On July 2, 2014, Upsher-Smith Laboratories, Inc. announced that Vogelxo™, a testosterone gel, is now available as a generic drug called Testosterone Gel (1%).
The drug is intended to treat men with the following:
- Primary hypogonadism, in which the testes do not produce enough testosterone
- Hypogonadtropic hypogonadism (secondary hypogonadism) caused by problems with the pituitary gland or hypothalamus
- Associated conditions
Testosterone gel is not intended for females or for males under the age of 18.
The gel may be dispensed in three different configurations: single-dose tubes, single-dose packets, and metered-dose pumps. Tubes and packets contain 50 mg of testosterone in 5 g of gel. Metered-dose pumps dispense 12.5 mg of testosterone in each pump actuation.
“The generic availability of Testosterone Gel in three convenient configurations is an important advance in the testosterone replacement therapy marketplace and should greatly increase access for the patients who need it,” said Upsher-Smith President and CEO Mark Evenstad in a press release.
The topical gel is applied daily to the shoulder or upper arm. It should not be applied to other parts of the body.
Men should cover the application area with a shirt. If they expect to come into skin-to-skin contact with another person, especially a woman or child, they should wash the area with soap and water first.
Before prescribing Testosterone Gel, physicians should ask patients if they have other medical conditions, particularly breast cancer, prostate cancer, an enlarged prostate, heart problems, kidney or liver problems, or sleep apnea.
Clinicians should also know about the medications their patients take. Testosterone Gel may interact with insulin, anticoagulants, and corticosteroids.
The most common side effects of Testosterone Gel are irritation at the application site and an increased red blood cell count. Headaches and increased blood pressure are also possible.
Complete prescribing information from Upsher-Smith may be found here. A medication guide for patients is available here.
Resources
MedlinePlus
“Hypogonadtropic hypogonadism”
(Updated: August 1, 2013)
http://www.nlm.nih.gov/medlineplus/ency/article/000390.htm
Sexual Medicine Society of North America
“Overview – Low Testosterone”
http://www.sexhealthmatters.org/low-testosterone/overview-low-testosterone
Upsher-Smith
“Highlights of Prescribing Information”
(Includes Full Prescribing Information and Medication Guide. June 2014)
http://www.upsher-smith.com/wp-content/uploads/TestosteroneGel-MI.pdf
“Upsher-Smith Announces Launch of The First and Only Generic Transdermal Testosterone Gel Available in Three Convenient Configurations”
(Press release. July 2, 2014)
http://www.upsher-smith.com/wp-content/uploads/109429-01-VGX-MNR-Press-Release-FINAL.pdf