Hypogonadism:

Indications for: TLANDO

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.

Adult Dosage:

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 Dosage:

<18yrs: not established.

TLANDO Contraindications:

Male breast or prostate cancer. Age-related hypogonadism. Pregnancy.

Boxed Warning:

Increases in blood pressure (BP).

TLANDO 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 Classification:

Androgen.

TLANDO 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.

Adverse Reactions:

Increased serum prolactin, hypertension, increased hematocrit, upper respiratory tract infection, increased weight, headache, musculoskeletal pain; gynecomastia, spermatogenesis (w. large doses).

Generic Drug Availability:

NO

How Supplied:

Caps—120

Pricing for TLANDO

112.5mg capsule (Qty: 120)
Appx. price $725
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