TM Owner Acerus Pharmaceuticals
Natesto 5.5mg Nasal Gel
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Indications & Clinical Uses
- Natesto 5.5 mg nasal gel delivers testosterone, an androgen hormone, through an unusual route for testosterone products: it is applied inside the nose rather than to the skin, taken by mouth, or injected.
- Each pump actuation delivers 5.5 mg of testosterone, and the approved dose is 11 mg total (one actuation in each nostril) three times daily.
- It is approved in adult men for testosterone replacement therapy in primary hypogonadism (a testicular problem, congenital or acquired) and hypogonadotropic hypogonadism (a pituitary or hypothalamic problem), where the body does not make enough natural testosterone; it is not approved for age-related low testosterone or for use in anyone under 18.
- Natesto is marketed in Canada and other countries by its originator, Acerus Pharmaceuticals; in the United States it has also been marketed under licence by Aytu BioScience.
Side Effects
- Natesto has no boxed warning, but it is a Schedule III controlled substance because testosterone can be misused, typically at doses higher than prescribed, and patients should be counselled about this along with the psychiatric and cardiovascular effects of misuse.
- The most common side effects, each affecting 3% or more of users, include a rise in PSA (a prostate marker), headache, runny nose, nosebleed, nasal discomfort, nasal crusting or scabbing, sinus infection and upper respiratory infection, reflecting the intranasal route.
- Serious risks shared with other testosterone products include blood clots in the veins or lungs, worsening sleep apnoea, fluid retention that can worsen heart failure, increased red blood cell count, possible effects on prostate growth, and suppressed sperm production and fertility.
- Seek urgent care for chest pain, sudden leg swelling or pain, shortness of breath, or sudden weakness on one side.
- Blow your nose gently before each dose and avoid blowing it hard for a few minutes after.
Precautions & Warnings
- Natesto is contraindicated in men with breast cancer or known or suspected prostate cancer, and should not be used by anyone who has had a heart attack or unstable heart disease within the past six months.
- Because it raises blood pressure, it is not recommended for men with poorly controlled hypertension, and blood pressure should be monitored regularly during treatment.
- Testosterone levels should be checked about one month after starting Natesto and periodically thereafter, with the dose adjusted if levels are consistently too high or too low; PSA, red blood cell count (haematocrit) and lipids should also be monitored.
- Natesto is for intranasal use only and must not be swallowed, injected, or applied to the skin.
- It is not for use in women, and is not approved for use in patients under 18 years old.
- Sleep apnoea can worsen in men using testosterone, particularly in those who are obese or have chronic lung disease, and should be monitored.
Avoid Interactions
- Tell your healthcare provider about all medicines you use before starting Natesto, especially insulin or other diabetes medicines, since testosterone can lower blood glucose and doses may need adjusting.
- Natesto can increase the effect of warfarin and other oral anticoagulants, raising bleeding risk, so the international normalised ratio (INR) should be checked more often when starting or stopping Natesto.
- Corticosteroids used with Natesto increase the risk of fluid retention.
- Other nasal medicines are not recommended alongside Natesto except sympathomimetic decongestants, which have been shown not to meaningfully reduce testosterone absorption; avoid routinely using other nasal sprays, gels or drops at the same time without checking with your prescriber.
- Because Natesto is a controlled substance, tell your pharmacist about any history of substance misuse.
- Always confirm any new prescription, over-the-counter medicine or supplement with your healthcare provider or pharmacist.
References
Frequently Asked Questions
Natesto is a testosterone nasal gel used in adult men with low testosterone caused by primary or pituitary (hypogonadotropic) hypogonadism. Unlike most testosterone products, it's applied inside the nose, not on the skin or by injection. It's not approved for age-related low testosterone or for use under age 18.
Natesto is a nasal gel, applied with a pump: one actuation (5.5 mg) in each nostril, three times daily, spaced 6 to 8 hours apart. Blow your nose gently before dosing and avoid blowing it hard for a few minutes afterward. Don't inject, swallow, or apply it to skin.
The most common Natesto side effects are nasal: runny nose, nosebleeds, nasal discomfort and crusting, plus headache and a rise in PSA. Serious risks include blood clots, worsening sleep apnoea, fluid retention and reduced sperm production. Seek urgent help for chest pain, leg swelling or sudden weakness on one side.
Avoid using other nasal sprays or gels alongside Natesto, apart from decongestants your prescriber approves. Tell your provider if you take insulin, since testosterone can lower blood sugar, or warfarin, since Natesto can increase bleeding risk. Natesto is a Schedule III controlled substance with misuse potential.
Yes. Testosterone levels are checked about one month after starting Natesto and periodically afterward, with dose adjusted if levels run too high or low. PSA, red blood cell count and blood pressure are also monitored regularly, since testosterone therapy can affect the prostate, blood count and blood pressure.
Yes, Natesto can suppress the body's own testosterone and sperm production, so it may reduce fertility while you're using it; discuss this with your provider if planning to have children. It's used long-term for confirmed hypogonadism, with regular monitoring, rather than for short courses.
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