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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 overall safety of EMEND was evaluated in approximately 6500 individuals.
Adverse Reactions in Adults in the Prevention of Nausea and Vomiting Associated with HEC and MEC
In 2 active-controlled, double-blind clinical trials in patients receiving highly emetogenic chemotherapy (HEC) (Studies 1 and 2), EMEND in combination with ondansetron and dexamethasone (EMEND regimen) was compared to ondansetron and dexamethasone alone (standard therapy) [see Clinical Studies].
In 2 active-controlled clinical trials in patients receiving moderately emetogenic chemotherapy (MEC) (Studies 3 and 4), EMEND in combination with ondansetron and dexamethasone (EMEND regimen) was compared to ondansetron and dexamethasone alone (standard therapy) [see Clinical Studies]. The most common adverse reaction reported in patients who received MEC in pooled Studies 3 and 4 was dyspepsia (6% versus 4%).
Across these 4 studies there were 1412 patients treated with the EMEND regimen during Cycle 1 of chemotherapy and 1099 of these patients continued into the Multiple-Cycle extension for up to 6 cycles of chemotherapy. The most common adverse reactions reported in patients who received HEC and MEC in pooled Studies 1, 2, 3 and 4 are listed in Table 5.
Table 5: Most Common Adverse Reactions in Patients
Receiving HEC and MEC from a Pooled Analysis of HEC and MEC Studies*
|EMEND, ondansetron, and dexamethasone†
|Ondansetron and dexamethasone‡
|white blood cell count decreased||4%||3%|
|alanine aminotransferase increased||3%||2%|
|*Reported in ≥ 3% of
patients treated with the EMEND regimen and at a greater incidence than
In a pooled analysis of the HEC and MEC studies, less common adverse reactions reported in patients treated with the EMEND regimen are listed in Table 6.
Table 6: Less Common Adverse
Reactions in EMEND-Treated Patients from a Pooled Analysis of HEC and MEC
|Infection and Infestations||oral candidiasis, pharyngitis|
|Blood and the Lymphatic System Disorders||anemia, febrile neutropenia, neutropenia, thrombocytopenia|
|Metabolism and Nutrition Disorders||decreased appetite, hypokalemia|
|Nervous System Disorders||dizziness, dysgeusia, peripheral neuropathy|
|Vascular Disorders||flushing, hot flush|
|Respiratory, Thoracic and Mediastinal Disorders||cough, dyspnea, oropharyngeal pain|
|Gastrointestinal Disorders||dry mouth, eructation, flatulence, gastritis, gastroesophageal reflux disease, nausea, vomiting|
|Skin and Subcutaneous Tissue Disorders||alopecia, hyperhidrosis, rash|
|Musculoskeletal and Connective Tissue Disorders||musculoskeletal pain|
|General Disorders and Administration Site Condition||edema peripheral, malaise|
|Investigations||aspartate aminotransferase increased, blood alkaline phosphatase increased, blood sodium decreased, blood urea increased, proteinuria, weight decreased|
|*Reported in > 0.5% of patients treated with the EMEND regimen, at a greater incidence than standard therapy and not previously described in Table 5.|
In an additional active-controlled clinical study in 1169 patients receiving EMEND and HEC, the adverse reactions were generally similar to that seen in the other HEC studies with EMEND.
In another CINV study, Stevens-Johnson syndrome was reported as a serious adverse reaction in a patient receiving the EMEND regimen with cancer chemotherapy.
Adverse reactions in the Multiple-Cycle extensions of HEC and MEC studies for up to 6 cycles of chemotherapy were generally similar to that observed in Cycle 1.
Adverse Reactions in Pediatric Patients 6 Months to 17 Years of Age in the Prevention of Nausea and Vomiting Associated with HEC or MEC
In a pooled analysis of 2 active-controlled clinical trials in pediatric patients aged 6 months to 17 years who received highly or moderately emetogenic cancer chemotherapy (Study 5 and a safety study, Study 6), EMEND in combination with ondansetron with or without dexamethasone (EMEND regimen) was compared to ondansetron with or without dexamethasone (control regimen).
There were 184 patients treated with the EMEND regimen during Cycle 1 and 215 patients received open-label EMEND for up to 9 additional cycles of chemotherapy.
In Cycle 1, the most common adverse reactions reported in pediatric patients treated with the EMEND regimen in pooled Studies 5 and 6 are listed in Table 7.
Table 7: Most Common Adverse Reactions in EMEND-Treated
Pediatric Patients in HEC and MEC Pooled Studies 5 and 6*
|EMEND and ondansetron†
|*Reported in ≥ 3% of patients treated with the EMEND regimen and at
a greater incidence than control regimen.
Forty-nine patients were treated with ifosfamide chemotherapy in each arm. Two of the patients treated with ifosfamide in the aprepitant arm developed behavioral changes (agitation = 1; abnormal behavior = 1), whereas no patient treated with ifosfamide in the control arm developed behavioral changes. Aprepitant has the potential for increasing ifosfamide-mediated neurotoxicity through induction of CYP3A4 [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
Adverse Reactions in Adult Patients in the Prevention of PONV
There were 564 patients treated with EMEND and 538 patients treated with ondansetron.
The most common adverse reactions reported in patients treated with EMEND for PONV in pooled Studies 7 and 8 are listed in Table 8.
Table 8: Most Common Adverse
Reactions in EMEND-Treated Patients in a Pooled Analysis of PONV Studies*
|EMEND 40 mg
(N = 564)
(N = 538)
|*Reported in ≥ 3% of patients treated with the EMEND 40 mg and at a greater incidence than ondansetron.|
In a pooled analysis of PONV studies, less common adverse reactions reported in patients treated with EMEND are listed in Table 9.
Table 9: Less Common Adverse Reactions in
EMEND-Treated Patients in a Pooled Analysis of PONV Studies*
|Infections and Infestations||postoperative infection|
|Metabolism and Nutrition Disorders||hypokalemia, hypovolemia|
|Nervous System Disorders||dizziness, hypoesthesia, syncope|
|Respiratory, Thoracic and Mediastinal Disorders||dyspnea, hypoxia, respiratory depression|
|Gastrointestinal Disorders||abdominal pain, dry mouth, dyspepsia|
|Skin and Subcutaneous Tissue Disorders||urticaria|
|General Disorders and Administration Site Conditions||hypothermia|
|Investigations||blood albumin decreased, bilirubin increased, blood glucose increased, blood potassium decreased|
|Injury, Poisoning and Procedural Complications||operative hemorrhage, wound dehiscence|
|*Reported in > 0.5% of patients treated with EMEND and at a greater incidence than ondansetron|
In addition, two serious adverse reactions were reported in PONV clinical studies in patients taking a higher than recommended dose of EMEND: one case of constipation, and one case of sub-ileus.
The following adverse reactions have been identified during post-approval use of EMEND. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders: pruritus, rash, urticaria, Stevens-Johnson syndrome/toxic epidermal necrolysis.
Immune system disorders: hypersensitivity reactions including anaphylactic reactions [see CONTRAINDICATIONS].
Nervous system disorders: ifosfamide-induced neurotoxicity reported after EMEND and ifosfamide coadministration.
Read the Emend Capsules (aprepitant capsules) Side Effects Center for a complete guide to possible side effects
Effect Of Aprepitant On The Pharmacokinetics Of Other Drugs
Aprepitant is a substrate, a weak-to-moderate (dose-dependent) inhibitor, and an inducer of CYP3A4 and CYP2C9 [see CLINICAL PHARMACOLOGY].
Aprepitant acts as a moderate inhibitor of CYP3A4 when administered as a 3-day regimen (125mg/80-mg/80-mg) and can increase plasma concentrations of concomitant drugs that are substrates for CYP3A4. Aprepitant acts as a weak inhibitor when administered as a single 40-mg dose and has not been shown to alter the plasma concentrations of concomitant drugs that are primarily metabolized through CYP3A4. Some substrates of CYP3A4 are contraindicated with EMEND [see CONTRAINDICATIONS]. Dosage adjustment of some CYP3A4 and CYP2C9 substrates may be warranted, as shown in Table 10.
Table 10: Effects of
Aprepitant on the Pharmacokinetics of Other Drugs
|Clinical Impact||Increased pimozide exposure|
|Intervention||EMEND is contraindicated [see CONTRAINDICATIONS].|
|Clinical Impact||Increased exposure to midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) may increase the risk of adverse reactions [see CLINICAL PHARMACOLOGY].|
|Intervention||3-day EMEND regimen
|Clinical Impact||Increased dexamethasone exposure [see CLINICAL PHARMACOLOGY].|
|Intervention||3-day EMEND regimen
|Clinical Impact||Increased methylprednisolone exposure [see CLINICAL PHARMACOLOGY].|
3-day EMEND regimen
Single 40 mg dose of EMEND
|Chemotherapeutic agents that are metabolized by CYP3A4|
|Clinical Impact||Increased exposure of the chemotherapeutic agent may increase the risk of adverse reactions [see CLINICAL PHARMACOLOGY].|
|Intervention||Vinblastine, vincristine, or ifosfamide or other chemotherapeutic agents
|Clinical Impact||Decreased hormonal exposure during administration of and for 28 days after administration of the last dose of EMEND [see WARNINGS AND PRECAUTIONS, Use In Specific Populations, CLINICAL PHARMACOLOGY].|
|Intervention||Effective alternative or back-up methods of contraception (such as condoms and spermicides) should be used during treatment with EMEND and for 1 month following the last dose of EMEND.|
|Examples||birth control pills, skin patches, implants, and certain IUDs|
|Clinical Impact||Decreased warfarin exposure and prolongation of prothrombin time (INR) [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].|
|Intervention||In patients on chronic warfarin therapy, monitor the prothrombin time (INR) in the 2-week period, particularly at 7 to 10 days, following initiation of the 3-day EMEND regimen with each chemotherapy cycle, or following administration of a single 40-mg dose of EMEND.|
|Clinical Impact||No change in the exposure of the 5-HT3 antagonist [see CLINICAL PHARMACOLOGY].|
|Intervention||No dosage adjustment needed|
|Examples||ondansetron, granisetron, dolasetron|
Effect Of Other Drugs On The Pharmacokinetics Of Aprepitant
Aprepitant is a CYP3A4 substrate [see CLINICAL PHARMACOLOGY]. Co-administration of EMEND with drugs that are inhibitors or inducers of CYP3A4 may result in increased or decreased plasma concentrations of aprepitant, respectively, as shown in Table 11.
Table 11: Effects of Other
Drugs on Pharmacokinetics of Aprepitant
|Moderate to Strong CYP3A4 Inhibitors|
|Clinical Impact||Significantly increased exposure of aprepitant may increase the risk of adverse reactions associated with EMEND [see ADVERSE REACTION and CLINICAL PHARMACOLOGY].|
|Intervention||Avoid concomitant use of EMEND|
|Strong CYP3A4 Inducers|
|Clinical Impact||Substantially decreased exposure of aprepitant in patients chronically taking a strong CYP3A4 inducer may decrease the efficacy of EMEND [see CLINICAL PHARMACOLOGY].|
|Intervention||Avoid concomitant use of EMEND|
|Examples||rifampin, carbamazepine, phenytoin|
Last reviewed on RxList: 12/26/2015
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