Natesto (Page 5 of 5)
16. HOW SUPPLIED/STORAGE AND HANDLING
16.1. How Supplied
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.
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.
16.3. Handling and Disposal
Used Natesto dispensers should be discarded in household trash in a manner that prevents accidental exposure of children or pets.
17. PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Use in Men With Known or Suspected Prostate or Breast Cancer
Men with known or suspected prostate or breast cancer should not use Natesto [see Contraindications ( 4) and Warnings and Precaution ( 5.3)].
Nasal Adverse Reactions
Nasal adverse reactions, including nasopharyngitis, rhinorrhea, epistaxis, nasal discomfort and nasal scabbing, were reported in clinical trials of Natesto. Advise patients to report any nasal symptoms or signs to their health care professional.
Potential Adverse Reactions With Androgens
Patients should be informed that treatment with androgens may lead to adverse reactions which include:
- Changes in urinary habits such as increased urination at night, trouble starting your urine stream, passing urine many times during the day, having an urge that you have to go to the bathroom right away, having urine accident, being unable to pass urine, and having a weak urine flow.
- Breathing disturbances, including those associated with sleep, or excessive daytime sleepiness.
- Too frequent or persistent erections of the penis.
- Nausea, vomiting, changes in skin color, or ankle swelling.
Patients Should be Advised of the Following Instructions For Use
- Read the Patient Information accompanying each Natesto metered dose pump.
- Prime the pump by depressing it 10 times prior to its first use. No priming is needed with subsequent uses of that pump.
- Administer Natesto intranasally and NOT to other parts of the body. Administer Natesto intranasally three times daily, once in the morning, once in the afternoon and once in the evening (6 to 8 hours apart), preferably at the same time each day.
- Keep Natesto out of the reach of children.
- Report any changes in their state of health, such as changes in urinary habits, breathing, sleep, mood, nasal irritation or rhinitis.
- Never share Natesto with anyone.
|Patient Information Natesto (Na-tes-to) CIII (testosterone) nasal gel|
| What is Natesto? |
| Who should not use Natesto? Do not use Natesto if you: |
|Talk to your healthcare provider before using Natesto if you have any of the above conditions.|
| Before using Natesto, tell your healthcare provider about all of your medical conditions, including if you: |
|Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.Using Natesto with certain other medicines can affect each other. Especially tell your healthcare provider if you take:|
| || || |
| How should I use Natesto? |
| What are the possible side effects of Natesto? Natesto may cause serious side effects, including: |
|Call your healthcare provider right away if you have any of the serious side effects listed above. These are not all the possible side effects of Natesto. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.The most common side effects of Natesto include: |
|Other side effects include more erections than normal for you or erections that last a long time.|
| How should I store Natesto? |
|General information about the safe and effective use of Natesto.|
|Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Natesto for a condition for which it was not prescribed. Do not give Natesto to other people, even if they have the same symptoms that you have. It may harm them.If you would like more information about Natesto, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Natesto that is written for health professionals. For more information go to www.natesto.com or call 1-855-298-8246.|
|What are the ingredients in Natesto? Active ingredient: testosteroneInactive ingredients: castor oil, oleoyl polyoxylglycerides, and colloidal silicon dioxide Marketed by: Aytu BioScience, Inc., Englewood, CO 80112 Manufactured by: Haupt Pharma Amareg GmbH, Donaustaufer Str. 378, Regensburg, Bavaria D-93055, Germany|
Instructions for Use
CIII (testosterone)nasal gel
Supplies needed to give your Natesto dose:
- 1 Natesto dispenser
- 2 clean, dry tissues
- a clean and flat surface, like a table
- a mirror
Parts of your Natesto dispenser (See Figure A)
Information about your Natesto:
- Do not blow your nose or sniff for 1 hour after using Natesto.
- Before you use Natesto for the first time, you will need to prime your Natesto pump.
How to prime your Natesto pump:
- Hold your Natesto dispenser over a sink, turn it upside down (invert) and slowly press the pump and release 10 times (See Figure B).
- All the Natesto that comes out when you prime your pump should be rinsed down the sink with warm water.
- If there is any Natesto on the tip of your Natesto actuator after priming, wipe the tip with a clean, dry tissue.
- If any Natesto gel gets on your hands, it is recommended to wash your hands with warm water and soap.
Giving your Natesto dose:
Step 1: Blow your nose.
Step 2: Remove the Natesto cap.
Step 3: While looking in the mirror, put your right first (index) finger on the pump of your Natesto actuator and slowly slide the tip of the actuator up into your left nostril until your finger on the pump touches the bottom of your nose (See Figure C).
Step 4: Gently tilt the Natesto actuator so that the hole in the tip touches the lateral (side) wall of your nostril. This will make sure that Natesto is given in the correct place (See Figure D).
Step 5: With the actuator in place, slowly push the pump down until it stops and remove the actuator from your nose.
Step 6: While looking in the mirror, put your left first (index) finger on the pump of your Natesto actuator and slowly slide the tip of the actuator up into your right nostril until your finger on the pump touches the bottom of your nose (See Figure E).
Step 7: Gently tilt the tip of the Natesto actuator so that the hole in the tip touches the lateral (side) wall of your nostril. This will make sure that Natesto is given in the correct place (See Figure F).
Step 8: Slowly push down on the pump until it stops and remove the actuator from your nose.
Step 9: Wipe the tip of the actuator with a clean, dry tissue.
Step 10: Replace the cap.
Step 11: Press your nostrils together just below the middle of your nose (bridge) and lightly rub them together (See Figure G).
- Replace your Natesto dispenser when the top of the piston inside the dispenser reaches the arrow at the top of the inside label (See Figure H).
How to throw away your empty Natesto dispenser:
- Safely throw away your empty Natesto dispenser in your household trash.
- Keep Natesto and all medicines out of the reach of children and pets.
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
Marketed by: Aytu BioScience, Inc., Englewood, CO 80112
Manufactured by: Haupt Pharma Amareg GmbH, Donaustaufer Str. 378, Regensburg, Bavaria D-93055, Germany
Principal Display Panel — Natesto Nasal Gel Carton
(testosterone) nasal gel
5.5 mg of testosterone per actuation*
*Each actuation delivers 0.122 g of gel.
Multi-dose pump capable of
dispensing 60 metered pump
For intranasal use only.
Warning: This package is not
child resistant. Keep out of
reach of children.
Total Contents: 11 g / dispenser.
Aytu BioScience, Inc.
Englewood, CO 80112
Haupt Pharma Amareg GmbH
Donaustaufer Sir. 378
Regensburg, Bavaria D93055, Germany
|NATESTO testosterone gel|
|Labeler — Aytu BioScience, Inc. (079847712)|
Revised: 12/2019 Aytu BioScience, Inc.
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