Moderate to severe symptoms of uterine fibroids

Active Ingredient: Linzagolix

Indication for Linzagolix

Population group: women, only adults (18 - 65 years old)
Therapeutic intent: Curative procedure

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

For this indication, competent medicine agencies globally authorize below treatments:

100-200 mg once daily

For:

Route of admnistration

Oral

Defined daily dose

100 - 200 mg

Dosage regimen

From 100 To 200 mg once every day

Detailed description

Linzagolix treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of uterine fibroids.

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

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

The recommended dose of linzagolix is:

  • 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).
  • 100 mg once daily for women in whom ABT is not recommended or who prefer to avoid hormonal therapy.
  • 200 mg once daily for short-term use (<6 months) in clinical situations when reduction of uterine and fibroid volume is desired. 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.

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

Linzagolix 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.

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.

Dosage considerations

Linzagolix can be taken with or without food.

Active ingredient

Linzagolix

Linzagolix is a selective, non-peptide gonadotropin-releasing hormone (GnRH) receptor antagonist that inhibits endogenous GnRH signalling by binding competitively to GnRH receptors in the pituitary gland, thereby modulating the hypothalamic-pituitary-gonadal axis.

Read more about Linzagolix

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