Pharmaceutical Form

Solution for injection in a pre-filled syringe. Each pre-filled syringe (5 ml) contains 250 mg fulvestrant. Clear, colorless to yellow, viscous solution free of particles.

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Indications

Fulvestrant EVER Pharma is intended for:

• as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:
   

- who have not previously received endocrine therapy or

- with recurrence during or after adjuvant anti-estrogen therapy or disease progression with anti-estrogen therapy.

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• 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 previously received endocrine therapy (see Fass section 5.1).

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Product Information

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

The mechanism of action is associated with down-regulation of estrogen receptor protein levels.
 

Clinical studies performed in postmenopausal women with primary breast cancer have shown that fulvestrant significantly downregulates estrogen receptor protein in estrogen receptor positive tumors compared to placebo

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Storage

No special storage instructions, no need to store in the refrigerator.

 

Packaging

Available in pre-filled syringe 10 x 5 ml disposable syringes

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Article number

10 x 5 ml: 403760

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ATC code

L02BA03

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For more information:

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