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EMEND TRI-PACK is a brand name for Aprepitant, supplied as a kit. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Serious Warnings and Precautions Drug interactions with:
Medicinal products, including chemotherapeutic agents, that are metabolized through CYP3A4 (see DRUG INTERACTIONS) Warfarin (see DRUG INTERACTIONS) Hormonal contraception (see DRUG INTERACTIONS) Drug Interactions CYP3A4 substrates: EMEND® is a moderate inhibitor of CYP3A4.
Caution should be used when EMEND® is co-administered 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 EMEND® and ifosfamide co-administration.
Caution and careful monitoring are advised. Refer to IFEX (ifosfamide for injection) product monograph. (see ADVERSE REACTIONS / Post-Market Adverse Drug Reactions and DRUG INTERACTIONS).
Warfarin:
Co-administration of EMEND® 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 the 3-day regimen of EMEND® with each chemotherapy cycle (see DRUG INTERACTIONS).
Hormonal contraception:
EMEND® may reduce the efficacy of hormonal contraception. Alternative or backup methods should be used during and for 1 month following the last dose of EMEND® (see DRUG INTERACTIONS). 5 times the systemic exposure at the adult human dose and have revealed no evidence of impaired fertility or harm to the fetus due to aprepitant.
However, there are no adequate and well-controlled studies in pregnant women; therefore, EMEND® is not recommended for use during pregnancy unless clearly necessary.
Nursing Women:
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 EMEND®.
Pediatrics (<18 years of age):
Safety and effectiveness of EMEND® in pediatric patients have not been established.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Aprepitant in Canada.
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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.
EMEND® (aprepitant capsules) Page 5 of 40 Geriatrics (≥65 years of age):
In 2 well-controlled clinical studies, of the total number of patients (N=544) treated with EMEND®, 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. ADVERSE REACTIONS Clinical Trial Adverse Experiences The overall safety of aprepitant was evaluated in approximately 6500 individuals.
Highly Emetogenic Chemotherapy (HEC) In 2 well-controlled clinical trials in patients receiving cisplatin-based chemotherapy, 544 patients were treated with aprepitant during Cycle 1 of chemotherapy and 413 of these patients continued into the Multiple-Cycle extension for up to 6 cycles of chemotherapy.
EMEND® was given in combination with ondansetron and dexamethasone and was generally well tolerated. Most adverse experiences reported in these clinical studies were described as mild to moderate in intensity. In Cycle 1, clinical adverse experiences were reported in approximately 74% of patients treated with the aprepitant regimen compared with approximately 72% of patients treated with standard therapy.
Table 1 shows the percent of patients with clinical adverse experiences reported at an incidence ≥3%. 6 In addition, isolated cases of serious adverse experiences, regardless of causality, of bradycardia, disorientation, and perforating duodenal ulcer were reported in highly emetogenic CINV clinical studies.
Moderately Emetogenic Chemotherapy (MEC) During Cycle 1 of 2 moderately emetogenic chemotherapy studies, 868 patients were treated with the aprepitant regimen and 686 of these patients continued into extensions for up to 4 cycles of chemotherapy.
In the combined analysis of Cycle 1 data for these 2 studies, adverse experiences were reported in approximately 69% of patients treated with the aprepitant regimen compared with approximately 72% of patients treated with standard therapy.
EMEND® (aprepitant capsules) Page 7 of 40 In the combined analysis of Cycle 1 data for these 2 studies, the adverse experience profile in both moderately emetogenic chemotherapy studies was generally comparable to the highly emetogenic chemotherapy studies.
Table 2 shows the percent of patients with clinical adverse experiences reported at an incidence ≥3%. 7 Nervous System […]