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This information outlines important safety considerations and precautions for the use of mifepristone, commonly prescribed for medical abortion. Please read this carefully and consult your healthcare provider if you have any questions or concerns.

• Potential Risks: Rarely, serious medical issues such as infections and excessive bleeding may occur. These can, in some cases, be life-threatening. It is crucial to consult your doctor and familiarize yourself with the Medication Guide and the Patient Agreement if you are in the United States. This medication is subject to the REMS Program requirements, which you must agree to and follow. If you reside in another country, consult your healthcare provider for specific regulations.

• Signs of Serious Infection: Seek immediate medical assistance if you experience symptoms like severe abdominal pain, fainting, a rapid heartbeat, or a fever exceeding 100.4ºF lasting more than four hours. These symptoms may indicate a severe infection, particularly if they arise more than 24 hours after taking misoprostol. Even in the absence of a fever, symptoms such as nausea, vomiting, diarrhea, or weakness require urgent medical attention.

• Vaginal Bleeding: While vaginal bleeding is expected during a medical abortion, it should be monitored closely. If you experience excessive bleeding—defined as soaking through two thick, full-size sanitary pads per hour for two consecutive hours—seek emergency care immediately. This may signal an incomplete abortion requiring prompt medical intervention.

• Contraindications: Do not use this medication if you have a confirmed or suspected ectopic pregnancy, undiagnosed adnexal mass, adrenal gland failure, or if you are on long-term corticosteroids. Additionally, those with allergies to prostaglandins, blood disorders, or who are taking blood thinners should avoid this medication. If you have an intrauterine device (IUD), it must be removed before taking mifepristone.

• Emergency Instructions: Your healthcare provider should provide clear instructions on who to contact and what actions to take in the event of an emergency, such as severe bleeding or infection. Always carry the Medication Guide if you need to seek emergency care or consult another healthcare professional.

This safety information is crucial for ensuring your well-being during the use of mifepristone. Always communicate with your healthcare provider for personalized advice and guidance.

Common side effects:

• nausea
• vomiting
• diarrhea
• dizziness
• weakness
• headache

• fever or chills

  Less common but important to monitor:

• bleeding

• cramping

  Serious side effects:

• persistent fever of 100.4°F (38°C) or higher
• severe abdominal pain
• fainting
• rapid heartbeat
• symptoms of a serious allergic reaction (rash, severe dizziness, swelling, difficulty breathing)
• nausea, vomiting, or diarrhea continuing for more than 24 hours after taking the second medication (misoprostol)

Mifepristone, also known as Mifeprex, can interact with a variety of medications. It’s important to inform your healthcare provider about all other medications or supplements you are taking, including prescription, over-the-counter, vitamins, and herbal products.

Certain medications should not be taken with mifepristone, as the interaction could be harmful. These include drugs like bepridil, cisapride, Cyclosporine, Dihydroergotamine, dronedarone, ergotamine, Fentanyl, Fluconazole, Ketoconazole, Lovastatin, mesoridazine, Pimozide, piperaquine, Posaconazole, quinidine, saquinavir, Simvastatin, Sirolimus, sparfloxacin, Tacrolimus, terfenadine, and Thioridazine. Your doctor might advise against using mifepristone or adjust your current medications.

For some medications, while their use with mifepristone is not usually recommended, it might be necessary in certain situations. If these drugs are prescribed together, your doctor may adjust doses or frequency. This list includes medications such as alfentanil, Alprazolam, Amiodarone, and many others.

Additionally, using mifepristone with Fluvastatin may increase the risk of certain side effects, but could be deemed necessary by your healthcare provider for your treatment plan.

Other drugs can alter how mifepristone is processed in the body, potentially affecting its efficacy. These include azole antifungals (e.g., Itraconazole), Dexamethasone, Erythromycin, rifamycins (e.g., Rifabutin), St. John's wort, and seizure medications like Carbamazepine and Phenytoin.

Moreover, mifepristone can affect the breakdown of other drugs, which might impact how they work. This includes medications such as cyclosporine, ergot alkaloids, fentanyl, pimozide, quinidine, certain statins (fluvastatin, lovastatin, simvastatin), sirolimus, tacrolimus, and Warfarin.

If you are taking low-dose Aspirin for heart attack or stroke prevention, continue as directed by your doctor, even though aspirin can increase bleeding risk when combined with mifepristone. Always consult your healthcare provider before making any changes to your medication regimen.