfarin therapy in the 2-week period, particularly at 7 to 10 days, following initiation of Aprepitant with each chemotherapy cycle. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Most common adverse reactions are: Single-dose fosaprepitant with MEC (≥2%): fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, pain in extremity. 3-day oral aprepitant with MEC (≥1% and greater than standard therapy): fatigue and eructation. Single-dose fosaprepitant with HEC: generally similar to 3-day oral aprepitant. In addition, infusion site reactions (3%) occurred. Single-dose Aprepitant (≥2%): headache and fatigue. at and www.Aprepitant.com or FDA Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of Aprepitant was evaluated as a single-dose in healthy subjects and established from adequate and well-controlled studies of intravenous fosaprepitant and/or oral aprepitant. Adverse reactions observed in these adequate and well-controlled studies are described below. Safety of Aprepitant A total of 200 healthy subjects received a single 130 mg dose of Aprepitant as a 30-minute infusion. Adverse reactions reported in at least 2% of subjects were headache (3%) and fatigue (2%). The safety profile of Aprepitant in 50 healthy subjects who received a single 2-minute injection was similar to that seen with a 30-minute infusion. Single-Dose Intravenous Fosaprepitant -- HEC In an active-controlled clinical study in patients receiving HEC, safety was evaluated for 1143 patients receiving a single intravenous dose of fosaprepitant, a prodrug of aprepitant, compared to 1169 patients receiving a 3-day regimen of oral aprepitant. When administered intravenously, fosaprepitant is converted to aprepitant within 30 minutes. The safety profile was generally similar to that seen in prior HEC studies with a 3-day regimen of oral aprepitant. However, infusion-site reactions occurred at a higher incidence in patients in the intravenous fosaprepitant group (3%) compared to those in the oral aprepitant group (0.5%). The reported infusion-site reactions included: infusion-site erythema, infusion-site pruritus, infusion-site pain, infusion-site induration and infusion-site thrombophlebitis. Adverse reactions associated with oral aprepitant may also be expected to occur with Aprepitant. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.