Prostate cancer

Active Ingredient: Leuprorelin

Indication for Leuprorelin

Population group: men, only adults (18 years old or older)
  • Metastatic prostate cancer.
  • Locally advanced prostate cancer, as an alternative to surgical castration.
  • As an adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer.
  • As an adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression.
  • As neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced prostate cancer.

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

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)

Detailed description

The usual recommended dose of leuprorelin is 3.75 mg presented as a one month depot injection and administered as a single intramuscular injection every month.

Leuprorelin must be administered under the supervision of a physician or a qualified health practitioner.

The dose of leuprorelin allowing the continuous release of leuprorelin acetate during one month is incorporated in a depot formulation. The lyophilized powder should be reconstituted and administered as a single intramuscular injection at monthly intervals. Intra-arterial or intravenous administration must be avoided. The vial of leuprorelin microsphere powder should be reconstituted immediately prior to administration by intramuscular injection. As with other drugs administered regularly by injection, the injection site should be varied periodically.

Leuprorelin therapy should not be discontinued when remission or improvement occurs.

Response to leuprorelin therapy should be monitored measuring serum levels of testosterone as well as prostate-specific antigen (PSA) periodically.

If a patient’s response appears to be sub-optimal, then it would be advisable to confirm that serum testosterone levels have reached or are remaining at castrate levels. Transient increases in acid phosphatase levels sometimes occur early in the treatment period but usually return to normal or near normal values by the 4th week of treatment.

Duration of treatment: Leuprorelin should be administered as monthly intramuscular injections. As a rule, prostate cancer therapy with leuprorelin entails long-term treatment and therapy should not be discontinued when remission or improvement occurs.

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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