Ryeqo

Ryeqo treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of uterine fibroids and/or endometriosis, after careful diagnosis. Pregnancy must be ruled out prior to initiating treatment.

Posology The recommended dose is one tablet taken once daily. When starting treatment, the first tablet must be taken within 5 days of the onset of menstrual bleeding. 8). 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.

Bone mineral density (BMD) loss and osteoporosis A dual X ray absorptiometry (DXA) scan is recommended after 1 year of treatment. 4). 3). 4). After at least 1 month of treatment, ovulation in women taking the recommended dose is inhibited and provides adequate contraception.

Women of childbearing potential must be advised that ovulation will return rapidly after discontinuing treatment. 4). Missed doses If a dose is missed, the missed tablet must be taken as soon as possible and treatment should be continued with the next tablet at the usual time on the following day.

If two or more tablets are missed for consecutive days, contraceptive protection may be reduced. 6). Elderly There is no relevant use of this medicinal product in the elderly population (≥65 years). 2). 2). 3). Paediatric population 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. Method of administration Oral use. Ryeqo can be taken with or without food, at about the same time.

2).

8%). Adverse reactions listed in Table 4 are classified according to frequency and system organ class. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), and not known (cannot be estimated from available data).

Tabulated list of adverse reactions Table 4. Adverse reactions in patients with uterine fibroids and endometriosis Psychiatric disorders Common Irritability Libido decreased* Nervous system disorders Very common Headache Common Dizziness Vascular disorders Very common Hot flush Rare Hypertension Gastrointestinal disorders Common Nausea Uncommon Dyspepsia Skin and subcutaneous tissue disorders Common Alopecia Hyperhidrosis Night sweats Uncommon Angioedema Urticaria Musculoskeletal and connective tissue disorders Common Arthralgia Reproductive system and breast disorders Common Uterine bleeding** Vulvovaginal dryness Uncommon Breast cyst Uterine myoma expulsion * includes libido decreased, libido loss and libido disorder.

** includes menorrhagia (heavy menstrual bleeding), metrorrhagia (intermenstrual bleeding), vaginal haemorrhage, uterine haemorrhage, polymenorrhoea, and menstruation irregular. 13 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Medical examination/consultation Prior to the initiation or reinstitution of this medicinal product, a complete medical history (including family history) must be taken. 4). During treatment, periodic check-ups must be carried out according to standard clinical practice.

Pregnancy must be ruled out prior to administering or re-initiation of Ryeqo. Risk of thromboembolic disorders The use of medicinal products containing an estrogen and a progestogen increases the risk of arterial or venous thromboembolism (ATE or VTE) compared with no use.

The risk of ATE/VTE with this medicinal product has not been established. It contains doses of estrogen and progestogen lower than the doses used in combined hormonal contraceptives and are provided in combination with relugolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist that suppresses ovarian production of estrogen and progesterone.

1). If an ATE/VTE occurs, treatment must be discontinued immediately. 3). Risk factors for venous thromboembolism (VTE) The risk for venous thromboembolic complications in women using a product with an estrogen and progestogen may increase substantially in a woman with additional risk factors, particularly if there are multiple risk factors (see Table 1 below).

5 Table 1. Risk factors for VTE Risk factor Comment Obesity (body mass index [BMI] over 30 kg/m2) Risk increases substantially as BMI rises. Prolonged immobilisation, major surgery or major trauma In these situations, it is advisable to discontinue use of the medicinal product (in the case of elective surgery at least four weeks in advance) and not resume until two weeks after complete remobilisation.

g. before 50 years. If a hereditary predisposition is suspected, the woman must be referred to a specialist for advice before using the medicinal product. Other medical conditions associated with VTE Cancer, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell disease.

Increasing age Particularly above 35 years. 6). Symptoms of VTE (deep vein thrombosis and pulmonary embolism) In the event of symptoms, women must be advised to get urgent medical attention and to inform the physician that she is taking this medicinal product.

Symptoms of deep vein thrombosis (DVT) can include: − unilateral swelling of the leg and/or foot or along a vein in the leg; − pain or tenderness in the leg which may be felt only when standing or walking; − increased warmth in the affected leg; red or discoloured skin on the leg.

Symptoms of pulmonary embolism (PE) can include: − sudden onset of unexplained shortness of breath or rapid breathing; − sudden coughing which may be associated with haemoptysis; − sharp chest pain; − severe light headedness or dizziness; − rapid or irregular heartbeat.

g. g. respiratory tract infections). g. transient ischaemic attack, stroke). Arterial thromboembolic events may be fatal. The risk for arterial thromboembolic complications in women using a product with an estrogen and progestogen may increase substantially in a woman with additional risk factors, particularly if there are multiple risk factors (see Table 2 below).

6 Table 2. Risk factors for ATE Risk factor Comment Increasing age Particularly above 35 years. Smoking Women are to be advised not to smoke if they wish to use the medicinal product. Hypertension Obesity (body mass index [BMI] over 30 kg/m2) Risk increases substantially as BMI increases.

g. before 50 years. If a hereditary predisposition is suspected, the woman must be referred to a specialist for advice before using the medicinal product. Migraine An increase in frequency or severity of migraine during use of the medicinal product (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation.

Other medical conditions associated with adverse vascular events Diabetes mellitus, hyperhomocysteinaemia, valvular heart disease and atrial fibrillation, dyslipoproteinaemia and systemic lupus erythematosus. Symptoms of ATE In the event of symptoms, women must be advised to get urgent medical attention and to inform the physician that she is taking this medicinal product.

Symptoms of a cerebrovascular accident can include: − sudden numbness or weakness of the face, arm or leg, especially on one side of the body; − sudden trouble walking, dizziness, loss of balance or coordination; − sudden confusion, trouble speaking or understanding; − sudden trouble seeing in one or both eyes; − sudden, severe or prolonged headache with no known cause; − loss of consciousness or fainting with or without seizure.

Temporary symptoms suggest the event is a transient ischaemic attack. Symptoms of myocardial infarction can include: − pain, discomfort, pressure, […]

1. g. 4). g. 4). g. 4). 4). 4). g. of the genital organs or the breasts). 4). 4). 6). 4). − Concomitant use of hormonal contraceptives