Download Natesto Safety Data Sheet (SDS)
NATESTO® (testosterone) Nasal Gel is an androgen indicated for replacement therapy in adult 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’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH] and luteinizing hormone [LH]) above the 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 serum testosterone concentrations but have gonadotropins in the normal or low range.
Limitations of use:
- Safety and efficacy of NATESTO® in men with “age-related hypogonadism” have not been established.
- Safety and efficacy of NATESTO® in males <18 years old have not been established.
IMPORTANT SAFETY INFORMATION
- NATESTO® is contraindicated in men with carcinoma of the breast or known or suspected prostate cancer and in women who are, or may become, pregnant or who are breastfeeding. NATESTO® may cause fetal harm when administered to a pregnant woman and serious adverse reactions in nursing infants.
- Nasal adverse reactions, including nasopharyngitis, rhinorrhea, epistaxis, nasal discomfort, and nasal scabbing, were reported in the clinical trial experience with NATESTO®. Patients should be instructed to report any nasal symptoms or signs to their healthcare professional. In that circumstance, healthcare professionals should determine whether further evaluation or discontinuation of NATESTO® is appropriate.
- Due to lack of clinical data on safety or efficacy in the following patient populations, NATESTO® is not recommended for use in patients with a history of nasal disorders, nasal or sinus surgery, nasal fracture within the previous 6 months or nasal fracture that caused a deviated anterior nasal septum, mucosal inflammatory disorders (e.g., Sjogren’s syndrome), and sinus disease.
- Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. Patients treated with androgens may be at increased risk for prostate cancer. Evaluation of patients for prostate cancer prior to initiating and during treatment with androgens is recommended.
- Increases in hematocrit, reflective of increases in red blood cell mass, may require discontinuation of NATESTO®.
- Venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone products. Patients with signs and symptoms consistent with DVT or PE need evaluation and may require discontinuation of treatment with NATESTO®.
- Long-term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of the possible risk when deciding whether to use or to continue to use NATESTO®.
- Due to lack of controlled studies in women and potential virilizing effects, NATESTO® is not indicated for use in women.
- Serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice) have been associated with prolonged use of high doses of oral methyltestosterone. NATESTO® is not known to cause these adverse effects. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). If these occur, promptly discontinue NATESTO® while the cause is evaluated.
- Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease.
- Administration of exogenous androgens, including NATESTO®, may lead to azoospermia through suppression of spermatogenesis; gynecomastia; sleep apnea (especially in patients with risk factors such as obesity and chronic lung disease); decreased concentrations of thyroxine-binding globulins; and changes in serum lipid profile.
- NATESTO® should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria).
- Periodic monitoring of prostate specific antigen (PSA), hematocrit, and lipid concentrations is recommended, as changes may require discontinuation of NATESTO®.
- The most common adverse reactions reported by ≥3% of patients were: PSA increased, headache, rhinorrhea, epistaxis, nasal discomfort, nasopharyngitis, bronchitis, upper respiratory tract infection (URI), sinusitis, and/or nasal scab.
- Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens and may necessitate a decrease in the dose of anti-diabetic medication. Changes in anticoagulant activity may be seen with androgens. The concurrent use of testosterone with corticosteroids may result in increased fluid retention and requires monitoring particularly in patients with cardiac, renal, or hepatic disease.
Please see full Prescribing Information.