Consumer Information for: EMEND

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

EMEND® , in combination with 5-HT3 antagonists and dexamethasone, is indicated for the prevention of nausea and vomiting associated with your cancer chemotherapy treatment.

What it does

EMEND® is a member of a new class of medicines called neurokinin 1 (NK1) receptor antagonists. EMEND® works by blocking neurokinin, a substance in the brain that causes nausea and vomiting.

When it should not be used

Do not take EMEND® if you are allergic to any of its ingredients.

Do not take EMEND® with pimozide, terfenadine, astemizole, or cisapride. Taking EMEND® with these medications could result in serious or life-threatening problems.

What the medicinal ingredient is

Aprepitant

What the non-medicinal ingredients are

Gelatin, hydroxypropyl cellulose, microcrystalline cellulose sodium lauryl sulfate, sucrose and titanium dioxide. The 125 mg capsule shell also contains red ferric oxide and yellow ferric oxide.

What dosage form it comes in

Each capsule contains 80 mg or 125 mg of aprepitant.

Warnings and precautions

Serious Warnings and Precautions

Drug interactions with:

  • Medicines that are likely to be broken down mainly by the liver
  • Warfarin
  • Hormonal contraception (birth control medicines)

BEFORE you use EMEND® talk to your physician or pharmacist if:

  • you have any past or present medical problems
  • you have liver problems
  • you have any allergies
  • you drive a car or operate machinery
  • you are pregnant or plan to become pregnant
  • you are breast-feeding or plan to breast-feed

Use in children
EMEND® should not be given to children under 18 years of age.

Use in the elderly
No dosage adjustment is necessary.

Interactions with this medication

Tell your physician about all medicines that you are taking or plan to take, even those you can get without a prescription or herbal products

Your physician may check that your medicines are working properly together if you are taking other medicines such as:

  • anti-anxiety drugs (such as alprazolam, midazolam)
  • birth control medicines (which may not work as well)
  • ketoconazole (an antifungal)
  • rifampin (an antibiotic)
  • paroxetine (a medicine used to treat a certain type of depression)
  • diltiazem (a medicine used to treat high blood pressure)
  • dexamethasone, methylprednisolone (steroid medicines used for a variety of conditions)
  • warfarin (a blood thinner)
  • tolbutamide (a medicine used to treat diabetes)
  • phenytoin (a medicine used to treat seizures)
  • some chemotherapy medications such as ifosfamid
Proper use of this medication

Usual Dose

Take EMEND® exactly as your physician has prescribed. The recommended dose of EMEND® is one 125 mg capsule by mouth 1 hour before you start your chemotherapy treatment on Day 1 and one 80 mg capsule by mouth each morning for the 2 days following your chemotherapy treatment.

EMEND® may be taken with or without food.

Overdose

If you take more than the prescribed dosage, contact your physician immediately.

Missed Dose

Try to take EMEND® as prescribed. However, if you miss a dose, contact your physician for further instructions.

Side effects and what to do about them

Any medicine may have unintended or undesirable effects, so-called side effects.

Like all prescription drugs, EMEND® may cause side effects.

The most common side effects included diarrhea, stomach pain, upset stomach, vomiting, dizziness, hiccups, fatigue, weakness, constipation, headache, hair loss, and loss of appetite.

Other side effects may also occur rarely, which include: anxiousness, fever with increased risk of infection, dry mouth, conjunctivitis (eye discharge and itching), excessive sweating, flushing, painful burning urination, muscle cramp or pain, taste disturbance, ringing in the ear (tinnitus), and low blood pressure.

The following side effects have been reported in general use with EMEND® : Allergic reactions, which may be serious, and may include hives, rash and itching and cause difficulty in breathing or swallowing. If you have an allergic reaction, stop taking EMEND® and call your physician right away.

Ask your physician or pharmacist for more information. Both have a more complete list of side effects. Tell your physician or pharmacist promptly about these or any other unusual symptoms.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and call your physician or pharmacist
Uncommon
Allergic reactions/ Angioedema (swelling of the face, eyes, lips, tongue, throat, difficulty in breathing or swallowing)     ✔
StevensJohnson syndrome/toxic epidermal necrolysis (severe skin reactions, blistering)     ✔
Urticaria (severe rash, itching, swelling of the hands and feet)     ✔

This is not a complete list of side effects. For any unexpected effects while taking EMEND® , contact your physician or pharmacist

How to store

Store at room temperature (15°C to 30°C).

Keep EMEND® and all medicines safely away from children.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

Also, you can report any suspected adverse reactions associated with the use of health products to Merck Canada Inc. by one of the following 2 ways:

  • Call toll-free at 1-800-567-2594
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-800-369-3090, or
    • Mail to: Merck Canada Inc.
      Pharmacovigilance
      P.O. Box 1005
      Pointe-Claire–Dorval, QC H9R 4P8

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.merck.ca

or by contacting the sponsor, Merck Canada Inc., at: 1-800-567-2594.

This leaflet was prepared by Merck Canada Inc.

Last revised: January 22, 2014

® Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Used under license.

©2011, 2013 Merck Canada Inc., a subsidiary of Merck & Co., Inc. All rights reserved.

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