Description
Testosterone nasal gel is used for the treatment of men whose bodies do not make enough natural testosterone, a condition called hypogonadism. Testosterone is a male hormone responsible for the growth and development of the male sex organs and maintenance of secondary sex characteristics.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Gel/Jelly
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of testosterone nasal gel in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of testosterone nasal gel in the elderly. However, elderly patients may be at an increased risk for developing heart and blood vessel problems, or prostate problems (including prostate cancer), which may require caution in patients receiving testosterone nasal gel.
Breastfeeding
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Anisindione
- Apixaban
- Azathioprine
- Bupropion
- Dabigatran Etexilate
- Dicumarol
- Edoxaban
- Insulin
- Insulin Aspart, Recombinant
- Insulin Bovine
- Insulin Degludec
- Insulin Detemir
- Insulin Glulisine
- Insulin Lispro, Recombinant
- Levoketoconazole
- Mercaptopurine
- Methotrexate
- Paclitaxel
- Paclitaxel Protein-Bound
- Phenprocoumon
- Rivaroxaban
- Warfarin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Licorice
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Blood clotting problems (eg, deep vein thrombosis, pulmonary embolism) or
- Diabetes or
- Drug abuse or dependence, history of or
- Enlarged prostate or
- Heart attack, history of or
- Hypercalcemia (high calcium in the blood) or
- Hyperlipidemia (high lipid or cholesterol in the blood) or
- Liver disease or
- Lung disease or breathing problems (eg, sleep apnea) or
- Problems with passing urine or
- Stroke, history of—Use with caution. May make these conditions worse.
- Breast cancer (males) or
- Prostate cancer, known or suspected—Should not be used in patients with these conditions.
- Blood disorder (eg, polycythemia)—May increase risk for thromboembolic diseases.
- Deviated anterior nasal septum (fracture in your nose that cause the inside of your nose to be crooked), or history of or
- Fracture in your nose, within the previous 6 months or
- Mucosal inflammatory disorders (eg, Sjögren's syndrome) or
- Nose disorders, history of or
- Nose or sinus surgery, history of—Use is not recommended in patients with these conditions.
- Heart disease (eg, congestive heart failure) or
- Kidney disease or
- Liver disease—Use with caution. Testosterone may cause edema (fluid retention) in patients with these conditions.
- Rhinitis, severe—Use of a different testosterone product should be considered in patients with this condition.
Proper Use
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.
- For hormone replacement:
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.
Precautions
It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.
Do not use Natesto® together with other medicines given into your nose (eg, oxymetazoline), unless your doctor says it is okay.
This medicine should not be used by women. Testosterone may cause birth defects if a pregnant woman comes in contact with the medicine. Make sure your doctor knows if your sexual partner is pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
This medicine may cause nasal problems. Check with your doctor right away if you have a runny nose, congestion, sneezing, nosebleeds, nasal discomfort, nasal scabbing, or nasal dryness while using this medicine.
This medicine may cause blood clotting problems. Check with your doctor right away if you have a chest pain, trouble breathing, coughing up blood, numbness or weakness in your arm or leg, or on one side of your body, or pain in your lower leg (calf) while using this medicine.
This medicine may increase your risk of having a heart attack or stroke. Tell your doctor right away if you have chest pain that may spread to your arms, jaw, back, or neck, faintness, headache, nausea, vomiting, trouble breathing, trouble seeing or speaking, or unusual sweating.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
Tell your doctor if your female partner or child starts to have male-like body changes while you are using this medicine. Such changes may include hair growth on the face, a deeper voice, or a significant increase in acne. The changes may also include an enlarged penis or clitoris, early development of pubic hair, increased erections or sexual desire, aggressive behavior, and bone problems.
In some cases, this medicine may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause fluid retention (edema) in some patients. Tell your doctor right away if you have bloating or swelling of the face, arms, hands, lower legs, or feet, tingling of the hands or feet, or unusual weight gain or loss.
This medicine may affect the results of the prostate specific antigen (PSA) test, which may be used to detect prostate cancer. Make sure you tell all of your doctors that you are using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Discomfort in the nose
- fever
- headache
- muscle aches
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
Less common
- Bloody nose
- body aches or pain
- chills
- cough
- difficulty with breathing
- ear congestion
- loss of voice
- pain or tenderness around the eyes and cheekbones
- sneezing
- tightness of the chest
Incidence not known
- Anxiety
- chest pain
- dizziness or lightheadedness
- fainting
- fast heartbeat
- pain, redness, or swelling in the arm or leg
- sudden shortness of breath or troubled breathing
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Change in sense of smell
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20110174
