Jatenzo
(testosterone undecanoate)Dosage & Administration
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Jatenzo Prescribing Information
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 causes such as 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 ].
Confirmation 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.
Dosing 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.
| 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 | |
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.
Pregnancy
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 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.
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.
Lactation
Risk Summary
JATENZO is not indicated for use in women.
Females 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 ], 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 ]. With either type of use, the impact on fertility may be irreversible.
Pediatric 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
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 ].
JATENZO is contraindicated in:
- Men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions ].
- Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman [see Use in Specific Populations ].
- Men with known hypersensitivity to JATENZO or any of its ingredients [see Description ].
Polycythemia
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 ].
Venous 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 higher risk of VTE (1.7% vs 1.2%) which included DVT (0.6% vs 0.5%) and PE (0.9% vs 0.5%) [see Adverse Reactions ].
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 ].
Worsening 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 ].
Blood 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 mmHg from baseline after 4 months of treatment in a clinical trial [see Adverse Reactions (6.1)]. In patients with hypertension on antihypertensive therapy, JATENZO increased the mean systolic/diastolic BP by 5.4/3.2 mmHg from baseline. Average blood pressures had not plateaued at the end of the trial .
The CV risk associated with topical testosterone gel was evaluated in TRAVERSE, a randomized, double-blind, placebo-controlled, CV outcomes study in men with a history of CV disease or multiple CV risk factors. In TRAVERSE, topical testosterone gel increased mean systolic blood pressure by 1.8 mmHg from baseline. However, the incidences of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction [MI] and non-fatal stroke, were similar between treatment groups (7% for topical testosterone gel vs 7.3% for placebo) [See Adverse Reactions ].
Monitor blood pressure periodically in men using JATENZO, especially men with hypertension. JATENZO is not recommended for use in patients with uncontrolled hypertension.
Abuse of Testosterone and Monitoring of Testosterone Concentrations
Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions [see Drug Abuse and Dependence ].
If testosterone abuse is suspected, check testosterone concentrations to ensure they are within therapeutic range [seeDose and Administration ]. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.
Not for Use in Women
Due to lack of controlled studies in women and potential virilizing effects, JATENZO is not indicated for use in women [see Contraindications andUse in Specific Populations ].
Potential for Adverse Effects on Spermatogenesis
With large doses of exogenous androgens, including JATENZO, spermatogenesis may be suppressed through feedback inhibition of pituitary FSH possibly leading to adverse effects on semen parameters including sperm count [see Use in Specific Populations ]. Patients should be informed of this possible risk when deciding whether to use or to continue to use JATENZO.
Hepatic Adverse Effects
Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. JATENZO is not known to cause these adverse effects. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g. jaundice). If these occur, promptly discontinue JATENZO while the cause is evaluated.
Edema
Androgens, including JATENZO, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.
Gynecomastia
Gynecomastia may develop and persist in patients being treated for hypogonadism.
Sleep Apnea
The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung disease.
Lipid Changes
Changes in the serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of testosterone therapy. Monitor the lipid profile periodically, particularly after starting testosterone therapy.
Hypercalcemia
Androgens, including JATENZO, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Monitor serum calcium concentrations regularly during treatment with JATENZO in these patients.
Decreased Thyroxine-binding Globulin
Androgens, including JATENZO, may decrease concentrations of thyroxin-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Risk of Depression and Suicide
Depression and suicidal ideation has been reported in patients treated with JATENZO in clinical trials. Advise patients and caregivers to seek medical attention for manifestations of new onset or worsening depression, suicidal ideation or behavior, anxiety, or other mood changes [see Adverse Events ].