XYOSTED

XYOSTED- testosterone enanthate injection
Antares Pharma, Inc.

WARNING: BLOOD PRESSURE INCREASES

  • XYOSTED can cause blood pressure (BP) increases that can increase the risk for major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death, with greater risk for MACE in patients with cardiovascular risk factors or established cardiovascular disease [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].
  • Before initiating XYOSTED, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled.
  • Starting approximately 6 weeks after initiating therapy, periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension in patients on XYOSTED.
  • Re-evaluate whether the benefits of XYOSTED outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease while on treatment.
  • Due to this risk, use XYOSTED only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies [see Indications and Usage (1) and Contraindications (4)].

1 INDICATIONS AND USAGE

XYOSTED (testosterone enanthate) injection is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

  • Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
  • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.

Limitations of Use:

  • Safety and efficacy of XYOSTED in males less than 18 years old have not been established [see Use in Specific Populations (8.4)].

2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 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.

2.3 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.

3 DOSAGE FORMS AND STRENGTHS

XYOSTED injection is available as 0.5 mL of a sterile, preservative-free and nonpyrogenic, clear, colorless to yellow solution containing testosterone enanthate. It is supplied in a single-dose syringe assembled in an autoinjector for subcutaneous administration. XYOSTED is available in three dosage strengths:

50 mg/0.5 mL

75 mg/0.5 mL

100 mg/0.5 mL

4 CONTRAINDICATIONS

XYOSTED is contraindicated in:

  • Men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions (5.4)].
  • Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman [see Use in Specific Populations (8.1)].
  • Men with known hypersensitivity to XYOSTED or any of its ingredients (testosterone enanthate and sesame oil).
  • Men with hypogonadal conditions, such as “age-related hypogonadism”, that are not associated with structural or genetic etiologies. The efficacy of XYOSTED has not been established for these conditions, and XYOSTED can increase BP that can increase the risk of MACE [see Boxed Warning and Warning and Precautions (5.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Blood Pressure Increases

In clinical trials, XYOSTED increased systolic BP in the first 12 weeks of treatment by an average of 4 mmHg based on ambulatory blood pressure monitoring (ABPM) and by an average of 4 mmHg from baseline following 1 year of treatment based on blood pressure cuff measurements [see Adverse Reactions (6.1)]. In the one-year trial, 10% of XYOSTED-treated patients were started on antihypertensive medications or required changes to their antihypertensive medication regimen.

These BP increases can increase the risk of MACE, with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease [see Boxed Warning].

In some patients, the increase in BP with XYOSTED may be too small to detect, but can still increase the risk for MACE.

Before initiating XYOSTED, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled. Check BP approximately 6 weeks after initiating XYOSTED and periodically thereafter. Treat new-onset hypertension or exacerbations of pre-existing hypertension. Re-evaluate whether the benefits of continued treatment with XYOSTED outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease.

5.2 Polycythemia

Increases in hematocrit reflective of increases in red blood cell mass may require discontinuation of XYOSTED.

Check that hematocrit is not elevated prior to initiating XYOSTED. Evaluate hematocrit approximately every 3 months while the patient is on XYOSTED. If hematocrit becomes elevated, stop XYOSTED until the hematocrit decreases to an acceptable level. If XYOSTED is restarted and again causes hematocrit to become elevated, stop XYOSTED permanently. An increase in red blood cell mass may increase the risk of thromboembolic events.

5.3 Cardiovascular Risk

Long term clinical safety trials have not been completed to assess the cardiovascular outcomes of testosterone replacement therapy in adult males. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of MACE, such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in adult males. XYOSTED can cause BP increases that can increase the risk of MACE [see Boxed Warning and Warnings and Precautions (5.1)]. Patients should be informed of this possible risk when deciding whether to use or to continue to use XYOSTED.

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