• Hypogonadism in men witb low serum testosterone concentrations.
• Delayed puberty in men.
• Androgen-responsive breast cancer in postmenopausal women (palliative).

Unlabeled Use:

• Masculinizing hormone therapy for transgender men (female-to-male)

Contraindicated in:

• Hypersensitivity
• Men with breast or prostate cancer
• OB: Pregnancy (may cause fetal virilization)
• Lactation: Lactation.

Use Cautiously in:

• Hypercalcemia
• Coronary artery disease
• Hypertension
• Benign prostatic hyperplasia
• Obesity or chronic lung disease (↑ risk of sleep apnea)
• Polycythemia
• Prepubertal males
• Geri: ↑risk of prostatic hyperplasia/carcinoma in older adults.

CV: MI, STROKE, VENOUS THROMBOEMBOLISM, edema, ↑ blood pressure.

Derm: male pattern baldness.

EENT: deepening of voice.

Endo: hypercholesterolemia.
women-: hirsutism.
men-: gynecomastia.

F and E: hypercalcemia, hyperkalemia, hyperphosphatemia.

GI: HEPATOTOXICITY, nausea, vomiting.

GU: women-: change in libido, clitoral enlargement, menstrual irregularities.
men-: erectile dysfunction, priapism, ↓ sperm count, prostatic enlargement.

Hemat: ↑hematocrit.

Local: pain at injection site.

Neuro: SUICIDAL THOUGHTS/BEHAVIOR, depression.

Resp: sleep apnea.

Drug-Drug:

• May ↑ action of warfarin, oral hypoglycemic agents, andinsulin.
• Concurrent use with corticosteroids may ↑ risk of edema formation.

(Generic available)

• Solution for intramuscular injection (in oil): 200 mg/mL;
• Solution for subcutaneous injection (autoinjector): 50 mg/0.5 mL; 75 mg/0.5 mL; 100 mg/0.5 mL;

Male Hypogonadism (replacement therapy)

• IM (Adults): 50–400 mg every 2–4 wk.
• SC (Adults): 75 mg once weekly.

Delayed Male Puberty

• IM (Children): 50–200 mg every 2–4 wk for up to 6 mo.

Palliative Management of Breast Cancer (in postmenopausal women)

• IM (Adults): 200–400 mg every 2–4 wk.

Masculinizing Hormone Therapy for Transgender Men (Female-to-Male) (off-label)

• IM (Adults): 100–200 mg every 2 wk or 50–100 mg once weekly.
• SC (Adults): 50–100 mg once weekly.

Delatestryl, Xyosted

• Responsible for the normal growth and development of male sex organs.
• Maintenance of male secondary sex characteristics:
  • Growth and maturation of the prostate, seminal vesicles, penis, scrotum,
  • Development of male hair distribution,
  • Vocal cord thickening,
  • Alterations in body musculature and fat distribution.

• Correction of hormone deficiency in male hypogonadism:
  • Initiation of male puberty.
• Suppression of tumor growth in some forms of breast cancer.

Therapeutic Classification: hormones

Pharmacologic Classification: androgens

Absorption: Well absorbed following IM and subcut administration; absorbed slowly.

Distribution: Crosses the placenta.

Protein Binding: 98%.

Metabolism/Excretion: Metabolized by the liver; 90% eliminated in urine as metabolites.

Half-life: IM — 10–100 min; subcut — Unknown.

Schedule III (C-III)

(androgenic effects†)

†Response is highly variable among individuals; may take mo.

• Instruct patient to use testosterone as directed. Do not use higher than prescribed doses. Explain rationale for prohibiting use of testosterone for increasing athletic performance. Testosterone is neither safe nor effective for this use and has a potential risk of serious side effects.
  • Advise patient to report the following signs and symptoms promptly: in male patients, priapism (sustained and often painful erections), difficulty urinating, or gynecomastia; in female patients, virilism (which may be reversible if medication is stopped as soon as changes are noticed), or hypercalcemia (nausea, vomiting, constipation, and weakness); in male or female patients, edema (unexpected weight gain, swelling of feet), hepatitis (yellowing of skin or eyes and abdominal pain), or unusual bleeding or bruising.
  • Advise patients with diabetes to monitor blood closely for alterations in blood glucose concentrations.
  • Radiologic bone age determinations should be evaluated every 6 mo in prepubertal children to determine rate of bone maturation and effects on epiphyseal centers.
  • Rep: May be teratogenic. Instruct females of reproductive potential to notify health care professional immediately if pregnancy is planned or suspected or if breastfeeding. May irreversibly impair fertility.
  • Emphasize the importance of regular follow-up physical exams, lab tests, and x-ray exams to monitor progress.

tess-TOSS-te-rone en-AN-thate

NDC Code^*

• 0143- West-Ward Pharmaceuticals Corp
  • 0143-9750- TESTOSTERONE ENANTHATE
    • 0143-9750-01- 5 mL in 1 VIAL, MULTI-DOSE (0143-9750-01)

• 0591- Actavis Pharma, Inc.
  • 0591-3221- Testosterone Enanthate
    • 0591-3221-26- 1 VIAL, MULTI-DOSE in 1 CARTON (0591-3221-26) > 5 mL in 1 VIAL, MULTI-DOSE

• 54436- Antares Pharma, Inc.
  • 54436-200- XYOSTED
    • 54436-200-01- 1 SYRINGE in 1 CARTON (54436-200-01) >.5 mL in 1 SYRINGE (54436-200-03)

• 54436- Antares Pharma, Inc.
  • 54436-200- XYOSTED
    • 54436-200-04- 4 SYRINGE in 1 CARTON (54436-200-04) >.5 mL in 1 SYRINGE (54436-200-02)

• 54436- Antares Pharma, Inc.
  • 54436-250- XYOSTED
    • 54436-250-01- 1 SYRINGE in 1 CARTON (54436-250-01) >.5 mL in 1 SYRINGE (54436-250-03)

• 54436- Antares Pharma, Inc.
  • 54436-250- XYOSTED
    • 54436-250-04- 4 SYRINGE in 1 CARTON (54436-250-04) >.5 mL in 1 SYRINGE (54436-250-02)

• 54436- Antares Pharma, Inc.
  • 54436-275- XYOSTED
    • 54436-275-01- 1 SYRINGE in 1 CARTON (54436-275-01) >.5 mL in 1 SYRINGE (54436-275-03)

• 54436- Antares Pharma, Inc.
  • 54436-275- XYOSTED
    • 54436-275-04- 4 SYRINGE in 1 CARTON (54436-275-04) >.5 mL in 1 SYRINGE (54436-275-02)