Locally advanced or metastatic hormone receptor (HR)-positive breast cancer in postmenopausal women

Active Ingredient: Fulvestrant

Indication for Fulvestrant

Population group: women, only adults (18 years old or older)

Fulvestrant is indicated:

  • as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:
    • not previously treated with endocrine therapy, or
    • with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.
  • in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.

In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.

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

500 mg once monthly

Route of admnistration


Defined daily dose

500 - 500 mg

Dosage regimen

From 500 To 500 mg once every 30 day(s)

Detailed description

The recommended dose is 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose.

Prior to the start of treatment with the combination of fulvestrant plus palbociclib, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice.

Dosage considerations

Fulvestrant should be administered as two consecutive 5 ml injections by slow intramuscular injection (1-2 minutes/injection), one in each buttock (gluteal area).

Caution should be taken if injecting fulvestrant at the dorsogluteal site due to the proximity of the underlying sciatic nerve.

Active ingredient


Fulvestrant is a competitive estrogen receptor (ER) antagonist with an affinity comparable to estradiol. Fulvestrant blocks the trophic actions of estrogens without any partial agonist (estrogen-like) activity.

Read more about Fulvestrant

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