Mifepristone: An Overview

Mifepristone is a medication typically used with Misoprostol to bring about an abortion during early pregnancy. It is part of the family of medicines known as antiprogestogen. It can also be used to manage conditions such as Cushing’s syndrome, as it can block the hormone responsible for it.

Furthermore, it’s important to note that while this information is designed to provide a broad overview of Mifepristone, it should not be used as a substitute for professional medical advice. Always consult your healthcare provider for personalized medical guidance.

Mifepristone: Action

Mifepristone works by blocking the action of progesterone, a hormone necessary for pregnancy to continue. Without progesterone, the lining of the uterus softens and breaks down, and bleeding like a menstrual period occurs. When used with a prostaglandin drug (like Misoprostol), it helps expel the pregnancy from the uterus.

Using Mifepristone for Medical Abortion

When used for medical abortion, Mifepristone is typically provided with another drug called Misoprostol. The World Health Organization (WHO) recommends a regimen consisting of 200 mg of Mifepristone followed by 800mcg of Misoprostol 24 to 48 hours later. The drugs induce a process similar to an early natural miscarriage and are effective up to 11 weeks of gestation.

Mifepristone for Cushing’s Syndrome

In addition to its use in medical abortion, Mifepristone is also approved for managing high blood sugar levels in adult patients with endogenous Cushing’s syndrome who are not candidates for surgery or have failed surgery. It blocks cortisol, which causes the symptoms of Cushing’s syndrome.

Before taking Mifepristone:

When considering the use of a medication, it is essential to weigh the potential risks against the benefits it may provide. This decision should be made in consultation with your healthcare provider. Prior to using this medication, the following factors should be considered:

Allergies:

Inform your doctor if you have ever experienced any unusual or allergic reactions to Mifepristone or any other medications. Additionally, disclose any other allergies you may have, including those to foods, dyes, preservatives, or animals. If using non-prescription products, carefully review the ingredients listed on the label or package.

Pediatric Use:

Studies conducted so far have not indicated any specific issues related to the use of Mifeprex® tablets in pregnant women under the age of 17. However, there is a lack of research on the effects of Mifepristone tablets in the pediatric population, therefore its safety and effectiveness remain undetermined.

Geriatric Use:

Currently, there is no available information on how age affects the impact of Mifeprex® tablets in elderly patients. Similarly, studies on the relationship between age and the effects of Mifepristone tablets in geriatric patients have not been conducted, though there have been no documented geriatric-specific problems thus far.

Breastfeeding:

Limited studies are available on the potential risk to infants when Mifepristone is used during breastfeeding. It is important to carefully consider the benefits and risks before using this medication while nursing.

Proper Use of Mifepristone:

Ensure you receive and carefully follow the Medication Guide accompanying this medication. If you require any further assistance, consult your doctor.

For patients utilizing Mifeprex tablets:

This medicine should solely be administered by your doctor and cannot be self-administered at home. The treatment regimen involves three visits to your doctor.
During the initial visit, one Mifepristone tablet will be provided. Two days later at the subsequent appointment, you will receive four tablets of Misoprostol, another medication. Two weeks post-treatment, on your third visit, your doctor will confirm the cessation of pregnancy, potentially through an ultrasound examination.
Expect bleeding and cramping for approximately 2 to 4 weeks following treatment. Notify your doctor if you experience minimal or no vaginal bleeding post-treatment.
In certain cases, surgical abortion may be necessary to conclude the pregnancy entirely. Surgical removal might also be required if any remnants of tissue persist in your uterus post-Mifepristone treatment.
Inform your doctor if you have an intrauterine device (IUD) as it must be removed before commencing treatment with this medicine.

For patients using Mifepristone tablets:

Your doctor will prescribe the appropriate dosage and frequency for this medication. The dosage may require adjustment to determine the optimal treatment. Adhere strictly to your doctor’s instructions and avoid exceeding the recommended dosage or frequency.
Consume the tablet whole without crushing, breaking, or chewing it, and have it with a meal.

Dosage:

Dosage instructions may vary among individuals. Adhere to your doctor’s guidance or the provided label instructions. The subsequent details portray typical dosages of this medicine. Refrain from altering your dose unless directed by your doctor.

Oral dosage form (tablets):

For pregnancy termination (77 days or less) in conjunction with Misoprostol:
- Adults—On Day 1, a single dose of 200 milligrams (mg), followed by 800 micrograms (mcg) (four-200 mcg tablets) of Misoprostol after 2 days, administered in the cheeks.
- Children—Usage not advised.
For treating hyperglycemia in patients with Cushing’s syndrome:
- Adults—Initially, 300 milligrams (mg) once daily, with potential dose adjustments as required, not exceeding 1200 mg daily.
- Children—Dosage determined by the doctor.

Missed Dose:

If a dose is skipped, take it promptly. However, if nearing the next scheduled dose, skip the missed dose and resume the regular dosing regimen. Avoid doubling doses.

Precautions for Using Mifepristone:

Throughout your treatment with Mifeprex®, it is crucial to make all three scheduled visits to your doctor’s office.

Using Mifepristone tablets while pregnant can harm your unborn child. Employ effective birth control methods, such as condoms, diaphragms, or cervical caps, during treatment and for one month following the final dose. Promptly notify your doctor if you suspect pregnancy while taking the medication.

Avoid using mifepristone if you are also using medications like Cyclosporine, Dihydroergotamine, Ergotamine, Fentanyl, Lovastatin, Pimozide, Quinidine, Simvastatin, Sirolimus, Tacrolimus, or steroid medications, as combining these drugs can lead to severe complications.

Consult your doctor if vaginal bleeding becomes excessive or prolongs beyond the expected duration while using this medication.

In the case of severe symptoms like persistent fever above 100.4 °F (ca. 38 °C), significant stomach pain, pelvic tenderness, weakness, nausea, vomiting, diarrhea, unexplained weight loss, or rapid heartbeat, seek immediate medical attention.

Be vigilant for signs of adrenal gland issues, including skin darkening, diarrhea, lightheadedness, increased hunger, mental distress, nausea, vomiting, skin rash, or unusual fatigue.

Mifepristone may impact heart rhythms, potentially causing QT prolongation. If you experience symptoms like rapid, irregular, or forceful heartbeats, contact your doctor promptly.

Avoid consuming grapefruit or grapefruit juice while on this medication, as they can affect its absorption in the body.

Do not take any new medications, including prescription, over-the-counter, herbal supplements like St. John’s wort, or vitamins, without prior discussion with your doctor.

Medication Interactions:

While some medications should never be combined, in certain situations, two different medications may be used together despite the possibility of interaction. Your doctor may consider adjusting the dosage or recommending other precautions. Inform your healthcare provider about all medications you are currently taking. The interactions listed below have been chosen based on their potential significance, but this list may not cover all possible interactions.

Use of this medication with the following medicines is not advised. Your doctor may opt not to proceed with this treatment or modify your current medication regimen.

Bepridil, Cisapride, Colchicine, Cyclosporine, Dihydroergotamine, Dronedarone, Ergotamine, Fentanyl, Fluconazole, Gepirone, Ketoconazole, Levoketoconazole, Lovastatin, Mavacamten, Mesoridazine, Pimozide, Piperaquine, Posaconazole, Quinidine, Saquinavir, Simvastatin, Sirolimus, Sparfloxacin, Tacrolimus, Terfenadine, Thioridazine.

While it is typically not advised to use this medication in conjunction with the following medicines, there may be situations where it is necessary. If both medications are prescribed concurrently, your doctor might adjust the dosage or frequency of one or both medications.

Adagrasib, Alfentanil, Alprazolam, Amiodarone, Amisulpride, Anagrelide, Apomorphine, Aprepitant, Aripiprazole, Aripiprazole Lauroxil, Arsenic Trioxide, Asenapine, Astemizole, Atazanavir, Azithromycin, Benzhydrocodone, Boceprevir, Bosutinib, Buprenorphine, Buserelin, Carbamazepine, Ceritinib, Chloroquine, Chlorpromazine, Cilostazol, Ciprofloxacin, Citalopram, Clarithromycin, Clofazimine, Clomipramine, Clothiapine, Clozapine, Cobicistat, Codeine, Conivaptan, Crizotinib, Dabrafenib, Daridorexant, Dasabuvir, Dasatinib, Degarelix, Delamanid, Desipramine, Deslorelin, Deutetrabenazine, Dexmedetomidine, Digoxin, Dihydrocodeine, Disopyramide, Dofetilide, Dolasetron, Domperidone, Donepezil, Doxorubicin, Doxorubicin Hydrochloride Liposome, Droperidol, Efavirenz, Elexacaftor, Encorafenib, Entrectinib, Erythromycin, Escitalopram, Etrasimod, Everolimus, Fedratinib, Fexinidazole, Finerenone, Fingolimod, Flecainide, Fluoxetine, Fluticasone, Formoterol, Fosaprepitant, Foscarnet, Fosphenytoin, Fostemsavir, Gemifloxacin, Glasdegib, Gonadorelin, Goserelin, Granisetron, Halofantrine, Haloperidol, Histrelin, Hydrocodone, Hydroxychloroquine, Hydroxyzine, Ibutilide, Idelalisib, Ifosfamide, Iloperidone, Imipramine, Indinavir, Inotuzumab Ozogamicin, Itraconazole, Ivabradine, Ivacaftor, Ivosidenib, Lapatinib, Lefamulin, Lemborexant, Lenvatinib, Leuprolide, Levofloxacin, Levomilnacipran, Lofexidine, Lopinavir, Lumefantrine, Lurbinectedin, Macimorelin, Mefloquine, Meperidine, Methadone, Metronidazole, Mirtazapine, Mobocertinib, Moxifloxacin, Nafarelin, Naloxegol, Nefazodone, Nelfinavir, Nifedipine, Nilotinib, Norfloxacin, Nortriptyline, Octreotide, Ofloxacin, Olanzapine, Olaparib, Ondansetron, Osilodrostat, Osimertinib, Oxaliplatin, Oxycodone, Ozanimod, Pacritinib, Paliperidone, Palovarotene, Panobinostat, Pasireotide, Pazopanib, Pentazocine, Phenobarbital, Phenytoin, Pimavanserin, Pitolisant, Ponesimod, Pralsetinib, Primidone, Procainamide, Prochlorperazine, Promethazine, Propafenone, Protriptyline, Quetiapine, Quinine, Quizartinib, Ranolazine, Relugolix, Ribociclib, Rifabutin, Rifampin, Rifapentine, Ritonavir, Selpercatinib, Sertraline, Sevoflurane, Simeprevir, Siponimod, Sirolimus Protein-Bound, Sodium Phosphate, Sodium Phosphate, Dibasic, Sodium Phosphate, Monobasic, Solifenacin, Sorafenib, Sotalol, St John’s Wort, Sufentanil, Sulpiride, Sunitinib, Telaprevir, Telavancin, Telithromycin, Tetrabenazine, Tezacaftor, Toremifene, Tramadol, Trazodone, Triclabendazole, Trifluoperazine, Trimipramine, Triptorelin, Valbenazine, Vamorolone, Vandetanib, Vardenafil, Vemurafenib, Venlafaxine, Vilanterol, Vilazodone, Vinflunine, Voclosporin, Voriconazole, Ziprasidone, Zolpidem, Zuclopenthixol, Zuranolone.

Combining this medication with any of the listed medicines may elevate the risk of specific side effects, yet the dual treatment approach could offer the most effective therapy for your condition. If both medications are prescribed simultaneously, your doctor might consider altering the dosage or frequency of one or both medications.

Amlodipine, Fluvastatin.

Interactions with Food, Tobacco, and Alcohol:

Avoiding certain foods or using alcohol or tobacco with Mifepristone may lead to interactions. It is important to be aware of these potential interactions to ensure the safe and effective use of the medication.

Mifepristone Side Effects:

While Mifepristone provides essential benefits, it may also lead to unwanted effects. Although not all side effects are common, prompt medical attention may be required if they do occur.

Immediate medical attention should be sought if any of the following side effects manifest:

Less common:

Profuse vaginal bleeding;
Unusual fatigue or weakness.

Incidence unknown:

Chest pain or discomfort;
Confusion;
Cough or hoarseness;
Rapid, weak pulse;
Fever or chills;
Lower back or side pain;
Pain or discomfort in arms, jaw, back, or neck;
Painful or difficult urination;
Pale, cold, or clammy skin;
Shortness of breath;
A sudden increase in stomach or shoulder pain;
Sweating;
Unusual or excessive vaginal bleeding.

Some side effects, while less common, may not necessitate immediate medical attention. These effects may diminish as your body adjusts to the medication. Your healthcare provider can offer guidance on managing these effects. Should the following side effects persist or become bothersome, consult your healthcare provider:

More common:

Abdominal or uterine cramping;
Back pain;
Diarrhea;
Dizziness;
Headache;
Nausea or vomiting.

Less common:

Acid or sour stomach;
Anxiety;
Belching;
Cough;
Fainting or lightheadedness upon standing;
Fever;
Flu-like symptoms;
Heartburn;
Increased vaginal discharge;
Indigestion;
Vaginal or genital itching;
Weakness;
Pain during intercourse;
Pain or tenderness around eyes and cheekbones;
Pale skin;
Shivering chills;
Stomach discomfort or pain;
Stuffy or runny nose;
Chest tightness;
Difficulty sleeping;
Labored breathing;
Labored breathing during physical exertion;
Unusual bleeding or bruising.

Additional side effects not mentioned here may occur in some individuals. If you experience any other effects, consult your healthcare provider.

For medical advice on side effects, contact your doctor. Adverse effects can also be reported to the FDA at 1-800-FDA-1088.

Summary

Mifepristone is a powerful medication with substantial effects on the body. Its primary use is to end early pregnancies, but it can also be beneficial in treating certain other health conditions. Due to severe potential side effects, its use must be under close medical supervision.

Remember, any drug, including Mifepristone, carries possible risks and benefits. Therefore, it is essential to have a thorough discussion about these with your healthcare provider. Always seek advice from healthcare professionals for individual recommendations and guidance.

Please note: This article provides no advice on personal medical conditions. Always consult a healthcare professional for personalized advice.

Reference:

Mifepak contains 5 tablets: 1 Mifepristone tablet by 200 mg with 4 Misoprostol tablets by 200mcg. It's convenient till 11 gestational weeks.

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Mifepristone: An Overview

Mifepristone: Action

Using Mifepristone for Medical Abortion

Mifepristone for Cushing’s Syndrome

Before taking Mifepristone:

Allergies:

Pediatric Use:

Geriatric Use:

Breastfeeding:

Proper Use of Mifepristone:

For patients utilizing Mifeprex tablets:

For patients using Mifepristone tablets:

Dosage:

Missed Dose:

Precautions for Using Mifepristone:

Medication Interactions:

Interactions with Food, Tobacco, and Alcohol:

Other Medical Problems

Mifepristone Side Effects:

Less common:

Incidence unknown:

More common:

Less common:

Summary

Reference:

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