Jatenzo testosterone undecanoate 158 mg Capsule, Liquid Filled
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Androgen class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Testosterone is used to treat low or no testosterone levels in men. Testosterone is a male sex hormone responsible for development and functioning of male sex organs and male characteristics. Testosterone works by replacing testosterone that is normally produced by the body.
Read the full MedlinePlus article ↗- Testosterone replacement is specifically for men whose bodies aren't making enough testosterone because of a medical condition — like a problem with the testes themselves (primary...
- What exactly is testosterone replacement therapy for — do I really need it?
- Yes, this is a serious concern. Children who accidentally touch the gel on your skin or clothing can absorb testosterone and develop early puberty signs — things like pubic hair gr...
- I use the gel — do I really need to worry about my kids or partner being exposed to it?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Testosterone Undecanoate — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII F8XAG1755S
A plant-derived oil from borage seeds, rich in fatty acids. It's used in formulations as an emollient and skin-conditioning agent to help maintain moisture and improve texture.
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UNII 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 2UMI9U37CP
Oleic acid is a naturally occurring fatty acid derived from plant or animal oils. It functions as an emulsifier and solvent in medicines, helping blend water and oil-based ingredients together and dissolving other components.
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UNII AV092KU4JH
A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
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UNII 7YC686GQ8F
A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
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UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
11 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $8.970 | $12,916.22 / 1440 capsules |
| Medicaid paysCMS SDUD · 12 mo | $8.70 | $12,532.03 / 1440 capsules |
| Medicare drug plans payPart D · Q2 2026 | $8.84 | $12,735.50 / 1440 capsules |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Jatenzo 158 mgthis 69087-0158-12 | TOLMAR | 120 capsules | $8.970 | — | Availability likely | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 8492369 ↗ | Method of use | U-2506 | Dec 20, 2030 |
| US 8241664 ↗ | Method of use | U-2506 | Mar 29, 2029 |
| US 8241664 ↗ | Method of use | U-2506 | Mar 29, 2029 |
| US 8492369 ↗ | Method of use | U-2506 | Dec 20, 2030 |
| US 8241664 ↗ | Method of use | U-2506 | Mar 29, 2029 |
| US 10543219 ↗ | Method of use | U-2506 | Apr 12, 2030 |
| US 10543219 ↗ | Method of use | U-2506 | Apr 12, 2030 |
| US 10543219 ↗ | Method of use | U-2506 | Apr 12, 2030 |
| US 11564933 ↗ | Method of use | U-1103 | Apr 12, 2039 |
| US 11564933 ↗ | Method of use | U-1103 | Apr 12, 2039 |
| US 11564933 ↗ | Method of use | U-1103 | Apr 12, 2039 |
| US 11179403 ↗ | Method of use | U-2506 | Apr 12, 2030 |
| US 11179403 ↗ | Method of use | U-2506 | Apr 12, 2030 |
| US 11179403 ↗ | Method of use | U-2506 | Apr 12, 2030 |
| US 11331325 ↗ | Method of use | U-2506 | Jan 6, 2027 |
| US 11331325 ↗ | Method of use | U-2506 | Jan 6, 2027 |
| US 11331325 ↗ | Method of use | U-2506 | Jan 6, 2027 |
| US 11426416 ↗ | Method of use | U-3420 | Apr 12, 2030 |
| US 8492369 ↗ | Method of use | U-2506 | Dec 20, 2030 |
| US 11426416 ↗ | Method of use | U-3420 | Apr 12, 2030 |
| US 11426416 ↗ | Method of use | U-3420 | Apr 12, 2030 |
| US 12605391 ↗ | Method of use | U-1103 | Apr 12, 2039 |
| US 12605391 ↗ | Method of use | U-1103 | Apr 12, 2039 |
| US 12605391 ↗ | Method of use | U-1103 | Apr 12, 2039 |
| US 11179402 ↗ | Drug substance | — | Apr 14, 2026 |
| US 11179402 ↗ | Drug substance | — | Apr 14, 2026 |
| US 10617696 ↗ | Drug substance | — | Apr 12, 2030 |
| US 8778916 ↗ | Drug product | — | Apr 12, 2030 |
| US 11179402 ↗ | Drug substance | — | Apr 14, 2026 |
| US 10617696 ↗ | Drug substance | — | Apr 12, 2030 |
| US 10617696 ↗ | Drug substance | — | Apr 12, 2030 |
| US 8778916 ↗ | Drug product | — | Apr 12, 2030 |
| US 8778916 ↗ | Drug product | — | Apr 12, 2030 |
Is there a generic version of JATENZO 158 MG CAPSULE?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69087-0158-12 You're viewing this | 12 BOTTLE, PLASTIC in 1 BOX (69087-158-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC | 2019-08-01 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE JATENZO (testosterone undecanoate) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Limitations of use: Safety and efficacy of JATENZO in men with “age-related hypogonadism” have not been established.
Safety and efficacy of JATENZO in males less than 18 years old have not been established [ see Use in Specific Populations ( 8.4 ) ]. JATENZO (testosterone undecanoate) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone ( 1 ). Limitations of use: Safety and efficacy of JATENZO in men with “age-related hypogonadism” have not been established ( 1 ) Safety and efficacy of JATENZO in males less than 18 years old have not been established ( 1 , 8.4 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Prior to initiating JATENZO, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these concentrations are below the normal range ( 2.1 ). Take JATENZO with food ( 2.2 ). Starting dose: 237 mg orally once in the morning and once in the evening.
Adjust the dose to a minimum of 158 mg twice daily and a maximum of 396 mg twice daily based on serum testosterone drawn 6 hours after the morning dose at least 7 days after starting treatment or following dose adjustment and periodically thereafter ( 2.2 ).
2.1Confirmation of Hypogonadism Before Initiation of JATENZO Prior to initiating JATENZO, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these testosterone concentrations are below the normal range.
2.2Dosing and Dose Adjustment Information Individualize the dosage of JATENZO based on the patient's serum testosterone concentration response to the drug. The recommended starting dose is 237 mg taken orally twice daily, once in the morning and once in the evening. Take JATENZO with food.
Dose Adjustment To ensure proper dose adjustment, measure serum testosterone concentrations 6 hours after the morning dose in plain tubes, clotted at room temperature for 30 minutes prior to centrifugation. Adjust the JATENZO dose based on this serum testosterone measurement as shown in Table 1. Wait seven days after starting treatment or adjusting the dose before checking the serum testosterone concentration.
Thereafter, periodically monitor serum testosterone concentrations 6 hours after the morning dose. Administer the same dose in the morning and evening. The minimum recommended dose is 158 mg twice daily.
The maximum recommended dose is 396 mg (two 198 mg capsules) twice daily. Table 1: JATENZO Dose Adjustment Scheme Testosterone Concentration in Serum From Plain Tube Drawn 6 hours After Morning Dose Current JATENZO Dose (mg, twice daily) New JATENZO Dose (mg, twice daily) Less than 425 ng/dL 158 198 198 237 237 316 (two 158 mg capsules) 316 (two 158 mg capsules) 396 (two 198 mg capsules) 425 ng/dL – 970 ng/dL No Dose Change More than 970 ng/dL 396 (two 198 mg capsules) 316 (two 158 mg capsules) 316 (two 158 mg capsules) 237 237 198 198 158 158 Discontinue Treatment
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS JATENZO capsules for oral use are available in three strengths: The 158 mg testosterone undecanoate capsules are opaque red and imprinted with “158” in white ink. The 198 mg testosterone undecanoate capsules are opaque white and imprinted with “198” in red ink. The 237 mg testosterone undecanoate capsules are opaque orange and imprinted with “237” in white ink.
JATENZO (testosterone undecanoate) capsules for oral use are available in the following strengths: 158 mg, 198 mg, 237 mg ( 3 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS JATENZO is contraindicated in: Men with carcinoma of the breast or known or suspected carcinoma of the prostate [ see Warnings and Precautions ( 5.3 ) ]. Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman [ see Use in Specific Populations ( 8.1 ) ].
Men with known hypersensitivity to JATENZO or any of its ingredients [ see Description ( 11 ) ]. Men with breast cancer or known or suspected prostate cancer ( 4 , 5.3 ). Women who are pregnant.
Testosterone may cause fetal harm ( 4 , 5.6 , 8.1 , 8.2 ). Known hypersensitivity to JATENZO or any of its ingredients ( 4 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Polycythemia: Monitor hematocrit approximately every 3 months to detect increased red blood cell mass and polycythemia ( 5.1 ). Venous thromboembolism (VTE): VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone. Evaluate patients with signs or symptoms consistent with DVT or PE ( 5.2 ).
Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer: Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH ( 5.3 ). Blood Pressure Increases: JATENZO can increase blood pressure, which can increase cardiovascular risk over time. Measure blood pressure periodically.
Not recommended for use in men with uncontrolled hypertension ( 5.4 ) Abuse of Testosterone: Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids (5.5 ). Potential for Adverse Effects on Spermatogenesis: Exogenous administration of androgens may lead to azoospermia ( 5.7 ). Edema: Edema, with or without congestive heart failure, may occur in patients with pre-existing cardiac, renal, or hepatic disease ( 5.9 , 6.1 ).
Sleep Apnea: Sleep apnea may occur in those with risk factors ( 5.11 ). Monitor prostate specific antigen (PSA) and lipid concentrations periodically ( 5.3 , 5.12 ). Risk of Depression and Suicide: Depression and suicidal ideation have occurred during clinical trials in patients treated with JATENZO ( 5.15 ).
5.1Polycythemia Increases in hematocrit reflective of increases in red blood cell mass, may require lowering the dose or discontinuation of JATENZO. Check that hematocrit is not elevated prior to initiating JATENZO. Evaluate hematocrit approximately every 3 months while the patient is on JATENZO.
If hematocrit becomes elevated, stop JATENZO until the hematocrit decreases to an acceptable concentration. If JATENZO is restarted and again causes hematocrit to become elevated, stop JATENZO permanently. An increase in red blood cell mass may increase the risk of thromboembolic events [see Warnings and Precautions ( 5.2 )] .
5.2Venous Thromboembolism There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone replacement products such as JATENZO. In the Testosterone Replacement therapy for Assessment of long-term Vascular Events and efficacy ResponSE in hypogonadal men (TRAVERSE) Study, a randomized, double-blind, placebo-controlled, cardiovascular (CV) outcomes study, compared to placebo, topical testosterone gel was associated with a numerically higher incidence of VTE (1.7% vs 1.2%) which included DVT (0.6% vs 0.5%) and PE events (0.9% vs 0.5%) [see Adverse Reactions ( 6.1 )].
Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with JATENZO and initiate appropriate workup and management [see Adverse Reactions ( 6.2 )] .
5.3Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms. Patients treated with androgens may be at increased risk for prostate cancer.
Evaluate patients for prostate cancer prior to initiating and during treatment with androgens [see Contraindications ( 4 )] .
5.4Blood Pressure Increases JATENZO can increase blood pressure. Ambulatory blood pressure monitoring (ABPM) demonstrated JATENZO increased systolic /diastolic BP by an average of 4.9/2.5 mm Hg from baseline after 4 months of treatment in a clinical trial [see Adverse Reactions (6.1)] . In patients with hypertension on anti…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions (incidence > 2%): polycythemia, diarrhea, dyspepsia, eructation, peripheral edema, nausea, increased hematocrit, headache, prostatomegaly, and hypertension ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Tolmar, Inc. at 1-844-4TO-LMAR or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of JATENZO was evaluated in a randomized, controlled clinical study with 166 patients treated with JATENZO twice daily with morning and evening meals for approximately 4 months. All patients were started on 237 mg twice daily, then the dose was titrated to 158 mg, 198 mg, 316 mg, or 396 mg twice daily to achieve testosterone concentrations in the eugonadal range.
Table 2 summarizes adverse reactions (≥2%) reported in this 4-month study. Table 2: Number (%) of Patients with Adverse Reactions ≥ 2% in a 4-Month Study with JATENZO Among the 569 patients who received JATENZO in all Phase 2 and 3 trials combined, the following adverse reactions were reported in >2% of patients: polycythemia, diarrhea, dyspepsia, eructation, peripheral edema, nausea, increased hematocrit, headache, prostatomegaly, and hypertension. Three of the 166 patients (1.8%) in the 4-month study experienced adverse reactions that led to premature discontinuation from the study, including rash (n=1) and headache (n=2).
Preferred Term Overall (N = 166) n (%) Headache 8 (4.8) Hematocrit increased 8 (4.8) Hypertension 6 (3.6) High-density lipoprotein decreased 5 (3.0) Nausea 4 (2.4) BP Increases In the 4-month clinical study, 24-hour ABPM was conducted on 166 patients. ABPM was conducted at baseline and at Day 139 of JATENZO therapy. A total of 135 patients had acceptable ABPM recordings at both time periods and were at least 85% compliant with study drug.
In that group, the mean change in 24-hour systolic BP and diastolic BP from baseline to final on-treatment visit on Day 139 (n=135) was +4.9 mm Hg (95% CI 3.5, 6.4) and +2.5 mm Hg (95% CI 1.5, 3.6), respectively. In patients with a history of hypertension who were receiving antihypertensive therapy, the mean ABPM systolic and diastolic BP increased by 5.4 mm Hg [95% CI 3.3, 7.6] and 3.2 mm Hg [95% CI 1.7, 4.7], respectively [n=67]. In patients with no history of hypertension, the mean ABPM systolic and diastolic blood pressure increased by 4.4 mm Hg [95% CI 2.3, 6.4] and 1.8 mm Hg [95% CI 0.2, 3.3], respectively [n=63].
Twelve (7.2%) patients on JATENZO either started antihypertensive medications or had their antihypertensive regimen increased during the study. A total of 6 patients were reported to have an adverse reaction of hypertension (2 patients with hypertension and 4 patients with worsening hypertension), and 3 were reported to have an adverse reaction of increased blood pressure. HR Increases JATENZO increased mean heart rate by an average of 2.2 beats per minute (bpm) [95% CI (1.0, 3.3), N=135] during the study.
Patients without a history of hypertension had a greater average increase in mean heart rate (2.7 bpm [95% CI (0.8, 4.6), N=63]) compared to patients with treated hypertension (1.9 bpm [95% CI (0.3, 3.5), N=67)]). Increases in Hematocrit Increases in hematocrit were reported in 8 of the 166 (4.8%) patients, which occurred in the second half of the study. None of these increases led to premature discontinuation of JATENZO.
Headaches Headaches were reported in 8 of the 166 patients (4.8%) of which three required treatment with analgesics or non-steroidal anti-inflammatory drugs and 2 led to premature discontinuation from the study. Five of these 8 patients had headache events that resolved within 1 to 2 days. Depression and suicidal ideation Two of the 166 pati…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients ( 7.1 ). Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of International Normalized Ratio (INR) and prothrombin time is recommended in patients taking warfarin ( 7.2 ).
Use of testosterone with corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease ( 7.3 ). Concomitant administration of medications that are known to increase blood pressure may lead to additional increases in blood pressure when used with JATENZO ( 7.4 ).
7.1Insulin Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of anti-diabetic medication.
7.2Oral Vitamin K Antagonist Anticoagulants Changes in anticoagulant activity may be seen with androgens; therefore, more frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking warfarin, especially at the initiation and termination of androgen therapy.
7.3Corticosteroids The concurrent use of testosterone with corticosteroids may result in increased fluid retention and requires careful monitoring particularly in patients with cardiac, renal or hepatic disease.
7.4Medications that May Also Increase Blood Pressure Some prescription medications and nonprescription analgesic and cold medications contain drugs known to increase blood pressure. Concomitant administration of these medications with JATENZO may lead to additional increases in blood pressure [see Warnings and Precautions ( 5.4 )].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Geriatric Patients: There are insufficient long-term safety data to assess the potential risks of cardiovascular disease and prostate cancer ( 8.5 ).
8.1Pregnancy Risk Summary JATENZO is contraindicated in pregnant women. Testosterone is teratogenic and may cause fetal harm based on data from animal studies and its mechanism of action [see Contraindications ( 4 ) and Clinical Pharmacology ( 12.1 )] . Exposure of a female fetus to androgens may result in varying degrees of virilization.
In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies did not meet current standards for nonclinical development toxicity studies. Data Animal Data In developmental studies conducted in rats, rabbits, pigs, sheep and rhesus monkeys, pregnant animals received intramuscular injection of testosterone during the period of organogenesis.
Testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. Structural impairments observed in females included increased anogenital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. Structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen.
Increased pituitary weight was seen in both sexes. Testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring. Hypertension was observed in pregnant female rats and their offspring exposed to doses approximately twice those used for testosterone replacement therapy.
8.2Lactation Risk Summary JATENZO is not indicated for use in women.
8.3Females and Males of Reproductive Potential Infertility During treatment with large doses of exogenous androgens, including JATENZO, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis [see Warnings and Precautions ( 5.7 )] , possibly leading to adverse effects on semen parameters including sperm count. Reduced fertility is observed in some men taking testosterone replacement therapy. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids [see Drug Abuse and Dependence ( 9.2 )] .
With either type of use, the impact on fertility may be irreversible.
8.4Pediatric Use The safety and efficacy of JATENZO in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.
8.5Geriatric Use There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing JATENZO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. No patients over 65 years of age were enrolled in the 4-month efficacy and safety clinical study utilizing JATENZO. Additionally, there is insufficient long-term safety data in geriatric patients utilizing JATENZO to assess the potentially increased risk of cardiovascular disease and prostate cancer.
Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH [see Warnings and Precautions ( 5.3 )].
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary JATENZO is contraindicated in pregnant women. Testosterone is teratogenic and may cause fetal harm based on data from animal studies and its mechanism of action [see Contraindications ( 4 ) and Clinical Pharmacology ( 12.1 )] . Exposure of a female fetus to androgens may result in varying degrees of virilization.
In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies did not meet current standards for nonclinical development toxicity studies. Data Animal Data In developmental studies conducted in rats, rabbits, pigs, sheep and rhesus monkeys, pregnant animals received intramuscular injection of testosterone during the period of organogenesis.
Testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. Structural impairments observed in females included increased anogenital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. Structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen.
Increased pituitary weight was seen in both sexes. Testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring. Hypertension was observed in pregnant female rats and their offspring exposed to doses approximately twice those used for testosterone replacement therapy.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and efficacy of JATENZO in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.
🧓 Geriatric Use ▾
8.5Geriatric Use There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing JATENZO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. No patients over 65 years of age were enrolled in the 4-month efficacy and safety clinical study utilizing JATENZO. Additionally, there is insufficient long-term safety data in geriatric patients utilizing JATENZO to assess the potentially increased risk of cardiovascular disease and prostate cancer.
Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH [see Warnings and Precautions ( 5.3 )].
🆘 Overdosage ▾
10 OVERDOSAGE There is a single report of acute overdosage with use of an approved injectable testosterone product: this subject had serum testosterone concentrations of up to 11,400 ng/dL which were implicated in a cerebrovascular accident. One case of overdose with JATENZO was reported in clinical trials. This patient inadvertently took a higher dose than prescribed (474 mg twice daily, which is 20% higher than the maximum recommended dose).
He did not report any adverse reactions associated with the overdose. Treatment of overdosage consists of discontinuation of JATENZO and appropriate symptomatic and supportive care.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies.
Primary hypogonadism is caused by defects of the gonads, such as Klinefelter syndrome or Leydig cell aplasia, whereas secondary hypogonadism (also known as hypogonadotropic hypogonadism) is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).
12.2Pharmacodynamics No specific pharmacodynamic studies were conducted using JATENZO.
12.3Pharmacokinetics Absorption JATENZO delivers physiologic amounts of testosterone, producing testosterone concentrations that approximate normal concentrations seen in healthy men. JATENZO was taken orally at a starting dose of 237 mg twice per day with meals in a multicenter, open-label, randomized, 2-arm, active-controlled trial in hypogonadal males. The dose was adjusted, as needed, on Days 14 and 56 between a minimum of 158 mg twice per day and a maximum of 396 mg twice per day based on the average plasma testosterone concentration obtained over 24 hours after the morning dose.
The average daily NaF-EDTA plasma testosterone concentration was 403 (± 128) ng/dL at the end of treatment, where the normal eugonadal range in NaF-EDTA plasma was 252-907 ng/dL in this study. Note that the titration scheme for use in clinical practice is based on serum total testosterone [ see Dosage and Administration ( 2.2 ) ]. Table 3 summarizes the pharmacokinetic (PK) parameters for plasma total testosterone in patients completing at least 105 days of JATENZO treatment administered twice daily.
Table 3: NaF-EDTA Plasma Testosterone C avg and C max at Final PK Visit PK = pharmacokinetic; C avg = 24-hour average concentration; C max = maximum concentration PK Parameter All Doses (N=151) C avg (ng/dL) Mean 403 SD 128 C max (ng/dL) Mean 1008 SD 581 Figure 2 summarizes the mean plasma total testosterone profile for the patients at the final PK visit. Figure 2: Mean (±SEM) Concentration-Time Profile for NaF-EDTA Plasma Total Testosterone in JATENZO Treated Subjects at Final PK Visit SEM = standard error of the mean; T = testosterone When JATENZO was dosed with different breakfasts containing various amounts of fat, the bioavailability with the 30 g fat, 45 g fat, and high-calorie high-fat breakfasts was comparable, but there was a food effect with the 15 g fat breakfast compared to the 30 g fat breakfast.
The 15 g fat breakfast had a 25% decrease in testosterone exposure compared to the 30 g fat breakfast. Figure 2 Distribution Circulating testosterone is primarily bound in serum to sex hormone-binding globulin (SHBG) and albumin. Approximately 40% of testosterone in plasma is bound to SHBG, 2% remains unbound (free) and the rest is loosely bound to albumin and other proteins.
Metabolism The androgenic activity of testosterone undecanoate occurs after the ester bond linking the testosterone to the undecanoic acid is cleaved by endogenous non-specific esterases. Undecanoic acid is metabolized like all fatty acids via the beta-oxidation pathway. Testosterone is metabolized to various 17-keto steroids through two different pathways.
The major active metabolites of testosterone are dihydrotestosterone (DHT) and estradiol. Drug Interaction Studies Clinical Pharmacology Studies Concomitant administration of JATENZO at 237 mg dose with midazolam (CYP3A4 substrate), digoxin (P-gp substrate), and rosuvastatin (BCRP substrate) had no clin…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies.
Primary hypogonadism is caused by defects of the gonads, such as Klinefelter syndrome or Leydig cell aplasia, whereas secondary hypogonadism (also known as hypogonadotropic hypogonadism) is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING JATENZO (testosterone undecanoate) capsules are available in three strengths of 158 mg, 198 mg, and 237 mg. Capsules are packaged as 120 units in wide-mouth, round, white HDPE bottles with white, polypropylene, child resistant caps and induction-sealed liner. 158 mg capsules are opaque red capsules imprinted with “158” in white ink and are supplied in bottles: NDC 69087-158-12.
198 mg capsules are opaque white capsules imprinted with “198” in red ink and are supplied in bottles: NDC 69087-198-12. 237 mg capsules are opaque orange capsules imprinted with “237” in white ink and are supplied in bottles: NDC 69087-237-12. Keep JATENZO out of reach of children.
Store at 20°C to 25ºC (68°F to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). Avoid exposing the capsules to moisture (store in a dry place).
📋 Description ▾
11 DESCRIPTION JATENZO (testosterone undecanoate) for oral use is provided as a gelatin capsule containing testosterone undecanoate, a fatty-acid ester of testosterone. Testosterone undecanoate is a white to off-white yellow crystalline powder. Testosterone, an androgen, is formed by cleavage of the ester side chain of testosterone undecanoate.
Testosterone undecanoate is chemically described as 17β-hydroxyandrost-4-en-3-one undecanoate. It has the empirical formula of C 30 H 48 O 3 and the molecular weight of 456.7. The structural formula for testosterone undecanoate is presented in Figure 1.
Figure 1: Testosterone Undecanoate JATENZO capsules are available in three strengths of 158 mg, 198 mg, and 237 mg. The 158 mg strength is an opaque red capsule that contains 158 mg of testosterone undecanoate and is imprinted with “158” in white ink. The 198 mg strength is an opaque white capsule that contains 198 mg of testosterone undecanoate and is imprinted with “198” in red ink.
The 237 mg strength is an opaque orange capsule that contains 237 mg of testosterone undecanoate and is imprinted with “237” in white ink. All capsule strengths also contain oleic acid, polyoxyl 40 hydrogenated castor oil (Cremophor RH 40), borage seed oil, peppermint oil, and butylated hydroxytoluene as inactive ingredients. Gelatin capsule shells are composed of the following inactive ingredients: Gelatin, sorbitol, glycerin, and purified water in all strengths, iron oxide red in 158 mg, FD&C Yellow #6 in 158 and 237 mg, and titanium dioxide in 198 and 237 mg capsules.
Figure 1
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Venous Thromboembolism Inform patients that JATENZO can cause venous thromboembolism. Advise patients of the signs and symptoms of venous thromboembolism, which may include the following: lower limb pain, edema, or erythema; and dyspnea or chest pain.
Advise patients to promptly report the signs and symptoms of venous thromboembolism, discontinue use of JATENZO, and seek urgent medical care. Increased Blood Pressure Inform patients that JATENZO can increase BP which can increase cardiovascular risk over time. Instruct patients about the importance of monitoring BP periodically while on JATENZO.
If BP increases while on JATENZO, antihypertensive medications may need to be started, added, or adjusted to control BP, or JATENZO may need to be discontinued. Other Adverse Reactions Inform patients that treatment with androgens may lead to adverse reactions which include: Changes in urinary habits related to effects on prostate size, such as increased urination at night, hesitancy, frequency, urinary urgency, having a urine accident, being unable to pass urine and weak urine flow Breathing disturbances that may reflect obstructive sleep apnea, including those associated with sleep, or excessive daytime sleepiness Too frequent or persistent erections of the penis Ankle swelling that may reflect peripheral edema Red blood cell count increase PSA increase Nausea and vomiting Instruct patients to report any changes in their state of health, such as changes in urinary habits, breathing, sleep, and mood including new onset or worsening of depression, or suicidal ideation.
Keep JATENZO out of the reach of children. Distributed by: Tolmar, Inc. Fort Collins, CO 80526 133462 Rev.
1 09/2025
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 09/2025 MEDICATION GUIDE JATENZO ® (juh-TEN-zoh) (testosterone undecanoate) capsules, for oral use CIII What is JATENZO? JATENZO is a prescription medicine that contains testosterone.
JATENZO is used to treat adult men who have low or no testosterone due to certain medical conditions. It is not known if JATENZO is safe or effective to treat men who have low testosterone due to aging. It is not known if JATENZO is safe or effective in children younger than 18 years old.
Improper use of JATENZO may affect bone growth in children. JATENZO is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your JATENZO in a safe place to protect it.
Never give your JATENZO to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law. JATENZO is not meant for use by women.
Do not take JATENZO if you: have breast cancer. have or might have prostate cancer. are a woman who is pregnant. JATENZO may harm your unborn baby. are allergic to JATENZO or any ingredients in JATENZO. See the end of this Medication Guide for a complete list of ingredients in JATENZO.
Before you take JATENZO, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure. have heart problems. have high red blood cell count (hematocrit) or high hemoglobin laboratory value. have urinary problems due to an enlarged prostate. have liver or kidney problems. have a history of mental health illness including suicidal thoughts or actions, depression, anxiety or mood disorder. have problems breathing while you sleep (sleep apnea).
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using JATENZO with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin medicines that decrease blood clotting (blood thinners) corticosteroids. medicines that increase blood pressure such as some cold medicines and pain medicines.
Know the medicines you take. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take JATENZO? Take JATENZO exactly as your healthcare provider tells you take it. Take JATENZO by mouth two times daily.
Take 1 time in the morning and take 1 time in the evening. Take JATENZO with food. Your healthcare provider may change your JATENZO dose.
Do not change your JATENZO dose without talking to your healthcare provider. What are the possible side effects of JATENZO? JATENZO may cause serious side effects including: Increase in blood pressure.
JATENZO can increase your blood pressure, which can increase your risk of having a heart attack or stroke over time. Your risk may be greater if you already have heart disease or if you have had a heart attack or stroke. You may need to start new blood pressure medicines or have your medicines adjusted to control your blood pressure while on JATENZO.
If your blood pressure cannot be controlled, JATENZO may need to be stopped. Your healthcare provider should check your blood pressure while you use JATENZO. Increase in red blood cell count (hematocrit) or hemoglobin.
JATENZO increases red blood cell counts in some patients. High red blood cell counts increase the risk of blood clots, strokes, and heart attacks. You may need to stop JATENZO if your red blood cell count increases.
Your healthcare provider should check your red blood cell count and hemoglobin while you use JATENZO. If you already have an enlarged prostate, your signs and symptoms may worsen while using JATENZO. These may include: increased urina…