Tlando Generic Name & Formulations
Legal Class
CIII
General Description
Testosterone undecanoate 112.5mg; caps.
Pharmacological Class
Androgen.
How Supplied
Caps—120
Manufacturer
Generic Availability
NO
Mechanism of Action
Endogenous androgens, including testosterone and dihydrotestosterone, are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics.
Tlando Indications
Indications
Testosterone replacement therapy in adult males with congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.
Limitations of Use
Safety and efficacy have not been established in males <18yrs.
Tlando Dosage and Administration
Adult
Prior to treatment, confirm diagnosis by ensuring serum testosterone has been measured in the AM on at least 2 separate days and that these concentrations are below normal range. Take with food. ≥18yrs: 225mg (2 caps) twice daily (AM + PM). Treatment continuation based on serum testosterone (see full labeling).
Children
<18yrs: not established.
Tlando Contraindications
Contraindications
Male breast or prostate cancer. Age-related hypogonadism. Pregnancy.
Tlando Boxed Warnings
Boxed Warning
Increases in blood pressure (BP).
Tlando Warnings/Precautions
Warnings/Precautions
Not substitutable with other oral testosterone undecanoate products. Not for use in women. Increases in BP can increase risk of major adverse cardiovascular events (MACE), including non-fatal MI, non-fatal stroke, CV death. Prior to treatment, consider baseline CV risk and ensure BP adequately controlled. Monitor BP approx. 3 weeks after initiation or dose increase and periodically thereafter; treat new-onset hypertension or exacerbations of preexisting hypertension. Reevaluate for continued treatment if CV risk factors or disease develops. Monitor hematocrit prior to initiation and approx. every 3 months during the 1st year of treatment, then every 6 months thereafter; if elevation occurs, withhold until acceptable level. Increased risk of worsening BPH; monitor. Evaluate for prostate cancer prior to and during treatment. Monitor for venous thromboembolism; discontinue if suspected. Preexisting cardiac, renal or hepatic disease (discontinue if edema occurs). Discontinue and evaluate if signs/symptoms of hepatic dysfunction (eg, jaundice) occur. Possible sleep apnea in patients with obesity or chronic lung disease. Testosterone and/or other anabolic androgenic steroid abuse. Monitor serum testosterone, PSA, liver function, lipid profile, serum calcium (in cancer patients at risk for hypercalcemia/hypercalciuria) periodically. Monitor serum prolactin levels prior to initiation and 3–4 months after starting; discontinue if serum prolactin levels remain elevated. Risk of depression, suicidal ideation. Elderly.
Tlando Pharmacokinetics
Elimination
Renal (~90%), fecal (~6%). Half-life: ~2 hours.
Tlando Interactions
Interactions
May alter insulin sensitivity and glycemic control; reduce dose of antidiabetic agents if needed. Increased fluid retention with concomitant corticosteroids; monitor. Monitor INR and PT with concomitant oral anticoagulants. Concomitant prescription or OTC analgesic and cold medications may lead to additional BP increases. May alter serum lipids; adjust dose of lipid-lowering drugs or discontinue testosterone. May affect thyroid levels.
Tlando Adverse Reactions
Adverse Reactions
Increased serum prolactin, hypertension, increased hematocrit, upper respiratory tract infection, increased weight, headache, musculoskeletal pain; gynecomastia, spermatogenesis (w. large doses).
Tlando Clinical Trials
See Literature
Tlando Note
Not Applicable
Tlando Patient Counseling
See Literature