Men with certain types of hypogonadism (low testosterone) can now administer their own testosterone injections at home, bringing their levels of this hormone into normal ranges.
Xyosted, which delivers testosterone therapy in a special one-use device, was approved by the U.S. Food and Drug Administration (FDA) in October 2018.
The drug is approved for men with two types of hypogonadism: primary hypogonadism and hypogonadotropic hypogonadism. The former refers to an inability to produce adequate amounts of testosterone because of problems in the testes. With the latter form, this inability is caused by problems in the pituitary gland or hypothalamus, two areas of the brain that trigger hormone production in the testes.
Xyosted is not intended for men with age-related hypogonadism - drops in hormone levels that naturally occur as men get older.
Xyosted is available by prescription only and is dispensed in 50 mg, 75 mg, and 100 mg doses.
Men using Xyosted inject the drug into their abdomen once a week. A doctor can train them in the proper injection procedure.
Injections are almost painless for most men, according to Antares Pharma, the manufacturer of Xyosted. In a trial of 150 men, 99.4% of the participants described the procedure “virtually pain free.”
Men should know that Xyosted can raise blood pressure, increasing the risk for heart attack and stroke, the company warned. It recommended consistent blood pressure monitoring for all patients using Xyosted.
Patients who have or might have prostate cancer or breast cancer should not use Xyosted, the company added. Pregnant women and patients who are allergic to any of the drug ingredients are also advised not to use it.
“FDA approves testosterone self-injection for hypogonadism in men”
(October 2, 2018)
(Page last updated: January 28, 2019)
Medscape Medical News
“FDA Clears First Autoinjectable Testosterone, Xyosted”
(October 2, 2018)
“Frequently Asked Questions (FAQs) About Xyosted”
“Highlights of Prescribing Information”
“How to use Xyosted” and “Important Safety Information”
“Instructions for Use”