Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Gedeon Richter Plc., Gyรถmrลi รบt 19-21, 1103 Budapest, Hungary
Ryeqo is indicated in adult women of reproductive age for:
Ryeqo treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of uterine fibroids and/or endometriosis.
One tablet of Ryeqo must be taken once daily, at about the same time with or without food. Tablets should be taken with some liquid as needed (see section 5.2).
A dual X ray absorptiometry (DXA) scan is recommended after 1 year of treatment. In patients with risk factors for osteoporosis or bone loss, a DXA scan is recommended prior to starting Ryeqo treatment (see section 4.4).
Pregnancy must be ruled out prior to initiating treatment with Ryeqo.
When starting treatment, the first tablet must be taken within 5 days of the onset of menstrual bleeding. If treatment is initiated on another day of the menstrual cycle, irregular and/or heavy bleeding may initially occur.
Ryeqo can be taken without interruption. Discontinuation should be considered when the patient enters menopause, as the symptoms of both uterine fibroids and endometriosis are known to regress when menopause begins.
Any hormonal contraception needs to be stopped prior to initiation of treatment, as concomitant use of hormonal contraceptives is contraindicated (see section 4.3).
Nonhormonal methods of contraception must be used for at least 1 month after initiation of Ryeqo.
After at least one month of Ryeqo use, Ryeqo inhibits ovulation in women taking the recommended dose and provides adequate contraception.
Women of childbearing potential must be advised that ovulation will return rapidly after discontinuing treatment. Therefore, a discussion with the patient, regarding appropriate contraceptive methods, must therefore take place prior to discontinuing treatment and alternative contraception needs to be started immediately after discontinuation of treatment (see section 4.4).
If one tablet is missed, the missed tablet must be taken as soon as possible and then continue the next day by taking a tablet at the usual time.
If two or more tablets are missed for consecutive days, contraceptive protection may be reduced. A nonhormonal method of contraception is to be used for the next 7 days of treatment (see section 4.6).
There is no relevant use of Ryeqo in the elderly population in the indications.
No dose adjustment for Ryeqo in patients with mild, moderate, or severe renal impairment is required (see section 5.2).
No dose adjustment for Ryeqo in patients with mild or moderate hepatic impairment is required (see section 5.2). Ryeqo is contraindicated in women with severe liver disease if liver function values have not returned to normal (see section 4.3).
There is no relevant use of Ryeqo in children aged under 18 years for the treatment of symptoms of uterine fibroids. The safety and efficacy of Ryeqo in children aged under 18 years for the treatment of endometriosis has not been established. No data are available.
Oral use.
Ryeqo can be taken with or without food. Tablets should be taken with some liquid as needed.
Single doses of relugolix up to 360 mg (9 times the recommended clinical dose of 40 mg) have been administered to healthy men and women and were generally well tolerated.
Overdoses up to 2 times the recommended dose have been reported during the clinical development of relugolix in combination with estradiol and norethisterone acetate without reports of adverse events. Supportive care is recommended if an overdose occurs. The amount of relugolix, estradiol or norethisterone removed by haemodialysis is unknown.
Serious ill effects have not been reported following acute ingestion of large doses of estrogen-containing drug products by young children. Overdose of estradiol and norethisterone acetate may cause nausea and vomiting, and withdrawal bleeding may occur in women.
3 years.
This medicinal product does not require any special storage condition.
Ryeqo tablets are packaged in high-density polyethylene (HDPE) bottles with desiccant and closed with an induction-sealed child-resistant polypropylene cap. Each bottle contains 28 tablets.
Pack sizes:
One bottle (28 tablets)
Three bottles (84 tablets).
Not all pack sizes may be marketed.
This medicinal product may pose a risk to the environment (see section 5.3). Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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