The announcement made by the Ministry of Health, Labour and Welfare of Japan on April 28, 2023 for the newly approved abortion drug, Mefeego Pack
Proper Use of the So-Called Oral Abortion Drug “Mefeego Pack”
Since only designated doctors under the Maternal Body Protection Law are allowed to use the so-called oral abortion drug "Mefeego Pack" and strict administration of the drug is required, we will provide some points to keep in mind so that the drug is used properly.
Outline of Mefeego Pack
Trade name: Mefeego Pack
Generic name: Mifepristone/Misoprostol
Approved to: Linepharma K.K.
Abortion for patients with a confirmed intrauterine pregnancy of 63 days (9 weeks and 0 day of gestation) or less
Dosage and Administration One Mifepristone tablet (200 mg as Mifepristone) is administered orally, and 36 to 48 hours later, depending on the condition of the patient, 4 Misoprostol buccal tablets (total 800 μg as Misoprostol) are placed between the gums and cheeks of the right and left molars, 2 tablets each for 30 minutes. 30 minutes after placement If any Misoprostol tablets remain in the oral cavity, swallow them. Abortion can only be performed at a medical institution with a designated Maternal Body Protection Law doctor.
It cannot be purchased at pharmacies or over the Internet.
Efficacy and Safety
1 Efficacy
In a domestic Phase III study, the percentage of subjects who had a successful abortion by 24 hours after receiving Misoprostol, which was considered the primary endpoint, was 93.3% (112/120 subjects).2 Safety
The incidence of adverse events in the domestic Phase III study was 57.5% (69/120 subjects), with the most common adverse events being lower abdominal pain (30.0%) and vomiting (20.8%). Serious adverse events reported included severe uterine bleeding (0.8%) and infection (frequency unknown).
Important Points to Consider in the Use of Mefeego Pack
In the "Precautions in the Use of Mifepristone and Misoprostol Products[attached at the bottom of this document] (Ministry of Health, Labour and Welfare, Pharmaceutical and Welfare Bureau, Drug Evaluation and Administration Division Director and Child and Family Health Division Director jointly issued a notice on April 28, 2023, No. 0428-5 and No. 54)”, the following precautions are indicated for the use of Mefeego Pack. The main contents of the notice are as follows:1. The drug should be administered under the confirmation of a designated doctor under the Maternal Body Protection Law.
2. For the time being, the drug should be used in a hospital or clinic where patients can be hospitalized until an appropriate system for its use is established.
Misoprostol should be used only in a hospital or clinic where patients can be admitted for the time being until the appropriate system for its use is established. After the administration of Misoprostol, patients must be hospitalized or must remain in the hospital until the fetal sac has been expelled.
The "appropriate system of use" should be defined as follows. The "for the time being, until an appropriate system for use is established" is subject to the implementation of sufficient research and studies after approval and the development of appropriate medical care coordination within that system.
The "appropriate medical coordination system for the time being until the appropriate system for use is established" shall be fully investigated and studied after approval, and the appropriate medical coordination system shall be evaluated in the course of the investigation and study.3. Each Prefectural Medical Association shall provide necessary supervision and guidance to designated doctors under the Maternal Body Protection Law by receiving monthly reports from drug manufacturers, distributors, and medical institutions, respectively, and checking the consistency of such reports as appropriate.
To those who wish to receive Mefeego Pack
The administration of Mefeego Pack is possible only after the physician has provided sufficient explanation of the risks and efficacy of the drug, as well as necessary measures, in accordance with the package insert and other relevant documents, and when consent has been obtained.The main points to be noted are as follows:
Mefeego Pack is not prescribed through online medical services. It is necessary to visit a medical institution.
The drug may cause lower abdominal pain. If abnormal pain persists, the patient should promptly receive a prescription for The drug at a medical institution, as there is a possibility of simultaneous intrauterine and extrauterine pregnancies.
If the pain persists, contact the prescribing healthcare facility immediately.
In rare cases, severe uterine bleeding may occur after the drug administration. Basically, bleeding that requires changing a nighttime sanitary napkin more than twice an hour should be reported.
If bleeding continues for more than 2 hours, which requires changing a nighttime sanitary napkin more than twice an hour, contact the prescribing health care provider as soon as possible.
Since uterine bleeding with syncope may occur, extreme caution is required when operating potentially hazardous machinery such as driving a car.
Even after a certain period has passed after the administration of this drug, infections such as endometritis may occur, and fatal episodes of infection such as sepsis have been reported.
If symptoms of infection such as fever, chills, fatigue, abnormal vaginal discharge, etc. are observed, contact the medical institution that prescribed the drug as soon as possible.
If an abortion using Mefeego Pack is not completed, surgical treatment may be considered.
In the case of an abortion with Mefeego Pack, uterine contents may remain even after the gestational sac has been expelled. In such cases, however, surgery to remove the uterine contents is not always necessary.
If you have an IUD or IUS, the IUD or IUS should be removed prior to administration of this product due to the risk of ineffectiveness or uterine damage.Contact for Consultation
In addition to the prescribing medical institution, the following counseling services are also available.
■PMDA (Pharmaceuticals and Medical Devices Agency) Pharmaceuticals Consultation Service
The PMDA provides consultation services on the efficacy and effectiveness of drugs, drug combinations, how to take and use drugs, and other concerns related to drugs.Telephone number: 03-3506-9457
Office hours: Weekdays from 9:00 a.m. to 5:00 p.m.
(Closed on Saturdays, Sundays, national holidays, and year-end and New Year holidays.Consultation Service for Patients and the Public | Pharmaceuticals and Medical Devices Agency (pmda.go.jp)
https://www.pmda.go.jp/safety/consultation-for-patients/0001.html■System for Relief from Adverse Reactions to Drugs
This is a public system that provides benefits such as medical expenses and pensions if a patient is hospitalized or becomes disabled after suffering serious side effects from the correct use of medicines provided at a hospital or clinic or purchased at a pharmacy. For details of the system, please contact PMDA.Phone number: 0120-149-931
Reception hours: Weekdays from 9:00 a.m. to 5:00 p.m.
(Closed on Saturdays, Sundays, national holidays, and year-end and New Year holidays.Adverse Drug Reactions Relief System (pmda.go.jp)
https://www.pmda.go.jp/kenkouhigai_camp/■Smart Health Consultation Office
This is a health consultation support site for young people regarding sex, pregnancy, etc.Smart Health Consultation Room - Health Consultation Support Site for Young People's Sexuality and Pregnancy (mhlw.go.jp)
https://youth.mhlw.go.jp/
