Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING TLANDO capsules for oral administration are available containing 112.5 mg of testosterone undecanoate. The capsules have a white opaque body imprinted with “112” in black ink and a grey opaque cap, banded with a colorless band. TLANDO capsules are supplied in HDPE bottles with a foil liner and a child resistant cap. Bottles of 120 capsules: NDC 54436-112-20. Store at 20ºC to 25°C (68ºF to 77°F); excursions permitted to 15ºC to 30°C (59ºF to 86°F). [See USP Controlled Room Temperature]. Dispose of unused TLANDO via a take-back option. If a take-back option is unavailable, follow FDA instructions at www.fda.gov/drugdisposal.; PRINCIPAL DISPLAY PANEL - 112.5 mg Bottle Label - 120 Capsules NDC 54436-112-20 Rx Only TLANDO TM (testosterone undecanoate) Capsules 112.5 mg CIII Dispense accompanying Medication Guide to each patient antares pharma 120 capsules Bottle Label 120
- 16 HOW SUPPLIED/STORAGE AND HANDLING TLANDO capsules for oral administration are available containing 112.5 mg of testosterone undecanoate. The capsules have a white opaque body imprinted with “112” in black ink and a grey opaque cap, banded with a colorless band. TLANDO capsules are supplied in HDPE bottles with a foil liner and a child resistant cap. Bottles of 120 capsules: NDC 54436-112-20. Store at 20ºC to 25°C (68ºF to 77°F); excursions permitted to 15ºC to 30°C (59ºF to 86°F). [See USP Controlled Room Temperature]. Dispose of unused TLANDO via a take-back option. If a take-back option is unavailable, follow FDA instructions at www.fda.gov/drugdisposal.
- PRINCIPAL DISPLAY PANEL - 112.5 mg Bottle Label - 120 Capsules NDC 54436-112-20 Rx Only TLANDO TM (testosterone undecanoate) Capsules 112.5 mg CIII Dispense accompanying Medication Guide to each patient antares pharma 120 capsules Bottle Label 120
Overview
TLANDO (testosterone undecanoate) capsules contain 112.5 mg testosterone undecanoate, an ester of testosterone, for oral administration. Testosterone, an androgen, is formed by cleavage of the ester side chain of testosterone undecanoate. The chemical name of testosterone undecanoate is 17β-undecanoyloxy-4-androsten-3-one. It has an empirical formula of C 30 H 48 O 3 and a molecular weight of 456.7. The structural formula is: Testosterone undecanoate is a white to off-white crystalline substance. The inactive ingredients in TLANDO capsules are ascorbyl palmitate, glyceryl monolinoleate, polyethylene glycol 8000, and polyoxyl 40 hydrogenated castor oil. The capsule shell contains black iron oxide, gelatin, and titanium dioxide. The capsule is imprinted with black ink that contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac. Structure
Indications & Usage
TLANDO 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 [see Dosage and Administration ( 2.2 )]. 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 [see Dosage and Administration ( 2.2 )]. Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established [see Use in Specific Populations ( 8.4 ) ] . TLANDO is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone ( 1 ). Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established ( 1 ).
Dosage & Administration
Prior to initiating TLANDO, 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 serum testosterone concentrations are below the normal range ( 2.2 ). Recommended dosage is 225 mg orally twice daily with food ( 2.3 ). Monitor serum testosterone after initiating TLANDO to determine if TLANDO should be continued or discontinued ( 2.3 ). 2.1 Important Dosage Information TLANDO is not substitutable with other oral testosterone undecanoate products. 2.2 Confirmation of Hypogonadism Before Initiation of TLANDO Prior to initiating TLANDO, 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 serum testosterone concentrations are below the normal range. 2.3 Recommended Dosage The recommended dosage of TLANDO is 225 mg (taken as two 112.5 mg capsules), orally twice daily, once in the morning and once in the evening. Take with food. Monitoring for Continued Use or Discontinuation Monitor serum testosterone (8 to 9 hours after the morning dose) 3 to 4 weeks after initiating TLANDO, and periodically thereafter. Based on serum testosterone measurements, determine if TLANDO should be continued or discontinued: Serum testosterone 300 - 1080 ng/dL: continue TLANDO Serum testosterone < 300 ng/dL: discontinue TLANDO Serum testosterone > 1080 ng/dL: discontinue TLANDO
Warnings & Precautions
Polycythemia : Monitor hematocrit approximately every 3 months during the first year after beginning TLANDO and then every 6 months thereafter during treatment. Discontinue TLANDO if necessary ( 5.2 ). Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer : Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. Evaluate patients for prostate cancer, including monitoring prostate specific antigen (PSA) prior to initiating and during treatment with androgens ( 5.4 ). Venous thromboembolism (VTE) : VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products. Discontinue TLANDO if VTE is suspected and initiate appropriate workup and management ( 5.5 ). Abuse of Testosterone and Monitoring of Serum Testosterone : If testosterone use at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids is suspected, check serum testosterone concentration ( 5.6 ). Potential for Adverse Effects on Spermatogenesis : TLANDO may cause azoospermia ( 5.8 , 8.3 ). Edema : Edema, with or without congestive heart failure (CHF) may occur in patients with preexisting cardiac, renal, or hepatic disease. Discontinue TLANDO and initiate appropriate workup ( 5.10 ). Sleep Apnea: TLANDO may potentiate sleep apnea in those with risk factors ( 5.11 ). Lipid Changes : Testosterone may affect serum lipid profile. Monitor patient lipid concentrations; if necessary, adjust dosage of lipid lowering drug(s) or discontinue TLANDO ( 5.13 ). Increases in Prolactin : 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 ( 5.16 ). 5.1 Increase in Blood Pressure In Study 18-001, TLANDO increased systolic BP after 4 months of treatment by an average of 4.3 mmHg based on ambulatory blood pressure monitoring (ABPM) and 4.8 mmHg from baseline based on blood pressure cuff measurements [see Adverse Reactions ( 6.1 )] . These BP increases can increase the risk of major adverse cardiovascular events (MACE), with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease. In some patients, the increase in BP with TLANDO may be too small to detect but can still increase the risk for MACE. Before initiating TLANDO, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled. Check BP approximately 3 weeks after initiating TLANDO and periodically thereafter. Treat new-onset hypertension or exacerbations of pre-existing hypertension. Re-evaluate whether the benefits of continued treatment with TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease. 5.2 Polycythemia Increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of TLANDO. Check hematocrit prior to initiating TLANDO. Evaluate hematocrit approximately 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 TLANDO is restarted and again causes hematocrit to become elevated, stop TLANDO permanently. An increase in red blood cell mass may increase the risk of thromboembolic events [ see Warnings and Precautions ( 5.5 ) ] . 5.3 Cardiovascular Risk Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. TLANDO can cause BP increases that can increase the risk of MACE [see Boxed Warning and Warnings and Precautions ( 5.1 )] . Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO. 5.4 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, including measurement of prostate specific antigen (PSA), prior to initiating and during treatment with androgens [see Contraindications ( 4 )] . 5.5 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 [ see Adverse Reactions ( 6.2 ) ] . 5.6 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. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions [ see Drug Abuse and Dependence ( 9 ) ] . If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. 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. 5.7 Not for Use in Women Due to lack of controlled studies in women and the potential for virilizing effects, TLANDO is not indicated for use in women [ see Use in Specific Populations ( 8.1 , 8.2 ) ] . 5.8 Potential for Adverse Effects on Spermatogenesis With large doses of exogenous androgens, including TLANDO, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) possibly leading to adverse effects on semen parameters including sperm count [ see Use in Specific Populations ( 8.3 ) ] . Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO. 5.9 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. TLANDO is not a 17 alpha-alkyl androgen and is not known to produce hepatic adverse effects associated with 17-alpha-alkyl androgens. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). If these occur, promptly discontinue TLANDO while the cause is evaluated. 5.10 Edema Androgens, including TLANDO, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease [ see Adverse Reactions ( 6.1 ) ] . In addition to discontinuation of the drug, appropriate work up and management of edema may be required. 5.11 Sleep Apnea The treatment of hypogonadal men with testosterone products may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases. 5.12 Gynecomastia Gynecomastia may develop and persist in patients being treated for hypogonadism. 5.13 Lipid Changes Changes in serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of testosterone therapy. Monitor the lipid profile periodically after starting testosterone therapy. 5.14 Hypercalcemia Androgens, including TLANDO, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Monitor serum calcium concentrations periodically in these patients. 5.15 Decreased Thyroxine-binding Globulin Androgens, including TLANDO, may decrease concentrations of thyroxin-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of triiodothyronine (T3) and thyroxine (T4). Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. 5.16 Increases in Prolactin Increases in serum prolactin have been reported in patients treated with TLANDO in clinical trials. Evaluate serum prolactin levels prior to initiating treatment with TLANDO. Re-evaluate serum prolactin levels 3 to 4 months after starting treatment. If serum prolactin remains elevated, discontinue TLANDO [ s ee Adverse Reactions ( 6.1 ) ] .
Boxed Warning
BLOOD PRESSURE INCREASES TLANDO can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death, with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 ) ] . Before initiating TLANDO, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled [ see Warnings and Precautions ( 5.3 ) ] . Three weeks after initiating therapy monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension [see Warnings and Precautions ( 5.1 )] . Re-evaluate whether the benefits of TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment [see Warnings and Precautions ( 5.3 )] . Due to this risk, use TLANDO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies [see Indications and Usage ( 1 ) and Contraindications ( 4 )]. WARNING: BLOOD PRESSURE INCREASES See full prescribing information for complete boxed warning TLANDO can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death ( 5.1 , 5.3 , 6.1 ). Before initiating TLANDO, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled ( 5.1 , 5.3 ). Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment ( 5.1 , 5.3 ). Due to this risk, use TLANDO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies ( 1 , 4 ).
Contraindications
TLANDO is contraindicated in: Patients with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions ( 5.4 )] . Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] . Known hypersensitivity to testosterone undecanoate or any of TLANDO’s ingredients [see Description ( 11 )]. Men with hypogonadal conditions, such as “age-related hypogonadism”, that are not associated with structural or genetic etiologies. The efficacy of TLANDO has not been established for these conditions, and TLANDO can increase BP that can increase the risk of MACE [see Boxed Warning and Warning and Precautions ( 5.1 )] . Carcinoma of the breast or known or suspected carcinoma of the prostate ( 4 ) Women who are pregnant. Testosterone may cause fetal harm ( 4 , 5.7 , 8.1 ) Hypersensitivity to TLANDO or any of its ingredients ( 4 ) Hypogonadal conditions not associated with structural or genetic etiologies ( 4 )
Adverse Reactions
Most common adverse reactions (incidence ≥ 2%): increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, weight increased, headache, and musculoskeletal pain ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Antares at 1-855-287-7476 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . The following clinically significant adverse reactions are discussed elsewhere in the labeling: Increase in Blood Pressure [see Warnings and Precautions ( 5.1 )] Polycythemia [see Warnings and Precautions ( 5.2 )] Cardiovascular Risk [see Warnings and Precautions ( 5.3 )] Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer [see Warnings and Precautions (( 5.4 )] Venous Thromboembolism [see Warnings and Precautions ( 5.5 )] Hepatic Adverse Effects [see Warnings and Precautions ( 5.9 )] Edema [see Warnings and Precautions ( 5.10 )] Sleep Apnea [see Warnings and Precautions ( 5.11 )] Gynecomastia [see Warnings and Precautions ( 5.12 )] Lipid Changes [see Warnings and Precautions ( 5.13 )] Hypercalcemia [see Warnings and Precautions ( 5.14 )] Decreased Thyroxine-binding Globulin [see Warnings and Precautions ( 5.15 )] Increases in Prolactin [see Warnings and Precautions ( 5.16 )] 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of TLANDO 225 mg twice daily, without dose titration, was evaluated in 233 hypogonadal males during two clinical studies: Study LPCN 1021-18-001 (18-001) and Study LPCN 1021-16-002 (16-002) [see Clinical Studies ( 14 )]. In Study 18-001, an uncontrolled ambulatory blood pressure monitoring (ABPM) study, 138 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately four months. Patients had a median age of 54 years (range 26-75), 79% were White, 18% were Black, and 2% were Asian. In 138 hypogonadal male patients, 70% (n=96) were obese (BMI≥30 kg/m 2 ), 24% (n=33) reported a history of type 2 diabetes, and 48% (n=66) reported a history of hypertension. Table 1 summarizes adverse reactions ( > 2%) reported in patients receiving TLANDO in Study 18-001. Table 1. Adverse Reactions ≥ 2% in Patients Receiving TLANDO in Study 18-001 Adverse Reaction Overall (N=138) n (%) Hypertension 7 (5.1) Hematocrit increased 6 (4.3) Upper respiratory tract infection 5 (3.6) Four of the 138 patients (2.9%) in Study 18-001 reported adverse reactions that led to premature discontinuation from the study, including dizziness (n=1), weight increased (n=1), insomnia (n=1), and hypertension (n=2). In Study 16-002, 95 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 24 days. The dose of TLANDO was not titrated. Patients had a median age of 56 years (range 29-74), 81% were White, 16% were Black, 2% were mixed race, and 1% were Asian; 26% were Hispanic. In 95 hypogonadal male patients, 70% (n=66) were obese (BMI≥30 kg/m 2 ), 23% (n=22) reported a history of type 2 diabetes, and 50% (n=47) reported a history of hypertension. Table 2 summarized adverse reactions ( > 2%) reported during Study 16-002 in patients receiving TLANDO. Table 2. Adverse Reactions ≥2% in Patients Receiving TLANDO in Study 16-002 Adverse Reaction Overall (N=95) n (%) Blood prolactin increased 6 (6.3) Weight increased 2 (2.1) Headache 2 (2.1) Musculoskeletal pain 2 (2.1) One of the 95 patients (1.1%) in the 24-day study reported an adverse reaction (gastric ulcer hemorrhage) that led to premature discontinuation from the study. Blood Pressure Increases In Study 18-001 24-hour ambulatory blood pressure monitoring (ABPM) was conducted in 138 male patients, 126 of whom completed the study. ABPM was conducted at 2 distinct 24-hour time periods: at baseline and following approximately 16 weeks of treatment with TLANDO. A total of 123 patients had acceptable 24-hour ABPM recordings at both time periods. In that group, the mean change in systolic BP from Baseline to End of Study was + 4.3 mmHg (95% CI 2.1, 6.5) and the mean change in diastolic BP was 1.4 mmHg (95% CI 0.5, 2.3). The ABPM systolic and diastolic blood pressure increased in patients with a history of hypertension at baseline [4.8 mmHg (95% CI 1.0, 8.5) and 1.6 mmHg (95% CI 0.1, 3.0), respectively (n=60)]. In patients with no history of hypertension at baseline systolic and diastolic blood pressure increased [3.9 mmHg (95% CI 0.9, 6.8) and 1.2 mmHg (95% CI -0.1, 2.5), respectively (n =63)]. Increases in Hematocrit Increases in hematocrit were reported in 6 of the 138 patients (4.3%) in Study 18-001. None of these increases led to premature discontinuation of TLANDO. Increases in Prolactin Increases in serum prolactin were reported in 6 (6.3%) of the 95 patients in the 24-day clinical study. The mean increase from baseline in serum prolactin was 7.0 ng/mL (n=93). The 4-month clinical study did not assess serum prolactin concentrations after the screening visit. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of testosterone replacement products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular Disorders : myocardial infarction, stroke Vascular Disorders: Venous thromboembolism
Drug Interactions
Insulin: In patients with diabetes, concomitant use with TLANDO may decrease blood glucose and insulin requirements ( 7.1) . Oral Anticoagulants: Concomitant use with TLANDO may cause changes in anticoagulant activity. Monitor International Normalized Ratio and prothrombin time frequently ( 7.2 ). Corticosteroids: Concomitant use with TLANDO may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease ( 7.3 ). Drugs that May Also Increase Blood Pressure: Concomitant use with TLANDO may lead to additional increases in blood pressure ( 7.4 ). 7.1 Insulin Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements. 7.2 Oral Anticoagulants Changes in anticoagulant activity may be seen with androgens. Frequent monitoring of INR and prothrombin time may be necessary in patients taking anticoagulants, especially at the initiation and termination of androgen therapy. 7.3 Corticosteroids The concurrent use of testosterone with corticosteroids may result in increased fluid retention and should be monitored cautiously, particularly in patients with cardiac, renal or hepatic disease. 7.4 Drugs that May Also Increase Blood Pressure Some prescription drugs and nonprescription analgesic and cold medications can increase blood pressure. Concomitant administration of these medications with TLANDO may lead to additional increases in blood pressure [ see Warnings and Precautions ( 5.1 ) ] .
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