Confirmation of Hypogonadism Before Initiation of XYOSTED

Prior to initiating XYOSTED, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.

Starting Dose and Dose Adjustment

The starting dose of XYOSTED is 75 mg, administered subcutaneously in the abdominal region once a week.

Dose adjustment

Measure total testosterone trough concentrations (measured 7 days after the most recent dose) following 6 weeks of dosing, following 6 weeks after dose adjustment, and periodically while on treatment with XYOSTED. A trough concentration between 350 ng/dL and 650 ng/dL generally provides testosterone exposures in the normal range during the entire dosing interval.

Decrease the dose by 25 mg if the total testosterone trough concentration (Ctrough) is ≥650 ng/dL.
Increase the dose by 25 mg if the total testosterone Ctrough is <350 ng/dL.
Maintain the same dose if the total testosterone Ctrough is ≥350 ng/dL and <650 ng/dL.

Important Administration Instructions

XYOSTED is for subcutaneous injection in the abdominal region only. Avoid intramuscular or intravascular injection.

Instruct patients on the proper use of XYOSTED and direct them to use the proper injection site. Refer to the Instructions for Use for proper use of XYOSTED.

Visually inspect XYOSTED for particulate matter and discoloration prior to administration. Do not use if the liquid is cloudy or if visible particles are present.

Do not use XYOSTED if the seal is broken.