Jatenzo
(Testosterone Undecanoate)By using PrescriberAI, you agree to the AI Terms of Use.
Jatenzo Prescribing Information
Boxed Warning, Increases in Blood Pressure Removed 03/2025
Indications and Usage (1) 03/2025
Contraindications, Men with “age related hypogonadism” (4) Removed 03/2025
Warnings and Precautions , Venous Thromboembolism (5.2) 03/2025
Warnings and Precautions, Blood Pressure Increases (5.4) 03/2025
Warnings and Precautions, Cardiovascular Risk (5.3) Removed 03/2025
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.
- 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 [seeUse in Specific Populations (].)
8.4 Pediatric UseThe 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.
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 is contraindicated in:
- Men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions (].)
5.3 Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate CancerPatients 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 ]. - 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 PregnancyRisk SummaryJATENZO 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 and Clinical Pharmacology ]. 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.DataAnimal DataIn 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.
- Men with known hypersensitivity to JATENZO or any of its ingredients [see Description (].)
11 DESCRIPTIONJATENZO (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 C30H48O3and 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
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 C30H48O3 and the molecular weight of 456.7. The structural formula for testosterone undecanoate is presented in
Figure 1.
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.
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.
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).