Emend
- Generic Name: aprepitant capsules
- Brand Name: Emend Capsules
Emend Capsules (Aprepitant Capsules) side effects drug center
Emend Side Effects Center
What Is Emend?
Emend (aprepitant) is an antiemetic (anti-nausea) used together with other medications to prevent nausea and vomiting that may be caused by surgery or cancer chemotherapy. Emend is given ahead of time and will not treat nausea or vomiting you already have.
What Are Side Effects of Emend?
Common side effects of Emend include:
- tiredness
- hiccups
- nausea
- vomiting
- heartburn
- stomach pain
- diarrhea
- constipation
- loss of appetite
- hair loss
- headache
- dizziness
- mild skin rash
- ringing in your ears
- sleep problems (insomnia).
Tell your doctor if you have serious side effects of Emend including:
- feeling like you might pass out;
- feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin; or
- fever, chills, body aches, flu symptoms, or sores in your mouth and throat.
Dosage for Emend
The recommended dose of Emend is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3.
What Drugs, Substances, or Supplements Interact with Emend?
Emend may interact with birth control pills, diltiazem, tolbutamide, blood thinners, midazolam or similar medicines, antidepressants, antibiotics, antifungals, cancer medicines, HIV medicines, seizure medications, steroids. Tell your doctor all medications you use.
Emend During Pregnancy and Breastfeeding
During pregnancy, Emend should be used only when prescribed. It is not known if this drug passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Emend (aprepitant) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Emend Consumer Information
Get emergency medical help if you have signs of an allergic reaction (hives, itching, difficult breathing, dizziness, trouble swallowing, fast heartbeat, wheezing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Call your doctor at once if you have:
- a light-headed feeling, like you might pass out;
- pain or burning when you urinate;
- sores or white patches in your mouth or throat, sore throat;
- low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
- dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.
Common side effects may include:
- stomach pain, indigestion, burping, loss of appetite;
- low blood cell counts;
- diarrhea, constipation;
- hiccups;
- abnormal liver function tests;
- headache, dizziness;
- dehydration;
- pain in your arms or legs;
- pain, hardening, redness, swelling, or itching where the medicine was injected;
- cough; or
- feeling weak or tired.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Emend (Aprepitant Capsules)
Emend Professional Information
SIDE EFFECTS
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 6800 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† (N=1412) |
Ondansetron and dexamethasone‡ (N=1396) |
|
| fatigue | 13% | 12% |
| diarrhea | 9% | 8% |
| asthenia | 7% | 6% |
| dyspepsia | 7% | 5% |
| abdominal pain | 6% | 5% |
| hiccups | 5% | 3% |
| white blood cell count decreased | 4% | 3% |
| dehydration | 3% | 2% |
| alanine aminotransferase increased | 3% | 2% |
| * Reported in ≥ 3% of patients treated with the EMEND regimen and at a greater incidence than standard therapy. † EMEND regimen ‡ Standard therapy |
||
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 Studies*
| Infection and Infestations | oral candidiasis, pharyngitis |
| Blood and the Lymphatic System Disorders | anemia, febrile neutropenia, neutropenia, thrombocytopenia |
| Metabolism and Nutrition Disorders | decreased appetite, hypokalemia |
| Psychiatric Disorders | anxiety |
| Nervous System Disorders | dizziness, dysgeusia, peripheral neuropathy |
| Cardiac Disorders | palpitations |
| 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† (N=184) |
Ondansetron‡ (N=168) |
|
| neutropenia | 13% | 11% |
| headache | 9% | 5% |
| diarrhea | 6% | 5% |
| decreased appetite | 5% | 4% |
| cough | 5% | 3% |
| fatigue | 5% | 2% |
| hemoglobin decreased | 5% | 4% |
| dizziness | 5% | 1% |
| hiccups | 4% | 1% |
| * Reported in ≥3% of patients treated with the EMEND regimen and at a greater incidence than control regimen. † EMEND regimen ‡ 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
In 2 active-controlled, double-blind clinical studies in patients receiving general anesthesia (Studies 7 and 8), 40-mg oral EMEND was compared to 4-mg intravenous ondansetron [see Clinical Studies].
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) |
Ondansetron (N = 538) |
|
| constipation | 9% | 8% |
| hypotension | 6% | 5% |
| * 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 |
| Cardiac Disorders | bradycardia |
| Vascular Disorders | hematoma |
| 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.
Other Studies
Angioedema and urticaria were reported as serious adverse reactions in a patient receiving EMEND in a non-CINV/non-PONV study (EMEND is only approved in the CINV and PONV populations).
Postmarketing Experience
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 entire FDA prescribing information for Emend (Aprepitant Capsules)
&Copy; Emend Patient Information is supplied by Cerner Multum, Inc. and Emend Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.