Jatenzo 237mg 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; Anabolic steroid
Pregnancy Category
Not applicable (Contraindicated in females)
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 (primary hypogonadism or hypogonadotropic hypogonadism). It helps restore testosterone levels to normal, which can improve symptoms like low energy, decreased sex drive, and muscle weakness.
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 your 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 drug take-back programs in your area.
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 your 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 drug take-back programs in your area.
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
- Take Jatenzo exactly as prescribed by your doctor, twice a day, with food. It is crucial to take it with a meal to ensure proper absorption.
- Do not crush, chew, or dissolve the capsules; swallow them whole.
- Regularly monitor your blood pressure at home as instructed by your doctor.
- Maintain a healthy lifestyle, including a balanced diet and regular exercise, to support overall cardiovascular health.
- Attend all scheduled doctor appointments and laboratory tests to monitor your testosterone levels, blood count, prostate health, and blood pressure.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose: 237 mg orally twice daily with food. Titrate based on serum testosterone levels.
Dose Range:
237 - 396 mg
Condition-Specific Dosing:
hypogonadism:
Initial dose 237 mg twice daily. Adjust dose based on pre-dose serum testosterone concentrations measured approximately 4 to 6 weeks after initiation or dose adjustment. The target testosterone range is 300-1000 ng/dL. Maximum dose is 396 mg twice daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in pediatric patients. Use in pediatric patients is not recommended.)
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.
Dialysis:
Not available
Hepatic 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.
Pharmacology
Mechanism of Action
Testosterone is an endogenous androgen. Androgens bind to androgen receptors in target tissues, regulating gene expression and influencing protein synthesis. In hypogonadal males, exogenous testosterone replaces deficient endogenous testosterone, promoting the development and maintenance of male primary and secondary sexual characteristics.
Pharmacokinetics
Absorption:
Bioavailability:
Variable, significantly increased when taken with food (especially high-fat meals).
Tmax:
Approximately 5-8 hours (for testosterone after Jatenzo).
FoodEffect:
Must be taken with food. Absorption is significantly increased when taken with a meal containing fat. Taking Jatenzo without food results in insufficient testosterone absorption.
Distribution:
Vd:
Approximately 1 L/kg (for testosterone).
ProteinBinding:
Approximately 98% (primarily to sex hormone-binding globulin [SHBG] and albumin).
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 12-15 hours (for testosterone after Jatenzo).
Clearance:
Not available
ExcretionRoute:
Primarily urine (approximately 90%) and feces (approximately 10%) as metabolites.
Unchanged:
Less than 6% of testosterone is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Therapeutic effects are gradual, typically observed over several weeks to months.
PeakEffect:
Peak serum testosterone levels occur approximately 5-8 hours post-dose.
DurationOfAction:
Sustained testosterone levels are maintained with twice-daily dosing.
Safety & Warnings
BLACK BOX WARNING
Jatenzo can cause blood pressure (BP) increases that 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 BP is adequately controlled. Periodically monitor BP during Jatenzo treatment and treat new-onset hypertension or exacerbations of pre-existing hypertension. Discontinue Jatenzo if BP remains uncontrolled.
Side Effects
Serious 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 experience 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
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
Signs of liver problems, including:
+ 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 attention:
Headache
Diarrhea
Heartburn
Burping
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 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
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
Signs of liver problems, including:
+ 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 attention:
Headache
Diarrhea
Heartburn
Burping
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:
- Sudden increase in blood pressure (e.g., severe headache, blurred vision)
- Signs of a heart attack (e.g., chest pain, shortness of breath, discomfort in other areas of the upper body)
- Signs of a stroke (e.g., sudden numbness or weakness, especially on one side of the body, sudden severe headache, sudden trouble seeing, sudden dizziness, loss of balance)
- Swelling in your ankles, feet, or hands (fluid retention)
- Difficulty urinating, frequent urination, or weak urine stream (signs of prostate enlargement)
- New or worsening sleep apnea (interrupted breathing during sleep)
- Changes in mood, aggression, or irritability
- Unexplained weight gain
- Yellowing of the skin or eyes (jaundice)
- Nausea, vomiting, or stomach pain
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. Describe the symptoms you experienced during an allergic reaction.
If you are a male with a history of breast or prostate cancer.
* Presence of certain health conditions, such as heart disease, kidney disease, or liver disease.
Female Patients:
This medication is not approved for use in females. 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.
Pediatric Considerations:
This medication is not intended for children. Do not administer this drug to a child.
Interactions with Other Medications and Health Conditions:
This is not an exhaustive list of all possible interactions. Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Verify that it is safe to take this medication with your existing medications and health conditions. Never start, stop, or change the dosage of any medication without 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. Describe the symptoms you experienced during an allergic reaction.
If you are a male with a history of breast or prostate cancer.
* Presence of certain health conditions, such as heart disease, kidney disease, or liver disease.
Female Patients:
This medication is not approved for use in females. 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.
Pediatric Considerations:
This medication is not intended for children. Do not administer this drug to a child.
Interactions with Other Medications and Health Conditions:
This is not an exhaustive list of all possible interactions. Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Verify that it is safe to take this medication with your existing medications and health conditions. Never start, stop, or change the dosage of any medication without 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 to understand the potential risks and benefits.
If you have an enlarged prostate, your symptoms may worsen while using this medication. If this occurs, contact your doctor promptly.
Individuals with sleep apnea should consult their doctor, as this condition may worsen with 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 crucial to discuss this with your doctor.
Adhere to your doctor's recommendations for regular blood work and other laboratory tests to ensure your safety while taking this medication.
Be aware that this medication may interfere with certain laboratory tests. 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, notify your doctor and discuss the potential risks.
This medication is classified as an anabolic steroid, which has been subject to abuse and misuse in the past. The misuse 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 and benefits 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.
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, 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 to understand the potential risks and benefits.
If you have an enlarged prostate, your symptoms may worsen while using this medication. If this occurs, contact your doctor promptly.
Individuals with sleep apnea should consult their doctor, as this condition may worsen with 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 crucial to discuss this with your doctor.
Adhere to your doctor's recommendations for regular blood work and other laboratory tests to ensure your safety while taking this medication.
Be aware that this medication may interfere with certain laboratory tests. 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, notify your doctor and discuss the potential risks.
This medication is classified as an anabolic steroid, which has been subject to abuse and misuse in the past. The misuse 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 and benefits 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.
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, consult your doctor.
Overdose Information
Overdose Symptoms:
- Headache
- Nervousness
- Irritability
- Weight gain
- Acne
- Increased frequency of erections
What to Do:
Seek immediate medical attention or call a poison control center. In the US, call 1-800-222-1222. Treatment is supportive and symptomatic. Discontinuation of the drug may be necessary.
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, especially in patients with pre-existing cardiac, renal, or hepatic disease.
Moderate Interactions
- Insulin and Oral Hypoglycemics: Androgens may decrease blood glucose levels, potentially reducing the need for insulin or other antidiabetic agents. Monitor blood glucose.
- Thyroid Hormones: Androgens may decrease levels of thyroxine-binding globulin (TBG), resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, and there is no clinical evidence of thyroid dysfunction.
- Cyclosporine: Testosterone may increase cyclosporine levels. Monitor cyclosporine levels.
Monitoring
Baseline Monitoring
Serum Testosterone
Rationale: To confirm diagnosis of hypogonadism and establish baseline for dose titration.
Timing: Prior to initiation of therapy (morning levels, two separate measurements).
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 and establish baseline for monitoring.
Timing: Prior to initiation of therapy (in men ≥40 years with risk factors for prostate cancer and in all men ≥50 years).
Digital Rectal Exam (DRE)
Rationale: To screen for prostate abnormalities.
Timing: Prior to initiation of therapy (in men ≥40 years with risk factors for prostate cancer and in all men ≥50 years).
Lipid Panel
Rationale: To assess cardiovascular risk factors.
Timing: Prior to initiation of therapy.
Blood Pressure
Rationale: To establish baseline due to risk of blood pressure elevation.
Timing: Prior to initiation of therapy.
Routine Monitoring
Serum Testosterone
Frequency: 4-6 weeks after initiation or dose adjustment, then periodically (e.g., every 3-6 months) once stable.
Target: 300-1000 ng/dL (pre-dose, morning levels).
Action Threshold: If levels are consistently above 1000 ng/dL or below 300 ng/dL, adjust dose.
Hematocrit (Hct)
Frequency: At 3 months and 6 months after initiation, 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: Annually, or more frequently as clinically indicated.
Target: Age-appropriate values.
Action Threshold: Significant increase in PSA or abnormal DRE warrants further urological evaluation.
Lipid Panel
Frequency: Annually.
Target: Guideline-recommended targets.
Action Threshold: Abnormalities may require intervention or re-evaluation of testosterone therapy.
Blood Pressure
Frequency: Regularly, especially during the initial weeks of therapy and with dose adjustments.
Target: Normal blood pressure.
Action Threshold: Significant or sustained increase in blood pressure may require dose reduction, discontinuation, or initiation/adjustment of antihypertensive therapy.
Symptom Monitoring
- Signs of polycythemia (e.g., dizziness, headache, fatigue, shortness of breath)
- Signs of prostate enlargement (e.g., urinary hesitancy, frequency, nocturia, decreased stream)
- Signs of cardiovascular events (e.g., chest pain, shortness of breath, leg swelling, weakness on one side of the body)
- Signs of fluid retention (e.g., edema, weight gain)
- Mood changes, irritability, aggression
- Sleep apnea worsening
- Breast tenderness or enlargement (gynecomastia)
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.
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. Due to the potential for serious adverse reactions in the breastfed infant, Jatenzo is contraindicated during breastfeeding.
Infant Risk:
High (potential for serious adverse reactions, including virilization).
Pediatric Use
Safety and efficacy 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
Older men treated with androgens may be at an increased risk for the development of prostate hypertrophy and prostate carcinoma. Increased risk of cardiovascular events and fluid retention. Close monitoring of PSA, DRE, and cardiovascular parameters is recommended.
Clinical Information
Clinical Pearls
- Jatenzo must be taken with food to ensure adequate absorption. Taking it without food will result in insufficient testosterone levels.
- Emphasize the importance of regular blood pressure monitoring due to the Black Box Warning for blood pressure increases.
- Patients should be educated on the signs and symptoms of polycythemia, prostate issues, and cardiovascular events.
- This formulation of testosterone (undecanoate) is absorbed primarily via the lymphatic system, bypassing first-pass hepatic metabolism, which differentiates it from older oral testosterone formulations.
- Regular monitoring of serum testosterone, hematocrit, PSA, and lipids is crucial for safe and effective therapy.
Alternative Therapies
- Testosterone gels (e.g., AndroGel, Testim, Fortesta, Natesto)
- Testosterone patches (e.g., Androderm)
- Testosterone injections (e.g., testosterone cypionate, testosterone enanthate)
- Testosterone buccal system (e.g., Striant)
- Testosterone pellets (e.g., Testopel)
- Other oral testosterone undecanoate formulations (e.g., Kyzatrex, Tlando)
Cost & Coverage
Average Cost:
Price range varies significantly per 30 capsules
Insurance Coverage:
Tier 3 or higher (Specialty drug)
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 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 overdose, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.