FDA has now approved the first subcutaneous testosterone auto-injector pen (Xyosted) for symptomatic patients with low testosterone levels. It is self-administered once weekly. It comes in three doses, 50 mg, 75, and 100 mg. Recommended starting dose is 75 mg per week. It can increase blood pressure, thus caution is advised in patients predisposed to hypertension and those at increased risk for cardiovascular events. Patients need to be monitor carefully after its initiation. Xyosted is not approved for women or males younger than age 18.
FDA has approved testosterone enanthate (Xyosted) subcutaneous injection for testosterone replacement therapy in men diagnosed with conditions associated with a deficiency or absence of endogenous testosterone.
Xyosted is the first FDA-approved subcutaneous testosterone enanthate product for once-weekly self-administration using a disposable auto-injector, the company said in a news release.
The FDA approved the product in three dosage strengths: 50 mg, 75 mg, and 100 mg.
"A once-weekly, at-home, subcutaneously administered testosterone product represents an exciting new treatment option for men suffering from hypogonadism," Jed Kaminetsky, MD, principal investigator of the Xyosted pivotal studies, said in the release.
"The subcutaneous dosing of Xyosted also removes transfer concerns commonly associated with gels and potentially reduces the need for in-office injection procedures that may require more frequent patient visits. Xyosted has been clinically shown to produce physiologically normal levels of testosterone with a narrow peak-to-trough ratio," added Kaminetsky, clinical assistant professor of urology at New York University School of Medicine, New York City.
The company expects Xyosted to be available before the end of this year.
In October 2017, the FDA declined to approve Xyosted over concerns that it can cause a clinically meaningful increase in blood pressure.
Xyosted contains a boxed warning regarding elevations in blood pressure that can increase the risk for major adverse cardiovascular events (MACE), including nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death. The risk for MACE is greater in patients with cardiovascular risk factors or established cardiovascular disease.
The label advises that the patient's baseline cardiovascular risk be considered before starting Xyosted and that blood pressure be adequately controlled. Periodic monitoring for new-onset hypertension or exacerbations of preexisting hypertension is advised.
Clinicians are also advised to reevaluate whether the benefits of Xyosted outweigh the risks in patients who develop cardiovascular risk factors or cardiovascular disease while on treatment.
Use of Xyosted is indicated only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
The safety and efficacy of Xyosted in men with age-related hypogonadism or in males younger than 18 years have not been established.