Natesto delivers
testosterone differently.1

Symptom relief through a different pharmacokinetic profile1

90% of men were in therapeutic range at day 901

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The numbers behind NATESTO

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Patients surveyed about NATESTO

  • 80% of patients were confident using NATESTO within 2 days
  • 70% of patients said they would switch to NATESTO
In a survey of a subset of men from the Phase 3 Trial taking NATESTO TID (n=66)5 TID=3 times daily
patient-icon-quick-transferrance

NATESTO minimizes the concern about transference in Low T treatment

  • Levels of testosterone have been shown to increase in female partners of topical testosterone users under certain conditions6
  • Patients and their families have expressed concern about the unintentional transfer of TRT

NATESTO has a favorable safety profile

Adverse Reactions Reported by ≥3% of Patients Treated with NATESTO (11 mg of testosterone) Three Times Daily in the 90-Day Clinical Study1

How to prescribe NATESTO

Prescribing a 30-day supply of NATESTO is easy
and convenient for your patients.

Connect your patients to copay savings* and prior authorization assistance

Eligible patients pay as low as $10 copay for up to 12 refills

To help make NATESTO more affordable for your patients, we’ve created the NATESTO Savings Program. Patients can easily activate their copay card on the Natesto.com ‘Patient’ website.

Natesto Savings Card

*On each valid NATESTO prescription or refill, pay as low as $10 copay on all prescriptions (minimum of 2 dispensers with a maximum of 3 dispensers per Rx), maximum benefits apply per use, for up to 12 refills. Cash paying patients pay no more than $199 (3 dispensers), max benefits apply per use, for up to 12 refills.

natesto-direct-prior-authorization-support

For prior authorization support, please call 1-833-NATESTO (1-833-628-3786), or simply Click Here for more information about NATESTODIRECT. To get started, download the NATESTODIRECT Enrollment Form by clicking below.

It’s time to treat Low T differently

  • 90% of men were within therapeutic range at day 901
  • Symptom relief is achievable with NATESTO1
  • Rapid absorption and high bioavailability through the nasal membranes2,3
  • Application in seconds
  • Minimizes the risk of unintentionally transferring testosterone to others6
  • Favorable safety profile
  • NATESTODIRECT offers Prior Authorization assistance, copay savings* and a dispensing pharmacy

Get started today with 1-833-NATESTO (628-3786)

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, pay as low as $10 copay on all prescriptions (minimum of 2 dispensers with a maximum of 3 dispensers per Rx), maximum benefits apply per use, for up to 12 refills. Cash paying patients pay no more than $199 (3 dispensers), max benefits apply per use, for up to 12 refills. To access the Cash benefit please call 1.833.NATESTO (628.3786). Patient is responsible for any remaining balance, 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 the USA and void where prohibited by law, taxed, or restricted. Aytu BioScience reserves the right to rescind, revoke, or amend this offer without notice. Card is limited to one per person, is not transferrable and cannot be reproduced.

REFERENCES
1. NATESTO® (Prescribing Information). Aytu Bioscience, Inc. Englewood, CO 12/2017.
2. Pires A, Fortuna A, Alves G, Falcão A. Intranasal drug delivery: how, why and what for? J Pharm Sci. 2009;12(3):288-311.
3. Bitter C, Suter-Zimmermann K, Surber C. Nasal drug delivery in humans. Curr Probl Dermatol. 2011;40:20-35.
4. Schoenfeld MJ, Shortridge E, Cui Z, Muram D, Medication adherence and treatment patterns for hypogonadal patients treated with topical testosterone therapy: a retrospective medical claims analysis. J Sex Med. 2013 May;10(5):1401-9. doi: 10.1111/ jsm.12114. Epub 2013 Mar 6.
5. Patient Market Research. Post-Phase III trial survey results. January 2014.
6. de Ronde W. Hyperandrogenism after transfer of topical gel: case report and review of published and unpublished studies. Hum Reprod. 2009;24(2):425-428.
7. Data on file, DOF-NT-02. Aytu BioScience, Inc. 2017.
8. Data on file, DOF-NT-04. Aytu BioScience, Inc. 2017.
9. Clinical Study Report TBS-1-2011-03. NATESTO®, a novel testosterone nasal gel, normalizes androgen levels in hypogonadal men. Trimel Biopharma SRL. May 28, 2013 (Final 2.0).
10. Lipshultz L, Westfield G, Guidry M, Bryson N, Khera M. Clinical Improvements in Erectile Function and Mood in Hypogonadal Men Treated with 4.5% Nasal Testosterone Gel. Presented at the American Urological Association 2017.
11. Conners W, Morgentaler A, Guidry M, Westfield G, Bryson N, Goldstein I. Preservation of Normal Concentrations of Pituitary Gonadotropins Despite Achievement of Normal Serum Testosterone Levels in Hypogonadal Men treated With a 4.5% Nasal Testosterone Gel. Presented at the American Urological Association 2017.
12. Rogol A, Guidry M, Bryson N, Westfield G, Dobs A, Intranasal Testosterone Therapy (TTh) Produces Normal, Not High, Estradiol (E2) And Dihydrotestosterone (DHT) Levels In Hypogonadal Men. Presented at the 2018 Endocrine Society Conference (ENDO).
13. Guidry M, Westfield G, Rogol A, Bryson N. One-Year Hematologic Safety of Natesto® (Testosterone) Nasal Gel In Men with Hypogonadism. Presented at ENDO Expo 2017.

INDICATION

What is NATESTO® (testosterone) Nasal Gel?

NATESTO is a prescription medicine that contains testosterone and is used to treat adult males who have low or no testosterone due to certain medical conditions. Your doctor will test the testosterone level in your blood before you start and while you are using NATESTO.

INDICATION

What is NATESTO® (testosterone) Nasal Gel?

NATESTO is a prescription medicine that contains testosterone and is used to treat adult males who have low or no testosterone due to certain medical conditions. Your doctor will test the testosterone level in your blood before you start and while you are using NATESTO.

NATESTO should not be used by men with breast cancer or known or suspected prostate cancer. NATESTO should not be used by women.

It is not known if NATESTO is safe or effective to treat men who have low testosterone due to aging.

Safety and effectiveness of NATESTO have not been established in children younger than 18 years old and NATESTO should not be used by children. NATESTO use by children may affect bone growth.

NATESTO is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your NATESTO in a safe place to protect it. Never give your NATESTO to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.

Important Safety Information

Who should not use NATESTO?

Do not use NATESTO if you:

  • Are a man who has breast cancer
  • Have or might have prostate cancer
  • Are pregnant or may become pregnant or are breastfeeding. NATESTO may harm your unborn or breastfeeding baby.
  • Talk to your doctor before using NATESTO if you have any of the above conditions.

What should I tell my doctor before using NATESTO? 

Before using NATESTO, tell your doctor about all of your medical conditions, including if you:

  • Have or have had nose (nasal) or sinus problems or nasal or sinus surgery
  • Have had a broken nose (fracture) within the past 6 months
  • Have or have had a fracture of your nose that caused the inside of your nose to be crooked (deviated anterior nasal septum)
  • Have or have had problems with swelling of the lining of your nose (mucosal inflammatory disorder)
  • Have breast cancer
  • Have or might have prostate cancer
  • Have urinary problems due to an enlarged prostate
  • Have heart problems
  • Have liver or kidney problems
  • Have problems breathing while you sleep (sleep apnea)

Tell your doctor about all the medicines you take, including prescription and over‐the‐counter medicines, vitamins, or herbal supplements.

Using NATESTO  with certain other medicines can affect each other. Especially tell your doctor if you take:

  • Insulin
  • Medicines that decrease blood clotting
  • Corticosteroids

How should I use NATESTO?

  • Use NATESTO exactly as your doctor tells you to. Your doctor will tell you how much NATESTO to use and when to use it.
  • NATESTO is for use in your nose (intranasally) only.
  • NATESTO can be used with a type of nasal spray called sympathomimetic decongestants such as oxymetazoline. NATESTO should not be used with other nasal sprays. It is not known if NATESTO is safe and effective when used with other nasal sprays.

What are the possible side effects of NATESTO?

NATESTO may cause serious side effects, including:

  • Nose (nasal) problems. Signs and symptoms of nasal problems may include runny nose, congestion, sneezing, nosebleed, nasal discomfort, nasal scabbing, or nasal dryness.
  • If you already have enlargement of your prostate gland, your signs and symptoms can get worse while using NATESTO. This can include: increased urination at night, trouble starting your urine stream, having to pass urine many times during the day, having an urge that you have to go to the bathroom right away, having a urine accident, and being unable to pass urine or weak urine flow.
  • Possible increased risk of prostate cancer. Your doctor should check you for prostate cancer or any other prostate problems before you start and while you use NATESTO.
  • Changes in red blood cells.
  • Blood clots in your legs or lungs. Signs and symptoms of a blood clot in your legs can include leg pain, swelling, or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
  • Possible increased risk of heart attack or stroke.
  • In large doses, NATESTO may lower your sperm count.
  • Possible increased risk of liver problems. Signs and symptoms of liver problems may include: nausea or vomiting, yellowing of your skin or whites of your eyes, dark urine, or pain on the right side of your stomach area (abdominal pain).
  • Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney, or liver disease.
  • Enlarged or painful breasts.
  • Problems breathing while you sleep (sleep apnea).

Call your doctor right away if you have any of the serious side effects listed above.

The most common side effects of NATESTO include:

  • Increased prostate specific antigen (a test used to screen for prostate cancer)
  • Headache
  • Runny nose
  • Nosebleeds
  • Nose pain
  • Sore throat, cough
  • Upper respiratory infection
  • Sinus infection
  • Nose scabs

Other side effects include more erections than normal for you or erections that last for a long time.

These are not all the possible side effects of NATESTO. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, please see Full Prescribing Information and Patient Information.