Nobel Pharma Corporation
Gemina(levonorgestrel/ethynyl estradiol)Domestic first, treatment for dysmenorrhea including levonorgestrel
On July 2, 2018, the manufacture and sale of a female hormone preparation containing levonorgestrel/ethinyl estradiol formulation (trade name Geminia combination tablets) was approved. Adaptation is "dysmenorrhea", dosage regimen is "one of the following 28 days 1 cycle (1 day tablet once a day for 21 consecutive days at constant time and 7 days off). 84 One day daily (1 tablet once a day for 77 consecutive days at a fixed time every day for 7 consecutive days, with 7 days rest) In either case the next cycle begins the next day after the end of one cycle regardless of the presence or absence of bleeding Then repeat in the same way ".
Dysmenorrhea is a pathological condition such as lower abdominal pain accompanying menstruation during menstruation period, lower back pain, abdominal bloating feeling, nausea, headache, weakness feeling and the like. Dysmenorrhea is characterized by "organic dysmenorrhea" (organic dysmenorrhea) with organic lesions in the pelvis such as endometriosis and "prostaglandin increased in the endometrium" function Severe dysmenorrhea "(primary dysmenorrhea).
In the treatment of dysmenorrhea, it is the first choice to use a combination of estrogen (E: follicle hormone) and progestin (P: luteal hormone), and in order to safely use the drug for a long period of time , Drug selection of progestin is important along with low dosage of estrogen. In Japan, low-dose estrogen, estrogen (EE) low-dose estrogen and progestin such as formulation with drospirenone (DRSP) (yards, yards flex) as a progestin, formulation with norethisterone as progestin (lunabel) Dose EP) formulation is used.
Geminian combination tablet is Japan's first low-dose EP preparation containing levonorgestrel (LNG) as a progestin in low-dose EE. Three-phase oral contraceptives (eg, Anju, Tricular, etc.) are clinically used as preparations containing the same ingredients. Gemina is the same as the lowest EE content (0.02 mg) among low-dose EP preparations that have indications for dysmenorrhea, and it is characterized by incorporating LNG as a progestin.
Research results overseas have confirmed that the EP formulation containing LNG has a lower risk of developing thrombosis than the EP formulation containing DRSP. Moreover, continuous administration of EP preparation is expected to reduce pain by reducing the number of menstrual cycles compared to the 28-day cycle administration, whereas on 28th day administration, breakthrough bleeding is less occurred as compared with continuous administration In some cases, Gemina is an EP formulation that can be selected for any administration method. Efficacy and safety were confirmed on a 28-day cycle administration and continuous administration in a domestic third phase long-term long-term comparison test (placebo-controlled double-blind study) over one year until approval. In case
88.8% of adverse reactions (including clinical laboratory test abnormalities) were observed from the phase III long-term comparison study in Japan. The main things are headaches, nausea, lower abdominal pain, amenorrhea, menorrhagia, illegal uterine bleeding, and an unexpected menstruation, so it is possible that thrombosis may occur as a serious side effect.