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Triptorelin Pamoate Suspension for injection

It is used to treat advanced prostate cancer and endometriosis

Generic Name: triptorelin

Brand Names: Trelstar LA, Trelstar Depot Mixject, Trelstar LA Mixject, Trelstar 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?

TRIPTORELIN (TRIP toe rel in) decreases testosterone in men and estrogen in women. It is used to treat advanced prostate cancer and endometriosis.

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 triptorelin, 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 into a muscle. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

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?

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

This medicine may also interact with the following medications:

  • cimetidine
  • herbal or dietary supplements, like black cohosh, DHEA
  • female hormones, like estrogen
  • male hormones, like testosterone
  • medicines for depression, anxiety, or psychotic disturbances
  • methyldopa
  • metoclopramide
  • phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
  • prasterone
  • reserpine

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine. You will need important blood work done while you are taking this medicine.

During the first weeks of treatment your symptoms may get worse. These should get better as you continue your treatment. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they continue to get worse.

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.

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
  • breast enlargement in both males and females
  • breathing problems
  • changes in vision
  • confused, not alert, other mental change
  • dark urine
  • new or worsening pain
  • pain, tingling, numbness in the hands or feet
  • swelling of the ankles, feet, hands
  • trouble passing urine or change in the amount of urine
  • vomiting
  • weakness or paralysis

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

  • change in sex drive or performance
  • constipation or diarrhea
  • dizziness
  • headache
  • hot flashes
  • nausea, stomach upset
  • pain at site where injected

Where should I keep my medicine?

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, 2010
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