Dosing & Uses
Dosage Forms & Strengths
tablet, buccal: Schedule III
- 30mg
Testosterone Replacement Therapy
Primary hypogonadism (congenital or acquired): Testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter Syndrome, chemotherapy, or toxic damage from alcohol or heavy metals; these men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above 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
1 buccal system (30 mg) to gum region q12hr; place above incisor on alternate sides of mouth
Dosing Considerations
Prior to initiating therapy, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least 2 separate days and that these serum testosterone concentrations are below the normal range
Limitations of use
- Safety and efficacy of testosterone in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established
- Safety and efficacy of testosterone in males aged <18 years have not been established
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
1-10%
Gum or mouth irritation
Abnormal taste
Gum pain or tenderness
Gum edema
Headache
Postmarketing Reports
Vascular Disorders: Venous thromboembolism
Myocardial infarction, stroke
Warnings
Contraindications
Male breast or prostate cancer
Hypersensitivity to ingredients, including soy
Women who are breast feeding, may become pregnant or are pregnant
Cautions
Edema with or without congestive heart failure, may be a complication in patients with pre-existing cardiac, renal, or hepatic disease
Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids; anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions
Potential for gynecomastia
Risk of sleep apnea in susceptible patients
Increase risk of BPH and prostate cancer in elderly; monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH
Increased hematocrit (polycythemia), reflective of increased red blood cell mass, may require discontinuation; increases risk for thromboemolism; monitor serum testosterone, prostate specific antigen (PSA), liver function, lipid concentrations, hematocrit and hemoglobin periodically
Skin burns reported at application site in patients wearing an aluminized transdermal system during a magnetic resonance imaging scan (MRI); because transdermal testosterone patch contains aluminum, it is recommended to remove system before undergoing MRI
Venous thromboembolism, including DVT and PE reported in patients using testosterone products; these observations have included patients with and without polycythemia; evaluate signs or symptoms consistent with DVT or PE; if venous thromboembolic event suspected, discontinue treatment with testosterone and initiate appropriate workup and management
Cardiovascular risks
- Some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with the use of testosterone replacement therapy
- January 31, 2014: The FDA is investigating the risk of stroke, MI, and death in men taking prescription testosterone drugs
- The investigationwas prompted by findings from 2 studies that suggest an increased risk of MI in men who take testosterone
- PLOS ONE (Jan 29, 2014): Analysis of men with a history of MI (N=55,593)showed men >65 yr had a 2-fold increase in the risk of MI within 90 days of filling an initial prescription for a testosterone drug; among younger men (<65 yr) with a history of heart disease, there was a 2- to 3-fold increased risk of MI
- The PLOS ONE study confirmed results of a much smaller study (JAMA November 6, 2013) which found that older men, many with underlying heart disease, had a 30% increased chance of death, MI, and stroke after taking testosterone therapy
Pregnancy & Lactation
Pregnancy Category: X
Lactation: Contraindicated
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Androgen that promotes the growth and development of male sex organs and maintains secondary sex characteristics in androgen deficient males.
Pharmacokinetics
Peak plasma time: 10-12 hr
Half-Life: 10-100 min
Protein binding: 98%
Concentration: 520-550 ng/dL
Excretion: Urine (90%); feces (6%)
Absorption: 10% of applied dose
Metabolism: Liver
Metabolites: Estradiol, dihydrotestosterone
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Formulary
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