Drugs A - Z

Histrelin Acetate Implant [Precocious puberty]

It is used to treat central precocious puberty

Generic Name: Supprelin

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?

HISTRELIN (his TREL in) is used to treat central precocious puberty. The implant contains a drug that is like a natural hormone in the body called gonadotropin-releasing hormone (GnRH).

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

They need to know if you have any of these conditions:
  • an unusual or allergic reaction to Histrelin, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

This medicine is placed under the skin of your arm by a health care professional in a clinic or office. After the implant is placed, keep the insertion site clean and dry for 24 hours. Avoid heavy lifting and strenuous exercise for 7 days after implant insertion. The surgical strips over the site should be allowed to fall off on their own over several days. The implant must be removed after 12 months. At this time, a new implant may be inserted to continue therapy.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

What if I miss a dose?

This does not apply. After 1 year, the implant will have to be removed. If you need to continue this medicine, the implant will be replaced at that time.

What may interact with this medicine?

  • female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections
  • herbal or dietary supplements, like black cohosh or DHEA
  • male hormones, like testosterone
  • medicines for depression, anxiety, or psychotic disturbances
  • prasterone

What should I watch for while using this medicine?

Visit your doctor for regular checks on your progress. During the first few weeks, the symptoms of puberty may get worse, but then will start to get better as treatment is continued. Check with your doctor if they do not start to get better after several weeks.

Rarely, the implant can be expelled from the body through the original incision site. You may notice the implant being expelled, or rarely, the implant may be expelled without your noticing it. If you believe the implant has been expelled from your body, call your doctor.

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
  • changes in vision
  • pain at the insertion site
  • severe headache
  • vomiting

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

  • redness or irritation at the insertion site

Where should I keep my medicine?

This does not apply. This drug is given in a hospital or clinic and will not be stored at home.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


Last Updated: May 04, 2009
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