4.1 Therapeutic indications

Ryeqo is indicated for treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

4.2 Posology and method of administration

Posology

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).

In patients with risk factors for osteoporosis or bone loss, a dual X ray absorptiometry (DXA) is recommended prior to starting Ryeqo treatment (see section 4.4).

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 with Ryeqo.

Ryeqo can be taken without interruption. Discontinuation should be considered when the patient enters menopause, as uterine fibroids are known to regress when menopause begins. A DXA scan is recommended after 1 year of treatment (see section 4.4).

Contraceptive properties of Ryeqo

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 treatment.

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).

Missed doses

If a dose is missed, treatment must be taken as soon as possible and then continue the next day at the usual time.

If doses are missed for 2 or more consecutive days, a nonhormonal method of contraception is to be used for the next 7 days of treatment (see section 4.6).

Special populations

Elderly

There is no relevant use of Ryeqo in the elderly population in the indication.

Renal impairment

No dose adjustment for Ryeqo in patients with mild, moderate, or severe renal impairment is required (see section 5.2).

Hepatic impairment

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).

Paediatric population

There is no relevant use of Ryeqo in children aged under 18 years for the indication of the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

Method of administration

Oral use

Ryeqo can be taken with or without food. Tablets should be taken with some liquid as needed.