Natesto Generic Name & Formulations
Testosterone 5.5mg; per pump actuation; nasal gel.
Metered-dose pump—11g (60 actuations)
Testosterone replacement therapy in adult males with congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.
Limitations of Use
Not established in men with age-related hypogonadism.
Natesto Dosage and Administration
Prior to treatment, confirm diagnosis by ensuring serum testosterone is below normal range as measured in the AM on at least 2 separate days. Administer intranasally once in the morning, afternoon, and evening (6–8hrs apart) at same time each day. ≥18yrs: 11mg (1 pump per nostril) three times daily (total dose: 33mg daily); check serum testosterone levels periodically as soon as one month after initiation. If severe rhinitis occurs; temporarily discontinue until resolve; use alternative if symptoms persist.
<18yrs: not established.
Male breast or prostate cancer. Pregnancy (Cat.X). Nursing mothers.
Natesto Boxed Warnings
Not for use in women. History of nasal disorders, nasal or sinus surgery, nasal fracture within previous 6 months or one that caused a deviated anterior nasal septum, mucosal inflammatory disorders (eg, Sjogren’s syndrome), or sinus disease: not recommended. Increased risk for worsening BPH; monitor for signs/symptoms. Evaluate for prostate cancer before starting therapy, and 3–6 months after initiation. Monitor hematocrit prior to initiation, at 3–6 months after starting therapy, then annually; if elevation occurs, withhold until acceptable level. Preexisting cardiac, renal, or hepatic disease (discontinue if edema occurs). Discontinue and evaluate if signs/symptoms of hepatic dysfunction (eg, jaundice) occur. Possible sleep apnea in patients with obesity or chronic lung diseases. Testosterone and/or other anabolic androgenic steroid abuse. Monitor serum testosterone, PSA, liver function, cholesterol, lipid profile, serum calcium (in cancer patients at risk for hypercalcemia/hypercalciuria) periodically. Monitor for venous thromboembolism; discontinue if suspected. Inform patients of possible increased risk of MI, stroke. Consider alternative if total testosterone consistently <300ng/dL; discontinue if consistently >1050ng/dL. Monitor for nasal adverse reactions; discontinue if appropriate. Men with BMI >35kg/m2: not established. Elderly.
Concomitant intranasal drugs other than sympathomimetic decongestants (eg, oxymetazoline): not recommended. May alter insulin sensitivity and glycemic control; reduce dose of antidiabetic agents if needed. Monitor INR and PT with concomitant oral anticoagulants. Increased fluid retention with concomitant corticosteroids; monitor. May affect thyroid levels.
Natesto Adverse Reactions
PSA increased, headache, rhinorrhea, epistaxis, nasal discomfort, nasopharyngitis, bronchitis, upper RTI, sinusitis, nasal scab; azoospermia, gynecomastia.
Natesto Clinical Trials
Natesto Patient Counseling