Other safety alerts
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| Canada: MIFEGYMISO (mifepristone and misoprostol tablets) - Updates to Product Monograph and Risk Management Plan |
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Health Canada, in collaboration with Celopharma, is issuing this communication to health professionals to inform them about modifications to the MIFEGYMISO product monograph and the Risk Management Plan including extension of the indication and changes to the Distribution and Education Program in Canada.
MIFEGYMISO (mifepristone tablet/misoprostol tablets) is a composite pack containing one mifepristone 200 mg tablet for oral use and four misoprostol 200 mcg tablets for buccal use. On 7 Nov 2017, Health Canada completed its review of a new submission to revise the indication, and update the Risk Management Plan.
MIFEGYMISO is now indicated for medical termination of a developing intra-uterine pregnancy with a gestational age up to nine weeks (63 days) as measured from the first day of the last menstrual period. The previous indication was for use up to seven weeks (49 days) as measured from the first day of the last menstrual period.
Registration of health professionals with Celopharma is no longer required in order to prescribe or dispense MIFEGYMISO. The MIFEGYMISO education program is not mandatory. However, MIFEGYMISO should be prescribed by health professionals with prior adequate knowledge of medical abortion and use of MIFEGYMISO or who have completed a MIFEGYMISO education program. The Education Program is now available to all health professionals and, like other educational tools, is available on the Celopharma website and through some professional associations. Mifegymiso can now be dispensed directly to patients by a pharmacist or a prescribing health professional. As was always the case, patients should take the medication as directed by their health professional, either at a health facility or at home.
Health professionals are required to do the following prior to prescribing MIFEGYMISO:
- Ensure 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 patients on the effects and risks of Mifegymiso, including bleeding, infection, and incomplete abortion;
- Ensure that patients have access to emergency medical care in the 14 days following administration of mifepristone; and,
- Schedule a follow-up 7 to 14 days after patients take mifepristone to confirm complete pregnancy termination and monitor for side effects.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../65030a-eng.php
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Nov 8, 2017
Issued at HKT 16:00
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