Health Canada updates prescribing and dispensing information for Mifegymiso

Starting date:

November 7, 2017

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Identification number:

RA-65034

• Issue
• What you should do
• What industry professionals should do
• Report health or safety concerns
• Media enquiries
• Public enquiries

Issue

OTTAWA – Health Canada is informing Canadians and health professionals of changes regarding the prescribing and dispensing of Mifegymiso.

Health Canada has received and rigorously reviewed new scientific evidence submitted by the drug sponsor, Linepharma (represented in Canada by Celopharma). The Department has also undertaken a thorough review of new and existing scientific literature on the safe use and effectiveness of Mifegymiso. This has formed the basis for the Department to authorize the following changes:   

• Mifegymiso can now be prescribed up to nine weeks (63 days) into a pregnancy, rather than the previous limit of seven weeks (49 days).
• Mifegymiso can now be dispensed directly to patients by a pharmacist or a prescribing health professional. Directions for use remain the same. Patients should take the medication as directed by their health professional, either at a health facility or at home.
• Health professionals should have appropriate knowledge about the medication before prescribing Mifegymiso. Education programs are available. However, health professionals are no longer required to complete an education program before they can prescribe Mifegymiso.
• While dialogue and information sharing between patients and health professionals is always important, the requirement for written patient consent to use Mifegymiso is being removed.
• Health professionals will no longer be required to register with Celopharma in order to prescribe or dispense Mifegymiso.

The formulation of Mifegymiso itself has not changed. It remains a combination product containing two medications: mifepristone and misoprostol. These medications are used in sequence for the medical termination of a pregnancy. The changes being announced today apply only to use and product labelling.

Health professionals who want training on the use of Mifegymiso can obtain it from Celopharma and from national and provincial medical groups.

The Patient Medication Information, the Patient Consent Form and the Patient Information Card can be found on the Celopharma website at www.celopharma.com. In addition, the Patient Medication Information and the Patient Information Card can be found inside the Mifegymiso package.

The most recent Product Monograph can be accessed on the Health Canada website, or by contacting the company at www.celopharma.com or at 1-877-230-4227.

Health Canada continues to monitor the safety profile of Mifegymiso through its post-market surveillance program, to help ensure that the benefits of the product continue to outweigh the risks. Should any issues arise, Health Canada will act quickly to assess them and take appropriate action.

What you should do

• Before taking Mifegymiso, have a discussion with your health professional about informed consent as well as the medication’s effects and risks.
• Obtain a printed copy of the Patient Information Card and the Patient Medication Information (a document that provides detailed information on the safe and effective use of Mifegymiso) from your health professional.
• Have an ultrasound to ensure that you don’t have an ectopic (outside the uterus) pregnancy and to have an assessment of gestation.
• Take Mifegymiso as directed by your health professional.
• Follow up with your health professional in 7 to 14 days to confirm whether the pregnancy has completely ended and to verify that there is no prolonged heavy bleeding or infection.
• Contact a health professional if you experience any serious or unexpected side effects related to Mifegymiso use, or if you wish to obtain additional information.

What industry professionals should do

• Ensure that you have adequate knowledge of the use of these medications to prescribe Mifegymiso.
• Discuss informed consent with the patient and provide the patient with the current Patient Medication Information and a completed Patient Information Card.
• Exclude ectopic pregnancy and confirm gestational age by ultrasound.
• Counsel the patient on the effects and risks of Mifegymiso, including bleeding, infection, and incomplete pregnancy termination.
• Ensure that the patient has access to emergency medical care in the 14 days following administration of mifepristone.
• Schedule a follow-up to occur 7 to 14 days after the patient takes mifepristone to confirm complete pregnancy termination and to monitor for side effects.

Report health or safety concerns

To report a side effect to a health product to Health Canada:

• Call toll-free at 1-866-234-2345
• Visit Health Canada’s Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709