May 26, 2016
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Emend

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Emend Capsules




Emend Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Emend (aprepitant) is used together with other medications to prevent nausea and vomiting that may be caused by surgery or cancer chemotherapy. It is given ahead of time and will not treat nausea or vomiting you already have. It is an antiemetic. Common side effects include tiredness and hiccups.

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. 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. During pregnancy, Emend should be used only when prescribed. It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Emend (aprepitant) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Emend in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • 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, sores in your mouth and throat.

Less serious side effects may include:

  • nausea, vomiting, heartburn, stomach pain;
  • diarrhea or constipation;
  • loss of appetite;
  • hiccups;
  • hair loss;
  • headache;
  • dizziness;
  • tired feeling;
  • mild skin rash;
  • ringing in your ears; or
  • sleep problems (insomnia).

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)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Emend Overview - Patient Information: Side Effects

SIDE EFFECTS: Tiredness and hiccups may occur. If either of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Emend (Aprepitant Capsules)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Emend FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 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†
(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)

Emend Capsules - User Reviews

Emend Capsules User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Emend Capsules sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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