Jatenzo 158mg Capsules

Testosterone is an endogenous androgen. Androgens bind to androgen receptors in target tissues (e.g., prostate, seminal vesicles, epididymis, testes, hair follicles, muscle, bone) and stimulate gene expression and protein synthesis. Testosterone undecanoate is an ester of testosterone, which is hydrolyzed to testosterone in the body. Oral administration with food facilitates lymphatic absorption of testosterone undecanoate, bypassing significant first-pass hepatic metabolism.

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 notice any of the following symptoms, contact your doctor immediately or seek 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
+ 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 may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Headache
Diarrhea
Heartburn
Burping

This is not an exhaustive list of possible side effects. 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.

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 patient 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, 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.

Pediatric Patients:
This medication is not intended for children. Do not administer this medication to a child.

Interactions with Other Medications and Health Conditions:
This is not an exhaustive list of all potential interactions. Inform your doctor and pharmacist about all prescription and over-the-counter medications, natural products, and vitamins you are taking, as well as any existing health problems. Verify that it is safe to take this medication with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without consulting your doctor.

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 while using this drug.

There may be an increased risk of developing prostate cancer associated with this medication. You should discuss this with your doctor.

Men with an enlarged prostate should be aware that their symptoms may worsen while taking this medication. If you experience any worsening of symptoms, contact your doctor promptly.

If you have sleep apnea, consult with your doctor, as this condition may worsen in some individuals taking testosterone.

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 should be performed as directed by your doctor. 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.

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

This medication is classified as an anabolic steroid, a class of drugs that has been subject to abuse and misuse. Anabolic steroid abuse can lead to dependence and severe health problems, including cardiovascular issues, stroke, liver damage, and mental or mood disorders. It is crucial to discuss these risks with your doctor.

In some individuals with cancer, high calcium levels have been reported with medications similar to this one. 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 use of this medication with your doctor.

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

• 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 fluid retention and edema, especially in patients with cardiac, hepatic, or renal disease.

• Insulin and oral hypoglycemic agents: Androgens may decrease blood glucose levels, potentially requiring a reduction in insulin or oral hypoglycemic dosage.
• Adrenocorticotropic hormone (ACTH): May increase fluid retention.
• Thyroid hormones: May decrease levels of thyroid-binding globulin, leading to increased free thyroid hormone levels (clinical significance usually minimal).

• Signs of fluid retention (edema, weight gain)
• Symptoms of benign prostatic hyperplasia (BPH) such as urinary urgency, frequency, nocturia, decreased stream
• Signs of cardiovascular events (chest pain, shortness of breath, leg swelling, weakness on one side of body)
• Mood changes, irritability, aggression
• Sleep apnea (worsening or new onset)
• Gynecomastia
• Skin changes (acne, oily skin)
• Hair loss (scalp) or increased body hair

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

Contraindicated in breastfeeding women. It is unknown if testosterone is excreted in human milk, but it could potentially cause serious adverse reactions in a breastfed infant.

Contraindicated in pediatric patients. Safety and effectiveness have not been established. Use in children can cause virilization in females, precocious puberty and premature epiphyseal closure in males, and may compromise adult height.

Use with caution in elderly men. Older patients may be at increased risk for prostate enlargement, prostate cancer, and cardiovascular events. Regular monitoring of PSA, hematocrit, and cardiovascular status is crucial.

• Jatenzo is an oral testosterone formulation that MUST be taken with food to ensure adequate absorption. Advise patients to take it with a meal, preferably a high-fat meal, for optimal bioavailability.
• Unlike other oral testosterone formulations (e.g., methyltestosterone), Jatenzo (testosterone undecanoate) is designed to be absorbed via the lymphatic system, reducing first-pass hepatic metabolism and minimizing hepatotoxicity concerns associated with 17-alpha alkylated androgens.
• The Black Box Warning for cardiovascular events and VTE is critical. Thoroughly screen patients for pre-existing cardiovascular disease or risk factors before initiating therapy.
• Regular monitoring of trough testosterone levels is essential for dose adjustment. Ensure patients understand the importance of consistent timing for blood draws (e.g., 5-8 hours after the morning dose).
• Emphasize the importance of prostate health monitoring (PSA and DRE) in men on testosterone therapy, especially those over 40 or with risk factors for prostate cancer.
• Educate patients on signs of polycythemia (e.g., headache, dizziness, fatigue) and fluid retention (e.g., swelling, weight gain) and to report them promptly.

• Other oral testosterone formulations (e.g., Tlando, Kyzatrex - also testosterone undecanoate capsules)
• Testosterone gels (e.g., AndroGel, Testim, Fortesta, Vogelxo)
• Testosterone transdermal patches (e.g., Androderm)
• Testosterone injections (intramuscular, e.g., Depo-Testosterone, Aveed; subcutaneous, e.g., Xyosted)
• Testosterone buccal systems (e.g., Striant)
• Testosterone pellets (e.g., Testopel)

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 your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.