Jatenzo 198mg Capsules
WARNING: High blood pressure has happened with this drug. Have your blood pressure checked as you have been told by your doctor.High blood pressure can raise the chance of heart attack, stroke, or death from heart disease. If you have high blood pressure or heart disease, talk with your doctor. @ COMMON USES: It is used to treat low testosterone levels.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Androgen
Pharmacologic Class
Androgen receptor agonist
Pregnancy Category
Category X
FDA Approved
Mar 2019
DEA Schedule
Schedule III
Overview
What is this medicine?
Jatenzo is a medication containing testosterone, a male hormone. It is used to treat adult men who have low testosterone levels due to certain medical conditions. It helps restore testosterone levels to normal, which can improve symptoms like low energy, low sex drive, and muscle weakness. It is taken by mouth as a capsule, always with food.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take this medication with food as directed.
Storing and Disposing of Your Medication
Keep this medication at room temperature in a dry place, avoiding storage in a bathroom. Store it in a secure location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist, who may be aware of local drug take-back programs.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take this medication with food as directed.
Storing and Disposing of Your Medication
Keep this medication at room temperature in a dry place, avoiding storage in a bathroom. Store it in a secure location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist, who may be aware of local drug take-back programs.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Always take Jatenzo with food, preferably a meal containing fat, to ensure proper absorption.
- Do not crush, chew, or dissolve the capsules; swallow them whole.
- Keep all appointments with your doctor for blood tests and check-ups to monitor your testosterone levels, blood count, prostate health, and blood pressure.
- Report any new or worsening symptoms, especially swelling in ankles/feet, shortness of breath, chest pain, or changes in urination.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose: 237 mg orally twice daily with food. Maintenance dose: 198 mg to 396 mg orally twice daily with food, based on testosterone levels and clinical response.
Dose Range:
198 - 396 mg
Condition-Specific Dosing:
Hypogonadism:
Initial: 237 mg twice daily. Adjust to 198 mg to 396 mg twice daily to maintain testosterone levels within the normal range (300-1000 ng/dL).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor for fluid retention.
Moderate:
No specific dose adjustment recommended, but monitor for fluid retention.
Severe:
Use with caution; monitor for fluid retention and adverse effects.
Dialysis:
Not available; use with caution and monitor closely.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
Use with caution; monitor for adverse effects.
Severe:
Contraindicated due to potential for exacerbation of hepatic dysfunction and fluid retention.
Pharmacology
Mechanism of Action
Testosterone is an endogenous androgen. Testosterone undecanoate is a prodrug of testosterone. After oral administration, it is absorbed and converted to testosterone. Testosterone acts on androgen receptors in target tissues to promote the development and maintenance of male primary and secondary sexual characteristics. It also affects erythropoiesis, bone density, lipid metabolism, and prostate growth.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable, significantly increased when taken with food (especially high-fat meals).
Tmax:
Approximately 4-5 hours (for testosterone after Jatenzo administration with food).
FoodEffect:
Absorption is significantly increased (up to 5-fold) when taken with food, particularly high-fat meals. Must be taken with food.
Distribution:
Vd:
Approximately 1 L/kg (for testosterone).
ProteinBinding:
Approximately 98% (to sex hormone-binding globulin [SHBG] and albumin).
CnssPenetration:
Limited, but testosterone and its metabolites can cross the blood-brain barrier.
Elimination:
HalfLife:
Approximately 15-20 hours (for testosterone after Jatenzo administration).
Clearance:
Approximately 13 mL/min/kg (for testosterone).
ExcretionRoute:
Mainly urine (90%) as conjugates of testosterone and its metabolites; feces (6%) as unconjugated metabolites.
Unchanged:
Less than 6% (excreted unchanged in urine).
Pharmacodynamics
OnsetOfAction:
Gradual, clinical effects typically seen within weeks to months.
PeakEffect:
Steady-state testosterone levels usually achieved within 7 days of twice-daily dosing.
DurationOfAction:
Maintains therapeutic testosterone levels with twice-daily dosing.
Safety & Warnings
BLACK BOX WARNING
Increases in blood pressure, which can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death. Before initiating Jatenzo, consider the patient's baseline cardiovascular risk and ensure blood pressure is adequately controlled. Periodically monitor blood pressure during Jatenzo treatment and treat new or worsening hypertension.
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 medical attention immediately:
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
+ 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. 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 symptoms that bother you or persist, contact your doctor:
Headache
Diarrhea
Heartburn
Burping
This list is not exhaustive. If you have questions or concerns about side effects, 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 medical attention immediately:
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
+ 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. 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 symptoms that bother you or persist, contact your doctor:
Headache
Diarrhea
Heartburn
Burping
This list is not exhaustive. If you have questions or concerns about side effects, 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:
- Swelling of the ankles, feet, or hands (fluid retention)
- Difficulty breathing, especially at night (sleep apnea exacerbation)
- Chest pain, shortness of breath, or discomfort in the arm/jaw (signs of heart problems)
- Sudden weakness or numbness on one side of the body, sudden severe headache, or vision changes (signs of stroke)
- Changes in urination, such as increased frequency, urgency, or difficulty urinating (prostate issues)
- Yellowing of the skin or eyes, dark urine, severe stomach pain (liver problems)
- Unexplained weight gain
- Mood changes, aggression, or irritability
- Pain or swelling in the legs (blood clot)
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 conditions to ensure safe treatment:
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 of the following health conditions: heart disease, kidney disease, or liver disease.
Additionally, please note the following:
This medication is not approved for use in females, as it may harm an unborn baby if taken during pregnancy. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss this with your doctor.
This medication is not suitable for children. Do not administer it to a child.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
* Any health problems you have.
Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
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 of the following health conditions: heart disease, kidney disease, or liver disease.
Additionally, please note the following:
This medication is not approved for use in females, as it may harm an unborn baby if taken during pregnancy. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss this with your doctor.
This medication is not suitable for children. Do not administer it to a child.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
* Any health problems you have.
Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose 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, it is crucial to closely monitor your blood sugar levels.
There may be an increased risk of developing prostate cancer associated with this medication. Discuss this potential risk with your doctor.
Men with an enlarged prostate should be aware that their symptoms may worsen while using this drug. If you experience any worsening of symptoms, contact your doctor promptly.
Individuals with sleep apnea should consult their doctor, as this condition may be exacerbated by testosterone treatment.
Treatment with this medication may lead to elevated cholesterol and triglyceride levels. Although the impact of these changes on heart health is not fully understood, it is essential to discuss this with your doctor.
Regular blood work and other laboratory tests, as directed by your doctor, are necessary to monitor your health while taking this medication.
Additionally, inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect the results of certain lab tests.
Be aware that blood clots have been reported in individuals taking this medication. If you have a history of blood clots, notify your doctor and discuss the potential risks.
This medication is classified as an anabolic steroid, and the 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 potential risks and consequences with your doctor.
In some individuals with cancer, medications like this one have been associated with elevated calcium levels. If you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain, contact your doctor immediately.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
It is essential to note that this medication is not approved for treating low testosterone levels caused by aging. Discuss the potential benefits and risks with your doctor.
Large doses of this medication may affect sperm production in males, potentially impacting fertility. This effect may be irreversible, even after discontinuing the medication. If you have concerns, consult your doctor.
If you have diabetes, it is crucial to closely monitor your blood sugar levels.
There may be an increased risk of developing prostate cancer associated with this medication. Discuss this potential risk with your doctor.
Men with an enlarged prostate should be aware that their symptoms may worsen while using this drug. If you experience any worsening of symptoms, contact your doctor promptly.
Individuals with sleep apnea should consult their doctor, as this condition may be exacerbated by testosterone treatment.
Treatment with this medication may lead to elevated cholesterol and triglyceride levels. Although the impact of these changes on heart health is not fully understood, it is essential to discuss this with your doctor.
Regular blood work and other laboratory tests, as directed by your doctor, are necessary to monitor your health while taking this medication.
Additionally, inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect the results of certain lab tests.
Be aware that blood clots have been reported in individuals taking this medication. If you have a history of blood clots, notify your doctor and discuss the potential risks.
This medication is classified as an anabolic steroid, and the 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 potential risks and consequences with your doctor.
In some individuals with cancer, medications like this one have been associated with elevated calcium levels. If you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain, contact your doctor immediately.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
It is essential to note that this medication is not approved for treating low testosterone levels caused by aging. Discuss the potential benefits and risks with your doctor.
Large doses of this medication may affect sperm production in males, potentially impacting fertility. This effect may be irreversible, even after discontinuing the medication. If you have concerns, consult your doctor.
Overdose Information
Overdose Symptoms:
- Priapism (prolonged, painful erection)
- Fluid retention (edema)
- Polycythemia (excess red blood cells)
- Irritability or aggression
What to Do:
Discontinue Jatenzo and provide symptomatic and supportive care. Contact a poison control center immediately (Call 1-800-222-1222 in the US).
Drug Interactions
Major Interactions
- Anticoagulants (e.g., warfarin): May increase anticoagulant activity, leading to increased risk of bleeding. Monitor INR/PT closely.
- Corticosteroids: Concomitant use may increase the risk of edema.
Moderate Interactions
- Insulin and oral hypoglycemics: Androgens may decrease blood glucose levels, requiring adjustment of antidiabetic medication dosage.
- Adrenocorticotropic hormone (ACTH): May increase risk of edema.
- Thyroid hormones: May decrease serum concentrations of thyroxine-binding globulin, leading to decreased total T4 levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged.
Minor Interactions
- Immunosuppressants (e.g., cyclosporine): May increase cyclosporine levels.
Monitoring
Baseline Monitoring
Serum Testosterone (total and free)
Rationale: To confirm diagnosis of hypogonadism and establish baseline levels.
Timing: Prior to initiation of therapy.
Hematocrit (Hct)
Rationale: To assess for polycythemia, a common adverse 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.
Timing: Prior to initiation of therapy (in men âĨ40 years old or with risk factors).
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 hepatic function, especially given oral administration.
Timing: Prior to initiation of therapy.
Blood Pressure
Rationale: To establish baseline and monitor for hypertension, a potential adverse effect.
Timing: Prior to initiation of therapy.
Routine Monitoring
Serum Testosterone (total)
Frequency: Approximately 7 days after initiation or dose adjustment, then periodically (e.g., every 3-6 months) once stable.
Target: 300-1000 ng/dL (normal physiological range).
Action Threshold: If consistently above 1000 ng/dL or below 300 ng/dL, adjust dose.
Hematocrit (Hct)
Frequency: At 3 months, then annually or as clinically indicated.
Target: <54%
Action Threshold: If Hct âĨ54%, discontinue therapy until Hct decreases, then reinitiate at a lower dose or consider phlebotomy.
Prostate-Specific Antigen (PSA)
Frequency: At 3-6 months, then annually (in men âĨ40 years old or with risk factors).
Target: Stable or within normal limits for age.
Action Threshold: Significant increase from baseline or age-specific normal, or abnormal digital rectal exam (DRE), warrants 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.
Blood Pressure
Frequency: Regularly, especially during initial therapy and dose adjustments.
Target: Within normal limits.
Action Threshold: Significant increase or development of hypertension requires management and re-evaluation of therapy.
Symptom Monitoring
- Signs of virilization in women or children (e.g., voice deepening, hirsutism, clitoromegaly)
- Signs of fluid retention (e.g., edema, weight gain)
- Symptoms of benign prostatic hyperplasia (BPH) or prostate cancer (e.g., urinary frequency, urgency, nocturia, decreased stream)
- Symptoms of sleep apnea (e.g., snoring, daytime somnolence)
- Mood changes, irritability, aggression
- Signs of cardiovascular events (e.g., chest pain, shortness of breath, leg swelling)
- Signs of liver dysfunction (e.g., jaundice, dark urine, abdominal pain)
Special Patient Groups
Pregnancy
Contraindicated in pregnant women. Testosterone can cause virilization of the female fetus, including clitoral enlargement, abnormal vaginal development, and fusion of the labia.
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, including virilization, Jatenzo is contraindicated during lactation.
Infant Risk:
High risk of virilization and other adverse effects.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Not indicated for use in pediatric patients. Use in children could cause premature epiphyseal closure and precocious puberty.
Geriatric Use
No specific dose adjustment is required based solely on age. However, geriatric patients may have an increased risk of prostate enlargement (BPH) and prostate cancer. Regular monitoring of PSA and DRE is crucial. Increased risk of cardiovascular events and fluid retention should also be considered.
Clinical Information
Clinical Pearls
- Jatenzo MUST be taken with food, specifically a meal containing fat, for adequate absorption. Taking it on an empty stomach will result in very low absorption and ineffective treatment.
- This oral testosterone formulation is designed to bypass first-pass hepatic metabolism, unlike older oral testosterone preparations, reducing the risk of hepatotoxicity.
- Patients should be educated on the importance of adherence to the twice-daily dosing schedule and the need for regular monitoring of testosterone levels, hematocrit, PSA, and blood pressure.
- The black box warning regarding blood pressure increases and cardiovascular risk is critical; baseline and ongoing blood pressure monitoring is essential.
- Jatenzo is indicated only for men with hypogonadism due to specific medical conditions, not for age-related decline in testosterone or for performance enhancement.
Alternative Therapies
- Testosterone topical gels (e.g., AndroGel, Testim, Fortesta, Vogelxo)
- Testosterone transdermal patches (e.g., Androderm)
- Testosterone buccal system (Striant)
- Testosterone subcutaneous pellets (Testopel)
- Testosterone injectable solutions (e.g., testosterone cypionate, testosterone enanthate, testosterone undecanoate)
Cost & Coverage
Average Cost:
Highly variable, typically $500-$1000+ per 120 capsules
Insurance Coverage:
Tier 2 or 3 (Specialty drug)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
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 name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
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 name of the medication taken, the amount consumed, and the time it occurred.