Aprepitant Capsules

Name: Aprepitant Capsules

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*

Infection 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.

Overdose

No specific information is available on the treatment of overdosage.

Drowsiness and headache were reported in one patient who ingested 1440 mg of EMEND (approximately 11 times the maximum recommended single dose).

In the event of overdose, EMEND should be discontinued and general supportive treatment and monitoring should be provided. Because of the antiemetic activity of EMEND, drug-induced emesis may not be effective in cases of EMEND overdosage.

Aprepitant is not removed by hemodialysis.

Patient information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Hypersensitivity Reactions

Advise patients that hypersensitivity reactions, including anaphylaxis, have been reported in patients taking EMEND. Advise patients to stop taking EMEND and seek immediate medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as hives, rash and itching, skin peeling or sores, or difficulty in breathing or swallowing.

Drug Interactions

Advise patients to discuss all medications they are taking, including other prescription, nonprescription medication or herbal products [see CONTRAINDICATIONS , WARNINGS AND PRECAUTIONS].

Warfarin: Instruct patients on chronic warfarin therapy to follow instructions from their healthcare provider regarding blood draws to monitor their INR during the 2-week period, particularly at 7 to 10 days, following initiation of the 3-day regimen of EMEND with each chemotherapy cycle, or following administration of a single 40-mg dose of EMEND for the prevention of postoperative nausea and vomiting [see WARNINGS AND PRECAUTIONS].

Hormonal Contraceptives: Advise patients that administration of EMEND may reduce the efficacy of hormonal contraceptives. Instruct patients to use effective alternative or back-up methods of contraception (such as condoms and spermicides) during treatment with EMEND and for 1 month following the last dose of EMEND [see WARNINGS AND PRECAUTIONS , Use In Specific Populations].

Uses of Aprepitant Capsules

  • It is used to prevent upset stomach and throwing up from chemo.
  • It is used to prevent upset stomach and throwing up from surgery.
  • It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Aprepitant Capsules?

  • If you have an allergy to aprepitant or any other part of this medicine (aprepitant capsules).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are taking any of these drugs: Cisapride or pimozide.
  • If you are taking any of these drugs: Clarithromycin, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, or troleandomycin.
  • If you are taking any of these drugs: Carbamazepine, diltiazem, phenytoin, or rifampin.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (aprepitant capsules) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How do I store and/or throw out Aprepitant Capsules?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

What is aprepitant (emend, emend 2-day, emend 3-day)?

Aprepitant blocks the actions of chemicals in the body that trigger nausea and vomiting.

Aprepitant is used together with other medications to prevent nausea and vomiting that may be caused by surgery or cancer chemotherapy.

Aprepitant is given ahead of time and will not treat nausea or vomiting that you already have.

Aprepitant may also be used for other purposes not listed in this medication guide.

Where can i get more information?

Your pharmacist can provide more information about aprepitant.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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