This prescribing information regards marketing authorisation of Ryeqo in the EU.
Please refer to the prescribing information of this medicinal product in your country of practice.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. NAME Ryeqo 40 mg/1 mg/0.5 mg film-coated tablets. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg relugolix, 1 mg estradiol (as hemihydrate), and 0.5 mg norethisterone acetate. Contains lactose. PHARMACEUTICAL FORM Film-coated tablet. THERAPEUTIC INDICATIONS Treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. POSOLOGY AND METHOD OF ADMINISTRATION Oral use. One tablet must be taken once daily, at about the same time with or without food. Tablets should be taken with some liquid as needed. 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. Pregnancy must be ruled out prior to initiating treatment. Ryeqo can be taken without interruption. Discontinuation should be considered when the patient enters menopause. More information on risk factor for osteoporosis or bone loss, contraceptive properties, missed doses and special populations, please consult complete SmPC. CONTRAINDICATIONS Hypersensitivity to the active substance(s) or to any of the excipients. Venous thromboembolic disorder, past or present (e.g. deep venous thrombosis, pulmonary embolism). Arterial thromboembolic cardiovascular disease, past or present (e.g. myocardial infarction, cerebrovascular accident, ischemic heart disease). Known thrombophilic disorders (e.g. protein C, protein S or antithrombin deficiency or activated protein C (APC)-resistance, including Factor V Leiden). Known osteoporosis. Headaches with focal neurological symptoms or migraine headaches with aura. Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts). Presence or history of liver tumours (benign or malignant). Presence or history of severe hepatic disease as long as liver function values have not returned to normal. Pregnancy or suspected pregnancy and breastfeeding. Genital bleeding of unknown aetiology. Concomitant use of hormonal contraceptives. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Nonhormonal methods of contraception must be used for at least 1 month after initiation of treatment. Due to the risk of bone loss, a DXA scan is recommended after the first 52 weeks of treatment. Discontinue treatment if jaundice develops. Ryeqo usually leads to a reduction in menstrual blood loss or amenorrhoea within the first 2 months of treatment. Provides adequate contraception when used for at least 1 month. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Please consult complete SmPC for more information and information on risk of thromboembolic disorders, renal impairment, depression, hypertension, gallbladder disease and laboratory tests. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Oral P-glycoprotein (P-gp) inhibitors. Strong cytochrome P450 3A4 (CYP3A4) and/or P-gp inducers. CYP3A4 inhibitors. CYP enzyme inducers. Plasma concentrations may either increase (e.g. cyclosporin) or decrease (e.g. lamotrigine) with use of Ryeqo. Dose adjustment of these medicinal products may be necessary. UNDESIRABLE EFFECTS Common: Irritability. Hot flush. Dyspepsia. Alopecia. Hyperhidrosis. Night sweats. Uterine bleeding. Breast cyst. Libido decreased. Uncommon: Uterine myoma expulsion. DATE OF REVISION OF THE TEXT June 2022. Medicinal product subject to prescription, not reimbursed. For more information, please contact the marketing authorisation holder. MA HOLDER Gedeon Richter, Plc., Gyömrői út 19-21, 1103 Budapest, Hungary. Promoting entity in Portugal: Gedeon Richter Portugal, S.A. Registered office: Edifício Meridiano – Avenida D. João II nº 30, 6ºB, 1990-092 Lisbon, Portugal. VAT number 509787606.
