YSELTY Film-coated tablet Ref.[50145] Active ingredients: Linzagolix

Posology

Yselty treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of uterine fibroids and/or endometriosis.

The recommended dose of Yselty is:

For Uterine Fibroids:

• 100 mg or, if needed, 200 mg once daily with concomitant hormonal add-back therapy (ABT, estradiol 1 mg and norethisterone acetate 0.5 mg tablet once daily), see section 5.1.
• 100 mg once daily for women in whom ABT is not recommended or who prefer to avoid hormonal therapy (see section 5.1)
• 200 mg once daily for short-term use (< 6 months) in clinical situations when reduction of uterine and fibroid volume is desired (see section 5.1). Fibroid size may increase when the treatment is stopped. Due to the risk of bone mineral density (BMD) decrease with prolonged use, the 200 mg dose without concomitant ABT should not be prescribed for longer than 6 months.

For Endometriosis:

• 200 mg once daily with concomitant hormonal add-back therapy

Pregnancy must be ruled out prior to initiating treatment with Yselty.

Yselty should preferably be started in the first week of the menstrual cycle and should be taken continuously once daily.

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

Yselty can be taken without interruption. A DXA scan is recommended after 1 year of treatment for all women, and there is a need for continued BMD monitoring thereafter (see section 4.4).

Missed dose

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

Special populations

Hepatic impairment

No dose adjustment is necessary in women with mild or moderate hepatic impairment (Child-Pugh A or B). Yselty should be avoided in women with severe hepatic impairment (Child-Pugh C) (see sections 4.4 and 5.2).

Renal impairment

Prescribers are recommended to monitor for adverse reactions in women who have mild renal impairment (eGFR = 60-89 mL/min; see section 4.4 and 5.2) although no dose adjustment is required. Yselty should be avoided in women with moderate (eGFR = 30-59 mL/min), severe renal impairment (eGFR < 30 mL/min) or end-stage renal disease (see sections 4.4 and 5.2).

Paediatric population

There is no relevant use of Yselty in children aged under 18 years for the indication of treatment of moderate to severe symptoms of uterine fibroids.

The safety and efficacy of Yselty in children aged under 18 years for the indication of treatment of endometriosis has not been established.

Method of administration

Oral use.

Yselty can be taken with or without food (see section 5.2).

The 200 mg dose can be taken as either one 200 mg tablet or two times a 100 mg tablet.

No case of overdose has been reported.

In cases of overdose, patients should be monitored closely, and management should be symptomatic and supportive.

For women taking regimens with concomitant ABT, overdose of estrogen and progestin may cause hormone-related symptoms, including but not limited to nausea, vomiting, breast tenderness, abdominal pain, drowsiness, fatigue, and withdrawal bleeding.

3 years.

This medicinal product does not require any special storage conditions.

PVC-PVDC/aluminium blister containing 14 film-coated tablets per blister.

Pack size of 28 film-coated tablets (two blisters of 14 film-coated tablets) or 84 film-coated tablets (six blisters of 14 film-coated tablets) per cardboard box.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.