VOGELXO- testosterone gel 
VOGELXO- testosterone gel, metered 
Upsher-Smith Laboratories, Inc.

----------

MEDICATION GUIDE

VOGELXO ™ (voh-JELKS-oh), CIII

(testosterone) gel

Read this Medication Guide that comes with Vogelxo before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Vogelxo?

1.
Early signs and symptoms of puberty have happened in young children who were accidentally exposed to testosterone through contact with men using Vogelxo.

Signs and symptoms of early puberty in a child may include:

  • enlarged penis or clitoris
  • early development of pubic hair
  • increased erections or sex drive
  • aggressive behavior

Vogelxo can transfer from your body to others.

2.
Women and children should avoid contact with the unwashed or unclothed area where Vogelxo has been applied to your skin.

Stop using Vogelxo and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to Vogelxo.

Signs and symptoms of exposure to Vogelxo in children may include:

  • enlarged penis or clitoris
  • early development of pubic hair
  • increased erections or sex drive
  • aggressive behavior

Signs and symptoms of exposure to Vogelxo in women may include:

  • changes in body hair
  • a large increase in acne

To lower the risk of transfer of Vogelxo from your body to others, you should follow these important instructions:

  • Apply Vogelxo only to the areas of your shoulders and upper arms that will be covered by a short sleeve T-shirt.
  • Wash your hands right away with soap and water after applying Vogelxo.
  • After the gel has dried, cover the application area with clothing. Keep the area covered until you have washed the application area well or have showered.
  • If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.
  • If a woman or child makes contact with the Vogelxo application area, that area on the woman or child should be washed well with soap and water right away.

What is Vogelxo?

Vogelxo is a prescription medicine that contains testosterone. Vogelxo is used to treat adult males who have low or no testosterone due to certain medical conditions.

Your healthcare provider will test your blood before you start and while you are taking Vogelxo.

It is not known if Vogelxo is safe or effective to treat men who have low testosterone due to aging.

It is not known if Vogelxo is safe or effective in children younger than 18 years old. Improper use of Vogelxo may affect bone growth in children.

Vogelxo is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your Vogelxo in a safe place to protect it. Never give your Vogelxo to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and it is against the law.

Vogelxo is not meant for use in women.

Who should not use Vogelxo?

Do not use Vogelxo if you:

Talk to your healthcare provider before using this medicine if you have any of the above conditions.

What should I tell my healthcare provider before using Vogelxo?

Before you use Vogelxo, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Vogelxo and certain other medicines you take can affect each other.

Especially, tell your healthcare provider if you take:

Know the medicines you take. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use Vogelxo?

Applying Vogelxo:

Vogelxo comes in tubes, packets, or in a pump.

Figure A
Figure

If you are using Vogelxo tubes:

If you are using Vogelxo packets:

If you are using the Vogelxo pump:

What are the possible side effects of Vogelxo?

Vogelxo can cause serious side effects including:

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effects of Vogelxo include:

Other side effects include more erections than are normal for you or erections that last a long time.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Vogelxo. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Vogelxo?

Keep Vogelxo and all medicines out of the reach of children.

General information about the safe and effective use of Vogelxo.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Vogelxo for a condition for which it was not prescribed. Do not give Vogelxo to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Vogelxo. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Vogelxo that is written for health professionals.

For more information, go to www.upsher-smith.com or call 1-888-650-3789.

What are the ingredients in Vogelxo?

Active ingredient: testosterone

Inactive ingredients: carbomer copolymer Type B, carbomer homopolymer Type C, diisopropyl adipate, ethyl alcohol, glycerin, methyl laurate, oleyl alcohol, polyethylene glycol, propylene glycol, purified water, and tromethamine

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by
UPSHER-SMITH LABORATORIES, INC.
Maple Grove, MN 55369

MADE IN CANADA

Revised 0515

Revised: 11/2016
Upsher-Smith Laboratories, Inc.