Natesto is 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], 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 testosterone serum concentrations but have gonadotropins in the normal or low range.
Limitations of use
- Safety and efficacy of Natesto in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
- Safety and efficacy of Natesto in males less than 18 years old have not been established [see Use In Specific Populations].
DOSAGE AND ADMINISTRATION
Prior to initiating Natesto, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.
The recommended dose of Natesto is 11 mg of testosterone (2 pump actuations; 1 actuation per nostril) administered intranasally three times daily for a total daily dose of 33 mg.
Serum total testosterone concentrations should be checked periodically, starting as soon as one month after initiating treatment with Natesto. When the total testosterone concentration consistently exceeds 1050 ng/dL, therapy with Natesto should be discontinued. If the total testosterone concentration is consistently below 300 ng/dL, an alternative treatment should be considered.
Natesto is administered intranasally three times daily once in the morning, once in the afternoon and once in the evening (6 to 8 hours apart), preferably at the same time each day. Patients should be instructed to completely depress the pump 1 time in each nostril to receive the total dose. Do not administer Natesto to other parts of the body.
Preparing the Pump
When using Natesto for the first time, patients should be instructed to prime the pump by inverting the pump, depressing the pump 10 times, and discarding any small amount of product dispensed directly into a sink and then washing the gel away thoroughly with warm water. The tip should be wiped with a clean, dry tissue. If the patient gets Natesto gel on their hands, it is recommended that they wash their hands with warm water and soap. This priming should be done only prior to the first use of each dispenser.
Administering the Dose
To administer the dose, patients should be instructed to perform the following steps:
- Blow the nose.
- Remove the cap from the dispenser.
- Place the right index finger on the pump of the actuator and while in front of a mirror, slowly advance the tip of the actuator into the left nostril upwards until their finger on the pump reaches the base of the nose.
- Tilt the actuator so that the opening on the tip of the actuator is in contact with the lateral wall of the nostril to ensure that the gel is applied to the nasal wall.
- Slowly depress the pump until it stops.
- Remove the actuator from the nose while wiping the tip along the inside of the lateral nostril wall to fully transfer the gel.
- Using your left index finger, repeat the steps outlined in bullets 3 through 6 for the right nostril.
- Use a clean, dry tissue to wipe the tip of the actuator.
- Replace the cap on the dispenser.
- Press on the nostrils at a point just below the bridge of the nose and lightly massage.
- Refrain from blowing the nose or sniffing for 1 hour after administration.
The dispenser should be replaced when the top of the piston inside the dispenser reaches the arrow at the top of the inside label. The inside label may be found by unwrapping the outer flap from around the container.
Use With Nasally Administered Drugs Other Than Sympathomimetic Decongestants
The drug interaction potential between Natesto and nasally administered drugs other than sympathomimetic decongestants is unknown. Therefore, Natesto is not recommended for use with nasally administered drugs other than sympathomimetic decongestants (e.g., oxymetazoline) [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
Temporary Discontinuation Of Use For Severe Rhinitis
If the patient experiences an episode of severe rhinitis, temporarily discontinue Natesto therapy pending resolution of the severe rhinitis symptoms. If the severe rhinitis symptoms persist, an alternative testosterone replacement therapy is recommended.
Dosage Forms And Strengths
Natesto is a slightly yellow gel for intranasal use and is available in a dispenser with a metered dose pump. One pump actuation delivers 5.5 mg of testosterone.
Storage And Handling
Natesto (testosterone) nasal gel is available as a metered dose pump containing 11 grams of gel dispensed as 60 metered pump actuations. One pump actuation delivers 5.5 mg of testosterone in 0.122 grams of gel.
Keep Natesto out of reach of children.
Store at 20°C to 25°C (68°F to 77°F). Excursions are permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.
Handling And Disposal
Used Natesto dispensers should be discarded in household trash in a manner that prevents accidental exposure of children or pets.
Marketed by: Endo Pharmaceuticals Inc., Malvern, PA 19355. Manufactured by: Haupt Pharma Amareg GmbH, Donaustaufer Str. 378, Regensburg, Bavaria D-93055, Germany. Approved: 05/2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/8/2015
Additional Natesto Information
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