Drugs A - Z

Goserelin Acetate Implant

It lowers the amount of sex hormones that the body makes

Generic Name: goserelin

Brand Names: Zoladex

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 10/20/2010] ISSUE: Gonadotropin-Releasing Hormone (GnRH) agonists will have new safety information added to the Warnings and Precautions section of the drug labels. This new information warns about increased risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer.

BACKGROUND: GnRH agonists are approved to treat the symptoms (palliative treatment) of advanced prostate cancer. The benefits of GnRH agonist use for earlier stages of prostate cancer that have not spread (non-metastatic prostate cancer) have not been established. FDA’s notification to manufacturers of GnRH agonists to add this safety information is based on the Agency’s review of several published studies. Most of the studies reviewed by FDA reported small but statistically significant increased risks of diabetes and/or cardiovascular events in patients receiving GnRH agonists.

RECOMMENDATIONS: Healthcare professionals should evaluate patients for risk factors for these diseases and carefully weigh the benefits and risks of using GnRH agonists before determining appropriate treatment for prostate cancer. Patients who are receiving treatment with GnRH agonists should undergo periodic monitoring of blood glucose and/or glycosylated hemoglobin (HbA1c). Healthcare professionals should also monitor patients for signs and symptoms suggestive of development of cardiovascular disease and manage according to current clinical practice. For more information visit the FDA website at: [Web] and [Web].

[Posted 05/03/2010] FDA notified healthcare professionals and patients of FDA’s preliminary and ongoing review which suggests an increase in the risk of diabetes and certain cardiovascular diseases in men treated with GnRH agonists, drugs that suppress the production of testosterone, a hormone that is involved in the growth of prostate cancer.

Most of the studies reviewed by FDA reported small, but statistically significant increased risks of diabetes and/or cardiovascular events in patients receiving GnRH agonists. FDA’s review is ongoing and the agency has not made any conclusions about GnRH agonists and whether they increase the risk of diabetes and cardiovascular disease in patients receiving these medications for prostate cancer.

Healthcare professionals and patients should be aware of these potential safety issues and carefully weigh the benefits and risks of GnRH agonists when determining treatment choices. FDA recommends that patients receiving GnRH agonists should be monitored for development of diabetes and cardiovascular disease. Patients should not stop their treatment with GnRH agonists unless told to do so by their healthcare professional.

Some GnRH agonists are also used in women and in children for other indications than those above. There are no known comparable studies that have evaluated the risk of diabetes and heart disease in women and children taking GnRH agonists. For more information visit the FDA website at: [Web] and [Web].

What is this medicine?

GOSERELIN (GOE se rel in) is similar to a hormone found in the body. It lowers the amount of sex hormones that the body makes. Men will have lower testosterone levels and women will have lower estrogen levels while taking this medicine. In men, this medicine is used to treat prostate cancer; the injection is either given once per month or once every 12 weeks. A once per month injection (only) is used to treat women with endometriosis, dysfunctional uterine bleeding, or advanced breast cancer.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions (some only apply to women):
  • diabetes
  • heart disease or previous heart attack
  • high blood pressure
  • high cholesterol
  • kidney disease
  • osteoporosis or low bone density
  • problems passing urine
  • spinal cord injury
  • stroke
  • tobacco smoker
  • an unusual or allergic reaction to goserelin, hormone therapy, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. It is given by a health care professional in a hospital or clinic setting. Men receive this injection once every 4 weeks or once every 12 weeks. Women will only receive the once every 4 weeks injection.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

  • female hormones like estrogen
  • herbal or dietary supplements like black cohosh, chasteberry, or DHEA
  • male hormones like testosterone
  • prasterone

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Your symptoms may appear to get worse during the first weeks of this therapy. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse after this time.

Your bones may get weaker if you take this medicine for a long time. If you smoke or frequently drink alcohol you may increase your risk of bone loss. A family history of osteoporosis, chronic use of drugs for seizures (convulsions), or corticosteroids can also increase your risk of bone loss. Talk to your doctor about how to keep your bones strong.

This medicine should stop regular monthly menstration in women. Tell your doctor if you continue to menstrate.

Women should not become pregnant while taking this medicine or for 12 weeks after stopping this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

Men should inform their doctors if they wish to father a child. This medicine may lower sperm counts. Talk to your health care professional or pharmacist for more information.


Last Updated: May 04, 2010
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