Loading…
FOSAPREPITANT is a brand name for Fosaprepitant, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE..................................................................................... 3 CONTRAINDICATIONS ....................................................................................................... 3 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
Serious Warnings and Precautions Drug interactions may occur with: Medicinal products, including chemotherapeutic agents that are metabolized through CYP3A4. Increased plasma concentrations of concomitant products may occur (see DRUG INTERACTIONS).
Warfarin, decreased prothrombin time may result (see DRUG INTERACTIONS). Hormonal contraception, reduced efficacy of contraceptives may occur (see DRUG INTERACTIONS). The following are clinically significant adverse events: Immediate hypersensitivity reactions including flushing, erythema, dyspnea and anaphylaxis/anaphylactic shock (see Hypersensitivity Reactions) Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis and anaphylactic shock, during or soon after infusion of fosaprepitant have occurred.
Symptoms including flushing, erythema, dyspnea, hypotension and syncope have been reported. Patients should be monitored during and after infusion. These hypersensitivity reactions have generally responded to discontinuation of the infusion and administration of appropriate therapy.
The infusion should not be reinitiated in patients who experience hypersensitivity reactions (see CONTRAINDICATIONS). Infusion site reactions (ISRs) have been reported with the use of fosaprepitant (see ADVERSE REACTIONS). , anthracycline-based) chemotherapy administration, particularly when associated with extravasation.
Necrosis was also reported in some patients with concomitant vesicant chemotherapy. Most ISRs occurred with the first, second or third exposure to single doses of fosaprepitant and in some cases, reactions persisted for two weeks or longer.
Treatment of severe ISRs consisted of medical, and in some cases surgical, intervention. Avoid infusion of fosaprepitant into small veins or through a butterfly catheter. If a severe ISR develops during infusion, discontinue the infusion and administer appropriate medical treatment.
Drug Interactions CYP3A4 substrates: fosaprepitant is a weak inhibitor of CYP3A4. Caution should be used when fosaprepitant is coadministered with CYP3A4 substrates, including chemotherapeutic agents (see DRUG INTERACTIONS). Serious post-marketing reports of neurotoxicity, a potential adverse reaction of ifosfamide, have been reported in patients after oral aprepitant and ifosfamide coadministration.
As fosaprepitant is rapidly converted to aprepitant after administration, caution and careful monitoring are advised if coadministered with ifosfamide. Refer to IFEX (ifosfamide for injection) product monograph. (see ADVERSE REACTIONS / Post-Market Adverse Drug Reactions and DRUG INTERACTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fosaprepitant in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
FOSAPREPITANT Product Monograph Page 5 of 33 Warfarin:
Coadministration of fosaprepitant with warfarin may cause a clinically significant decrease in the INR. 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 (see DRUG INTERACTIONS).
Hormonal contraception:
Fosaprepitant may reduce the efficacy of hormonal contraception. Alternative or backup methods should be used during and for 1 month following the last dose of FOSAPREPITANT (see DRUG INTERACTIONS).
Special Populations Pregnant Women:
There are no adequate and well-controlled studies in pregnant women; therefore, FOSAPREPITANT is not recommended for use during pregnancy unless clearly necessary (see TOXICOLOGY, Reproduction and Development).
Nursing Women:
Fosaprepitant, when administered intravenously, is rapidly converted to aprepitant. Aprepitant is excreted in the milk of lactating rats. It is not known whether this drug is excreted in human milk; therefore, breastfeeding is not recommended during treatment with FOSAPREPITANT.
Pediatrics (<18 years of age):
Safety and effectiveness of fosaprepitant in pediatric patients have not been established.
Geriatrics (≥65 years of age):
In 2 well-controlled clinical studies, of the total number of patients (N=544) treated with aprepitant, 31% were 65 and over, while 5% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Greater sensitivity of some older individuals cannot be ruled out. Dosage adjustment in the elderly is not necessary.
Hepatic Impairment:
There are no clinical data or pharmacokinetic data in patients with severe hepatic impairment (Child-Pugh score >9). FOSAPREPITANT should be used with caution in these patients (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions).
ADVERSE REACTIONS Clinical Trial Adverse Experiences The overall safety of fosaprepitant was evaluated in approximately 1600 individuals. Moderately Emetogenic Chemotherapy (MEC) In an active-controlled clinical trial in patients receiving MEC, safety was evaluated in 504 patients receiving a single dose of fosaprepitant in combination with ondansetron and dexamethasone (fosaprepitant regimen) compared to 497 patients receiving ondansetron and dexamethasone alone (control regimen).
Table 1 shows the percent of patients with clinical adverse experiences reported with fosaprepitant at an incidence ≥ 3%, regardless of causality. 2 General disorders and administration site conditions Asthenia Fatigue Metabolism and nutrition disorders Decreased appetite Musculoskeletal and […]