Vogelxo 1%(12.5mg/1.25gm) Pump

Manufacturer UPSHER-SMITH Active Ingredient Testosterone Gel(tes TOS ter one) Pronunciation VOH-gel-zoh (Vogelxo); tes TOS ter one (Testosterone)
WARNING: Wash the site where the drug was used before it touches anyone else's skin.Do not let this drug or the treated area touch anyone else's skin. They could have side effects from touching this drug. Cover the treated area with clothes.If a female or a child touches the gel, they will need to wash their skin with soap and water. @ COMMON USES: It is used to treat low testosterone levels.
đŸˇī¸
Drug Class
Androgen
đŸ§Ŧ
Pharmacologic Class
Androgen; Sex hormone
🤰
Pregnancy Category
Category X
✅
FDA Approved
Mar 2014
âš–ī¸
DEA Schedule
Schedule III

Overview

â„šī¸

What is this medicine?

Vogelxo is a gel containing testosterone, a male hormone. It is used to treat men who have low testosterone levels due to certain medical conditions. It helps restore testosterone levels, which can improve symptoms like low energy, reduced sex drive, and decreased muscle mass. It is applied to the skin daily.
📋

How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to use this medication as directed and follow all instructions carefully.

Apply this medication only to your skin, as directed. Do not take it by mouth.
Wash your hands before and after applying the medication to prevent spreading it to other parts of your body or to other people.
Use this medication at the same time every day to maintain a consistent routine.
Be aware that different products may have varying strengths, so read and follow the label carefully to ensure you're using the correct dosage.
Avoid applying this medication to sensitive areas, such as the genitals, and keep it out of your eyes.
If you're using a pump, prime it according to the package insert instructions before the first use. Some products come in pumps, while others come in packets.
After applying the medication, wait for the recommended amount of time before bathing, showering, or swimming. Check the package insert for specific instructions.
Allow the medication to dry completely before covering the treated area with clothing.
To minimize fire risk, avoid exposure to flames, sparks, or smoking until the medication is dry.
Apply this medication to clean, dry, healthy skin. Certain products are designed for specific areas of the body, so be sure to follow the package insert instructions for proper application.

Storage and Disposal

To maintain the medication's effectiveness and safety:

Store it at room temperature, away from freezing temperatures.
Keep it in a dry place, avoiding storage in a bathroom or areas prone to moisture.
* Protect the medication from heat, open flames, or sparks.

Missed Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
💡

Lifestyle & Tips

  • Apply the gel to clean, dry, intact skin of the shoulders, upper arms, or abdomen once daily, preferably in the morning.
  • Wash hands thoroughly with soap and water immediately after applying the gel.
  • Allow the application site to dry completely before dressing. Do not apply to the genitals or breasts.
  • Cover the application site with clothing after the gel has dried to prevent transfer to others.
  • Avoid swimming, showering, or washing the application site for at least 2 hours after application.
  • To prevent accidental transfer to women or children, avoid skin-to-skin contact with others at the application site. If contact occurs, the exposed area on the other person should be washed immediately with soap and water.
  • Store the medication safely out of reach of children and pets.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Initial dose: 50 mg (4 pump actuations) applied once daily to clean, dry, intact skin of the shoulders, upper arms, or abdomen. Dose may be adjusted based on serum testosterone levels and clinical response, up to a maximum of 100 mg (8 pump actuations) daily.
Dose Range: 50 - 100 mg

Condition-Specific Dosing:

hypogonadism: Initial dose: 50 mg (4 pump actuations) applied once daily. Adjust dose based on morning serum testosterone levels obtained approximately 14 days after starting treatment or dose adjustment. Target testosterone range: 300-1000 ng/dL.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established; contraindicated in males with delayed puberty due to risk of premature epiphyseal closure.
Adolescent: Not established; contraindicated in males with delayed puberty due to risk of premature epiphyseal closure.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, but use with caution.
Moderate: No specific dose adjustment recommended, but use with caution.
Severe: No specific dose adjustment recommended, but use with caution. Monitor for fluid retention.
Dialysis: Not available; use with caution and monitor for fluid retention.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, but use with caution.
Moderate: No specific dose adjustment recommended, but use with caution.
Severe: Not recommended due to potential for fluid retention and exacerbation of hepatic dysfunction.
Confidence: Medium

Pharmacology

đŸ”Ŧ

Mechanism of Action

Testosterone is an endogenous androgen. Androgens are responsible for the normal growth and development of male sex organs and for maintenance of secondary sex characteristics. Testosterone acts by binding to androgen receptors in target tissues, leading to gene transcription and protein synthesis. In some tissues, testosterone is converted to dihydrotestosterone (DHT) by 5-alpha reductase, which then binds to the same androgen receptor with higher affinity.
📊

Pharmacokinetics

Absorption:

Bioavailability: Approximately 9-14% (transdermal absorption varies)
Tmax: Approximately 4 hours after application
FoodEffect: Not applicable for transdermal gel

Distribution:

Vd: Approximately 1 L/kg
ProteinBinding: Approximately 98% (primarily to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 10-100 minutes (endogenous testosterone); effective half-life after transdermal application is longer due to sustained absorption from skin reservoir.
Clearance: Approximately 10 mL/min/kg
ExcretionRoute: Approximately 90% in urine as conjugates of testosterone and its metabolites; approximately 6% in feces, mostly unconjugated.
Unchanged: Less than 6% of a testosterone dose is excreted unchanged in the urine.
âąī¸

Pharmacodynamics

OnsetOfAction: Within days to weeks for some effects (e.g., mood, energy); weeks to months for others (e.g., muscle mass, bone density).
PeakEffect: Serum testosterone levels typically reach steady-state within 14 days of daily application.
DurationOfAction: 24 hours (with daily application)
Confidence: Medium

Safety & Warnings

âš ī¸

BLACK BOX WARNING

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
Virilization has been reported in children and women who were secondarily exposed to testosterone gel. Cases of secondary exposure were reported with both approved and unapproved testosterone products. Signs of virilization included, but were not limited to, pubic hair development, enlarged clitoris, and increased libido in females, and penile and clitoral enlargement in children. In most cases, these signs and symptoms regressed with removal of the testosterone product and avoidance of further exposure. In some cases, however, the signs and symptoms did not fully regress. To minimize the potential for secondary exposure, patients should be advised to use the product as directed and to follow precautions.
âš ī¸

Side Effects

Urgent Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Prolonged or frequent erections
Urinary problems, such as:
+ Trouble passing urine
+ Pain while urinating
+ Weak or dripping urine stream
+ Frequent urination
Loss of bladder control
New or worsening behavioral or mood changes, including:
+ Depression
+ Thoughts of suicide
Enlarged breasts or breast pain
Shortness of breath, significant weight gain, or swelling in the arms or legs
Upset stomach or vomiting
Trouble breathing while sleeping
Excessive daytime sleepiness
Weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Changes in skin color
Changes in testicle size or shape
Signs of a blood clot, including:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, color changes, or pain in a leg or arm
+ Trouble speaking or swallowing
Liver problems, which can be life-threatening. Seek medical help if you experience:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for guidance:

Headache
Acne
Diarrhea
Emotional changes
Fatigue or weakness
Sleep disturbances
* Irritation at the site of application

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
🚨

Seek Immediate Medical Attention If You Experience:

  • Signs of too much testosterone: acne, hair loss, increased body hair, aggression, irritability, breast enlargement (gynecomastia), swelling in ankles or feet.
  • Signs of prostate problems: difficulty urinating, frequent urination, weak urine stream, blood in urine.
  • Signs of blood clots: pain, swelling, warmth, or redness in a leg, sudden shortness of breath, chest pain.
  • Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, severe stomach pain, unusual tiredness.
  • Signs of allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
📋

Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the symptoms you experienced.
If you are a male with a history of breast or prostate cancer.
If you have any pre-existing medical conditions, such as heart disease, kidney disease, or liver disease.
If you are female, as this medication is not approved for use in women. Additionally, if you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential risks with your doctor, as this medication may harm an unborn baby.
* If the patient is a child, as this medication is not intended for pediatric use.

This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
âš ī¸

Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

If you have diabetes, you will need to closely monitor your blood sugar levels.

There may be an increased risk of developing prostate cancer. Discuss this with your doctor.

If you have an enlarged prostate, your symptoms may worsen while using this medication. Contact your doctor if you experience any changes.

If you have sleep apnea, consult with your doctor, as this medication may exacerbate the condition.

This medication may cause high blood pressure, which can increase the risk of heart attack, stroke, or death from heart disease. Have your blood pressure checked regularly, as advised by your doctor. If you have pre-existing high blood pressure or heart disease, discuss this with your doctor.

Treatment with this medication may lead to increased cholesterol and triglyceride levels. The impact of these changes on heart health is unknown, so it is crucial to discuss this with your doctor.

Regularly undergo blood work and other laboratory tests as directed by your doctor. Be aware that this medication may affect certain lab tests, so inform all your healthcare providers and laboratory personnel that you are taking this medication.

There is a risk of blood clots associated with this medication. If you have a history of blood clots, inform your doctor and discuss the potential risks.

This medication is an anabolic steroid, and misuse or abuse of anabolic steroids can lead to dependence and severe health problems, including cardiovascular issues, stroke, liver damage, and mental or mood disorders. Discuss the risks with your doctor.

In some individuals with cancer, medications like this one have caused high calcium levels. If you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain, contact your doctor immediately.

If a child or female accidentally comes into contact with the gel or solution, they may experience adverse effects. In children, these effects may include aggressive behavior, enlarged sex organs, or premature pubic hair growth. In females, they may include a deepened voice, changes in body hair, or acne. If this occurs, contact the doctor promptly.

If a pregnant individual comes into contact with the gel or solution, contact the doctor immediately.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

This medication is not approved for treating low testosterone levels caused by aging. Discuss the potential benefits and risks with your doctor.

High doses of this medication may affect sperm production in males, potentially impacting fertility. This effect may be irreversible, even after stopping the medication. If you have concerns, discuss them with your doctor.
🆘

Overdose Information

Overdose Symptoms:

  • Severe acne
  • Increased body hair
  • Aggression
  • Irritability
  • Fluid retention (edema)
  • Polycythemia (excess red blood cells, leading to symptoms like headache, dizziness, fatigue)

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and may involve discontinuing the medication and monitoring for adverse effects.

Drug Interactions

🔴

Major Interactions

  • Oral anticoagulants (e.g., warfarin)
  • Corticosteroids (e.g., prednisone)
  • Insulin and other antidiabetic agents
🟡

Moderate Interactions

  • Adrenocorticotropic hormone (ACTH)
  • Bupropion
  • Cyclosporine
  • Thyroid hormones

Monitoring

đŸ”Ŧ

Baseline Monitoring

Serum Testosterone (total and free)

Rationale: To confirm diagnosis of hypogonadism and establish baseline levels.

Timing: Prior to initiation of therapy (morning sample, 8-10 AM)

Hematocrit (Hct) and Hemoglobin (Hgb)

Rationale: To assess for polycythemia, a common side effect of testosterone therapy.

Timing: Prior to initiation of therapy

Prostate-Specific Antigen (PSA)

Rationale: To screen for prostate cancer, as testosterone can stimulate prostate growth. Required for men >40 years with risk factors or >50 years.

Timing: Prior to initiation of therapy

Lipid Panel

Rationale: To assess cardiovascular risk factors, as testosterone may affect lipid profiles.

Timing: Prior to initiation of therapy

Liver Function Tests (LFTs)

Rationale: To assess baseline liver function, especially in patients with pre-existing hepatic impairment.

Timing: Prior to initiation of therapy

📊

Routine Monitoring

Serum Testosterone (total)

Frequency: Approximately 14 days after initiation or dose adjustment, then every 3-6 months, then annually.

Target: 300-1000 ng/dL (morning sample)

Action Threshold: If consistently above 1000 ng/dL, reduce dose or discontinue. If consistently below 300 ng/dL, consider dose increase.

Hematocrit (Hct)

Frequency: At 3 and 6 months after initiation, then annually.

Target: <54%

Action Threshold: If Hct >54%, reduce dose, temporarily discontinue, or phlebotomize.

Prostate-Specific Antigen (PSA)

Frequency: At 3-6 months after initiation, then annually (for men >40 with risk factors or >50).

Target: Stable or within age-appropriate limits

Action Threshold: If PSA increases significantly or is outside normal limits, evaluate for prostate cancer.

Digital Rectal Exam (DRE)

Frequency: Annually (for men >40 with risk factors or >50).

Target: Normal

Action Threshold: If abnormal, evaluate for prostate cancer.

Lipid Panel

Frequency: Annually.

Target: Within normal limits

Action Threshold: If abnormal, consider lifestyle modifications or lipid-lowering therapy.

đŸ‘ī¸

Symptom Monitoring

  • Signs of polycythemia (e.g., headache, dizziness, fatigue, shortness of breath)
  • Signs of prostate enlargement (e.g., urinary frequency, urgency, nocturia, weak stream)
  • Signs of fluid retention (e.g., edema, weight gain)
  • Signs of cardiovascular events (e.g., chest pain, shortness of breath, leg pain)
  • Mood changes, irritability, aggression
  • Skin reactions at application site (e.g., redness, irritation, blistering)
  • Signs of gynecomastia (breast enlargement or tenderness)

Special Patient Groups

🤰

Pregnancy

Contraindicated in pregnant women. Testosterone can cause virilization of the female fetus.

Trimester-Specific Risks:

First Trimester: High risk of virilization of female fetus (e.g., clitoral enlargement, abnormal external genitalia).
Second Trimester: High risk of virilization of female fetus.
Third Trimester: High risk of virilization of female fetus.
🤱

Lactation

Contraindicated in breastfeeding women. It is unknown if testosterone is excreted in human milk, but due to the potential for serious adverse reactions in the breastfed infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: High risk of virilization in breastfed infant if excreted in milk.
đŸ‘ļ

Pediatric Use

Not indicated for use in pediatric patients. Use in children can cause premature epiphyseal closure, leading to stunted growth, and virilization in females. Safety and efficacy have not been established.

👴

Geriatric Use

Older men treated with androgens may be at an increased risk for the development of prostate hypertrophy and prostate cancer. Increased monitoring for prostate-related adverse events (PSA, DRE) is recommended. Cardiovascular risk should also be carefully considered.

Clinical Information

💎

Clinical Pearls

  • Emphasize proper application technique and strict adherence to precautions to prevent secondary exposure to women and children.
  • Morning application is preferred to mimic the natural diurnal rhythm of testosterone.
  • Patients should be advised that the full therapeutic effects may not be seen for several weeks to months.
  • Regular monitoring of serum testosterone, hematocrit, and prostate health (PSA, DRE) is crucial.
  • Counsel patients on potential side effects, including skin irritation, polycythemia, and prostate changes.
  • Testosterone therapy is not indicated for age-related decline in testosterone without a confirmed diagnosis of hypogonadism.
🔄

Alternative Therapies

  • Testosterone injections (e.g., testosterone cypionate, enanthate)
  • Testosterone patches (e.g., Androderm)
  • Testosterone buccal system (e.g., Striant)
  • Testosterone nasal gel (e.g., Natesto)
  • Testosterone oral capsules (e.g., Jatenzo, Tlando)
  • Testosterone pellets (e.g., Testopel)
💰

Cost & Coverage

Average Cost: $300 - $600 per 30-day supply (approx. 2-4 pumps/day)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (Brand), Tier 1 (Generic)
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.