Testosterone Nasal Gel

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Testosterone Nasal Gel

Testosterone nasal gel delivers testosterone directly into the nostril. Natesto is the only FDA approved nasal testosterone replacement therapy. It is administered three times daily once in the morning, once in the afternoon and once in the evening (6 to 8 hours apart).

According to the Phase 3 clinical trials for FDA approval, the average testosterone concentration in the blood was in the normal range for 90 percent of men who used the nasal gel three times daily, compared with 71 percent of men using it twice a day. As such, the manufacturer’s recommended dosing is three times a day in each nostril, for a total daily dose of 33 mg.1

 


 

Dosing and Administration

Natesto testosterone nasal gel is available as a metered-dose pump. One pump actuation delivers 5.5 mg of testosterone. The recommended dose of Natesto is 11 mg of testosterone (2 pump actuations, one per nostril), applied intranasally three times daily for a total of 33 mg of testosterone per day.

Since Natesto is administered into the nostril, men with certain chronic nasal conditions and alteration in nasal anatomy may not be able to use this product.

 

Use in Patients with Chronic Nasal Conditions and Alterations in Nasal Anatomy

Since Natesto is taken through the nostrils, Natesto is not recommended for use in the following patients:

  • History of nasal disorders
  • History of nasal or sinus surgery
  • History of nasal fracture within the previous 6 months
  • Nasal fracture that caused a deviated anterior septum
  • Mucosal inflammatory disorders
  • Sinus disease

Pros:

  • Convenient/easy-to-use, self-administered form of testosterone.
  • Does not carry the risk of transfer to others like testosterone gel.

Cons:

  • Must be applied every day three times a day at the same time each day.
  • Not suitable for men with nasal or sinus problems.
  • May not fully raise testosterone levels back up to normal desired levels. In clinical trials, 10% of men did not achieve normal levels after 90 days of treatment. The mean serum total testosterone concentrations on day 90 following administration of Natesto (11 mg of testosterone) three times daily was 421 ng/dL.1

 

Suppliers

The only testosterone nasal gel approved by the FDA is Natesto (Endo Pharmaceuticals, Inc). Endo Pharmaceuticals provides further information like cost and coverage, treatment and administration, and important safety information about Natesto HERE. Full prescribing information is also available HERE.

 

For more information on the different available TRT administration methods, select any of the the links below.

EMG’s TRT Resource: Types of Testosterone

 

1. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205488s000lbl.pdf.