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Nafarelin Acetate Nasal spray

It will lower the amount of testosterone in males and estrogen in females

Generic Name: nafarelin nasal

Brand Names: Synarel

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?

NAFARELIN (naf A re lin) is a man-made hormone that is like a hormone made in the body. It will lower the amount of testosterone in males and estrogen in females. It is used to treat endometriosis. This medicine is also used to diagnose and to treat precocious puberty.

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
  • osteoporosis or low bone density
  • stroke
  • tobacco smoker
  • unusual vaginal bleeding
  • an unusual or allergic reaction to nafarelin, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

This medicine is for use in the nose only. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

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

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:
  • herbal products like chasteberry

This medicine may also interact with the following medications:

  • other nose sprays

What should I watch for while using this medicine?

Visit your doctor for regular check ups. Your symptoms may get worse for a short time after starting this medicine. Talk to your doctor if your symptoms do not get better.

This medicine can make your bones weaker over time. If you smoke or drink alcohol often you may increase your risk of bone loss. Also, a family history of osteoporosis, and use of corticosteroids or drugs for seizures can increase your risk of bone loss. Talk to your doctor about ways to help keep your bones strong.

If you use a decongestant nose spray, wait for 2 hours after using this medicine to use the decongestant spray.

Use a non-hormonal method of birth control while taking this medicine. If you think you might be pregnant, 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:
  • breathing problems
  • changes in vision
  • chest pain
  • depression, mood changes
  • sudden headache
  • swelling of hands, feet
  • vaginal bleeding, discharge
  • vomiting

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

  • acne
  • body odor
  • change in sex drive or performance
  • hot flashes
  • increase in breast size at start of therapy
  • runny nose
  • trouble sleeping
  • vaginal dryness

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Store bottle right side up. Protect from light. Throw away any unused medicine after the expiration date.

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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