[Drug name]

Generic name: Mifepristone 10mg Tablets

English name: Mifepristone 10mg Tablets

[Composition]

The main ingredient of this product is mifepristone, its chemical name is: 11 β-[4-(N, N-dimethylamino)-1-phenyl]-17 β-hydroxy-17 α-(1-propynyl)-estra-4, 9-dien-3-one

[Description]

This product is yellowish tablets

[Indications]

This product is indicated for the preoperative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, with the course of treatment of 3 months.

[Posology and Method of Administration]

po. 10mg once daily. From the 1st to 3rd day of menstruation, take 1 tablet on an empty stomach or 2 hours after eating. Fasting for 2 hours after taking the tablet is performed, and taking it continuously for 3 months is a course of treatment. There are no data from studies with a course of treatment longer than 3 months or a course of treatment of 6 months, therefore, the course of treatment should not exceed 3 months.

[Clinical Trial]

Two phase III multicenter randomized controlled trials were conducted to evaluate the efficacy of the drug. The subjects in both trials were patients with uterine fibroids, and the course of treatment was 3 months (84 days). Study 1 was a multicenter, randomized, positive-controlled trial with leuprolide acetate administered subcutaneously every 28 days as the positive control. Study 2 was a multicenter, randomized, double-blind, placebo-controlled trial. The main efficacy indicators of the two studies were: the change rate of the maximum uterine fibroid volume before and after treatment; Secondary efficacy indicators: improvement of anemia before and after treatment, including changes in red blood cell count, hemoglobin and hematocrit; Improvement of clinical symptoms before and after treatment, including changes in menstrual flow, compression symptoms, dysmenorrhea and non-menstrual lower abdominal pain.

In Study 1, there were 501 patients with uterine fibroids, including 307 patients in mifepristone 10mg tablets group, 102 patients in mifepristone 25 mg tablets group and 92 patients in leuprolide acetate group. After 3 months of treatment, the maximum change rate of fibroid volume and amenorrhea were shown in Table 1, and there was no statistical difference among the three groups. However, the incidence of amenorrhea was 76.41%, 72.00% and 55.06% in the three groups after 1 month of treatment. There was a significant difference between the mifepristone 10mg group and the enantone group. After 3 months of treatment, the hemoglobin, red blood cell count and hematocrit in the three groups were significantly increased compared with those before treatment (see Table 1 for details), and the symptoms of fibroid compression and lower abdominal pain in the three groups were significantly relieved.

In Study 2, there were 132 patients with uterine fibroids, including 66 patients in the mifepristone 10mg tablets group and 66 patients in the placebo group. The maximum change rate of fibroid volume and amenorrhea after 3 months of treatment are shown in Table 1. Mifepristone significantly reduced the size of the largest leiomyoma compared with the placebo group. The incidence of amenorrhea in mifepristone 10mg group was 83.87%. After 3 months of treatment, the mean values of hemoglobin, red blood cell count and hematocrit increased in the mifepristone 10mg tablets group. See Table 1 for details. Compared with placebo group, mifepristone 10mg group was more effective in correcting anemia.

Table 1: Primary and some secondary efficacy results in Phase III

*: The geometric mean and 95% confidence interval of the change rate of the maximum postoperative fibroid before and after treatment in the test group minus the placebo group derived from the analysis of covariance;

[Pharmacological Effect]

Mifepristone is a receptor-level progesterone (P) antagonist, with high affinity to the progesterone receptor (PR), and can effectively inhibit the physiological effects of progesterone.

[Storage]

Sealed, protected from the light.

[Package]

Aluminum-plastic package, 15 tablets per sheet, 2 sheets per pack.

[Shelf Life]

36 months