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BEFORE YOU DECIDE
BEFORE YOU DECIDE
FDA Approved Changes to Mifeprex
FDA Approved Changes to Mifeprex
On March 30, 2016, the Food and Drug Administration released new labeling
information on the Mifeprex (mifepristone/misoprostol) medical abortion protocol.
Mifeprex is now approved, in a regimen with misoprostol, to end a pregnancy through
70 days gestation (70 days or less since the first day of a woman’s last menstrual period).
The approved Mifeprex dosing regimen is:
On March 30, 2016, the Food and Drug Administration released new labeling
information on the Mifeprex (mifepristone/misoprostol) medical abortion protocol.
Mifeprex is now approved, in a regimen with misoprostol, to end a pregnancy through
70 days gestation (70 days or less since the first day of a woman’s last menstrual period).
The approved Mifeprex dosing regimen is:
On Day One: 200 mg of Mifeprex taken by mouth.
On Day One: 200 mg of Mifeprex taken by mouth.
24 to 48 hours after taking Mifeprex: 800 mcg of misoprostol taken buccally (in the cheek pouch),
at a location appropriate for the patient.
24 to 48 hours after taking Mifeprex: 800 mcg of misoprostol taken buccally (in the cheek pouch),
at a location appropriate for the patient.
About seven to fourteen days after taking Mifeprex: follow-up with the healthcare provider to make
sure the abortion is complete and to check for complications.
About seven to fourteen days after taking Mifeprex: follow-up with the healthcare provider to make
sure the abortion is complete and to check for complications.
Because of the risk of serious complications, Mifeprex is only available through a restricted program.
This program requires abortion providers to warn patients about the risks and what to do if
complications happen. Women who have taken Mifeprex should seek immediate medical care for:
Because of the risk of serious complications, Mifeprex is only available through a restricted program.
This program requires abortion providers to warn patients about the risks and what to do if
complications happen. Women who have taken Mifeprex should seek immediate medical care for:
• Sustained fever, severe abdominal pain, prolonged heavy bleeding, or fainting.
• Sustained fever, severe abdominal pain, prolonged heavy bleeding, or fainting.
• Abdominal pain or discomfort, or general malaise (“feeling sick,” including weakness, nausea,
vomiting or diarrhea, with or without fever) for more than 24 hours after taking misoprostol.
• Abdominal pain or discomfort, or general malaise (“feeling sick,” including weakness, nausea,
vomiting or diarrhea, with or without fever) for more than 24 hours after taking misoprostol.
• These symptoms could be a sign of serious complications.
• These symptoms could be a sign of serious complications.
This information replaces existing Mifeprex/mifepristone content in the magazine/brochure.
This information replaces existing Mifeprex/mifepristone content in the magazine/brochure.
BEFORE YOU DECIDE
BEFORE YOU DECIDE
FDA Approved Changes to Mifeprex
FDA Approved Changes to Mifeprex
On March 30, 2016, the Food and Drug Administration released new labeling
information on the Mifeprex (mifepristone/misoprostol) medical abortion protocol.
Mifeprex is now approved, in a regimen with misoprostol, to end a pregnancy through
70 days gestation (70 days or less since the first day of a woman’s last menstrual period).
The approved Mifeprex dosing regimen is:
On March 30, 2016, the Food and Drug Administration released new labeling
information on the Mifeprex (mifepristone/misoprostol) medical abortion protocol.
Mifeprex is now approved, in a regimen with misoprostol, to end a pregnancy through
70 days gestation (70 days or less since the first day of a woman’s last menstrual period).
The approved Mifeprex dosing regimen is:
On Day One: 200 mg of Mifeprex taken by mouth.
On Day One: 200 mg of Mifeprex taken by mouth.
24 to 48 hours after taking Mifeprex: 800 mcg of misoprostol taken buccally (in the cheek pouch),
at a location appropriate for the patient.
24 to 48 hours after taking Mifeprex: 800 mcg of misoprostol taken buccally (in the cheek pouch),
at a location appropriate for the patient.
About seven to fourteen days after taking Mifeprex: follow-up with the healthcare provider to make
sure the abortion is complete and to check for complications.
About seven to fourteen days after taking Mifeprex: follow-up with the healthcare provider to make
sure the abortion is complete and to check for complications.
Because of the risk of serious complications, Mifeprex is only available through a restricted program.
This program requires abortion providers to warn patients about the risks and what to do if
complications happen. Women who have taken Mifeprex should seek immediate medical care for:
Because of the risk of serious complications, Mifeprex is only available through a restricted program.
This program requires abortion providers to warn patients about the risks and what to do if
complications happen. Women who have taken Mifeprex should seek immediate medical care for:
• Sustained fever, severe abdominal pain, prolonged heavy bleeding, or fainting.
• Sustained fever, severe abdominal pain, prolonged heavy bleeding, or fainting.
• Abdominal pain or discomfort, or general malaise (“feeling sick,” including weakness, nausea,
vomiting or diarrhea, with or without fever) for more than 24 hours after taking misoprostol.
• Abdominal pain or discomfort, or general malaise (“feeling sick,” including weakness, nausea,
vomiting or diarrhea, with or without fever) for more than 24 hours after taking misoprostol.
• These symptoms could be a sign of serious complications.
• These symptoms could be a sign of serious complications.
This information replaces existing Mifeprex/mifepristone content in the magazine/brochure.
This information replaces existing Mifeprex/mifepristone content in the magazine/brochure.