Breast cancer

Active Ingredient: Leuprorelin

Indication for Leuprorelin

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

As treatment in pre- and perimenopausal women with advanced breast cancer suitable for hormonal manipulation.

As adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine responsive early stage breast cancer in pre- and perimenopausal women at higher risk of disease recurrence (young age, high grade tumour, lymph node involvement). In women who have received chemotherapy, premenopausal status must be confirmed after completion of chemotherapy.

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

11.25 mg once every 3 month

Route of admnistration

Intramuscular

Defined daily dose

11.25 - 11.25 mg

Dosage regimen

From 11.25 To 11.25 mg once every 90 day(s)

Detailed description

Advanced breast cancer

The recommended dose is 11.25 mg administered as a single subcutaneous injection every 3 months.

Early breast cancer

The recommended dose is 11.25 mg administered as a single subcutaneous injection every 3 months in combination with tamoxifen or an aromatase inhibitor.

In women receiving chemotherapy, leuprorelin should be commenced after completion of chemotherapy, once premenopausal status has been confirmed.

The recommended treatment duration for adjuvant treatment in combination with other hormonotherapy is up to 5 years.

In combination with aromatase inhibitor for advanced and early breast cancer

Treatment with leuprorelin must be initiated at least 6-8 weeks before starting aromatase inhibitor treatment. A minimum of one injection of leuprorelin should be administered before commencement of aromatase inhibitor treatment.

Ovarian suppression should be confirmed by low blood concentrations of FSH and estradiol prior to starting aromatase inhibitor treatment and measurements should be repeated every three months during combination therapy with leuprorelin and an aromatase inhibitor.

During treatment with an aromatase inhibitor, leuprorelin must not be interrupted to avoid rebound increases in circulating estrogens in premenopausal women.

3.75 mg once every month

Route of admnistration

Intramuscular

Defined daily dose

3.75 - 3.75 mg

Dosage regimen

From 3.75 To 3.75 mg once every 30 day(s)

3.75 mg once every month

Route of admnistration

Subcutaneous

Defined daily dose

3.75 - 3.75 mg

Dosage regimen

From 3.75 To 3.75 mg once every 30 day(s)

Active ingredient

Leuprorelin

Leuprorelin is inactive when given orally due to poor membrane permeability and an almost complete inactivation by intestinal proteolytic enzymes. Leuprorelin has potent LHRH agonist properties when given during short-term and intermittent therapy, however, when administered in a continuous, nonpulsatile manner, LHRH analogs induce inhibition of gonadotropin secretion and suppression of testicular steroidogenesis.

Read more about Leuprorelin

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