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Natesto Direct

Looking for discrete, confidential delivery to your home or doctor’s office? Simply ask your doctor about NATESTODirect.

Through NATESTODirect, you can get:

  • Reimbursement counseling to minimize out-of-pocket expenses
  • Confidential delivery to your home or doctor’s office
  • Medication refill reminders
  • Side effect management and condition-specific educational support
  • Programs to help you take medications as prescribed

QualitySpecialtyPharmacy.com

Have your doctor contact:
PHONE: 844.460.0608
FAX: 844.772.1288
EMAIL: Natesto@qsprx.com
NATESTODirect
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FREQUENTLY ASKED QUESTIONS

Hypogonadism is a term used to describe low testosterone in men. It occurs when the male testes are unable to produce sufficient testosterone (the male sex hormone). Testosterone is made by the testes and is regulated in the brain by the hypothalamus and the pituitary gland. The testosterone hormone plays a key role in masculine growth and development of the male sex organs and maintenance of other physical characteristics of men.

Natesto is a prescription medicine, in the form of a nasal gel 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 to check for testosterone deficiency and while you are using Natesto.

Natesto is the first and only FDA-approved intranasal testosterone replacement therapy. Other medicines used to treat testosterone efficiency come in the form of testosterone injection, skin patch, and skin gel. By contrast, Natesto is a topical gel applied in the nose, and is not required by the FDA to display a “Black Box Warning.”

The FDA requires prescription drugs like testosterone patches and gels to display a Black Box Warning on the prescription drug’s label. This is because the drugs can cause users to experience serious side effects and adverse reactions that may lead to disability, hospitalization, or death. This warning is designed to call attention to serious or life-threatening risks. Click here to download “A Guide To Drug Safety Terms at FDA.”

A topical treatment is applied externally on the body where it can be absorbed by the skin or mucous membranes.

With its high vascularity, the nose offers an effective route of drug delivery due to its rapid absorption into the bloodstream.

Natesto takes about 10 seconds to apply.

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)

Natesto may be applied 3 times a day, allowing for a flexible dosing schedule.

  • 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

Unlike other testosterone replacement therapy (TRT) medicines, Natesto is a fast-acting medicine that creates rapid peaks and troughs within the normal range throughout the day. Instead of being constantly in your bloodstream, which can slow down your natural production of testosterone, Natesto® delivers rapid absorption into the bloodstream through the nose.

In a clinical trial, 90% of men using Natesto 3 times daily had testosterone levels within normal range at Day 90.

Natesto may improve mood, erectile function, and energy.2

Natesto has a favorable safety profile and is not required by the FDA to display a “Black Box Warning”.

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
  • 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

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
Frequently Asked Questions
*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 that $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 pay 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). Englewood, CO: Aytu BioScience, Inc; 2016.
2. 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) on file at the offices of Aytu BioScience, Inc. Claims associated with b.i.d. administration have not been evaluated by FDA.
3. NATESTO® (Prescribing Information). Aytu Bioscience, Inc. Englewood, CO 12/2017.

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.