Details for: EMEND IV
Company: MERCK CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02363356 | EMEND IV | FOSAPREPITANT (FOSAPREPITANT DIMEGLUMINE) | 150 MG / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
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.
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 non-medicinal ingredients are
edetate disodium, polysorbate 80, lactose anhydrous, sodium hydroxide and/or hydrochloric acid (for pH adjustment).
What dosage form it comes in
Powder for injection. Each vial contains 150 mg of fosaprepitant.
Warnings and precautions
Serious Warnings and Precautions
Drug interactions may occur with:
- Medicines that are likely to be broken down mainly by the liver. This may increase the levels of the medication in your blood.
- Warfarin. It may affect your blood test results.
- Hormonal contraception (birth control medicines). It may reduce the effectiveness of the birth control you are taking. Discuss with your physician regarding use of an alternate or backup method of birth control during and for 1 month after the last dose of EMEND® IV.
Possible serious side effects:
- Severe allergic (hypersensitivity) reactions during or soon after infusion. Signs include swelling (face, eyes, lips, tongue, throat and skin), rash, itching, redness of the face and skin, difficulty in breathing and swallowing, and serious drop in blood pressure.
BEFORE you use EMEND® IV talk to your physician or pharmacist if you:
- have any past or present medical problems
- have liver problems
- have any allergies
- drive a car or operate machinery
- are pregnant or plan to become pregnant
- 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)
- some chemotherapy medications such as ifosfamide
Proper use of this medication
EMEND® IV may be taken with or without food.
Usual dose
EMEND® IV 150 mg given on Day 1 only.
- Day of chemotherapy: EMEND® IV 150 mg will be given to you intravenously approximately 30 minutes before you start your chemotherapy treatment.
Overdose
Side effects and what to do about them
Like all prescription drugs, EMEND® IV may cause side effects. Just because side effects have occurred in other patients does not mean you will get them. If you experience any side effects that bother you, please contact your doctor or pharmacist.
Side effects include:
- low white blood cell counts
- diarrhea
- stomach pain
- constipation
- upset stomach
- nausea
- vomiting
- fatigue
- dizziness
- weakness
- loss of appetite
- joint pain
- taste disturbance
- headache
- urinary tract infection
- dehydration
- pain and/or tingling in the limbs
- anxiety
- nose bleeds
- hiccups
- low red blood cell counts
- chest pain
- shortness of breath
- sores in the mouth
Infusion-site reactions include:
- pain
- hardening
- swelling of a vein caused by a blood clot
- redness and/or itching at the infusion site
Side effects seen with EMEND® capsules may also be seen with EMEND® IV.
- upset stomach and pain
- trouble sleeping (insomnia)
- hair loss (alopecia)
- fever
- ringing in the ears
- slow heart rate
- ulcers
- disorientation
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.
| Symptoms / Effects | Talk with your physician or pharmacist Only if severe | Talk with your physician or pharmacist In all cases | Stop taking drug and call your physician or pharmacist |
|---|---|---|---|
| Uncommon | |||
| Allergic reactions, which may be sudden and/or serious, and may include: swelling (face, eyes, lips, tongue, throat and skin), rash, itching, redness of the face/skin, difficulty in breathing/ swallowing, and serious decrease of blood pressure. | ✔ | ||
| Stevens-Johnson 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® IV, contact your physician or pharmacist.
How to store
Vials: Sterile powder for intravenous use. Store at 2–8°C.
Keep EMEND® IV and all medicines safely away from children.
Reporting side effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 1908C
Ottawa, ON
K1A 0K9
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about EMEND® IV or EMEND® capsules:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website or Merck Canada website www.merck.ca or by calling Merck Canada at 1-800-567-2594
To report an adverse event related to EMEND® IV, please contact 1-800-567-2594.
This leaflet was prepared by Merck Canada Inc.
Last revised: October 17, 2018
®Merck Sharp & Dohme Corp. Used under license.
©2011, 2018 Merck Canada Inc. All rights reserved