Testosterone, Intranasal Gel

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KEY POINTS

• This medicine is a gel that you put in your nose to increase levels of testosterone. Use it exactly as directed. If a child or woman has come in contact with this medicine, contact your healthcare provider right away.
• This medicine may raise cholesterol, increase the risk of blood clots, or cause other serious side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: androgen; male hormone

Generic and brand names: testosterone, intranasal gel; Natesto

What is this medicine used for?

This medicine is a gel that you put in your nose to increase levels of testosterone (male hormone).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Men should not use this medicine if they have breast cancer or prostate cancer.

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or hormone, or to soy products
• A stroke or transient ischemic attack (TIA)
• Blood clots or blood disorders
• Breast cancer or prostate cancer
• Diabetes
• Heart disease or a heart attack
• High cholesterol
• Liver or kidney disease
• Lung or breathing problems such as asthma, COPD, or sleep apnea
• Nose or sinus problems, including a broken nose, infections, or frequent nosebleeds
• Nasal or sinus surgery
• Trouble urinating or an enlarged prostate gland

Females of childbearing age: This medicine MUST NOT be used by pregnant women or those who are breast-feeding because it may harm the baby. Avoid contact with this medicine.

How do I use it?

Check the label on the medicine for directions about your specific dose. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine must only be used in the nose, and not on any other part of the body. You should blow your nose before using this medicine. Do not blow your nose or sniff for 1 hour after using this medicine.

What if I miss a dose?

If you miss a dose, use it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

If a child or woman has come in contact with this medicine, contact your healthcare provider right away. Pregnant women must avoid contact with this medicine. It can harm the infant. If a pregnant woman does come in contact with the gel in any way, wash the area with lots of soap and water and contact her healthcare provider.

This medicine may:

• Raise your cholesterol.
• Increase your risk for prostate cancer or an enlarged prostate.
• Make breast cancer worse.
• Worsen heart failure symptoms by causing you to retain fluid.
• Lower your sperm count. Talk with your healthcare provider about this.

You may need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine is a controlled substance. It is illegal for you to give it to anyone else.

Rarely, this medicine may cause a painful erection of the penis that will not return to normal. If this happens, contact your healthcare provider or get medical care right away. It can lead to permanent erectile dysfunction if not treated.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Chest pain; sudden shortness of breath; pain, swelling, warmth, or redness in your leg; too frequent erections or erections that last more than 4 hours; trouble urinating or more frequent urination; unexplained nausea or vomiting; changes in skin color; yellowing of your skin or eyes; dark urine; light bowel movements; pain or swelling of the hands, feet, or ankles or any unexplained swelling; tender or enlarged breasts; breathing problems, especially while sleeping; dizziness; fainting; severe runny or stuffy nose; constant sneezing or itchy nose.

Other: Headache, runny or stuffy nose, nosebleed, nose pain or irritation, sore throat, nose scabs, nasal dryness, sneezing, cough.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Diabetes medicines such as glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• Saw palmetto
• Warfarin (Coumadin)

Talk with your healthcare provider before using other nasal sprays while you are using this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Protect it from heat, high humidity, and bright light. Dispose of the empty container safely away from children and pets.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.