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degarelix acetate Vials 80 mg, 120 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
WHO
Manufacturer #30830

Established in 2021, this GMP manufacturer is a leading CTD dossier owner and manufacturer, supplying high-quality pharmaceutical products across multiple countries and regions worldwide. Specializing in cytotoxic products, it operates advanced production lines for liquid injections, lyophilized injections, tablets, and capsules. As a CTD dossier owner and manufacturer, it adheres to strict regulatory standards, holding GMP approvals from WHO cGMP, ISO 9001:2015, and authorities in the Philippines, Cambodia, Kenya, Sri Lanka, and Syria. This GMP manufacturer, as a CTD dossier owner and manufacturer, ensures excellence in pharmaceutical development.

Degarelix Acetate

Degarelix Acetate is a long-acting, synthetic peptide of the acetate class. It has gonadotrophin-releasing hormone antagonistic properties. It is also a potent GnRH receptor antagonist, that is used for the treatment of patients with advanced prostate cancer. Degarelix actions block gonadotrophin-releasing hormone receptors, which are situated on the surfaces of gonadotroph cells in the anterior pituitary. The blocking results in a reduction in the secretion of luteinizing hormone (LH) by pituitary gonadotroph cells and so decreasing testosterone production by interstitial cells in the testes. Degarelix Acetate is sold under the brand name Firmagon among others. The US Food and Drug Administration approved Degarelix in 2008, for the treatment of patients with advanced prostate cancer in the United States. By 2009, It was subsequently approved by the European Commission in 2009, for use in adult males with advanced, hormone-dependent prostate cancer.

Dosage and administration

Degarelix Acetate is available as in injection in 80gm and 120gm in a single vial. It is to be administered only subcutaneously and must not be administered intravenously. The usual adult dose, on which the treatment begins is set at a 240 mg given as two injections of 120 mg each. This is then followed by a maintenance doses of 80 mg, administered as a single injection every 28 days.

The cost of Degarelix Acetate

In the USA, the consumers have to pay around $519, for subcutaneous powder for injection of 80 mg for a supply of one powder for injection. This medicine is much cheaper in UK, whereht consumers have to pay an average retial price of £129.37, for subcutaneous powder for injection of 80 mg for a supply of one powder for injection.

How does Degarelix Acetate Work?

GnRH receptor blockers also called antagonists are synthetic peptide derivatives of the natural GnRH decapeptide. GnRH decapeptide is a hormone made by neurons in the hypothalamus. Degarelix Acetate competes with natural GnRH for binding to GnRH receptors in the pituitary gland. This binding blocks the release of LH and FSH from the pituitary and the blocking is reversible. LH reduction leads to a rapid and sustained suppression of testosterone release from the testicles. It also subsequently decreases the growth of the prostate cancer. The final result is a This reduction in prostate-specific antigen levels.

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