ted at an incidence ≥3% during Cycle 1 of the moderately emetogenic chemotherapy study in patients treated with the aprepitant regimen or standard therapy, respectively: decreased hemoglobin (2.3%, 4.7%) and decreased white blood cell count (9.3%, 9.0%).
The adverse experience profiles in the Multiple-Cycle extensions for up to 6 cycles of chemotherapy were generally similar to that observed in Cycle 1.
Stevens-Johnson syndrome was reported as a serious adverse experience in a patient receiving aprepitant with cancer chemotherapy in another CINV study.
Other Studies with Postoperative Nausea and Vomiting
In well-controlled clinical studies in patients receiving general anesthesia, 564 patients were administered 40 mg aprepitant orally and 538 patients were administered 4 mg ondansetron I.V. EMEND was generally well tolerated. Most adverse experiences reported in these clinical studies were described as mild to moderate in intensity. Clinical adverse experiences were reported in approximately 60% of patients treated with 40 mg aprepitant compared with approximately 64% of patients treated with 4 mg ondansetron I.V.
Additional adverse experiences were observed in patients receiving general anesthesia. In the patients treated with aprepitant (40 mg) for postoperative nausea and vomiting, the following additional adverse experiences were reported, regardless of causality, at an incidence ≥3%: anemia, bradycardia, flatulence, hypotension, pruritus, pyrexia.
The following adverse experiences were reported, regardless of causality, in patients treated with aprepitant for postoperative nausea and vomiting at an incidence of >0.5% and greater than with ondansetron: abdominal pain, abdominal pain upper, blood pressure decreased, dizziness, dyspepsia, hematoma, hypoesthesia, hypothermia, hypovolemia, hypoxia, operative hemorrhage, pain, postoperative infection, respiratory depression, syncope, urticaria, wound dehiscence.
Other adverse experiences (incidence ≤0.5%) reported, regardless of causality, in patients treated with aprepitant 40 mg for postoperative nausea and vomiting included: bowel sounds abnormal, dysarthria, miosis, sensory disturbance, stomach discomfort, visual acuity reduced, wheezing.
Laboratory Adverse Experiences with Postoperative Nausea and Vomiting
One laboratory adverse experience, hemoglobin decreased (40 mg aprepitant), was reported, regardless of causality, at an incidence ≥3% in a patient receiving general anesthesia.
The following additional laboratory adverse experiences (incidence >0.5% and greater than ondansetron), regardless of causality, were reported in patients treated with aprepitant 40 mg: blood albumin decreased, blood bilirubin increased, blood glucose increased, blood potassium decreased, glucose urine present.
The adverse experience of ALT increased occurred with similar incidence in patients treated with aprepitant as in patients treated with ondansetron.
Other Studies
In addition, two serious adverse experiences were reported in postoperative nausea and vomiting (PONV) clinical studies in patients taking a higher dose of aprepitant: one case of constipation, and one case of sub-ileus.
Angioedema and urticaria were reported as serious adverse experiences in a patient receiving aprepitant in a non-CINV/non-PONV study.
Post-Marketing Experience:
The following adverse reactions have been iden |
