1. What is Mifeprex Abortion Pill, and how does it Work?
Mifeprex is a drug that blocks hormone (progesterone) needed for continuing pregnancy. The medicine is also known by its generic name, Mifepristone. When the medicine is used with another drug Misoprostol, it can cause an end to early pregnancy (4 to 10 week gestation, or up till 70 days from the first day of female’s last menstrual period).
2. Who must not take Mifeprex?
Some females should not use Mifeprex. A person must not take this drug, if she is more than 70 days due her pregnancy, or if she:
- On long-term corticosteroid therapy, ectopic pregnant (pregnancy outside uterus).
- Is allergic to Mifepristone, Misoprostol or similar medications.
- Has adrenal glands problem or inherited porphyria.
- Has IUD (intrauterine device) inserted (must be removed before intake of Mifeprex).
- Is taking anticoagulant drugs or products, or has bleeding problems.
3. What are the approved changes done to Mifeprex Label by the FDA on March 29, 2016?
Mifeprex was first approved in 2000 by the FDA. In 2016, a supplemental application of the medicine given by its marketing company was approved. The approval stated few changes in the dosing of Mifeprex and dosage regimen for taking Mifepristone and Misoprostol (involving Misoprostol dosing route change from oral to buccal), the time difference between taking both the drugs, and location at which the female may use Misoprostol.
The new label also modified gestational age until which Mifeprex can be effective and safe, and process of follow-up following the drug administration. The labeling is revised so that it meets FDA’s current regulations and labeling requirements. The organization has also permitted changes to present Risk Evaluation and Mitigation Strategy (REMS) in reflecting the upgrades approved for supplemental application, and to allow Mifeprex REMS to be consistent with recently certified REMS.
4. Where can women Buy Mifeprex?
Healthcare providers who meet particular qualifications are supplied with Mifeprex. The drug is only dispensed in certain clinics, hospitals, medical offices, or under supervision of a certified provider. Buy mifeprex online with best cost available over the internet.
5. What are the Eligibility Criteria for Healthcare Providers to Obtain and Dispense Mifeprex?
The healthcare providers who wish to gain certification for prescribing Mifeprex must know how to accurately date pregnancies and diagnose ectopic pregnancies. They must be able to offer any required surgical intervention or have arrangements for other in providing such care. They should ensure females an access to emergency care, medical facilities, and agree to their responsibilities, along with signing and reviewing Patient Agreement Form. The healthcare providers must provide the patient a copy of this form and Medication Guide.
Some states permit healthcare providers other than doctors to prescribe the medicine. Thus, healthcare providers must check for their individual state laws.
6. Are there any Limitations on Mifeprex Distribution?
There are certain restrictions on the drug, so that it can be used safely by women. The FDA considered safety data available since Mifeprex was approved in 2000, and information given by the drug companies that market this medication.
7. What are the Possible Mifeprex Side Effects?
Women can expect vaginal bleeding and cramping as normal part of the treatment. In cases where vaginal bleeding is too heavy, it needs to be stopped by an invasive procedure, which has to be performed at a clinic or office. The common side effects to the drug are weakness, vomiting, fever/chills, nausea, diarrhea, dizziness, and headache on the first day or the next on using the two abortion pills. The medication guide of Mifeprex contains details of the side effects in ‘Adverse Reactions’ section.
8. Which Serious Events have been reported on Mifeprex Use?
The reports concerning females who took Mifeprex involve a case of ectopic pregnancy causing death. There have been cases of severe systemic infection also known as sepsis; wherein some were fatal, and an incident of heart attack (non-fatal). However, it is unknown these adverse events caused had any real relationship because of Mifeprex and Misoprostol use.
If the FDA receives any new information about serious incidences on utilization of a medicine, it conveys the details to doctors and patients for safety.
9. What Must Healthcare Providers do to Ensure Safety for Women Taking Mifeprex?
Medical abortion providers and healthcare practitioners of emergency rooms must investigate any signs of sepsis in female undergoing a pregnancy termination. Hemoconcentration and significant leukocytosis on a market left shift could indicate sepsis. The physicians must also observe if there are signs of vomiting, nausea, weakness, abdomen pain, or diarrhea. Even without a fever, these symptoms may depict a serious infection. A complete blood count check for patients must be done.
10. How Soon a Female can get Pregnant after Using Mifeprex?
As soon as the woman terminates her pregnancy, she can become pregnant again. If she wants to prevent pregnancy, then she must use a birth control method before resuming sexual activity.
11. What is the Mifeprex Cost?
The medicine price is not regulated by the FDA in the United States, nor does it have a legal control on insurance companies which may or may not cover the price of this medication. The costing depends on distributors, manufacturers, and retailers.
12. In Which Countries is Mifeprex Approved?
Since 1988, Mifepristone has been available in France. The drug is also approved in the Sweden, United Kingdom, and around 60 countries.
Source: mifeprex question and answers
Categorised in: Abortion Pills
This post was written by Marcella