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Switching to JATENZO Titration Access Is Easy With JATENZO

SWITCHING TO JATENZO

JATENZO has five dosing options to titrate up or down for your patients1

Depending on how your patient responds to JATENZO, his dose may need to be adjusted up or down.1

Individualize the dosage of JATENZO based on the patient’s serum testosterone concentration response to the drug.1

Each dose is taken twice daily with food1

30-day supply, dispense as written. Refer to the full Prescribing Information for titration instructions.

158 mg BID

198 mg BID

237 mg BID

316 mg BID

396 mg BID

recommended
starting dose

PO=per os (by mouth).

Capsules are not actual size.

TITRATION

Physicians say almost half of patients require titration after the initial dose4

Individualize his dose based on his serum testosterone concentration.1

Monitor Regularly1,3*

After 7 days of starting a new dose, you can evaluate his serum testosterone by testing 4-6 hours after the morning dose to determine if dose should be adjusted1

Select your current dose

396 mg BID

316 mg BID

237 mg BID

Recommended starting dose

198 mg BID

158 mg BID

What level do you see?

Here's your recommended step

TITRATE UP
CONTINUE WITH CURRENT DOSE
TITRATE DOWN
DISCONTINUE TREATMENT.
Re-Test/
Re-Assess
Therapy

*Assess serum concentrations after at least 7 days (4-6 hours after AM dose). Continue to monitor as needed as dose adjustment needs can persist.1

†Dispense as written for 30-day supply of JATENZO.

ACCESS IS EASY WITH JATENZO

Get JATENZO through our recommended network pharmacies

  • Sterling Specialty Pharmacy
  • Invictus Pharmacy

Eligible patients with commercial insurance may pay as little as $0 for every JATENZO prescription with no cap on copay assistance†

  • With approved commercial insurance, patient may pay as little as $0
  • If commercial insurance rejects coverage, patient may pay $150

Learn About Copay Assistance

†Restrictions may apply. See Eligibility for more details.

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IMPORTANT SAFETY INFORMATION FOR JATENZO (testosterone undecanoate)

Indication and Limitations of Use:

JATENZO®(testosterone undecanoate) capsules, CIII, 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)
  • Hypogonadotropic hypogonadism (congenital or acquired)

Safety and efficacy of JATENZO in males less than 18 years old have not been established.

IMPORTANT SAFETY INFORMATION FOR JATENZO (testosterone undecanoate)

WARNING: INCREASES IN BLOOD PRESSURE

  • 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 blood pressure is adequately controlled.
  • Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of JATENZO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment.
  • Due to this risk, use JATENZO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.

CONTRAINDICATIONS

JATENZO is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate, in women who are pregnant, in men with a known hypersensitivity to JATENZO or its ingredients, or in men with hypogonadal conditions that are not associated with structural or genetic etiologies.

WARNINGS AND PRECAUTIONS

Increase blood pressure and Major Adverse Cardiovascular Events. JATENZO can increase blood pressure, which can increase the risk of MACE, with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease.

Increase in hematocrit and polycythemia. High red blood cell counts increase the risk of clots, strokes, and heart attacks.

Benign prostatic hyperplasia (BPH). Patients may see worsening signs and symptoms of BPH.

Prostate cancer. Patients treated with androgens may be at increased risk for prostate cancer.

Venous thromboembolic events (VTE). Deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone replacement products like JATENZO.

Abuse. Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Testosterone abuse can lead to serious cardiovascular and psychiatric adverse reactions.

Suppression of spermatogenesis. Large doses of androgens, like JATENZO, can suppress spermatogenesis.

Hepatic adverse events. JATENZO is not known to cause liver adverse events; however, patients should be instructed to report any signs of hepatic dysfunction.

Retention of sodium and water.

Gynecomastia.

Sleep apnea. Testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung disease.

Changes in the serum lipid profile may require dose adjustment of lipid-lowering drugs or discontinuation of testosterone therapy.

Risk of hypercalcemia.

ADVERSE EVENTS

The most common adverse events of JATENZO (incidence ≥2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).

DRUG INTERACTIONS

JATENZO can cause changes in insulin sensitivity or glycemic control and changes in anticoagulant activity. Use of testosterone and corticosteroids concurrently may increase fluid retention. Use of prescription and nonprescription analgesic cold medications with JATENZO have been known to increase blood pressure.

Please see full Prescribing Information, including BOXED WARNING on increases in blood pressure.

To report suspected adverse reactions contact Tolmar at 1-844-4TOLMAR (486-5627) or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

References

1. JATENZO® [prescribing information]. Fort Collins, CO: Tolmar; 2023.

2. Swerdloff RS, Wang C, White WB, et al. A new oral testosterone undecanoate formulation restores testosterone to normal concentrations in hypogonadal men. J Clin Endocrinol Metab. 2020;105(8):2515-2531.

3. Swerdloff RS, Dudley RE. A new oral testosterone undecanoate therapy comes of age for the treatment of hypogonadal men. Ther Adv Urol. 2020;12:1-16.

4. Data on file. The Landmark SERMO survey: The state of TRT in 2024. (conducted February 16-March 1, 2024). Tolmar, Inc.

5. Data on file. The Harris Poll. Hypogonadism Patient Research: Executive Summary (conducted May 6-June 5, 2020). Tolmar, Inc.

6. Data on file. Clinical Study Report: CLAR-15012. Tolmar, Inc.

7. Petrova TV, Koh GY. Organ-specific lymphatic vasculature: From development to pathophysiology. J Exp Med. 2018;215(1):35-49.

8. Data on file. Clinical Study Report: CLAR-09009. Tolmar, Inc.

9. Data on file. Clinical Study Report: CLAR-09007. Tolmar, Inc.

10. Shoskes JJ, Wilson MK, Spinner ML. Pharmacology of testosterone replacement therapy preparations. Transl Androl Urol. 2016;5(6):834-843.