Goserelin Acetate is marketed by AstraZeneca with the brand name Zoladex. It was first launched in 1987 and is currently the second-largest selling GnRH analogue in the world. It is currently available in more than one hundred markets.
Zoladex 3.6 mg subcutaneous monthly biodegradable implant was first approved by the FDA on November 3, 1989 for treatment of prostate cancer, a 10.8 mg subcutaneous 3-month biodegradable implant and other indications were subsequently approved.
Goserelin Acetate is used to treat hormone-sensitive cancers of the prostate and breast (in pre-/perimenopausal women) and some benign gynaecological disorders (endometriosis, uterine fibroids and endometrial thinning). In addition, goserelin is used in assisted reproduction and in the treatment of precocious puberty. The syringe applicator comes with a protective sleeve, called the SafeSystem, to reduce and prevent needlestick injuries to administering healthcare professionals.
It is available as a 1-month depot and a long-acting 3-month depot. Both depots are used for the treatment of prostate cancer, endometriosis and uterine fibroids but only the 1-month depot is approved for breast cancer, endometrial thinning and assisted reproduction.
NOTE: The above license is probably from the USA. It should be noted that licensed indications may vary from country to country. For example, in the UK the 1-month depot is licensed for prostate cancer, endometriosis, uterine fibroids, breast cancer, endometrial thinning and assisted reproduction, and not as above. You are advised to consult a Healthcare Professional or your local regulatory authorities if you need more information on your local license for this product.
Goserelin Acetate may cause a temporary increase in bone pain and symptoms of prostatic cancer during the first few weeks of treatment. As the body adjusts to the medication, the symptoms will disappear. Goserelin may cause bone pain, hot flushes, headache, stomach upset, difficulty urinating (isolated cases), weight gain, swelling and tenderness of breasts (infrequent), decreased erections and reduced sexual desire. Bone pain can be managed symptomatically, and decreased libido can be treated by Levitra (Vardenafil) or other similar oral therapies.
"Pharmaceutical Composition Containing Goserelin for In-Situ Implant" in Patent Application Approval Process
Jul 11, 2013; By a News Reporter-Staff News Editor at Women's Health Weekly -- A patent application by the inventors Nadkarni, Sunil S. (Bhat,...