Testosterone Nasal Gel

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

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

Dosage Forms And Strengths

Natesto is a slightly yellow gel for intranasal use and is available in a dispenser with a metered dose pump. One pump actuation delivers 5.5 mg of testosterone.

Storage And Handling

Natesto (testosterone) nasal gel is available as a metered dose pump containing 11 grams of gel dispensed as 60 metered pump actuations. One pump actuation delivers 5.5 mg of testosterone in 0.122 grams of gel.

NDC 63481-239-01

Keep Natesto out of reach of children.

Store at 20°C to 25°C (68°F to 77°F). Excursions are permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.

Used Natesto dispensers should be discarded in household trash in a manner that prevents accidental exposure of children or pets.

Marketed by: Endo Pharmaceuticals Inc., Malvern, PA 19355. Manufactured by: Haupt Pharma Amareg GmbH, Donaustaufer Str. 378, Regensburg, Bavaria D-93055, Germany. Approved: 05/2015

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Natesto was evaluated in a multicenter, open-label, 90-day clinical study. Patients could continue treatment with Natesto in two, open-label extension periods for an additional 90 and 180 days, respectively. A total of 306 hypogonadal men with morning testosterone concentrations ≤ 300 ng/dL received Natesto. Of these, 78 received Natesto at a dose of 11 mg three times daily.

Among the 78 patients who received Natesto three times daily in the 90-day clinical study, the most common adverse reactions were: prostate specific antigen (PSA) increased, headache, rhinorrhea, epistaxis, nasal discomfort, nasopharyngitis, upper respiratory tract infection (URI), sinusitis, bronchitis and nasal scab. PSA increased was considered an adverse reaction by meeting one of two pre-specified criteria: (1) increase from baseline serum PSA greater than 1.4 ug/L, or (2) serum PSA greater than 4.0 ug/L.

Table 1 shows adverse reactions reported by ≥ 3% of patients treated with 11 mg three times daily in the 90-day clinical study.

Table 1: Adverse Reactions Reported by ≥ 3% of Patients Treated with Natesto (11 mg of testosterone) Three Times Daily in the 90-Day Clinical Study

Adverse reactions reported by > 2% but < 3% of patients in the 90-day clinical study include: blood pressure increased, dysgeusia, nasal dryness, nasal congestion, and cough.

Among the 78 patients who received Natesto three times daily in the 90-day clinical study, a total of 69 patients received Natesto three times daily in the first 90-day extension period. Among these 69 patients, the most common adverse reactions were: nasopharyngitis, PSA increased, parosmia, nasal discomfort, rhinorrhea and nasal scab.

Table 2 shows adverse reactions reported by ≥ 3% of patients who received Natesto three times daily in both the 90-day clinical study and in the 90-day extension period.

Table 2: Adverse Reactions Reported by ≥ 3% of Patients in Both the 90-Day Clinical Study and in the 90-Day Extension Period

A total of 18 patients received Natesto three times daily in all three treatment periods, including the 90-day clinical study, the first 90-day extension period, and the second 180-day extension period. Among these 18 patients, the following adverse reactions were reported in more than one patient each: nasopharyngitis, parosmia, PSA increased, nasal discomfort, nasal scab and hypertension. The following adverse reactions were reported in one patient each: nausea, nasal excoriation, thyroid stimulating hormone increased, decreased appetite, myalgia, anosmia, testicular atrophy, epistaxis, nasal septum disorder, nasal discomfort, and rhinorrhea.

In patients who received Natesto three times daily, mean serum PSA concentrations increased by 0.2 ng/mL, 0.1 ng/mL, and 0.2 ng/mL after 90, 180 and 360 days, respectively.

Among all subjects (n=306) who received Natesto at any dose in the 90-day clinical study and its 90-and 180-day extension periods, a total of 6 subjects withdrew from treatment for the following adverse reactions, reported by 1 subject each: nasal discomfort, headache, dysgeusia, PSA increased, allergic reaction (hives, swollen lips and tongue), and 1 patient with myalgia, arthralgia, fever, chills and petechiae.

Among all subjects (n=306) who received Natesto at any dose in the 90-day clinical study and its 90-and 180-day extension periods, a total of 4 subjects had a hematocrit level > 55%. These 4 patients had baseline hematocrits of 48% and 51%. In no case did hematocrit exceed 58%.

Among all subjects (n=306) who received Natesto at any dose in the 90-day clinical study and its 90-and 180-day extension periods, the following nasal adverse reactions were reported: nasopharyngitis (8.2%), rhinorrhea (7.8%), epistaxis (6.5%), nasal discomfort (5.9%), parosmia (5.2%), nasal scab (5.2%), upper respiratory infection (4.2%), nasal dryness (4.2%), and nasal congestion (3.9%).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of testosterone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular Disorders: myocardial infarction, stroke [see WARNINGS AND PRECAUTION].

Vascular Disorders: Venous thromboembolism [see WARNINGS AND PRECAUTION]

Read the entire FDA prescribing information for Natesto (Testosterone Nasal Gel)

Use testosterone nasal gel as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with testosterone nasal gel.
• Wash your hands before and after use.
• Follow how to use as you have been told by the doctor or read the package insert.
• Do not take this medicine by mouth. Use in your nose only. Keep out of your mouth and eyes (may burn).
• If you get testosterone nasal gel on the skin, wash it off right away with soap and water.
• Use this medicine at the same time of day.
• You will need to prime the pump before first use. Do this by turning it upside down and pressing down on the pump 10 times. If any drug comes out during priming, wash down the sink with warm water.
• Blow your nose before use.
• Do not blow your nose or sniff for 1 hour after using testosterone nasal gel.
• Follow how to clean carefully.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of high calcium levels like weakness, confusion, feeling tired, headache, upset stomach and throwing up, hard stools (constipation), or bone pain.
• For males, erections (hard penis) that happen often or that last a long time.
• Passing urine more often.
• Trouble passing urine.
• Passing urine in a weak stream or drips.
• Not able to control passing urine.
• Mood changes.
• Low mood (depression).
• Change in how you act.
• Enlarged breasts.
• Breast pain.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Upset stomach or throwing up.
• Trouble breathing when sleeping.
• Feeling sleepy during the day.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Change in color of skin.
• Change in size or shape of testicles.
• Very bad irritation where this medicine is used.
• Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.
• Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call the doctor right away if your child has signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Nosebleed.
• Dry nose.
• Nose pain or irritation.
• Runny nose.
• Stuffy nose.
• Nose scabs.
• Sneezing.

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 testosterone nasal gel 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.

Testosterone is available in these forms: transdermal patch, topical gel, topical solution, nasal gel, and buccal tablet. It is also available as an implant that a healthcare provider inserts under your skin or an oil that a healthcare provider injects into your muscle.

Testosterone is used to treat males with hypogonadism. Males with this condition can’t make enough of the hormone testosterone.

Testosterone nasal gel is available as the brand-name drug Natesto. It’s not available as a generic drug.

The more common side effects of this drug may include increased level of prostate-specific antigen (measured to screen for prostate cancer), headache, runny nose, nosebleeds, and nose pain. They can also include sore throat, cough, upper respiratory infection, sinus infection, and nose scabs.

In some cases testosterone may cause serious side effects. These can include enlarged prostate, increased risk of prostate cancer, blood clots in your lungs or the veins of your legs, increased risk of heart attack or stroke, and lowered sperm count. Other serious side effects include swelling of your ankles, feet, or body, enlarged or painful breasts, problems sleeping (sleep apnea), and erections that last longer than 4 hours.

• Increased risk of heart attack or stroke See Details

• Blood clots See Details

• Misuse warning See Details

What is testosterone?

Testosterone is a controlled prescription drug. It is available in these forms: transdermal patch, topical gel, topical solution, nasal gel, and buccal tablet. 

The nasal gel is available as the brand-named drug Natesto. It isn’t available as a generic drug.

Testosterone is also available as an implant that is inserted under your skin by a healthcare provider or an oil that is injected into your muscle by a healthcare provider.

Why it's used

Testosterone is used to treat males with hypogonadism. Males with this condition can’t make enough of the hormone testosterone.

How it works

Testosterone belongs to a class of drugs called androgens. A class of drugs is a group of medications that work in a similar way.

More Details