IMPORTANT SAFETY INFORMATION & INDICATIONS

TLANDO (testosterone undecanoate) capsules, for oral use, CIII anchor

TLANDO INDICATIONS AND USAGE

TLANDO (testosterone undecanoate) is 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’s 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 TLANDO in males less than 18 years old have not been established.
• Safety and efficacy of TLANDO in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

TLANDO is contraindicated in:

• Patients with carcinoma of the breast or known or suspected carcinoma of the prostate.
• Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman.
• Known hypersensitivity to testosterone undecanoate or any of TLANDO’s ingredients.

WARNINGS AND PRECAUTIONS

Polycythemia: Check hematocrit prior to initiating TLANDO and evaluate every 3 months during the first year of treatment, and then every 6 months thereafter while the patient is taking TLANDO. If hematocrit becomes elevated, stop TLANDO until hematocrit decreases to an acceptable concentration.  If hematocrit increases again after TLANDO is restarted, stop treatment permanently.

Venous Thromboembolism: There have been post marketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone replacement products such as TLANDO. 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 TLANDO and initiate appropriate workup and management.

Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer: Monitor patients with BPH for worsening signs and symptoms. Evaluate patients for prostate cancer, including measurement of prostate specific antigen (PSA), prior to initiating and during treatment with androgens.

Blood Pressure Increases: TLANDO can increase blood pressure which can increase cardiovascular risk over time. Monitor BP periodically in men using TLANDO, especially men with hypertension. TLANDO is not recommended for use in patients with uncontrolled hypertension.

Abuse of Testosterone and Monitoring of Serum 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. If abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids.

Not for Use in Women: TLANDO is not indicated for use in women.

Potential for Adverse Effects on Spermatogenesis: Large doses of androgens like TLANDO can suppress spermatogenesis. Inform patients of this risk before prescribing TLANDO.

Hepatic Adverse Effects: Prolonged use of high doses of alpha-alkyl androgen has been associated with serious hepatic adverse effects, however TLANDO is not this type of compound and therefore is not known to cause serious hepatic adverse effects. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction. If these occur, promptly discontinue TLANDO while the cause is evaluated.

Edema: Edema may occur in patients with or without congestive heart failure and with preexisting cardiac, renal or hepatic disease. In addition to discontinuing TLANDO, appropriate workup and management of edema may be required.

Sleep Apnea: TLANDO may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.

Lipid Changes: TLANDO may affect serum lipid profile. Monitor patient lipid concentrations periodically; if necessary, adjust dosage of lipid lowering drug(s) or discontinue TLANDO.

Increases in Prolactin: Increases in serum prolactin have been reported in patients treated with TLANDO in clinical trials. Monitor serum prolactin levels prior to initiation of TLANDO and 3 to 4 months after starting TLANDO. Discontinue TLANDO if serum prolactin levels remain elevated.

Other warnings to consider: gynecomastia; hypercalcemia in cancer patients; and decreased thyroxine-binding globulin.

ADVERSE REACTIONS

The most commonly reported adverse reactions (≥ 2%) were: increased blood prolactin (6%), hypertension (5%), increased hematocrit (4%), upper respiratory tract infection (4%), weight increased (2%), headache (2%), and musculoskeletal pain (2%).

DRUG INTERACTIONS

Insulin: TLANDO can cause changes in insulin sensitivity or glycemic control. Androgens may decrease blood glucose requiring a decrease in the dose of anti-diabetic medication.

Oral Anticoagulants: Anticoagulant activity may be seen with androgens. Frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking anticoagulants, especially at initiation and termination of androgen therapy.

Corticosteroids: Concurrent use of testosterone with corticosteroids may increase fluid retention and requires careful monitoring, particularly in patients with cardiac, renal, or hepatic disease.

Medications that May Also Increase Blood Pressure: Concomitant administration of medications or drugs known to increase BP with TLANDO may lead to additional BP increases.

DOSAGE AND ADMINISTRATION

TLANDO is not substitutable with other oral testosterone undecanoate products.

For more information, call 1-844-VERITY-1 (1-844-837-4891)

Please note that this information is not comprehensive. Please click here for full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Verity Pharma at 1-844-837-4891 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.