Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Xyosted for Testosterone Replacement

Antares Pharma news release; 2018 Oct 1

Antares Pharma, Inc. has announced the approval of Xyosted (testosterone enanthate) injection by the US Food and Drug Administration (FDA) for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Xyosted is the first FDA-approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable QuickShot auto injector. Antares Pharma, Inc., is headquartered in Ewing, NJ.

Dosage/administration: Xyosted has been approved in 3 dosage strengths, 50 mg, 75 mg, and 100 mg.

Adverse reactions: The most commonly reported adverse reactions (>5%) were increased hematocrit, hypertension, increased PSA, injection site bruising, and headache.

Citation:

Antares receives FDA approval of Xyosted (testosterone enanthate) injection for testosterone replacement therapy in adult males. [news release]. Ewing, NJ: Antares Pharma, Inc. October 1, 2018. https://www.antarespharma.com/application/files/2715/3835/7488/XYOSTED_FDA_Approval_Final.pdf. Accessed October 3, 2018.

This Week's Must Reads

Racial/Ethnic Differences in Glycemic Control in T1D, JAMA; ePub 2018 Sep 7; Kahkoska, Shay, et al

Youth Fasting Glucose and Midlife Cognitive Function, Diabetes Care; 2018 Oct; Bancks, Carnethon, et al

Prolactin Concentration Linked with Lower T2D Risk, Diabetologia; ePub 2018 Oct 11; Li, Rice, et al

Hypothalamic Obesity Treatment Strategies Explored, Obesity; ePub 2018 Oct 8; Rose, Horne, et al

MetS Severity Z Score Helps Track T2D Treatment , Diabetes Care; ePub 2018 Oct 1; DeBoer, et al

Must Reads in FDA Actions

FDA Approves Xyosted for Testosterone Replacement, Antares Pharma news release; 2018 Oct 1

FDA Approves Updates to Tresiba Label, Novo Nordisk news release; 2018 Mar 26

FDA Approves New Guardian Sensor 3 Arm Indication , Medtronic news release; 2018 Feb 26