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Leuprolide Acetate Solution for injection

It is used to treat the symptoms of prostate cancer

Generic Name: leuprolide  |  Brand Name: Lupron

Brand Names: Lupron Depot-Gyn, Viadur, Lupron, Lupron Depot-Ped, Eligard, Lupron Depot

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?

LEUPROLIDE (loo PROE lide) is a man-made hormone. It is used to treat the symptoms of prostate cancer. This medicine may also be used to treat children with early onset of puberty. It may be used for other hormonal conditions.

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

They need to know if you have any of these conditions:
  • diabetes
  • heart disease or previous heart attack
  • high blood pressure
  • high cholesterol
  • pain or difficulty passing urine
  • spinal cord metastasis
  • stroke
  • tobacco smoker
  • an unusual or allergic reaction to leuprolide, benzyl alcohol, 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 or into a muscle. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. While this medicine may be prescribed for children as young as 8 years for selected conditions, precautions do apply.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • chasteberry

This medicine may also interact with the following medications:

  • herbal or dietary supplements, like black cohosh or DHEA
  • female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections
  • male hormones, like testosterone

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. During the first week, your symptoms may get worse, but then will improve as you continue your treatment. You may get hot flashes, increased bone pain, increased difficulty passing urine, or an aggravation of nerve symptoms. Discuss these effects with your doctor or health care professional, some of them may improve with continued use of this medicine.

Female patients may experience a menstrual cycle or spotting during the first 2 months of therapy with this medicine. If this continues, contact your doctor or health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • chest pain
  • depression or memory disorders
  • pain in your legs or groin
  • pain at site where injected
  • severe headache
  • swelling of the feet and legs
  • visual changes
  • vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • breast swelling or tenderness
  • decrease in sex drive or performance
  • diarrhea
  • hot flashes
  • loss of appetite
  • muscle, joint, or bone pains
  • nausea
  • redness or irritation at site where injected
  • skin problems or acne


Last Updated: May 04, 2010
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