• Hypogonadism in men with low serum testosterone concentrations.

Contraindicated in:

• Hypersensitivity
• OB: Lactation: Pregnancy and lactation
• Male patients with breast or prostate cancer
• Women.

Use Cautiously in:

• Pre-existing cardiac, renal, or liver disease
• Sleep apnea
• Obesity
• Chronic lung disease
• Polycythemia
• Nasal disorders, nasal/sinus surgery, nasal fracture in previous 6 mo, nasal fracture that caused deviated anterior nasal septum, mucosal inflammatory disorders (e.g. Sjogren's syndrome), or sinus disorders (nasal gel)
• Geri: ↑risk of prostatic hyperplasia/carcinoma
• Pedi: Males <18 yr (safety and effectiveness not established).

CV: MI, STROKE, VENOUS THROMBOEMBOLISM, edema, hot flashes, hypertension.

EENT: deepening of voice.
nasal gel: epistaxis, nasal scabbing, nasopharyngitis, rhinorrhea.

GI: ↑liver enzymes, nausea, vomiting.

GU: ↓fertility, nocturia, priapism, prostatic enlargement, urinary hesitancy, urinary incontinence.

Endo: acne, breast pain, change in libido, gynecomastia, hypercholesterolemia.

Derm: alopecia, dry skin, pruritis.

Hemat: anemia, polycythemia.

Local: chronic skin irritation.

Drug-Drug:

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

(Generic available)

• 1% topical gel (Androgel): 25 mg/packet; 50 mg/packet;
• 1% topical gel (Testim): 50 mg/unit–dose tube;
• 1% topical gel (Vogelxo): 50 mg/unit–dose tube; 50 mg/packet; 12.5 mg/actuation in 75–g metered dose pump (each pump dispenses 60 metered doses);
• 1.62% topical gel (Androgel): 20.25 mg/packet; 40.5 mg/packet; 20.25 mg/actuation in 88–g metered dose pump (each pump dispenses 60 metered doses);
• 2% topical gel (Fortesta): 10 mg/actuation in 60–g metered dose pump (each pump dispenses 120 metered doses);
• Nasal gel (Natesto): 5.5 mg/actuation in 11–g metered dose pump (each pump delivers 60 metered doses);

Topical testosterone products are not interchangeable

• Transdermal (Adults): Androgel 1% or Testim — 5 g (contains 50 mg of testosterone; 5 mg systemically absorbed) applied once daily (morning preferable), if needed may be ↑ to maximum of 10 g (contains 100 mg of testosterone; 10 mg systemically absorbed); Androgel 1.62% — 40.5 mg of testosterone (2 pump actuations) applied once daily (morning preferable); dose may be adjusted down to a minimum of 20.25 mg or up to a maximum of 81 mg of testosterone, if needed (dose based on serum testosterone levels)Fortesta — 40 mg of testosterone (4 pump actuations) applied once daily (morning preferable); dose may be adjusted down to a minimum of 10 mg or up to a maximum of 70 mg of testosterone, if needed (dose based on serum testosterone levels); Vogelxo — 50 mg of testosterone (1 tube, 1 packet, or 4 pump actuations) applied once daily; dose may be adjusted up to a maximum of 100 mg of testosterone, if needed (dose based on serum testosterone levels).
• Intranasal (Adults): 1 actuation (5.5 mg) in each nostril 3 times daily.

Androgel, Fortesta, Natesto, Testim, Vogelxo

• 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.

Therapeutic Classification: hormones

Pharmacologic Classification: androgens

Absorption: Skin serves as reservoir for sustained release of testosterone into systemic circulation; 10% absorbed into systemic circulation during 24–hr period. Well absorbed through nasal mucosa.

Distribution: Crosses the placenta.

Protein Binding: 98%.

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

Half-life: 10–100 min.

Schedule III (C-III)

(androgenic effects†)

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

• Advise patient to report the following signs and symptoms promptly: priapism (sustained and often painful erections), difficulty urinating, breathing problems, gynecomastia, edema (unexpected weight gain, swelling of feet), hepatitis (yellowing of skin or eyes and abdominal pain), or unusual bleeding or bruising.
• 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 notify health care professional if their female sexual partner develops signs/symptoms of virilization (e.g. change in body hair distribution, significant increase in acne, deepening of voice, menstrual irregularities).
• Advise diabetic patients to monitor blood closely for alterations in blood glucose concentrations.
• Emphasize the importance of regular follow-up physical exams and lab tests to monitor progress.
• Topical: Gel:Instruct patient to apply gel to clean, dry, intact skin. Gel should not be applied to the genital area.
  • Advise patient to avoid showering or swimming for at least 5–6 hr (2 hr Vogelxo) after applying the gel.
  • Instruct patient using Androgel or Vogelxo multi-dose pump or Fortesta to prime pump before using it for first time by completely depressing the pump three times (Androgel or Vogelxo) or 8 times (Fortesta) and then discarding the dispensed gel. Each depression of the multi-dose pump delivers 1.25 g of product.
  • Advise patient to wash their hands immediately after applying the gel. Instruct patient to wear clothing over the application site once the gel has dried to minimize the transfer of testosterone to other people, especially children. If somebody else's skin comes into contact with gel, advise them to wash the affected skin surface thoroughly with soap and water.
  • Advise patient to avoid fire, flame, or smoking until gel has dried since gel contains alcohol and is flammable.
• Intranasal: Advise patient to notify health care professional if nasal signs or symptoms (nasopharyngitis, rhinorrhea, epistaxis, nasal discomfort, nasal scabbing) occur.

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NDC Code^*

• 0051- AbbVie Inc.
  • 0051-8425- Androgel
    • 0051-8425-30- 30 PACKET in 1 CARTON (0051-8425-30) > 2.5 g in 1 PACKET (0051-8425-01)

• 0051- AbbVie Inc.
  • 0051-8450- Androgel
    • 0051-8450-30- 30 PACKET in 1 CARTON (0051-8450-30) > 5 g in 1 PACKET (0051-8450-01)

• 0051- AbbVie Inc.
  • 0051-8462- Androgel
    • 0051-8462-30- 30 PACKET in 1 CARTON (0051-8462-30) > 2.5 g in 1 PACKET (0051-8462-01)

• 0051- AbbVie Inc.
  • 0051-8462- Androgel
    • 0051-8462-31- 30 PACKET in 1 CARTON (0051-8462-31) > 1.25 g in 1 PACKET (0051-8462-12)

• 0051- AbbVie Inc.
  • 0051-8462- Androgel
    • 0051-8462-33- 1 BOTTLE, PUMP in 1 CARTON (0051-8462-33) > 88 g in 1 BOTTLE, PUMP