Ryeqo
Authorised
This medicine is authorised for use in the European Union
relugolix / estradiol / norethisterone acetate
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Ryeqo is a medicine used in women of reproductive age to treat:
- moderate to severe symptoms of uterine fibroids (non-cancerous growths in the womb);
- symptoms of endometriosis (a condition in which tissue similar to the lining of the womb grows elsewhere in the body).
For endometriosis, Ryeqo is used for women who have already had treatment for the condition.
Ryeqo contains the active substances relugolix, estradiol and norethisterone acetate.
The medicine can only be obtained with a prescription and treatment should be started by a doctor experienced in diagnosing and treating uterine fibroids or endometriosis.
Ryeqo is available as tablets. The recommended dose is one tablet a day at around the same time each day. Treatment should begin within 5 days from the start of a menstrual period to avoid initial irregular or heavy bleeding. After starting the treatment, Ryeqo can be taken without interruption.
The use of hormonal contraceptive methods must be stopped before starting Ryeqo. Nonhormonal methods of contraception must be used for at least one month after starting Ryeqo. After a month, Ryeqo provides adequate protection against pregnancy.
For more information about using Ryeqo, see the package leaflet or contact your doctor or pharmacist.
One of the active substances in Ryeqo, relugolix, blocks the pituitary gland (a gland that controls many other hormone-producing glands in the body) from releasing luteinizing hormone and follicle-stimulating hormone, which in turn prevents the production of progesterone and decreases the production of oestrogen. Both progesterone and oestrogen are hormones that are involved in fibroid growth, and oestrogen promotes growth of tissue similar to that lining the womb.
Another active substance of Ryeqo, estradiol, a form of the natural sex hormone oestrogen that helps to reduce symptoms related to the lowered levels of oestrogen, such as hot flushes and bone density loss. However, estradiol used alone can cause hyperplasia (growth) of the endometrium (the lining of the womb), which could lead to endometrial cancer. Ryeqo, therefore, also contains the active substance norethisterone acetate, a synthetic progesterone replacement that blocks the effects of estradiol on the womb, reducing the risk of endometrial growth.
Uterine fibroids
Ryeqo has been shown to be effective in treating symptoms linked to uterine fibroids in two studies involving women of reproductive age (from 18 to 50 years) with heavy menstrual bleeding. In both studies, around 500 women received either Ryeqo or placebo (a dummy treatment) for 24 weeks.
In the first study, 73% (94 out of 128) of women using Ryeqo reported monthly menstrual blood loss of fewer than 80 mL and at least 50% less blood loss than before the treatment, compared with 19% (24 out of 128) of those taking placebo. In the second study, 71% (89 out of 126) achieved this reduction in the volume of blood lost while using Ryeqo, compared with 15% (19 out of 129) of those given the placebo.
Endometriosis
Ryeqo has been also shown to be effective in treating symptoms of endometriosis in two studies involving women of reproductive age (from 18 to 50 years) with symptoms of moderate-to-severe pain. In both studies, around 630 patients received either Ryeqo or placebo for 24 weeks.
In the first study, 75% (158 out of 212) of women using Ryeqo reported a reduction in menstrual pain compared with 27% (57 out of 212) of those taking placebo. The proportion of women with a reduction in non-menstrual pain was also higher with Ryeqo (59%) than with placebo (40%).
In the second study, 75% (155 out of 206) achieved a reduction in menstrual pain while using Ryeqo, compared with 31% (62 out of 204) of those given the placebo. In addition, the proportion of women with a reduction in non-menstrual pain was higher among those who had Ryeqo (66%) than those who had placebo (43%).
The most common side effects with Ryeqo (which may affect up to 1 in 10 people) include headaches, hot flushes and bleeding from the womb.
Ryeqo must not be used in women who have, or have had, venous thromboembolism (blood clots in the veins) or those who have had a stroke or a heart attack. It must also not be used in women who have a blood clotting disorder, osteoporosis, migraines or headaches with neurological symptoms, cancers that are influenced by sex hormones (such as breast cancer or genital cancer), liver tumours, or abnormal liver function, or in those who are pregnant, breastfeeding or have genital bleeding of unknown cause.
Ryeqo must not be used together with hormonal contraception. For the full list of side effects and restrictions of Ryeqo, see the package leaflet.
Symptoms linked to uterine fibroids and endometriosis can be serious and debilitating. Ryeqo was shown to be effective at reducing moderate to severe symptoms of uterine fibroids, such as heavy menstrual periods. It also reduces menstrual and non-menstrual pain linked to endometriosis.
The side effects are considered manageable. Therefore, the European Medicines Agency decided that Ryeqo’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ryeqo have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Ryeqo are continuously monitored. Suspected side effects reported with Ryeqo are carefully evaluated and any necessary action taken to protect patients.
This overview was last updated in June 2021.
Product information
Latest procedure affecting product information:
IB/0022
18/01/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Ryeqo
- Active substance
- relugolix
- norethisterone acetate
- estradiol hemihydrate
- International non-proprietary name (INN) or common name
- relugolix
- estradiol
- norethisterone acetate
- Therapeutic area (MeSH)
- Leiomyoma
- Anatomical therapeutic chemical (ATC) code
- H01CC54
Pharmacotherapeutic group
Pituitary and hypothalamic hormones and analoguesTherapeutic indication
Ryeqo is indicated in adult women of reproductive age for:
- treatment of moderate to severe symptoms of uterine fibroids,
- symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.
News on Ryeqo
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