Mifepristone

Mifepristone is an FDA-registered drug product whose active ingredient is MIFEPRISTONE. It is labelled by GenBioPro, Inc. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 43393-001, application ANDA091178, label effective 20260606. It is one of 2 FDA drug label records sharing the active ingredient MIFEPRISTONE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing MIFEPRISTONE are most often described in connection with: mifepristone tablets, indicated regimen, medical termination, intrauterine pregnancy, through days, progestin antagonist. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Mifepristone tablets, 200 mg is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation. Mifepristone tablets, 200 mg is a progestin antagonist indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation. ( 1 )

2 DOSAGE AND ADMINISTRATION 200 mg Mifepristone on Day 1, followed 24-48 hours after Mifepristone dosing by 800 mcg buccal misoprostol. ( 2.1 ) Instruct the patient what to do if significant adverse reactions occur. ( 2.2 ) Follow-up is needed to confirm complete termination of pregnancy. ( 2.3 ) 2.1 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 Mifepristone tablets, 200mg begins [see Contraindications ( 4 )]. The dosing regimen for Mifepristone tablets, 200 mg and misoprostol is: Mifepristone 200 mg orally + misoprostol 800 mcg buccally • Day One: Mifepristone 200 mg Administration One 200 mg tablet of Mifepristone is taken in a single oral dose. • Day Two or Three: Misoprostol Administration (minimum 24-hour interval between, Mifepristone 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). Patients taking Mifepristone tablets, 200 mg must take misoprostol within 24 to 48 hours after taking Mifepristone. 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 ( 14 )] , discuss with the patient an appropriate location for them to be when taking the misoprostol, taking into account that expulsion could begin within 2 hours of administration. Figure 1 2.2 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 ( 6 )] . 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 the patient has questions following the administration of the misoprostol The name and phone number of the healthcare provider who will behandling emergencies. 2.3 Post-treatment Assessment: Day 7 to 14 Patients should follow-up with their healthcare provider approximately 7 to 14 days after the administration of Mifepristone. 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. Patients 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, patients may be treated with another dose of misoprostol 800mcg buccally. There have been rare reports of uterine rupture in women who took mifepristone tablets, 200 mg and misoprostol, including women with prior uterine rupture or uterine scar and patients who received multiple doses of misoprostol within 24 hours. Patients 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 ( 8.1 )] . Advise the patient whether you will provide such care or will refer her to another provider as part of counseling prior to prescribing Mifepristone tablets, 200 mg. 2.4 Contact for Consultation For consultation 24 hours a day, 7 days a week with an expert in mifepristone, call GenBioPro, Inc. at 1-855-MIFEINFO (1-855-643-3463).

4 CONTRAINDICATIONS Administration of Mifepristone tablets, 200 mg and misoprostol for the termination of pregnancy (the “treatment procedure”) is contraindicated in patients with any of the following conditions: Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy) [ see Warnings and Precautions ( 5.4 )] Chronic adrenal failure (risk of acute adrenal insufficiency) Concurrent long-term corticosteroid therapy (risk of acute adrenal insufficiency) History of allergy to mifepristone, misoprostol, or other prostaglandins (allergic reactions including anaphylaxis, angioedema, rash, hives, and itching have been reported [ see Adverse Reactions ( 6.2 )]) Hemorrhagic disorders or concurrent anticoagulant therapy (risk of heavy bleeding) Inherited porphyrias (risk of worsening or of precipitation of attacks) Use of Mifepristone tablets, 200 mg and misoprostol for termination of intrauterine pregnancy is contraindicated in patients with an intrauterine device (“IUD”) in place (the IUD might interfere with pregnancy termination). If the IUD is removed, Mifepristone tablets, 200 mg may be used. Confirmed/suspected ectopic pregnancy or undiagnosed adnexal mass ( 4 ) Chronic adrenal failure ( 4 ) Concurrent long-term corticosteroid therapy ( 4 ) History of allergy to mifepristone, misoprostol, or other prostaglandins ( 4 ) Hemorrhagic disorders or concurrent anticoagulant therapy ( 4 ) Inherited porphyria ( 4 ) Intrauterine device (IUD) in place ( 4 )

6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: Infection and sepsis [ see Warnings and Precautions ( 5.1 )] Uterine bleeding [ see Warnings and Precautions ( 5.2 )] Most common adverse reactions (>15%) are nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact GenBioPro, Inc. at 1-855-643-3463 or [email protected] or www.MIFEINFO.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Information presented on common adverse reactions relies solely on data from US studies, because rates reported in non-US studies were markedly lower and are not likely generalizable to the US population. In three US clinical studies totaling 1,248 women through 70 days gestation who used mifepristone 200 mg orally followed 24-48 hours later by misoprostol 800mcg buccally, women reported adverse reactions in diaries and in interviews at the follow-up visit. These studies enrolled generally healthy women of reproductive age without contraindications to mifepristone or misoprostol use according to the Mifepristone tablets, 200 mg product label.Gestational age was assessed prior to study enrollment using the date of the woman's last menstrual period, clinical evaluation, and/or ultrasound examination. About 85% of patients report at least one adverse reaction following administration of Mifepristone tablets, 200 mg and misoprostol, and many can be expected to report more than one such reaction. The most commonly reported adverse reactions (>15%) were nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness (see Table 1). The frequency of adverse reactions varies between studies and may be dependent on many factors including the patient population and gestational age. Abdominal pain/cramping is expected in all medical abortion patients and its incidence is not reported in clinical studies. Treatment with Mifepristone tablets, 200 mg and misoprostol is designed to induce uterine bleeding and cramping to cause termination of an intrauterine pregnancy. Uterine bleeding and cramping are expected consequences of the action of Mifepristone tablets, 200 mg and misoprostol as used in the treatment procedure. Most patients can expect bleeding more heavily than they do during a heavy menstrual period [ see Warnings and Precautions ( 5.2 ) ] . Table 1 lists the adverse reactions reported in US clinical studies with incidence >15% of women. Table 1 Adverse Reactions Reported in Women Following Administration of Mifepristone (oral) and Misoprostol (buccal) in US Clinical Studies Adverse Reaction # US studies Number of Evaluable Women Range of frequency (%) Upper Gestational Age of Studies Reporting Outcome Nausea 3 1,248 51-75% 70 days Weakness 2 630 55-58% 63 days Fever/chills 1 414 48% 63 days Vomiting 3 1,248 37-48% 70 days Headache 2 630 41-44% 63 days Diarrhea 3 1,248 18-43% 70 days Dizziness 2 630 39-41% 63 days One study provided gestational-age stratified adverse reaction rates for women who were 57-63 and 64-70 days; there was little difference in frequency of the reported common adverse reactions by gestational age. Information on serious adverse reactions was reported in six US and four non-US clinical studies, totaling 30,966 women through 70 days gestation who used mifepristone 200mg orally followed 24-48 hours later by misoprostol 800mcg buccally. Serious adverse reaction rates were similar between US and non-US studies, so rates from both US and non-US studies are presented. In the US studies, one studied women through 56 days gestation, four through 63 days gestation, and one through 70 days gestation, while in the non-US studies, two studied women through 63 days gestation, and two through 70 days gestation. Serious adverse reactions were reported in <0.5% of women. Information from the US and non-US studies is presented in Table 2. Table 2 Serious Adverse Reactions Reported in Women Following Administration of Mifepristone (oral) and Misoprostol (buccal) in US and Non-US Clinical Studies NR= Not reported * This outcome represents a single patient who experienced death related to sepsis. Adverse Reaction US Non-US # of studies Number of Evaluable Women Range of frequency (%) # of studies Number of Evaluable Women Range of frequency (%) Transfusion 4 17,774 0.03-0.5% 3 12,134 0-0.1% Sepsis 1 629 0.2% 1 11,155 <0.01% * ER visit 2 1,043 2.9-4.6% 1 95 0 Hospitalization Related to Medical Abortion 3 14,339 0.04-0.6% 3 1,286 0-0.7% Infection without sepsis 1 216 0 1 11,155 0.2% Hemorrhage NR NR NR 1 11,155 0.1% 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of Mifepristone tablets, 200 mg and misoprostol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Infections and infestations: post-abortal infection (including endometritis, endomyometritis, parametritis, pelvic infection, pelvic inflammatory disease, salpingitis) Blood and the lymphatic system disorders: anemia Immune system disorders: allergic reaction (including anaphylaxis, angioedema, hives, rash, itching) Psychiatric disorders: anxiety Cardiac disorders: tachycardia (including racing pulse, heart palpitations, heart pounding) Vascular disorders: syncope, fainting, loss of consciousness, hypotension (including orthostatic), light-headedness Respiratory, thoracic and mediastinal disorders: shortness of breath Gastrointestinal disorders: dyspepsia Musculoskeletal, connective tissue and bone disorders: back pain, leg pain Reproductive system and breast disorders: uterine rupture, ruptured ectopic pregnancy, hematometra, leukorrhea General disorders and administration site conditions: pain

FDA lists 2 drug label records with MIFEPRISTONE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Mifepristone used for?
1 INDICATIONS AND USAGE Mifepristone tablets, 200 mg is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation. Mifepristone tablets, 200 mg is a progestin antagonist indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation. ( 1 )

Who makes Mifepristone?
GenBioPro, Inc. is the labeler of record for Mifepristone. 2 FDA label records share the active ingredient MIFEPRISTONE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Mifepristone come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Mifepristone prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing MIFEPRISTONE?
Yes. 2 FDA drug label records list MIFEPRISTONE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Mifepristone been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.