Vogelxo 1%(50mg/5gm) Gel 5gm Udt
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.
Drug Class
Androgen
Pharmacologic Class
Androgen receptor agonist
Pregnancy Category
Category X
FDA Approved
Oct 2014
DEA Schedule
Schedule III
Overview
What is this medicine?
Vogelxo is a gel applied to the skin to replace testosterone in men who do not produce enough of this hormone naturally. It helps improve symptoms like low energy, low sex drive, and muscle weakness. It's important to apply it correctly and prevent it from getting on other people, especially women and children.
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. Use this medication only on your skin, as directed. It is essential to wash your hands before and after applying the medication.
Application Instructions
Apply the medication at the same time every day.
Be aware that different products may have varying strengths, so carefully read and follow the label instructions.
Avoid getting the medication on other parts of your body or on other people.
Do not apply the medication to the genital area.
* Keep the medication out of your eyes.
Special Instructions for Pump and Packet Products
If you are using a pump, you will need to prime it before the first use. Follow the priming instructions provided in the package insert. If you are using packets, follow the instructions for application.
Post-Application Instructions
After applying the medication, wait for the recommended amount of time before bathing, showering, or swimming. Refer to the package insert for specific details. Allow the medication to dry completely before covering the treated area with clothing. Avoid exposure to fire, flames, or smoking until the medication is dry.
Skin Preparation and Application
Apply the medication to clean, dry, healthy skin. Certain products are designed for specific areas of the body, so be sure to read the package insert to understand where to apply the medication.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures. Keep it in a dry place, avoiding storage in a bathroom. Protect the medication from heat or open flames.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use this medication only on your skin, as directed. It is essential to wash your hands before and after applying the medication.
Application Instructions
Apply the medication at the same time every day.
Be aware that different products may have varying strengths, so carefully read and follow the label instructions.
Avoid getting the medication on other parts of your body or on other people.
Do not apply the medication to the genital area.
* Keep the medication out of your eyes.
Special Instructions for Pump and Packet Products
If you are using a pump, you will need to prime it before the first use. Follow the priming instructions provided in the package insert. If you are using packets, follow the instructions for application.
Post-Application Instructions
After applying the medication, wait for the recommended amount of time before bathing, showering, or swimming. Refer to the package insert for specific details. Allow the medication to dry completely before covering the treated area with clothing. Avoid exposure to fire, flames, or smoking until the medication is dry.
Skin Preparation and Application
Apply the medication to clean, dry, healthy skin. Certain products are designed for specific areas of the body, so be sure to read the package insert to understand where to apply the medication.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures. Keep it in a dry place, avoiding storage in a bathroom. Protect the medication from heat or open flames.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Apply the gel once daily at approximately the same time each morning to clean, dry, intact skin of the shoulders, upper arms, or abdomen.
- Wash hands thoroughly with soap and water immediately after applying the gel.
- Allow the application site to dry completely before dressing. Cover the application site with clothing once dry.
- Avoid showering, swimming, or washing the application site for at least 2 hours after application.
- Avoid skin-to-skin contact with others at the application site to prevent secondary exposure.
- Do not apply to the genitals, breasts, or broken skin.
- Store at room temperature, away from moisture and heat.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
50 mg (one 5gm packet or 4 pump actuations) applied once daily to the shoulders, upper arms, or abdomen.
Dose Range:
50 - 100 mg
Condition-Specific Dosing:
initialDose:
50 mg once daily
doseAdjustment:
Adjust based on serum testosterone levels and clinical response, not to exceed 100 mg daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (contraindicated for hypogonadism in prepubertal males due to risk of premature epiphyseal closure and precocious puberty)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment, use with caution.
Moderate:
No specific dose adjustment, use with caution.
Severe:
No specific dose adjustment, use with caution; monitor for fluid retention.
Dialysis:
Not available
Hepatic Impairment:
Mild:
No specific dose adjustment, use with caution.
Moderate:
No specific dose adjustment, use with caution; monitor liver function.
Severe:
No specific dose adjustment, use with caution; monitor liver function.
Pharmacology
Mechanism of Action
Exogenous testosterone diffuses across cell membranes and binds to androgen receptors in target tissues. The testosterone-receptor complex then translocates to the nucleus, where it binds to DNA and stimulates gene transcription, leading to the synthesis of various proteins responsible for the development and maintenance of male secondary sexual characteristics. Testosterone can also be converted to dihydrotestosterone (DHT) by 5-alpha reductase, which also binds to androgen receptors, and to estradiol by aromatase.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 10% of the applied dose reaches systemic circulation (highly variable transdermal absorption).
Tmax:
2-4 hours after application; steady-state levels typically reached within 2-4 days.
FoodEffect:
Not applicable for topical gel.
Distribution:
Vd:
Approximately 1 L/kg.
ProteinBinding:
Approximately 98% bound to plasma proteins, primarily sex hormone-binding globulin (SHBG) and albumin.
CnssPenetration:
Yes
Elimination:
HalfLife:
Systemic half-life of testosterone is short (10-100 minutes), but sustained release from skin reservoir results in prolonged systemic exposure.
Clearance:
Not readily quantifiable for topical formulations.
ExcretionRoute:
Approximately 90% in urine (as conjugates of testosterone and its metabolites), 6% in feces (mostly unconjugated).
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Clinical effects may be observed within weeks to months (e.g., libido, energy, mood).
PeakEffect:
Steady-state serum testosterone levels are typically achieved within 2-4 days of daily application.
DurationOfAction:
Daily application maintains therapeutic testosterone levels.
Safety & Warnings
BLACK BOX WARNING
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE. Cases of secondary exposure to testosterone resulting in virilization of children and women have been reported. Vogelxo can transfer from the patient to others who come into contact with the application site. Patients should be advised to strictly adhere to recommended instructions for use.
Side Effects
Serious 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 experience 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
Urination problems, such as:
+ Trouble passing urine
+ Pain while passing urine
+ 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
Skin color changes
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. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that concern you or do not go away, contact your doctor or seek medical help:
Headache
Acne
Diarrhea
Mood swings
Fatigue or weakness
Sleep disturbances
* Irritation at the site of application
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience 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
Urination problems, such as:
+ Trouble passing urine
+ Pain while passing urine
+ 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
Skin color changes
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. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that concern you or do not go away, contact your doctor or seek medical help:
Headache
Acne
Diarrhea
Mood swings
Fatigue or weakness
Sleep disturbances
* Irritation at the site of application
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 virilization in women or children (e.g., new or increased body hair, deepening voice, enlarged clitoris, male pattern baldness, acne, changes in menstrual periods). Seek immediate medical attention if these occur in someone exposed to the gel.
- Signs of polycythemia (e.g., dizziness, headache, fatigue, shortness of breath, redness of skin).
- Signs of fluid retention (e.g., swelling in ankles, feet, or hands; sudden weight gain).
- Signs of prostate problems (e.g., difficulty urinating, frequent urination, weak urine stream).
- Signs of liver problems (e.g., yellowing of skin or eyes, dark urine, unusual tiredness, nausea, vomiting, abdominal pain).
- Chest pain, shortness of breath, or leg pain/swelling (may indicate blood clots or cardiovascular events).
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 allergic reaction 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 is not an exhaustive list of all potential interactions. Therefore, it is crucial to inform your doctor and pharmacist about all the medications you are taking (including prescription and over-the-counter drugs, natural products, and vitamins) and any health problems you have. This will help ensure your safety while taking this medication. Never start, stop, or change the dosage of any medication without first consulting 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 allergic reaction 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 is not an exhaustive list of all potential interactions. Therefore, it is crucial to inform your doctor and pharmacist about all the medications you are taking (including prescription and over-the-counter drugs, natural products, and vitamins) and any health problems you have. This will help ensure your safety while taking this medication. Never start, stop, or change the dosage of any medication without first consulting your doctor.
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 associated with this medication. Discuss this with your doctor.
Men with an enlarged prostate should be aware that their symptoms may worsen while using this drug. If this occurs, contact your doctor promptly.
Individuals with sleep apnea should consult their doctor, as this condition may deteriorate in people using testosterone.
This medication can cause high blood pressure. Follow your doctor's instructions for regular blood pressure checks. High blood pressure can increase the risk of heart attack, stroke, or death from heart disease. If you have pre-existing high blood pressure or heart disease, discuss this with your doctor.
Treatment with this medication may lead to elevated cholesterol and triglyceride levels. The impact of these changes on heart health is not fully understood. Consult your doctor to discuss this further.
Regularly undergo blood work and other laboratory tests as advised by your doctor. This medication may interfere with certain lab tests, so inform all your healthcare providers and laboratory personnel that you are taking this drug.
There is a risk of blood clots associated with this medication. If you have a history of blood clots, inform your doctor and discuss this further.
This medication is an anabolic steroid, and anabolic steroid abuse 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. Immediately contact your doctor if you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain.
If a child or female accidentally comes into contact with the gel or solution, they may experience adverse effects. In children, these can include aggressive behavior, enlarged sex organs, and premature pubic hair growth. In females, symptoms may include a deepened voice, changes in body hair, or acne. If this occurs, contact your doctor promptly. If a pregnant woman is exposed to the gel or solution, seek medical attention immediately.
Older adults (65 years and above) should use this medication with caution, as they may be more susceptible to side effects.
This medication is not approved for treating low testosterone levels caused by aging. Discuss this with your doctor.
High doses of this medication can affect sperm production in males and potentially impact fertility. This effect may be irreversible even after stopping the medication. If you have concerns, consult your doctor.
If you have diabetes, you will need to closely monitor your blood sugar levels.
There may be an increased risk of developing prostate cancer associated with this medication. Discuss this with your doctor.
Men with an enlarged prostate should be aware that their symptoms may worsen while using this drug. If this occurs, contact your doctor promptly.
Individuals with sleep apnea should consult their doctor, as this condition may deteriorate in people using testosterone.
This medication can cause high blood pressure. Follow your doctor's instructions for regular blood pressure checks. High blood pressure can increase the risk of heart attack, stroke, or death from heart disease. If you have pre-existing high blood pressure or heart disease, discuss this with your doctor.
Treatment with this medication may lead to elevated cholesterol and triglyceride levels. The impact of these changes on heart health is not fully understood. Consult your doctor to discuss this further.
Regularly undergo blood work and other laboratory tests as advised by your doctor. This medication may interfere with certain lab tests, so inform all your healthcare providers and laboratory personnel that you are taking this drug.
There is a risk of blood clots associated with this medication. If you have a history of blood clots, inform your doctor and discuss this further.
This medication is an anabolic steroid, and anabolic steroid abuse 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. Immediately contact your doctor if you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain.
If a child or female accidentally comes into contact with the gel or solution, they may experience adverse effects. In children, these can include aggressive behavior, enlarged sex organs, and premature pubic hair growth. In females, symptoms may include a deepened voice, changes in body hair, or acne. If this occurs, contact your doctor promptly. If a pregnant woman is exposed to the gel or solution, seek medical attention immediately.
Older adults (65 years and above) should use this medication with caution, as they may be more susceptible to side effects.
This medication is not approved for treating low testosterone levels caused by aging. Discuss this with your doctor.
High doses of this medication can affect sperm production in males and potentially impact fertility. This effect may be irreversible even after stopping the medication. If you have concerns, consult your doctor.
Overdose Information
Overdose Symptoms:
- Priapism (prolonged, painful erection)
- Virilization (in women/children)
- Polycythemia (excess red blood cells)
- Fluid retention (edema)
- Mood changes (e.g., irritability, aggression)
What to Do:
Discontinue medication. Provide symptomatic and supportive care. Contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Major Interactions
- Oral Anticoagulants (e.g., Warfarin): May increase anticoagulant activity, requiring dose reduction of the anticoagulant.
- Corticosteroids (e.g., Prednisone): Increased risk of edema, especially in patients with cardiac, renal, or hepatic disease.
- Insulin and Oral Hypoglycemics: May decrease blood glucose, requiring dose adjustment of antidiabetic agents.
Moderate Interactions
- ACTH: Increased risk of edema.
- Bupropion: Theoretical increased risk of seizures (based on testosterone's effect on seizure threshold).
Monitoring
Baseline Monitoring
Serum Testosterone (total and free)
Rationale: To confirm diagnosis of hypogonadism and establish baseline levels.
Timing: Prior to initiation of therapy (at least two morning measurements).
Hematocrit (Hct) and Hemoglobin (Hb)
Rationale: To assess for polycythemia risk.
Timing: Prior to initiation of therapy.
Prostate-Specific Antigen (PSA)
Rationale: For prostate cancer screening, especially in men over 40-50 years.
Timing: Prior to initiation of therapy.
Lipid Panel
Rationale: To assess cardiovascular risk factors.
Timing: Prior to initiation of therapy.
Liver Function Tests (LFTs)
Rationale: To assess baseline liver function, especially if hepatic impairment is suspected.
Timing: Prior to initiation of therapy.
Routine Monitoring
Serum Testosterone (total)
Frequency: 2-4 weeks after initiation or dose adjustment, then every 3-6 months.
Target: 300-1000 ng/dL (or age-appropriate normal range, measured approximately 2-4 hours after application).
Action Threshold: If consistently above target range, reduce dose or discontinue. If consistently below, consider dose increase or alternative therapy.
Hematocrit (Hct)
Frequency: At 3-6 months, then annually.
Target: <54%
Action Threshold: If Hct > 50%, reduce dose. If Hct > 54%, discontinue therapy until Hct decreases, then reinitiate at a lower dose.
Prostate-Specific Antigen (PSA)
Frequency: Annually for men > 40 years with risk factors or > 50 years.
Target: Age-appropriate normal range.
Action Threshold: Refer to urologist if significant increase from baseline, abnormal digital rectal exam (DRE), or PSA > 4 ng/mL (or > 3 ng/mL in high-risk patients).
Lipid Panel
Frequency: Annually.
Target: Normal lipid profile.
Action Threshold: Manage dyslipidemia according to clinical guidelines.
Blood Pressure
Frequency: Routinely.
Target: Normal blood pressure.
Action Threshold: Manage hypertension according to clinical guidelines.
Symptom Monitoring
- Signs of virilization (e.g., hirsutism, voice deepening, clitoromegaly in women/children from secondary exposure)
- Signs of polycythemia (e.g., dizziness, headache, fatigue, shortness of breath)
- Signs of fluid retention (e.g., edema, weight gain)
- Signs of prostate issues (e.g., urinary hesitancy, frequency, urgency, nocturia)
- Mood changes, irritability, aggression
- Sleep apnea (worsening or new onset)
- Gynecomastia
- Application site reactions (e.g., irritation, rash)
Special Patient Groups
Pregnancy
Contraindicated. Testosterone is teratogenic and can cause virilization of a female fetus.
Trimester-Specific Risks:
First Trimester:
High risk of virilization of female fetus.
Second Trimester:
High risk of virilization of female fetus.
Third Trimester:
High risk of virilization of female fetus.
Lactation
Contraindicated. It is unknown if testosterone is excreted in human milk, but due to the potential for serious adverse reactions in a nursing infant (e.g., virilization), use is not recommended.
Infant Risk:
High risk of virilization and other adverse effects.
Pediatric Use
Not indicated for pediatric use. Safety and efficacy have not been established. Use in children can cause premature epiphyseal closure and precocious puberty. Contraindicated in males with hypogonadism prior to puberty.
Geriatric Use
Use with caution. Older men may be at increased risk for prostate enlargement (BPH) and prostate cancer. Close monitoring of PSA and hematocrit is recommended. Increased risk of cardiovascular events and fluid retention.
Clinical Information
Clinical Pearls
- Emphasize strict adherence to application instructions to prevent secondary exposure to women and children, which is a Black Box Warning.
- Patients should wash hands thoroughly after application and cover the application site with clothing once dry.
- Not for use in women; can cause irreversible virilization.
- Regular monitoring of serum testosterone, hematocrit, and PSA is crucial for safe and effective therapy.
- Educate patients on signs of polycythemia, fluid retention, and prostate issues, and when to seek medical attention.
- Consider alternative formulations (e.g., injections, patches) if adherence to topical application or concerns about secondary exposure are significant.
Alternative Therapies
- Lifestyle modifications (e.g., diet, exercise, weight loss)
- Addressing underlying causes of hypogonadism (e.g., pituitary disorders)
- Gonadotropin therapy (e.g., hCG) for men with secondary hypogonadism who desire fertility.
Cost & Coverage
Average Cost:
Highly variable, typically $300-$600 per 30-day supply
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand), generic often Tier 1.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial resource 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, we encourage you to discuss them with 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 detailed information, including the substance taken, the amount, and the time it occurred.