April 30, 2016
Recommended Topic Related To:

Mifeprex (RU486)

"Risk factors for repeat pregnancy terminations include teenage pregnancy, social deprivation, two or more previous live births or miscarriages at the time of the initial termination, and the use of posttermination contraception with implants and "...

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Mifeprex




Indications
Dosage
How Supplied

INDICATIONS

MIFEPREX is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation.

DOSAGE AND ADMINISTRATION

Dosing Regimen

For purposes of this treatment, pregnancy is dated from the first day of the last menstrual period. The duration of pregnancy may be determined from menstrual history and clinical examination. Assess the pregnancy by ultrasonographic scan if the duration of pregnancy is uncertain or if ectopic pregnancy is suspected.

Remove any intrauterine device (“IUD”) before treatment with MIFEPREX begins [see CONTRAINDICATIONS].

The dosing regimen for MIFEPREX and misoprostol is:

  • MIFEPREX 200 mg orally + misoprostol 800 mcg buccally
    • Day One: MIFEPREX Administration One 200 mg tablet of MIFEPREX is taken in a single oral dose.
    • Day Two or Three: Misoprostol Administration (minimum 24-hour interval between MIFEPREX and misoprostol) Four 200 mcg tablets (total dose 800 mcg) of misoprostol are taken by the buccal route.

Tell the patient to place two 200 mcg misoprostol tablets in each cheek pouch (the area between the cheek and gums) for 30 minutes and then swallow any remnants with water or another liquid (see Figure 1).

Figure 1

Place two 200 mcg misoprostol tablets in each cheek pouch - Illustration

2 pills between cheek and gum on left side + 2 pills between cheek and gum on right side

Patients taking MIFEPREX must take misoprostol within 24 to 48 hours after taking MIFEPREX. The effectiveness of the regimen may be lower if misoprostol is administered less than 24 hours or more than 48 hours after mifepristone administration.

Because most women will expel the pregnancy within 2 to 24 hours of taking misoprostol [see Clinical Studies], discuss with the patient an appropriate location for her to be when she takes the misoprostol, taking into account that expulsion could begin within 2 hours of administration.

Patient Management Following Misoprostol Administration

During the period immediately following the administration of misoprostol, the patient may need medication for cramps or gastrointestinal symptoms [see ADVERSE REACTIONS].

Give The Patient
  • Instructions on what to do if significant discomfort, excessive vaginal bleeding or other adverse reactions occur
  • A phone number to call if she has questions following the administration of the misoprostol
  • The name and phone number of the healthcare provider who will be handling emergencies.

Post-treatment Assessment: Day 7 To 14

Patients should follow-up with their healthcare provider approximately 7 to 14 days after the administration of MIFEPREX. This assessment is very important to confirm that complete termination of pregnancy has occurred and to evaluate the degree of bleeding. Termination can be confirmed by medical history, clinical examination, human Chorionic Gonadotropin (hCG) testing, or ultrasonographic scan. Lack of bleeding following treatment usually indicates failure; however, prolonged or heavy bleeding is not proof of a complete abortion.

The existence of debris in the uterus (e.g., if seen on ultrasonography) following the treatment procedure will not necessarily require surgery for its removal.

Women should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days. Women report experiencing heavy bleeding for a median duration of 2 days. Up to 8% of women may experience some type of bleeding for more than 30 days. Persistence of heavy or moderate vaginal bleeding at the time of follow-up, however, could indicate an incomplete abortion.

If complete expulsion has not occurred, but the pregnancy is not ongoing, women may be treated with another dose of misoprostol 800 mcg buccally. There have been rare reports of uterine rupture in women who took Mifeprex and misoprostol, including women with prior uterine rupture or uterine scar and women who received multiple doses of misoprostol within 24 hours. Women who choose to use a repeat dose of misoprostol should have a follow-up visit with their healthcare provider in approximately 7 days to assess for complete termination.

Surgical evacuation is recommended to manage ongoing pregnancies after medical abortion [see Use In Specific Populations]. Advise the patient whether you will provide such care or will refer her to another provider as part of counseling prior to prescribing MIFEPREX.

Contact For Consultation

For consultation 24 hours a day, 7 days a week with an expert in mifepristone, call Danco Laboratories at 1-877-4 Early Option (1-877-432-7596).

HOW SUPPLIED

Dosage Forms And Strengths

Tablets containing 200 mg of mifepristone each, supplied as 1 tablet on one blister card. MIFEPREX tablets are light yellow, cylindrical, and bi-convex tablets, approximately 11 mm in diameter and imprinted on one side with “MF.”

Storage And Handling

MIFEPREX is only available through a restricted program called the MIFEPREX REMS Program [see WARNINGS AND PRECAUTIONS].

MIFEPREX is supplied as light yellow, cylindrical, and bi-convex tablets imprinted on one side with “MF.” Each tablet contains 200 mg of mifepristone. One tablet is individually blistered on one blister card that is packaged in an individual package (National Drug Code 64875-001-01).

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

Manufactured for: Danco Laboratories, LLC P.O. Box 4816 New York, NY 10185 1-877-4 Early Option (1-877-432-7596) www.earlyoptionpill.com. Revised: Mar 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/12/2016

Indications
Dosage
How Supplied

Mifeprex - User Reviews

Mifeprex User Reviews

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