Vogelxo 1%(50mg/5gm)gel 5gm Pkt
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
May 2014
DEA Schedule
Schedule III
Overview
What is this medicine?
Vogelxo is a gel containing testosterone, a male hormone. It's used to treat men who have low testosterone levels due to certain medical conditions. You apply it to your skin, and it helps restore your testosterone levels, which can improve symptoms like low energy, reduced 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. 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 before the first use, following the instructions in the package insert.
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 instructions in the package insert.
Storage and Disposal
To maintain the medication's effectiveness and safety:
Store it at room temperature, avoiding freezing temperatures.
Keep it in a dry place, away from bathrooms and heat sources, such as open flames.
* Protect the medication from heat and open flames.
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 dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses to make up for the missed one.
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 before the first use, following the instructions in the package insert.
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 instructions in the package insert.
Storage and Disposal
To maintain the medication's effectiveness and safety:
Store it at room temperature, avoiding freezing temperatures.
Keep it in a dry place, away from bathrooms and heat sources, such as open flames.
* Protect the medication from heat and open flames.
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 dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses to make up for the 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 your 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.
- To prevent transfer to others, wear clothing that covers the application site. If skin-to-skin contact is anticipated, wash the application site thoroughly with soap and water beforehand.
- Store the gel at room temperature, away from moisture and heat. Keep out of reach of children and pets.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
50 mg (one 5 gm packet) applied once daily to clean, dry, intact skin of the shoulders, upper arms, or abdomen.
Dose Range:
50 - 100 mg
Condition-Specific Dosing:
initialDose:
50 mg once daily
doseAdjustment:
Based on serum testosterone levels and clinical response. May be increased to 75 mg or 100 mg daily. Maximum recommended dose is 100 mg daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in males younger than 18 years of age)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution. Monitor for fluid retention.
Dialysis:
Considerations: Use with caution, monitor for fluid retention and adverse effects.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution. Monitor liver function.
Severe:
Contraindicated in severe hepatic impairment due to potential for exacerbation of liver dysfunction and fluid retention.
Pharmacology
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, where it is converted to dihydrotestosterone (DHT) by 5-alpha reductase, or aromatized to estradiol by aromatase. Both testosterone and DHT bind to the androgen receptor, activating gene transcription and protein synthesis.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 9-14% (transdermal absorption varies)
Tmax:
Approximately 4-5 hours after application
FoodEffect:
Not applicable for transdermal gel
Distribution:
Vd:
Approximately 1 L/kg
ProteinBinding:
Approximately 98% (to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration:
Limited (testosterone crosses the blood-brain barrier, but its direct effects on CNS are complex)
Elimination:
HalfLife:
Approximately 10-100 minutes (endogenous testosterone); for transdermal, effective half-life is longer due to reservoir effect in skin, leading to sustained levels.
Clearance:
Approximately 1.2 L/min
ExcretionRoute:
Approximately 90% in urine (as conjugates of testosterone and its metabolites), 6% in feces (unconjugated metabolites)
Unchanged:
Less than 6% (in urine)
Pharmacodynamics
OnsetOfAction:
Within days to weeks for clinical effects (e.g., libido, energy); serum levels stabilize within 1-2 weeks.
PeakEffect:
Serum testosterone levels typically reach steady state within 14 days of daily application.
DurationOfAction:
Daily application maintains therapeutic levels.
Safety & Warnings
BLACK BOX WARNING
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE AND VENOUS THROMBOEMBOLISM (VTE)
**Secondary Exposure:** Virilization in children and women can occur following secondary exposure to testosterone gel. Cases of secondary exposure have been reported with testosterone topical gel products, including cases in children. Healthcare providers should advise patients to strictly adhere to recommended instructions for use, especially regarding application site, hand washing, and clothing to prevent secondary exposure.
**Venous Thromboembolism (VTE):** Cases of VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone products. Evaluate patients with symptoms of VTE. If a VTE is suspected, discontinue testosterone therapy and initiate appropriate workup and management.
**Secondary Exposure:** Virilization in children and women can occur following secondary exposure to testosterone gel. Cases of secondary exposure have been reported with testosterone topical gel products, including cases in children. Healthcare providers should advise patients to strictly adhere to recommended instructions for use, especially regarding application site, hand washing, and clothing to prevent secondary exposure.
**Venous Thromboembolism (VTE):** Cases of VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone products. Evaluate patients with symptoms of VTE. If a VTE is suspected, discontinue testosterone therapy and initiate appropriate workup and management.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediate medical attention:
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 during sleep
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 advice:
Headache
Acne
Diarrhea
Emotional changes
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, 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.
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 immediate medical attention:
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 during sleep
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 advice:
Headache
Acne
Diarrhea
Emotional changes
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, 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 virilization in women or children (e.g., new or increased body hair, deepening voice, acne, changes in menstrual periods, enlarged clitoris in females; enlarged penis/clitoris, pubic hair, increased erections/libido, aggressive behavior in children). Seek immediate medical attention if these occur.
- Signs of prostate problems (e.g., difficulty urinating, frequent urination, weak urine stream, blood in urine).
- Signs of blood clots (e.g., sudden chest pain, shortness of breath, pain/swelling in leg, redness/warmth in leg). Seek immediate medical attention.
- Signs of fluid retention (e.g., swelling in ankles or feet, sudden weight gain).
- Signs of liver problems (e.g., yellowing of skin or eyes, dark urine, severe stomach pain, unusual tiredness).
- Changes in mood, aggression, or irritability.
- Worsening of sleep apnea (loud snoring, pauses in breathing during sleep).
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, such as foods or drugs. 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, including 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, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems, to your doctor and pharmacist. This will enable them to assess the safety of taking this medication in conjunction with your other treatments and health conditions. Never start, stop, or modify 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, such as foods or drugs. 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, including 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, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems, to your doctor and pharmacist. This will enable them to assess the safety of taking this medication in conjunction with your other treatments and health conditions. Never start, stop, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Diabetes Management
If you have high blood sugar (diabetes), you will need to closely monitor your blood sugar levels while taking this medication.
Prostate Cancer Risk
There may be an increased risk of prostate cancer associated with this medication. Discuss this risk with your doctor.
Enlarged Prostate
If you have an enlarged prostate, your symptoms may worsen while taking this medication. Contact your doctor if you experience any changes.
Sleep Apnea
If you have sleep apnea, consult with your doctor, as this medication may exacerbate the condition.
Blood Pressure Monitoring
High blood pressure has been reported with this medication. Follow your doctor's instructions for regular blood pressure checks. Elevated blood pressure can increase the risk of heart attack, stroke, or death from heart disease. If you have high blood pressure or heart disease, discuss this with your doctor.
Cholesterol and Triglyceride Changes
Treatment with this medication may lead to increased cholesterol and triglyceride levels. The impact of these changes on heart health is unknown. Discuss this with your doctor.
Lab Tests and Monitoring
Regularly have your blood work and other lab tests checked as directed by your doctor. This medication may affect certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this medication.
Blood Clots
Blood clots have been reported with this medication. If you have a history of blood clots, inform your doctor.
Anabolic Steroid Abuse
This medication is an anabolic steroid, which has been associated with abuse and misuse. Anabolic steroid abuse can lead to dependence and severe health problems, including heart or blood vessel problems, stroke, liver problems, and mental or mood disorders. Discuss this with your doctor.
High Calcium Levels
In some individuals with cancer, high calcium levels have been reported with medications like this one. Seek medical attention immediately if you experience symptoms of high calcium levels, such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain.
Accidental Exposure
If a child or female accidentally comes into contact with the gel or solution, they may experience adverse effects. In children, these effects include aggressive behavior, enlarged sex organs, and premature pubic hair growth. In females, these effects include a deep voice, changes in body hair, or acne. If someone who is pregnant touches the gel or solution, contact your doctor immediately.
Geriatric Use
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Low Testosterone Levels
This medication is not approved for treating low testosterone levels caused by aging. Discuss this with your doctor.
Reproductive Effects
High doses of this medication may affect sperm production in males and potentially impact fertility. If you have concerns, discuss this with your doctor.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Diabetes Management
If you have high blood sugar (diabetes), you will need to closely monitor your blood sugar levels while taking this medication.
Prostate Cancer Risk
There may be an increased risk of prostate cancer associated with this medication. Discuss this risk with your doctor.
Enlarged Prostate
If you have an enlarged prostate, your symptoms may worsen while taking this medication. Contact your doctor if you experience any changes.
Sleep Apnea
If you have sleep apnea, consult with your doctor, as this medication may exacerbate the condition.
Blood Pressure Monitoring
High blood pressure has been reported with this medication. Follow your doctor's instructions for regular blood pressure checks. Elevated blood pressure can increase the risk of heart attack, stroke, or death from heart disease. If you have high blood pressure or heart disease, discuss this with your doctor.
Cholesterol and Triglyceride Changes
Treatment with this medication may lead to increased cholesterol and triglyceride levels. The impact of these changes on heart health is unknown. Discuss this with your doctor.
Lab Tests and Monitoring
Regularly have your blood work and other lab tests checked as directed by your doctor. This medication may affect certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this medication.
Blood Clots
Blood clots have been reported with this medication. If you have a history of blood clots, inform your doctor.
Anabolic Steroid Abuse
This medication is an anabolic steroid, which has been associated with abuse and misuse. Anabolic steroid abuse can lead to dependence and severe health problems, including heart or blood vessel problems, stroke, liver problems, and mental or mood disorders. Discuss this with your doctor.
High Calcium Levels
In some individuals with cancer, high calcium levels have been reported with medications like this one. Seek medical attention immediately if you experience symptoms of high calcium levels, such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain.
Accidental Exposure
If a child or female accidentally comes into contact with the gel or solution, they may experience adverse effects. In children, these effects include aggressive behavior, enlarged sex organs, and premature pubic hair growth. In females, these effects include a deep voice, changes in body hair, or acne. If someone who is pregnant touches the gel or solution, contact your doctor immediately.
Geriatric Use
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Low Testosterone Levels
This medication is not approved for treating low testosterone levels caused by aging. Discuss this with your doctor.
Reproductive Effects
High doses of this medication may affect sperm production in males and potentially impact fertility. If you have concerns, discuss this with your doctor.
Overdose Information
Overdose Symptoms:
- Symptoms of overdose are generally not expected with topical application due to limited absorption and feedback mechanisms. However, excessively high levels could lead to exaggerated adverse effects such as polycythemia, fluid retention, or virilization.
What to Do:
Discontinue the medication. Symptomatic and supportive treatment should be provided. Contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention if severe symptoms occur.
Drug Interactions
Contraindicated Interactions
- Pregnant women (due to risk of virilization of female fetus)
- Breastfeeding women (due to risk of virilization of infant)
Major Interactions
- Oral anticoagulants (e.g., warfarin): May increase anticoagulant activity, leading to increased risk of bleeding. Monitor INR/PT closely.
- Corticosteroids (e.g., prednisone): Concomitant use may increase the risk of fluid retention and edema, especially in patients with cardiac, hepatic, or renal disease.
- Insulin and other antidiabetic agents: Androgens may decrease blood glucose and insulin requirements. Monitor blood glucose and adjust antidiabetic therapy as needed.
Moderate Interactions
- Thyroid hormones: Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged. Clinical significance is usually minimal, but monitor thyroid function if symptoms arise.
- Immunosuppressants (e.g., cyclosporine): Testosterone may increase cyclosporine levels. Monitor cyclosporine levels.
Minor Interactions
- Diuretics: May increase risk of fluid retention when used with testosterone.
Monitoring
Baseline Monitoring
Serum Testosterone (total and free)
Rationale: To confirm diagnosis of hypogonadism and establish baseline for treatment efficacy.
Timing: Before initiation of therapy (morning levels, typically two measurements on separate days).
Hematocrit (Hct) and Hemoglobin (Hgb)
Rationale: Testosterone therapy can stimulate erythropoiesis, leading to polycythemia/erythrocytosis.
Timing: Before initiation of therapy.
Prostate-Specific Antigen (PSA)
Rationale: To screen for prostate cancer and benign prostatic hyperplasia (BPH), as testosterone can stimulate prostate growth.
Timing: Before initiation of therapy (in men âĨ40 years with BPH or âĨ50 years without BPH).
Digital Rectal Exam (DRE)
Rationale: To screen for prostate abnormalities.
Timing: Before initiation of therapy (in men âĨ40 years with BPH or âĨ50 years without BPH).
Lipid Panel (Total Cholesterol, HDL, LDL, Triglycerides)
Rationale: Testosterone therapy may affect lipid profiles.
Timing: Before initiation of therapy.
Liver Function Tests (LFTs)
Rationale: To assess baseline liver function, especially in patients with pre-existing hepatic conditions.
Timing: Before initiation of therapy.
Routine Monitoring
Serum Testosterone (total)
Frequency: Approximately 14 days after initiation or dose adjustment, then periodically (e.g., every 3-6 months) once stable.
Target: 300-1000 ng/dL (or within the mid-normal range for healthy young men)
Action Threshold: If levels are consistently above 1000 ng/dL, reduce dose or discontinue. If levels are consistently below 300 ng/dL, consider dose increase.
Hematocrit (Hct)
Frequency: At 3 months, then annually.
Target: <54%
Action Threshold: If Hct >54%, discontinue therapy until Hct decreases, then restart at a lower dose or consider phlebotomy.
Prostate-Specific Antigen (PSA) and Digital Rectal Exam (DRE)
Frequency: At 3-6 months, then annually (or as clinically indicated based on age and risk factors).
Target: Stable or within normal limits for age.
Action Threshold: Significant increase in PSA or abnormal DRE warrants further urological evaluation.
Lipid Panel
Frequency: Annually or as clinically indicated.
Target: Within normal limits.
Action Threshold: Significant adverse changes may require intervention or re-evaluation of therapy.
Liver Function Tests (LFTs)
Frequency: Periodically, especially if signs of hepatic dysfunction or in patients with pre-existing liver conditions.
Target: Within normal limits.
Action Threshold: Significant elevations warrant investigation and potential discontinuation.
Symptom Monitoring
- Signs of virilization in women or children (e.g., voice deepening, hirsutism, clitoromegaly, premature puberty)
- Signs of prostate enlargement (e.g., urinary hesitancy, frequency, nocturia, decreased stream)
- Signs of fluid retention (e.g., edema, weight gain, worsening heart failure)
- Signs of cardiovascular events (e.g., chest pain, shortness of breath, leg pain/swelling suggestive of DVT/PE, stroke symptoms)
- Mood changes, aggression, irritability
- Sleep apnea (worsening or new onset)
- Breast tenderness or enlargement (gynecomastia)
Special Patient Groups
Pregnancy
Contraindicated in pregnant women. Testosterone can cause virilization of a female fetus, leading to ambiguous genitalia, clitoral enlargement, and fusion of the labia. Pregnant women should avoid contact with Vogelxo application sites.
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 in breastfeeding women. It is unknown if testosterone is excreted in human milk. However, due to the potential for serious adverse reactions in the breastfed infant (e.g., virilization), use is contraindicated.
Infant Risk:
High risk of virilization and other adverse effects.
Pediatric Use
Not indicated for use in pediatric patients. Safety and efficacy have not been established. Use in children could lead to premature epiphyseal closure and precocious puberty.
Geriatric Use
Use with caution in elderly men. Increased risk of prostate enlargement (BPH) and prostate cancer. Increased risk of cardiovascular events and fluid retention. Close monitoring of PSA, DRE, Hct, and cardiovascular status is recommended.
Clinical Information
Clinical Pearls
- Emphasize strict adherence to application instructions and precautions to prevent secondary exposure, especially to women and children. This is a critical safety point.
- Remind patients that the gel must be applied to clean, dry, intact skin and allowed to dry completely before dressing or contact with others.
- Stress the importance of regular monitoring of testosterone levels, hematocrit, and prostate health (PSA, DRE) as directed by their healthcare provider.
- Educate patients on the signs and symptoms of potential adverse effects, such as polycythemia, fluid retention, prostate issues, and cardiovascular events, and when to seek medical attention.
- Advise patients that clinical response to testosterone therapy may take several weeks to months to become apparent.
Alternative Therapies
- Other testosterone formulations (e.g., injectable testosterone esters like testosterone cypionate/enanthate, testosterone transdermal patches, testosterone buccal systems, testosterone nasal gel, testosterone subcutaneous pellets)
- For hypogonadism not requiring testosterone replacement: Lifestyle modifications (diet, exercise, weight loss), management of underlying conditions (e.g., pituitary disorders), GnRH pulsatile therapy (for hypogonadotropic hypogonadism with fertility desire).
Cost & Coverage
Average Cost:
Varies, typically $300-$600 per 30 packets (50mg/5gm)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (varies by insurance plan)
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 for guidance. 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 quantity, and the time it occurred.