testosterone gel

(redirected from Fortesta)
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testosterone gel

(tess-toss-te-rone jel) ,

Androgel

(trade name),

Fortesta

(trade name),

Testim

(trade name)

Classification

Therapeutic: hormones
Pharmacologic: androgens
Pregnancy Category: X

Indications

Hypogonadism in androgen-deficient men.

Action

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.

Therapeutic effects

Correction of hormone deficiency in male hypogonadism.

Pharmacokinetics

Absorption: Skin serves as reservoir for sustained release of testosterone into systemic circulation; 10% absorbed into systemic circulation during 24–hr period.
Distribution: Crosses the placenta.
Protein Binding: 98%.
Metabolism and Excretion: Metabolized by the liver; 90% eliminated in urine as metabolites.
Half-life: 10–100 min.

Time/action profile (androgenic effects†)

ROUTEONSETPEAKDURATION
Transdermal (gel)30 minunknown24 hr
†Response is highly variable among individuals; may take months

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Obstetric / 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; Geriatric: ↑ risk of prostatic hyperplasia/carcinoma; Pediatric: Males <18 yr (safety and effectiveness not established).

Adverse Reactions/Side Effects

Cardiovascular

  • edema
  • hot flashes
  • hypertension

Gastrointestinal

  • ↑ liver enzymes
  • nausea
  • vomiting

Genitourinary

  • nocturia
  • priapism
  • prostatic enlargement
  • urinary hesitancy
  • urinary incontinence

Endocrinologic

  • acne
  • breast pain
  • change in libido
  • gynecomastia
  • hypercholesterolemia

Dermatologic

  • alopecia
  • dry skin
  • pruritis

Hematologic

  • anemia
  • polycythemia

Local

  • chronic skin irritation

Interactions

Drug-Drug interaction

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

Route/Dosage

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).

Availability (generic available)

1% gel (Androgel): 2.5-g unit-dose packets in boxes of 30, 5-g unit-dose packets in boxes of 30, 75–g metered dose pump (each pump dispenses 60 metered 1.25–g doses)
1% gel (Testim): 5-g unit-dose tubes in boxes of 30
1.62% gel (Androgel): Metered dose pump (each pump dispenses 120 metered 10–mg doses)
Gel (Fortesta): 60–g metered dose pump (each pump dispenses 60 metered 20.25–mg doses)

Nursing implications

Nursing assessment

  • Monitor intake and output ratios, weigh patient twice weekly, and assess patient for edema. Report significant changes indicative of fluid retention.
  • Monitor for breast enlargement, persistent erections, and increased urge to urinate in men. Monitor for difficulty urinating in elderly men, because prostate enlargement may occur.
  • Lab Test Considerations: Monitor hemoglobin and hematocrit periodically during therapy; may cause polycythemia.
    • Monitor hepatic function tests, prostate specific antigen, and serum cholesterol levels periodically during therapy. May ↑ serum AST, ALT, and bilirubin, ↑ cholesterol levels, and suppress clotting factors II, V, VII, and X.
    • Monitor blood glucose closely in patients with diabetes who are receiving oral hypoglycemic agents or insulin.
    • Monitor serum testosterone concentrations 14 days after starting therapy.

Potential Nursing Diagnoses

Sexual dysfunction (Indications,  Side Effects)

Implementation

  • Apply gel once daily, preferably in the morning, to clean dry intact skin of shoulders and upper arms (Androgel™ and Testim™) or abdomen (Androgel™ only) or front or inner thighs (Fortesta™). Gel should not be applied to scrotum (5–30x more permeable than other sites). Refer to the chart on the pump label to determine how many full pump depressions are required for the daily prescribed dose.
    • The dose of Fortesta™ should be titrated based on the serum testosterone concentration from a single blood draw 2 hours after applying Fortesta™ and at approximately 14 days and 35 days after starting treatment or following dose adjustment.

Patient/Family Teaching

  • 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 after applying the gel.
  • Instruct patient using Androgel™ multi-dose pump or Fortesta™ to prime pump before using it for first time by completely depressing the pump three times (Androgel) 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.
  • 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.
    • 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.

Evaluation/Desired Outcomes

  • Resolution of the signs of androgen deficiency without side effects.
References in periodicals archive ?
In large doses FORTESTA Gel and Testosterone Gel may lower your sperm count
To lower the risk of transfer of FORTESTAGel or Testosterone Gel from your body to others, you should: Apply FORTESTA gel or Testosterone Gel only to the front and inside area of your thighs that will be covered by clothing and wash your hands right away with soap and water after applying FORTESTA Gel or Testosterone Gel.
62% II-29 Teva Pharmaceuticals Receives NDA Acceptance from FDA for Bio -T-Gel II-30 Endo Pharmaceuticals' Fortesta Gel Secures FDA Acceptance II-30 Acrux Receives US FDA Approval for Axiron Topical Solution II-30
Gergel was responsible for a number of late stage development programs and product approvals, including BEMA Buprenorphine, which is in Phase 3, Abuse-Deterrent Opana ER for chronic pain, and Fortesta and Aveed(TM) for hypogonadism.
Androgel, Androderm, Axirom, Bio-T-Gel, Delatestryl, Depo-Testosterone, Fortesta, Striant, Testim, Testopel
Ross Feller Casey has been contacted by other men nationwide who also have suffered severe cardiovascular events while on or shortly after taking testosterone replacement drugs, such as Testim, AndroGel, AndroDerm, Axiron and Fortesta.
AndroGel (AbbVie) II-12 Axiron (Acrux and Eli Lilly) II-12 Axiron - A Comparison with Other Products II-12 Eli Lilly to Turn Axiron into a Global TRT Brand II-13 Axiron's Patent Profile II-14 Testim (Auxilium) II-14 Table 7: Global Market of Testim by Geographic Region (2011 & 2012): Breakdown of Annual Value Sales in US$ Million for US and Rest of World Markets (includes corresponding Graph/Chart) II-14 Testim Scores High on Efficacy over AndroGel II-15 Small Packaging Works for Testim II-15 Androderm (Actavis) II-15 Fortesta (Endo Health Solutions) II-16 Tostran (Prostrakan Group) II-16 Testopel (Auxilium) II-16 Restandol (Organon) II-16 Striant (Auxilium) II-17 Testopel (Auxilium) II-17 Nebido (Bayer HealthCare Pharmaceuticals) II-17
Commonly used testosterone medications include Androgel, Depo-Testosterone, Axiron, Testim, Androderm, Fortesta, Delatestryl, Methiest, Testred, Android and Straint.
Chadds Ford PA) and ProStrakan Group Plc (Galashiels GBR) received marketing clearance for their Fortesta testosterone gel to treat men with low levels of the hormone.
25p after the speciality pharmaceutical company said that it has gained approval from the US Food and Drug Administration for Fortesta (testosterone) Gel, indicated for the treatment of male hypogonadism.
Bart is currently evaluating cases that involve some of the most commonly prescribed testosterone therapies such as Androgel, Androderm, Android 10, Axiron, Depo-Testosterone, Bio-T-Gel, Delatestryl, Fortesta, Striant, Testim and Testopel.