Classes
DEA Class; Rx
Common Brand Names; Natesto
- Androgens
Description
Primary androgen in humans synthesized by testes, ovaries, and adrenal cortex; available in a variety of dosage forms
Primarily used in males with primary hypogonadism or with hypogonadism due to medical conditions; may be used for a limited duration for constitutional delay of puberty; used off-label in men with sexual dysfunction due to low testosterone associated with aging
Not recommended for low testosterone status alone due to aging due to potential risk for cardiovascular events and stroke
Indications
Indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
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 (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range
Hypogonadotropic hypogonadism (congenital or acquired): Idiopathic 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
Contraindications
Men with carcinoma of the breast
Men with known or suspected prostate cancer
Pregnant or breast-feeding women; testosterone may cause fetal harm
Adverse Effects
- Nasopharyngitis (8.2%)
- Rhinorrhea (7.8%)
- Epistaxis (6.5%)
- Nasal discomfort (5.9%)
- Increased PSA (5.1-5.8%)
- Nasal scab (5.2%)
- Parosmia (5.2%)
- Headache (3.8-4.3%)
- Upper respiratory tract infection (4.2%)
- Nasal dryness (4.2%)
- Nasal congestion (3.9%)
- Bronchitis (3.8%)
- Sinusitis (3.8%)
- ncreased blood pressure (2-3%)
- Dysgeusia (2-3%)
- Cough (2-3%)
Warnings
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
Nasal adverse reactions reported, including nasopharyngitis, rhinorrhea, epistaxis, nasal discomfort, and nasal scabbing
Monitor for nasal signs and symptoms; not recommended for patients with chronic nasal conditions or alterations in nasal anatomy (eg, nasal or sinus surgery, nasal fracture within previous 6 months, deviated anterior nasal septum, mucosal inflammatory disorders [Sjogren syndrome], sinus disease)
Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms
Increased hematocrit (polycythemia), reflective of increased red blood cell mass, may require discontinuation; increases risk for thromboemolism
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
Women and children should not use testosterone intranasal
Pregnancy and Lactation
Pregnancy Category: X
Lactation: Contraindicated; unknown if excreted into human breast milk
Maximum Dosage
Dependent on indication for therapy, as well as route of administration and specific product chosen for use.
Dependent on indication for therapy, as well as route of administration and specific product chosen for use.
Dependent on indication for therapy, as well as route of administration and specific product chosen for use.
Dependent on indication for therapy, as well as route of administration and specific product chosen for use.
Safety and efficacy have not been established.
How supplied
Testosterone
intranasal gel: Schedule III
- 5.5mg/actuation