Natesto

Testosterone is a naturally occurring male hormone necessary for many processes in the body.

Testosterone nasal (for use in the nose) is used to treat conditions in men that result from a lack of natural testosterone.

Testosterone nasal may also be used for purposes not listed in this medication guide.

You should not use this medicine if you have prostate cancer or male breast cancer.

Testosterone nasal should not be used by a woman. Testosterone can cause birth defects in an unborn baby.

You should not use this medicine if you are allergic to testosterone nasal gel, or if you have:

• prostate cancer; or
• male breast cancer.

To make sure testosterone nasal is safe for you, tell your doctor if you have:

• a history of problems with your sinuses or nasal passages;
• a history of surgery on your nose or sinuses;
• a broken nose (now or within the past 6 months);
• a deviated septum (crooked nose);
• breast cancer, prostate cancer;
• enlarged prostate, urination problems;
• sleep apnea (breathing stops during sleep);
• heart disease, history of heart attack or stroke;
• a history of blood clots; or
• liver disease or kidney disease.

Older men who use testosterone nasal may have an increased risk of prostate enlargement. If you are over 65, talk with your doctor about your specific risk.

This medicine should not be used by a woman. Testosterone can cause birth defects in an unborn baby. A pregnant woman should avoid coming into contact with testosterone nasal gel. If contact does occur, wash with soap and water right away.

Testosterone nasal is not approved for use by anyone younger than 18 years old.

Included as part of the PRECAUTIONS section.

Testosterone is a prescription medication used to treat low testosterone levels (hypogonadism) in men who do not produce enough natural testosterone. It may also be used to treat delayed puberty in adolescent males. Testosterone may also be administered to women to treat certain types of cancer.

Testosterone is a hormone that is usually produced by the body. It controls the growth, development, and function of male sexual organs and characteristics.

This medication comes in several topical forms for the skin, nose, and mouth that are applied to the body one to three times daily, depending on the dosage form.

This medication is also available in an injectable form to be given directly into a muscle (IM) by a healthcare professional.

Common side effects of testosterone include irritation and redness at the site of application, headache, acne, stomach pain, nervousness, hair loss, changes in mood and behavior, and changes in the ability to taste or smell.

Serious side effects have been reported with testosterone. See the “Testosterone Precautions” section.

Topical:

Common side effects of topical testosterone include the following:

• Breast enlargement
• Decreased sexual desire
• Acne
• Hair loss
• Hot flashes
• Depression
• Changes in mood
• Nervousness
• Headache
• Weakness
• Insomnia
• Dry skin
• Changes in the ability to taste or smell
• Skin irritation at the site of application

Injectable:

Common side effects of injectable testosterone include the following:

• Nausea and vomiting
• Changes in skin color
• Ankle swelling
• Increased calcium levels in the blood
• Enlarged breasts
• Enlarged prostate in men
• Deepening of the voice, the appearance of facial hair, and acne in women

This is not a complete list of testosterone side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Serious side effects have been reported with topical testosterone including the following:

• Swelling of the hands, feet, ankles, and lower legs
• Breathing problems, especially during sleep
• Excessive frequency or duration of penile erections in males
• Difficulty urinating or changes in urination habits
• Changes in skin color
• Liver dysfunction or liver cancer

Serious side effects have been reported with injectable testosterone including the following:

• Virilization in women, which includes amenorrhea or menstrual irregularities, deepening of the voice, clitoral enlargement
• Sexual changes or dysfunction in males, which includes breast enlargement and excessive frequency or duration of penile erections

Do not take testosterone if you:

• are allergic to testosterone or to any of its ingredients
• are a male with breast or prostate cancer
• are a woman who is or may become pregnant

Before taking testosterone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to testosterone or to any of its ingredients
• have or have had prostate cancer or an enlarged prostate
• have or have had breast cancer
• have sleep apnea
• have heart problems
• have diabetes
• have kidney disease
• have lung disease
• have liver disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if testosterone crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using testosterone.

Testosterone is a naturally occurring male hormone necessary for many processes in the body.

Testosterone nasal (for use in the nose) is used to treat conditions in men that result from a lack of natural testosterone.

Testosterone will not enhance athletic performance and should not be used for that purpose.

Testosterone nasal may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label. Never use testosterone nasal in larger amounts, or for longer than prescribed.

Misuse of testosterone can cause dangerous or irreversible effects, such as enlarged breasts, small testicles, infertility, high blood pressure, heart attack, stroke, liver disease, bone growth problems, addiction, and mental effects such as aggression and violence.

Do not share this medicine with another person.

Do not take by mouth or use on the skin. Testosterone nasal is for use only in the nose.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Blow your nose gently before using testosterone nasal gel.

Wash with soap and water if the gel gets on your hands or skin while using it.

While using testosterone nasal, you may need frequent blood tests.

Use testosterone nasal regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not share this medicine with another person.

Store at room temperature away from moisture and heat.

Your doctor will test the testosterone levels in your blood before you start and while you are using this medicine.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.

To use:

• If you are using this medicine for the first time, you will need to prime the pump. To do this, hold the Natesto® pump over a sink, turn it upside down, and slowly press the pump for 10 times.
• If any medicine comes out during priming, discard it into the sink and rinse down the drain with warm water.
• Wipe the tip with a clean, dry tissue if there is any medicine left on the tip of the pump. Now it is ready to use.
• If you get the medicine on your hands, wash it away with warm water and soap.
• Gently blow your nose to clear the nostrils.
• While looking in the mirror, insert the tip of the pump into your left nostril and gently tilt it so that it touches the side wall of your nostrils to ensure it is applied properly.
• Slowly press the pump until it stops and remove the tip slowly from your nose.
• Do the same steps applying the medicine into your right nostril.
• After using the pump, wipe the tip with a clean, dry tissue and put the cap back on.
• Press your nostrils together just below the middle of your nose and lightly rub them together.
• Do not blow your nose or sniff 1 hour after using this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nasal dosage form (gel):
  • For hormone replacement:
    • Adults—11 milligrams (mg), or 1 pump actuation in each nostril, 3 times a day (once in the morning, once in the afternoon, and once in the evening, about 6 to 8 hours apart).
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the medicine in a safe place. Do not give it to anyone else, even if you have the same symptoms.

• It is used to treat low testosterone levels.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Pimples (acne).
• Loose stools (diarrhea).
• Emotional ups and downs.
• Change in sex interest.
• Change in sex ability.
• Feeling tired or weak.
• Not able to sleep.
• Irritation where Natesto is used.
• Cough.
• Throat irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.