The Use of MIFEGYMISO in Canada

The Use of MIFEGYMISO in Canada

MIFEGYMISO (mifepristone tablet/misoprostol tablets) is indicated for medical termination of a developing intra-uterine pregnancy with a gestational age up to 63 days as measured from the first day of the last menstrual period in a presumed 28-day cycle.

MIFEGYMISO (mifepristone tablet/misoprostol tablets) is a composite pack containing mifepristone 200 mg tablet and misoprostol 200 mcg tablets.

 

Product Name Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients 

 

 

mifepristone

 

Oral

 

Tablet/200 mg

 

For a complete listing see Dosage Forms, Composition and Packaging section.

 

 

misoprostol

 

Buccal

 

Tablet/200 mcg

 

For a complete listing see Dosage Forms, Composition and Packaging section.

MIFEGYMISO should be prescribed by health professionals with adequate knowledge of medical abortion and/or who have completed a MIFEGYMISO education program.

EDUCATION PROGRAM IS AVAILABLE FOR HEALTH PROFESSIONALS ON THIS SITE

This Educational Program has been developed to train health professionals to ensure safe and effective use of MIFEGYMISO. It provides information on the use of MIFEGYMISO for the termination of early pregnancy. Additional pre- and post-abortion care information is also provided.

Prior to prescribing MIFEGYMISO, health professionals must:

 

  • Ensure that patients have access to emergency medical care in the 14 days following administration of mifepristone;
  • Schedule follow-up 7 to 14 days after patients take mifepristone to confirm complete pregnancy termination;
  • Exclude ectopic pregnancy and confirm gestational age by an appropriate method;
  • Counsel each patient on the risks and benefits of MIFEGYMISO, including bleeding, infection and incomplete abortion;
  • Obtain the patient’s informed consent to take the drug.

Each patient should be provided with a printed copy of the MIFEGYMISO Patient Information Card. The Patient Information Card should be completed by the health professional. These documents as well as a consent form can be obtained by download from this site, request by email to info@linepharma.com or by phone at +1-877-230-4227.

Patients should be advised to take their Patient Information Card with them if they visit an emergency room or another health professional who did not prescribe MIFEGYMISO, so that the health professional will be aware that the patient is undergoing a medical abortion.

ADDITIONAL INFORMATION

For further details on the Phase IV study for MIFEGYMISO in Canada, please click here.

We encourage all providers and dispensing pharmacists to register with the Canadian Abortion Providers Support (CAPS). CAPS is a university-based Canadian online community for health professionals certified to provide MIFEGYMISO that is managed in collaboration with the SOGC, CFPC, and Canadian Pharmacists’ Association. Practice guidelines, patient handouts, the latest information on subsidy options for MIFEGYMISO, and “Ask-an-Expert” features are available to support professionals. Similarly, the Choice Connect App makes finding the nearest abortion care easier by connecting patients to providers based on their specific needs. New providers are encouraged to reach out to Choice Connect to ensure their listing is made available to patients.

Providers and dispensing pharmacists are encouraged to familiarize themselves with Action Canada for Sexual Health and Rights (Action Canada), a progressive, pro-choice charitable organization committed to advancing and upholding sexual and reproductive health and rights in Canada and globally. Among other national and international programming, Action Canada runs a 24/7 toll-free access line for abortion referrals and a public online directory. You can access the public online directory here and you can register here to be added to Action Canada’s private directory and/or its public online directory. You may also refer to the National Abortion Federation Canada (NAF Canada). NAF Canada is the professional association of abortion providers. NAF Canada members include clinics, hospitals, and physicians who together care for more than half of the women who choose abortion in Canada each year. NAF Canada sets the standards for quality abortion care through their evidence-based Clinical Policy Guidelines for abortion care and provides continuing medical education in all aspects of abortion care.

MIFEGYMISO Adverse Drug Reaction Overview

The most frequent undesirable effects which were observed during treatment with MIFEGYMISO were:

 

  • Reproductive system disorders: vaginal bleeding, sometimes heavy and prolonged uterine cramping.
  • Gastrointestinal disorders: nausea, vomiting, diarrhea and abdominal pain.
  • General disorders: headache, dizziness, chills and fever.

What happens if a patient vomits the dose of mifepristone?

If a patient has vomited more than 1 hour after taking the dose of mifepristone (the tablet in the green box), the medication was probably absorbed, and she does not need to return to her prescribing health professional. If she had vomited less than 1 hour after taking the dose of mifepristone (the tablet in the green box), she should return to her prescribing health professional to get a new prescription for the medication along with an anti-nausea medication.

The peak of concentration for single dose of 200mg Mifepristone is reached after 0.75 hours.

What happens if a patient vomits the dose of misoprostol?

While we understand that a normal symptom of the misoprostol includes vomiting (as well as low-grade fever, chills, nausea, diarrhea), the question is about what to do if a patient vomits immediately (or almost immediately) after taking the misoprostol tablets (for example, it hasn’t been 30 minutes yet since she placed it in her cheek, or it’s immediately after she swallowed any remaining fragments at the 30-minute mark).

The cut off time is 1 hour after Misoprostol intake because the peak of concentration for Misoprostol is reached after 0.5 hours.

What actions should the patient take if she vomits before the cut-off time? For example, should she get another prescription for Misoprostol?

If the patient vomits before the cut-off time, it is advised to take another dose of misoprostol.

What actions should the patient take if she vomits after the cut-off time?

No action is required.

ordering mifegymiso

To place an order email: linepharma@lsu3pl.ca or phone: 1-877-230-4227 extension 2. Pharmacy orders can be placed with your wholesaler.


Product Monograph

Patient Medication Insert

Patient Consent Form

Patient Information Card

Patient Information Booklet

Terms of Sale

Pandemic Response

Mifepristone ਅਤੇMisoprostol ਗਰਭ-ਅਵਸਥਾ

Misoprostolو Mifepristone ّ لإنھاء الحمل الطبي

Mifepristone和Misoprostol 药物终止妊娠

Protocol for Medication Abortion via

Contraception Consensus: Updated

DISCLAIMER

THE INFORMATION PROVIDED ON THIS WEBSITE IS FOR GENERAL INFORMATION ONLY

Linepharma International Inc. and its affiliates make every effort to ensure the accuracy and reliability of the information that appears on this website but cannot guarantee that it is error free or complete.

Formerly Celopharma Inc., Linepharma International Inc. is the Canadian sales and distribution arm of Linepharma International.

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