Yselty

Yselty can only be obtained with a prescription, and treatment should be started and supervised by a doctor experienced in the diagnosis and treatment of uterine fibroids.

Yselty is available as tablets to be taken by mouth once a day. Treatment should preferably start during the first week of the menstrual period. Before starting treatment with Yselty, pregnancy must be ruled out.

The recommended dose of Yselty is either 100 mg or 200 mg once a day, depending on whether it is used short-term or long-term and whether it is used with hormonal add-back therapy (ABT, which comprises estradiol 1 mg and norethisterone acetate 0.5 mg taken once daily).

In patients with risk factors for osteoporosis or bone loss, a dual X-ray absorptiometry (DXA) scan is recommended before starting Yselty; a DXA scan is also recommended for all patients after 1 year of treatment with Yselty.

For more information about using Yselty, see the package leaflet or contact your doctor or pharmacist.

The active substance in Yselty, linzagolix choline, is a gonadotropin-releasing hormone (GnRH) receptor antagonist. By attaching to GnRH receptors (targets) in the pituitary gland, it blocks the action of GnRH, leading to decreased blood concentrations of estrogen and progesterone, two hormones that promote the growth of uterine fibroids. Lower concentrations of estrogen and progesterone cause fibroid cells to stop dividing and to eventually die, which shrinks the fibroids and reduces the symptoms they cause (such as bleeding from the womb during or outside the menstrual period and abdominal pain such as period pain).

Yselty reduced bleeding associated with uterine fibroids in two main studies involving a total of 1,109 women. Women took either placebo (a dummy treatment) or one of two different doses of Yselty (100 or 200 mg once a day), with or without ABT.

After 24 weeks of treatment, more women taking Yselty with or without ABT reported monthly menstrual blood loss of fewer than 80 mL and at least 50% less blood loss than before the treatment, compared with placebo (56-76% of women using Yselty versus 35% of women on placebo in the first study, 56-93% versus 29% in the second study). The highest number of patients who benefited from treatment in both studies was in the group of women treated with Yselty 200 mg plus ABT. The effect of Yselty was maintained until the end of the study (52 weeks).

The most common side effects with Yselty are hot flushes (which may affect more than 1 in 10 people) and headache (which may affect up to 1 in 10 people). In the studies, these were more frequent with high doses of Yselty, and less frequent when Yselty was taken with ABT.

Yselty must not be used in women who are pregnant or breastfeeding, in women with known osteoporosis and in women who have genital bleeding of unknown cause; in women taking ABT, the contraindications for this therapy also apply.

For the full list of side effects and restrictions of Yselty, see the package leaflet.

Yselty was shown to improve bleeding associated with uterine fibroids when used with or without ABT. Yselty may impact bone density, and the product information includes recommendations on how to monitor patients for bone loss, and how to manage those with additional risk factors for developing osteoporosis. Aside from this, Yselty was generally well tolerated and its side effects are considered manageable.

The European Medicines Agency therefore decided that Yselty’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 Yselty have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Yselty are continuously monitored. Suspected side effects reported with Yselty are carefully evaluated and any necessary action taken to protect patients.

Yselty received a marketing authorisation valid throughout the EU on 14 June 2022.