Patient Medication Information: uses, side effects, how to take - Emend IV (Merck Canada, 115 mg)
ABOUT THIS MEDICATION
What the medication is used for:
EMEND® IV, 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® IV is a member of a class of medicines called neurokinin 1 (NK1) receptor antagonists. Fosaprepitant when administered intravenously is rapidly converted to aprepitant. Aprepitant works by blocking neurokinin, a substance in the brain that causes nausea and vomiting.
No clinical trials that involved the use of fosaprepitant and both dexamethasone and a 5-HT3 antagonist class of antiemetics have been submitted.
When it should not be used:
Do not take EMEND® IV if you are allergic to fosaprepitant dimeglumine, aprepitant or any of the other ingredients of EMEND® IV.
Do not take EMEND® IV with pimozide, terfenadine, astemizole, or cisapride. Taking EMEND® IV with these medications could result in serious or life-threatening problems.
What the medicinal ingredient is:
Fosaprepitant dimeglumine
What the important non-medicinal ingredients are:
edetate disodium, polysorbate 80, lactose anhydrous, sodium hydroxide and/or hydrochloric acid (for pH adjustment).
What dosage forms it comes in:
Powder for injection. Each vial contains 115 mg of fosaprepitant.
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® IV 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® IV 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)
Following the infusion of EMEND® I.V., the early concentration of aprepitant in the blood is double that of an EMEND® capsule (125 mg); therefore, a possible risk for increased side effects cannot be ruled out.”
PROPER USE OF THIS MEDICATION
EMEND® IV is given as an intravenous infusion over 15 minutes on Day 1 only of a 3-day regimen.
Usual dose:
EMEND® IV 115-mg given intravenously 30 minutes before chemotherapy treatment on Day 1, and EMEND® 80-mg taken orally each morning on Day 2 and 3.
EMEND® IV may be taken with or without food.
Overdose:
If you take more than the prescribed dosage, contact your physician or contact a poison control centre immediately.
Missed Dose:
If you miss a scheduled dose of EMEND®, contact your physician for advice.
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® IV may cause side effects. The most common side effects in cancer patients taking the oral aprepitant regimen included diarrhea, stomach pain, upset stomach, dizziness, hiccups, fatigue, constipation, headache, and loss of appetite.
The most common side effects with EMEND® IV were injection site pain, hardening of site of injection and headache.
Other side effects of aprepitant 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, itching, muscle cramp or pain, taste disturbance.
The following side effects have been reported in general use: Allergic reactions, which may be sudden and/or serious, and may include hives, rash, itching, redness of the face/skin, and cause difficulty in breathing or swallowing.
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 | ||||
| Symptoms / Effects | Talk with your physician or pharmacist | Stop taking drug and call your physician or pharmacist | ||
| Only if severe | In all cases | |||
| Uncommon | Allergic reactions/ Angioedema (swelling of the face, eyes, lips, tongue, throat, difficulty in breathing or swallowing) | √ | ||
Stevens- Johnson syndrome (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® IV, contact your physician or pharmacist.
HOW TO STORE IT
Vials: Sterile powder for intravenous use. Store at 2-8°C.
Keep EMEND® IV and all medicines safely away from children.
REPORTING SUSPECTED 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 0701D
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect
or at Merck Frosst Canada Ltd. 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 1-877-428-8675, or
Mail to: Merck Frosst Canada Ltd.
P.O. Box 1005
Pointe-Claire - Dorval, QC H9R 4P8 NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program or Merck Frosst do not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.merckfrosst.com
or by contacting the sponsor, Merck Frosst Canada Ltd., at: 1-800-567-2594
Last revised: March 23, 2010
EMEND® is a Registered Trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Used under license.