Testosterone Nasal Gel

Testosterone nasal gel is used to treat symptoms of low testosterone in adult men who have hypogonadism (a condition in which the body does not produce enough natural testosterone). Testosterone nasal gel is used only for men with low testosterone levels caused by certain medical conditions, including disorders of the testicles, pituitary gland, (a small gland in the brain), or hypothalamus (a part of the brain) that cause hypogonadism. Your doctor will order certain lab tests to check your testosterone levels to see if they are low before you begin to use testosterone. Testosterone should not be used to treat the symptoms of low testosterone in men who have low testosterone due to aging ('age-related hypogonadism'). Testosterone is in a class of medications called androgenic hormones. Testosterone is a hormone produced by the body that contributes to the growth, development, and functioning of the male sexual organs and typical male characteristics. Testosterone works by replacing testosterone that is normally produced by the body.

Testosterone comes as a gel to apply to the inside of the nose using a dispenser pump. It is usually used three times a day in each nostril. To help you remember to apply testosterone nasal gel, apply it at about the same times each day and space your doses about 6 to 8 hours apart. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use testosterone nasal gel exactly as directed. Do not apply more or less of it or apply it more often than prescribed by your doctor.

If you have severe cold symptoms (sneezing, congestion, runny nose), tell your doctor. Your doctor may decide to stop your medication until you are better or change you to another medication.

Before you use testosterone nasal gel for the first time, read the written directions that come with it. To use the nasal gel, follow these steps:

1. Blow your nose to clear your nasal passages.
2. Remove the cap from the dispenser.
3. To prime the pump before the first use, hold the dispenser upside down over a sink. Slowly press down on the pump 10 times. Always discard the extra medication that comes out after priming the pump down the drain with warm water. Wipe the tip of the dispenser with a clean, dry tissue.
4. Look in a mirror and put your right first (index) finger on the pump and slowly insert the tip of the dispenser into your left nostril until your finger on the pump touches the bottom of your nose. Gently tilt the dispenser so that the hole in the tip touches the outside wall in your nostril. Slowly press down on the pump until it stops. Remove the tip of the dispenser from your nostril and repeat these steps in your right nostril, using your left first (index) finger on the pump.
5. Wipe the tip of the dispenser with a clean, dry tissue and put the cap back on the dispenser pump.
6. Press your nostrils together just below the middle of your nose and lightly rub your nostrils together.
7. Do not sniff or blow your nose for 1 hour after you apply testosterone nasal gel.
8. Wash your hands with soap and warm water right away if testosterone gel gets on your hands.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using testosterone nasal gel,

• tell your doctor and pharmacist if you are allergic to testosterone, any other medications, or any of the ingredients in testosterone nasal gel. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking while using testosterone nasal gel. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following nonprescription product may interact with testoterone nasal gel: oxymetazoline. Be sure to let your doctor and pharmacist know that you are taking this medication before you start using testosterone nasal gel. Do not start this medication while using testosterone nasal gel without discussing with your healthcare provider.
• tell your doctor if you have breast cancer or have or may have prostate cancer. Your doctor will probably tell you that you should not use testosterone nasal gel.
• tell your doctor if you have or ever had nasal problems (allergies, sinus problems, or polyps), nasal or sinus surgery, a broken nose that occurred within the last 6 months, a deviated nasal septum (crooked inside middle section of the nose) caused by a broken nose, urinary problems due to benign prostate hyperplasia (BPH; an enlarged prostate), high blood levels of calcium, sleep apnea (a sleep disorder that causes breathing to stop for short periods during sleep), diabetes, or lung, heart, kidney, or liver disease.
• you should know that testosterone nasal gel is only for use in adult men. Children, teenagers, and women should not use this medication. Testosterone may stop bone growth and cause precocious puberty (early puberty) in children and teenagers. Testosterone may cause deepening of voice, hair growth in unusual places, genital enlargement, decrease in breast size, male-pattern hair loss, and unusual menstrual cycles in women. If testosterone is used by a woman who is pregnant, may become pregnant or is breastfeeding, it may harm the baby.
• you should know that there have been reports of serious side effects in people who use testosterone at higher doses, along with other male sex hormone products, or in ways other than directed by a doctor. These side effects may include a heart attack, heart failure, or other heart problems; stroke and mini-stroke; liver disease; seizures; or mental health changes such as depression, mania (frenzied, abnormally excited mood), aggressive or unfriendly behavior, hallucinations (seeing things or hearing voices that do not exist), or delusions (having strange thoughts or beliefs that have no basis in reality). People who use higher doses of testosterone than recommended by a doctor may also experience withdrawal symptoms such as depression, extreme tiredness, craving, irritability, restlessness, loss of appetite, inability to fall asleep or stay asleep, or a decreased sex drive, if they suddenly stop using testosterone. Be sure to use testosterone nasal gel exactly as directed by your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra gel to make up for a missed dose.

Testosterone nasal gel may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• cough
• sinus pain
• changed sense of smell

Tell your doctor if any of these symptoms occur:

• runny nose
• dryness, discomfort, irritation, or scabbing in the nose
• nosebleed
• sneezing
• nasal congestion

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:

• lower leg pain, swelling, warmth, or redness
• shortness of breath
• chest pain
• difficulty breathing, especially at night
• nausea or vomiting
• swelling of the hands, feet, and ankles
• sudden unexplained weight gain
• slow or difficult speech
• dizziness or faintness
• weakness or numbness of an arm or leg
• erections of the penis that happen too often or do not go away
• difficulty urinating, weak urine flow, frequent urination, sudden need to urinate right away
• extreme tiredness
• yellowing of the skin or eyes
• dark urine

Testosterone nasal gel may cause a decrease in the number of sperm (male reproductive cells) produced, especially if it is used at high doses. Talk to your doctor about the risks of using this medication if you are a man and would like to have children.

Testosterone may increase the risk of developing prostate cancer. Talk to your doctor about the risks of using this medication.

Testosterone nasal gel may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Store testosterone nasal gel in a safe place so that no one else can use it accidentally or on purpose. Keep track of how much medication is left so you will know if any is missing.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to testosterone nasal gel.

Before having any laboratory tests, tell your doctor and the laboratory personnel that you are using testosterone nasal gel. This medication may affect the results of certain laboratory tests.

Do not let anyone else use your medication. Testosterone nasal gel is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Natesto^®