Vogelxo

Generic name: testosterone topical
Brand names: Androderm, AndroGel Packets, AndroGel Pump 1.25 g/actuation, FIRST-Testosterone, Fortesta, Testim, Vogelxo
Drug class: Androgens and anabolic steroids

Medically reviewed by  A Ras MD.

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 using 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.

Description

Vogelxo (testosterone) gel, for topical use is a clear to translucent hydroalcoholic topical gel containing testosterone, an androgen. Vogelxo provides continuous transdermal delivery of testosterone for 24 hours, following a single application to intact, clean, dry skin of the shoulders and/or upper arms.

Vogelxo is available in unit-dose tubes, unit-dose packets, and a metered-dose pump. One 5-g or two 5-g tubes/packets of Vogelxo contains 50 mg or 100 mg of testosterone, respectively. One pump actuation dispenses 1.25 g of gel, which contains 12.5 mg of testosterone. Four pump actuations or eight pump actuations contain 50 mg or 100 mg of testosterone, respectively. Each metered-dose pump container is capable of dispensing 60 pump actuations.

The active pharmacological ingredient in Vogelxo is testosterone. Testosterone USP is a white to practically white crystalline powder chemically described as 17-β hydroxyandrost-4-en-3-one. The structural formula is shown in the following figure:

Chemical Structure

Testosterone (C19H28O2)                              MW: 288.42

Inactive ingredients in Vogelxo are 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.

Mechanism of Action

Endogenous androgens, including testosterone and dihydrotestosterone (DHT) are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of the prostate, seminal vesicles, penis, and scrotum; the development of male hair distribution, such as facial, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, and alterations in body musculature and fat distribution.

Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter’s syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).

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

1. Vogelxo can transfer from your body to others including, children and women. Children and women should avoid contact with the unwashed or not covered (unclothed areas) where Vogelxo has been applied to your skin. Early signs and symptoms of puberty have occurred in young children who have come in direct contact with testosterone by touching areas where men have used Vogelxo.

Children
Signs and symptoms of early puberty in a child when they come in direct contact with Vogelxo may include:

  • Abnormal sexual changes:
    • enlarged penis or clitoris.
    • early growth of hair near the vagina or around the penis (pubic hair).
    • erections or acting out sexual urges (sex drive).
  • Behavior problems:
    • acting aggressively, behaving in an angry or violent way.

Women
Signs and symptoms in women when they come in direct contact with Vogelxo may include:

  • changes in body hair.
  • an abnormal increase in pimples (acne).

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 happened through accidental touching of the area where you have applied Vogelxo.

2. To lower the risk of transfer of Vogelxo from your body to others, 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 child or woman touches the area where you have applied Vogelxo, that area on the child or woman should be washed well with soap and water right away.

Who should not use Vogelxo?

Do not use Vogelxo if you:

  • have breast cancer.
  • have or might have prostate cancer.
  • are a woman who is pregnant. Vogelxo may harm your unborn baby.
  • Women who are pregnant or who may become pregnant should avoid contact with the area of skin where Vogelxo has been applied.

What should I tell my healthcare provider before using Vogelxo?

Before using Vogelxo, tell your healthcare provider about all of your medical conditions including if you:

  • have breast cancer.
  • have or might have prostate cancer.
  • have urinary problems due to an enlarged prostate.
  • have heart problems.
  • have liver or kidney problems.
  • have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using Vogelxo with certain other medicines you take can affect each other.

Especially, tell your healthcare provider if you take:

  • insulin
  • medicines that decrease blood clotting (blood thinners)
  • corticosteroids

How should I use Vogelxo?

  • See the detailed Instructions for Use for information about how to use Vogelxo at the end of this Medication Guide.
  • It is important that you apply Vogelxo exactly as your healthcare provider tells you to.
  • Your healthcare provider may change your Vogelxo dose. Do not change your Vogelxo dose without talking to your healthcare provider.
  • Apply Vogelxo at the same time each day. Vogelxo should be applied after showering or bathing.

What are the possible side effects of Vogelxo?

Vogelxo can cause serious side effects including:

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

  • If you already have enlargement of your prostate gland your signs and symptoms can get worse while using Vogelxo. This can include:
    • increased urination at night.
    • trouble starting your urine stream.
    • having to pass urine many times during the day.
    • having an urge to go to the bathroom right away.
    • having a urine accident.
    • being unable to pass urine or weak urine flow.
  • Possible increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use Vogelxo.
  • Blood clots in your legs or lungs. Signs and symptoms of a blood clot in your legs can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
  • Possible increased risk of heart attack or stroke.
  • In large doses Vogelxo may lower your sperm count.
  • Swelling of your ankles, feet, or body, with or without heart failure.
  • Enlarged or painful breasts.
  • Having problems breathing while you sleep (sleep apnea).

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:

  • skin irritation where Vogelxo is applied
  • increased red blood cell count
  • headache
  • increased blood pressure

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.

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.

You can ask your pharmacist or healthcare provider for information about Vogelxo that is written for health professionals.

How should I store Vogelxo?

  • Store Vogelxo at room temperature between 68º to 77ºF (20º to 25ºC).
  • Safely throw away used Vogelxo containers in the household trash. Be careful to prevent accidental exposure of children or pets.
  • Keep Vogelxo away from fire.

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

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

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

Instructions for use for Vogelxo

Vogelxo (voh-JELKS-oh), CIII

(testosterone)

gel, for topical use

Applying Vogelxo:

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

  • Before applying Vogelxo, make sure that your shoulders and upper arms are clean, dry, and there is no broken skin.
  • The application sites for Vogelxo are the shoulders and the upper arms that will be covered by a short sleeve t-shirt (See Figure A). Do not apply Vogelxo to any other parts of your body such as your penis, scrotum, or stomach area (abdomen).

Vogelxo application sites include the shoulder and upper arms.

(Figure A)

If you are using Vogelxo tubes:

  • Remove the cap from the tube and use the top of the cap to puncture the metal seal on the top of the tube.
  • Squeeze from the bottom of the tube to the top.
  • Squeeze all of the Vogelxo out of the tube into the palm of your hand.
  • Vogelxo is to be applied only to the areas of your shoulders and upper arms that will be covered by a short sleeve t-shirt.
  • Apply Vogelxo to the application site. Rub the gel onto your skin for several seconds.
  • Vogelxo is flammable until dry. Let Vogelxo dry before smoking or going near an open flame.
  • Let the application site dry for a few minutes before putting on a t-shirt.
  • Wash your hands with soap and water right away after applying Vogelxo.
  • Put the cap back on the tube.
  • Avoid showering, swimming, or bathing for at least 2 hours after you apply Vogelxo.

If you are using Vogelxo packets:

  • Tear open the packet completely at the notch on the top edge. Squeeze from the bottom of the packet to the top.
  • Squeeze all of the Vogelxo out of the packet into the palm of your hand. Apply Vogelxo to the application site. Rub the gel onto your skin for several seconds.
  • Let the application site dry for a few minutes before putting on a t-shirt.
  • Wash your hands with soap and water right away after applying Vogelxo.

If you are using the Vogelxo pump:

  • Before using a new bottle of Vogelxo for the first time, you will need to prime the pump. To prime the Vogelxo pump, remove the cap and slowly push the pump all the way down 3 times.
  • Do not use any Vogelxo that came out while priming. Wash it down the sink to avoid accidental exposure to others. Your Vogelxo pump is now ready to use.
  • Remove the cap from the pump. Then position the nozzle over the palm of your hand and slowly push the pump all the way down. Your healthcare provider will tell you the number of times to press the pump for each dose.
  • Apply Vogelxo to the application site. Rub the gel onto your skin for several seconds.
  • Let the application site dry for a few minutes before putting on a t-shirt.
  • Wash your hands with soap and water right away.
  • Put the cap back on the pump.

How should I store Vogelxo?

  • Store Vogelxo at room temperature between 68º to 77ºF (20º to 25ºC).
  • Safely throw away used Vogelxo containers in the household trash. Be careful to prevent accidental exposure of children or pets.
  • Keep Vogelxo away from fire.

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

Label

PRINCIPAL DISPLAY PANEL – 50 MG TUBE CARTON

  • NDC 0245-0871-05
  • Vogelxo®
    (testosterone) gel
    50 mg testosterone per tube
  • Each unit-dose tube
    contains 5 grams of gel.
  • CIII
  • For topical use only.
  • Topical testosterone products may have different doses, strengths,
    or application instructions that may result in different systemic exposure.
  • To be applied to the shoulders and upper arms.
  • PHARMACIST: Dispense the Medication Guide provided separately
    to each patient.
  • Contains 30 Unit-dose Tubes
    Rx only
  • UPSHER-SMITH
PRINCIPAL DISPLAY PANEL - 50 mg Tube Carton

PRINCIPAL DISPLAY PANEL – 12.5 MG BOTTLE CARTON

  • NDC 0245-0872-42
  • Vogelxo®
    (testosterone) gel
    12.5 mg of testosterone
    per pump actuation*
  • *Each actuation delivers
    1.25 grams of gel.
    Multi-dose pump capable of
    dispensing 60 metered
    pump actuations.
  • CIII
  • For topical use only.
  • Topical testosterone products may have different
    doses, strengths, or application instructions that
    may result in different systemic exposure.
  • To be applied to the shoulders and upper arms.
  • PHARMACIST: Dispense the Medication Guide
    provided separately to each patient.
  • 2 canisters containing 88 grams each
    Rx only
  • UPSHER-SMITH
PRINCIPAL DISPLAY PANEL - 12.5 mg Bottle Carton

SRC: NLM .