Testosteronedrug info
testosterone undecanoate 237 MG Oral Capsule [Jatenzo]
What it is used for
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. 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.
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.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective September 30, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective September 30, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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