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  • TRT in seconds…

    See how NATESTO®fits into yourpatient’s busy day

  • The first and only FDA-approved intranasal testosterone replacement therapy1

    Because it uses bioadhesive gel technology and is applied inside the nose, NATESTO® has a reduced risk of being unintentionally transferred to others.2
  • How can NATESTO® help your patients with Low T?

    90%

    of patients receiving NATESTO® achieved

    testosterone levels within the normal range1*

    • The most common adverse events were prostate specific antigen (PSA) increased, headache, rhinorrhea, epistaxis, nasal discomfort, nasopharyngitis, upper respiratory tract infection (URI), sinusitis, bronchitis and nasal scab1
  • Connect your patients to savings

    Eligible patients pay no more than $25 for up to 12 refills

    Patients can activate a copay card at Natesto.com

    On each valid NATESTO® prescription or refill (3 dispensers), maximum savings is $150 per use, up to 13 uses. Patient is responsible for any balance remaining.

HOW TO USE NATESTO®

Instruct your patients to apply NATESTO® correctly

APPLICATION STEPS

PRESCRIBING NATESTO®

Find out how to prescribe a 30 day supply of NATESTO®

HOW TO PRESCRIBE
*STUDY DESIGN

Results from a total of 78 hypogonadal men (morning testosterone ≤300 ng/dL) who received NATESTO® 11 mg 3 times daily (total daily dose: 33 mg) in a multicenter, open-label, 90-day clinical study (N=306). Of these, 73 hypogonadal men were included in the statistical evaluation of efficacy. The primary endpoint was the percentage of patients with an average serum total testosterone concentration (Cavg) within the normal range (300-1050 ng/dL) on Day 90.1

ELIGIBILITY AND RESTRICTIONS

On each valid NATESTO® prescription or refill, maximum savings is $150 per use, up to 13 uses. Patient is responsible for any balance remaining, and for reporting receipt of this coupon benefit to any insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the coupon, as may be required. Patient, pharmacist, and prescriber agree not to seek reimbursement for all or any part of the benefit received by the patient through this offer.

Offer only valid for male patients over age 18 who have private health insurance. Offer not valid for uninsured patients or for patients eligible for Medicaid, Medicare, TRICARE, Veterans Affairs or any other state or federal healthcare program (including state prescription drug programs). Offer good only in USA and void where prohibited by law, taxed, or restricted. Aytu Pharmaceuticals reserves the right to rescind, revoke, or amend this offer without notice. Card is limited to one per person, is not transferable, and cannot be reproduced. This card is not health insurance.

INDICATION

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.

More Safety Info
 

Download Natesto Safety Data Sheet (SDS)

INDICATION

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.

References

1.
NATESTO® (Prescribing Information). Englewood, CO: Aytu BioScience, Inc; 2016.
2.
Data on file, DOF-NT-01. Endo Pharmaceuticals, Inc; 2015.

Intended for U.S. Residents Only

Rx Only

NATESTO® is a trademark of Acerus Pharmaceuticals SRL.

Distributed by: Aytu BioScience, Inc.

Manufactured for: Aytu BioScience, Inc.

Manufactured by: Haupt Pharma Amareg GmbH, Donaustaufer Str. 378,

Regensburg, Bavaria D-93055, Germany

© 2016 Aytu BioScience, Inc. All Rights Reserved. Englewood CO 80112

INDICATION & IMPORTANT SAFETY INFORMATION

INDICATION

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:

INDICATION

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 for NATESTO®
  • 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, 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®
  • Some postmarketing studies have shown an increased risk of major adverse cardiovascular events (MACE) with use of testosterone replacement therapy. Patients should be informed of this possible risk when deciding 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 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.