Jatenzo

Last updated on RxList: 9/14/2020
Jatenzo Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Jatenzo?

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.

What Are Side Effects of Jatenzo?

Common side effects of Jatenzo include:

Dosage for Jatenzo?

The starting dose of Jatenzo is 237 mg orally once in the morning and once in the evening. The dose of Jatenzo is adjusted to a minimum of 158 mg twice daily and a maximum of 396 mg twice daily.

What Drugs, Substances, or Supplements Interact with Jatenzo?

Jatenzo may interact with insulin, anticoagulants, corticosteroids, or medications that increase blood pressure. Tell your doctor all medications and supplements you use.

Jatenzo During Pregnancy and Breastfeeding

Jatenzo is not indicated for use in women and is therefore unlikely to be used in women who are pregnant or breastfeeding.

Additional Information

Our Jatenzo (testosterone undecanoate) Capsules, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Jatenzo Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Testosterone can increase your blood pressure, which can increase your risk of heart attack, stroke, or death. You may need to stop using testosterone or start taking blood pressure medication.

Call your doctor at once if you have:

  • swelling in your feet, ankles or legs;
  • pain or swelling in your breasts;
  • breathing problems during sleep (breathing may stop);
  • unusual changes in mood or behavior, new or worsening depression, thoughts about hurting yourself;
  • liver problems--nausea, vomiting, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes);
  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
  • signs of a blood clot deep in the body--pain, swelling, warmth, or redness in your leg; or
  • worsening symptoms of an enlarged prostate--increased urination, a weak stream of urine, an urgent need to urinate, or loss of bladder control.

Common side effects may include:

  • increased red blood cell counts;
  • an enlarged prostate;
  • erections that are more frequent or that last longer than usual;
  • increased blood pressure;
  • nausea, heartburn, burping;
  • diarrhea;
  • headache; or
  • swelling in your lower legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Jatenzo (Testosterone Undecanoate Capsules)

Jatenzo Professional Information

SIDE EFFECTS

Clinical 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

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)

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).

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. 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 mmHg (95% CI 3.5, 6.4) and 2.5 mmHg (95% CI 1.5, 3.6), respectively.

The ABPM systolic and diastolic increases were larger in patients with a history of hypertension who were being treated with antihypertensive therapy (5.4 mmHg [95% CI 3.3, 7.6] and 3.2 mmHg [95% CI 1.7, 4.7], respectively [n=67]) compared to patients with no history of hypertension at baseline (4.4 mmHg [95% CI 2.3, 6.4] and 1.8 mmHg [95% CI 0.2, 3.3], respectively [n=63]).

The BP measured in a clinic setting using BP cuff measurements rose during the course of treatment with a mean systolic increase of 2.8 mmHg (95% CI 1.0, 4.6) and a mean diastolic increase of 0.6 mmHg (95% CI -0.7, 1.9) at the final on-treatment visit (Day 139).

Twelve (7.2%) patients on JATENZO started antihypertensive or had their antihypertensive regimen increased during the course of 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 patients (1.2%) reported either worsening depression (n=1) or new-onset depression (n=1). One of the 569 patients (0.2%) in clinical trials had suicidal ideation. Each patient completed the study.

Increases In Serum PSA

The mean increase from baseline in PSA was 0.2 ng/mL (n=161). Increases in serum PSA concentrations, defined as an increase from baseline of at least 1.4 ng/mL or PSA greater than 4 ng/mL, occurred in 3 (1.9%) of the patients at the final visit.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of testosterone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular Disorders: myocardial infarction, stroke [see WARNINGS AND PRECAUTIONS]

Vascular Disorders: Venous thromboembolism [see WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for Jatenzo (Testosterone Undecanoate Capsules)

© Jatenzo Patient Information is supplied by Cerner Multum, Inc. and Jatenzo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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