Jatenzo

Approved Uses

Jatenzo is prescribed for adult men who have a deficiency or absence of natural testosterone. This condition, known as hypogonadism, must be confirmed by laboratory tests and associated with specific medical causes. It is used to treat two main types of testosterone deficiency:

• Primary hypogonadism: This occurs when the testes are unable to produce enough testosterone due to conditions such as Klinefelter syndrome, orchidectomy (surgical removal of the testes), or damage from chemotherapy or toxins.
• Hypogonadotropic hypogonadism: This occurs when the parts of the brain that signal the testes to produce testosterone (the pituitary gland or hypothalamus) are damaged by tumors, trauma, or radiation.

Important Limitations

Jatenzo is not intended for use in men who have low testosterone levels simply due to aging. The safety and effectiveness of using this medication for age-related low testosterone have not been established. Additionally, it is not approved for use in women or children.

Mechanism of Action

Jatenzo contains testosterone undecanoate, which is a form of the naturally occurring male hormone testosterone. It belongs to a class of medications known as androgens. This medication works by replacing or supplementing the testosterone that the body is not making naturally due to certain medical conditions.

In the body, testosterone is responsible for the normal growth and development of male sex organs and the maintenance of secondary sex characteristics. These functions include:

• Growth and maintenance of muscle mass
• Maintenance of bone density
• Distribution of body hair
• Development of the male reproductive system

Absorption Process

Jatenzo is designed to be absorbed through the lymphatic system in the digestive tract rather than being processed immediately by the liver. When taken with food, the medication enters the bloodstream through this lymphatic pathway, which allows the testosterone to reach effective levels in the body. By restoring testosterone to a normal range, the medication helps reverse symptoms caused by low hormone levels.

Common Side Effects

Many people using Jatenzo experience mild side effects. These may include:

• Headache
• Nausea or diarrhea
• Acne
• Increased red blood cell count (hematocrit)
• Increased prostate-specific antigen (PSA) levels
• Anxiety
• Swelling in the legs, feet, or ankles

Serious Side Effects

Some side effects can be severe and require medical attention. Contact a healthcare provider immediately if you experience:

• High blood pressure: Jatenzo can significantly increase blood pressure, which may raise the risk of heart attack or stroke.
• Blood clots: Symptoms may include pain, swelling, or warmth in the legs, or sudden chest pain and shortness of breath.
• Liver problems: Although rare with this specific oral form, signs include yellowing of the skin or eyes (jaundice), dark urine, or pain in the upper right stomach area.
• Prostate changes: Increased risk of an enlarged prostate or worsening of existing prostate symptoms, such as difficulty urinating.
• Sleep apnea: New or worsening breathing problems while sleeping, such as snoring or gasping for air.
• Mood changes: Increased aggression, irritability, depression, or other emotional changes.
• Reduced sperm count: High doses of testosterone may lower sperm production, which can affect fertility.

Boxed Warning: Increased Blood Pressure

Jatenzo can cause an increase in blood pressure, which may lead to a higher risk of major cardiovascular events, including heart attack, stroke, and cardiovascular death. Blood pressure should be monitored before starting treatment and periodically during therapy. This risk may be higher in individuals with pre-existing heart disease or high blood pressure.

Contraindications

• Men with breast cancer or known or suspected prostate cancer.
• Women who are pregnant or may become pregnant, as testosterone can cause harm to a developing fetus.
• Individuals with a known hypersensitivity to Jatenzo or any of its ingredients.

Cardiovascular and Blood Risks

• Polycythemia: Testosterone treatment can cause an increase in red blood cell count (hematocrit). This may increase the risk of blood clots, stroke, or heart attack. Periodic blood tests are necessary to monitor these levels.
• Fluid Retention: Edema (swelling) with or without heart failure can occur, particularly in patients with existing heart, kidney, or liver disease.

Prostate and Urinary Effects

Treatment with testosterone may worsen symptoms of an enlarged prostate (benign prostatic hyperplasia) or increase the risk of developing prostate cancer. Regular screenings for prostate health are typically recommended during treatment.

Other Precautions

• Sleep Apnea: Jatenzo may worsen pre-existing sleep apnea, especially in those with risk factors such as obesity or chronic lung disease.
• Lipid Changes: Changes in cholesterol levels (serum lipid profile) may occur, which may require adjustments to other medications or monitoring.
• Liver Health: While Jatenzo is an oral testosterone, it is processed differently than older oral testosterones; however, monitoring of liver function may still be required.

Abuse and Misuse

Testosterone is a controlled substance. Misuse or abuse of testosterone, particularly at doses higher than prescribed, can lead to serious health complications including heart disease, liver toxicity, and psychiatric issues such as aggression or depression.

Pregnancy

Jatenzo is not indicated for use in females and should not be taken by anyone who is pregnant or planning to become pregnant. Testosterone is known to cause fetal harm. If a pregnant woman is exposed to this medication, it may lead to virilization, which is the development of male physical characteristics in a female fetus.

Breastfeeding

There is no information available regarding the presence of Jatenzo in human breast milk, its effects on the breastfed infant, or its impact on milk production. Due to the potential for serious adverse effects in a nursing child, use of this medication is typically avoided during breastfeeding. It is important to consult with a healthcare provider to discuss the risks and benefits of treatment.

Fertility

Treatment with testosterone products like Jatenzo may reduce sperm count and impact male fertility. This suppression of sperm production may be temporary or permanent. Individuals concerned about future fertility should discuss these risks with their doctor before starting treatment.

Dosage Forms

Jatenzo is provided as a softgel capsule for oral administration. It is designed to be taken by mouth with food. This medication is not available in other forms, such as topical gels, transdermal patches, or injectable liquids.

FDA Approval and Indications

Jatenzo was approved by the U.S. Food and Drug Administration (FDA) as an oral treatment for testosterone replacement therapy in adult males. It is indicated for conditions associated with a deficiency or absence of endogenous testosterone, such as primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

Boxed Warning

The FDA has required a boxed warning for Jatenzo because it can cause increases in blood pressure. Elevated blood pressure can increase the risk of major adverse cardiovascular events, including heart attack, stroke, and cardiovascular death. Healthcare providers are advised to monitor blood pressure regularly before and during treatment.

Regulatory Classification

Jatenzo is classified by the Drug Enforcement Administration (DEA) as a Schedule III controlled substance due to the potential for misuse and abuse. Misuse of testosterone, often in combination with other anabolic androgenic steroids and at doses higher than recommended, can lead to serious cardiovascular and psychiatric adverse events.

Class-Wide Safety Communications

The FDA has issued class-wide labeling changes for all prescription testosterone products. These updates highlight the risks of heart attack and stroke associated with testosterone use. Additionally, the labeling includes information about the risks of abuse and dependence associated with testosterone and other anabolic steroids.

Insurance Coverage and Prior Authorization

Most insurance plans require prior authorization for Jatenzo. This means your healthcare provider must submit documentation to your insurance company to prove medical necessity before the medication is covered. Your out-of-pocket costs, such as copays or coinsurance, will vary based on your specific insurance plan's formulary.

Brand-Name Status

Jatenzo is a brand-name medication, and there is currently no generic version of oral testosterone undecanoate available. Brand-name drugs typically have a higher price point than generic alternatives. The availability of a generic version depends on the expiration of patents and regulatory approvals.

Factors Affecting Price

Several factors can influence the final price you pay at the pharmacy:

• Pharmacy Selection: Prices can vary between different retail pharmacies and mail-order services.
• Dosage Strength: Jatenzo is available in several strengths, and the total cost may change depending on the specific dose required for your treatment.
• Financial Assistance: Some patients may be eligible for manufacturer savings cards or patient assistance programs that can help reduce out-of-pocket expenses. Eligibility for these programs often depends on your insurance status and income level.