Principal Display Panel - 112.5 Mg Bottle Label - 120 Capsules

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 )].

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 ) ] .

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 ).

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.

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 )] .

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.

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 ).

Advise the patients to read the FDA-approved patient labeling ( Medication Guide ).

The safety and effectiveness of TLANDO 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.

There have not been sufficient numbers of geriatric patients in controlled clinical studies with TLANDO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. Of the 95 patients enrolled in Study 16-002, the 24-day major safety and effectiveness study utilizing TLANDO, 16 (16.8%) were over 65 years of age.  Additionally, there is insufficient long-term safety data in geriatric patients utilizing TLANDO 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 and hypertension [see Warnings and Precautions ( 5.1 )] and 5.4 ].

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 .

TLANDO contains testosterone undecanoate, a schedule III controlled substance.

Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice.

There is one report of acute overdosage with use of an approved injectable testosterone product: this subject had serum testosterone levels of up to 11,400 ng/dL with a cerebrovascular accident. Treatment of overdosage consists of discontinuation of TLANDO and appropriate symptomatic and supportive care.

TLANDO is not substitutable with other oral testosterone undecanoate products.

This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 03/2022 MEDICATION GUIDE TLANDO ® (Tee-lan-doh) (testosterone undecanoate) capsules, for oral use CIII What is the most important information I should know about TLANDO? TLANDO can cause serious side effects, including: • Increase in blood pressure. TLANDO can increase your blood pressure, which can increase your risk of having a heart attack or stroke and can increase your risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke. If your blood pressure increases while on TLANDO, blood pressure medicines may need to be started. If you are taking blood pressure medicines, new blood pressure medicines may need to be added or your current blood pressure medicines may need to be changed to control your blood pressure. If your blood pressure cannot be controlled, TLANDO may need to be stopped. Your healthcare provider will monitor your blood pressure while you are being treated with TLANDO. What is TLANDO? TLANDO is a prescription medicine that contains testosterone. TLANDO is used to treat adult men who have low or no testosterone due to certain medical conditions. It is not known if TLANDO is safe or effective in children younger than 18 years old. Improper use of TLANDO may affect bone growth in children. TLANDO is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your TLANDO in a safe place to protect it. Never give your TLANDO to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law. TLANDO is not meant for use by women. Do not take TLANDO if you: have breast cancer. have or might have prostate cancer. are a woman who is pregnant. TLANDO may harm your unborn baby. are allergic to TLANDO or any ingredients in TLANDO. See the end of this Medication Guide for a complete list of ingredients in TLANDO. have low testosterone without certain medical conditions. For example, do not take TLANDO if you have low testosterone due to age. Before you take TLANDO, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure. have heart problems. have high red blood cell count (hematocrit) or high hemoglobin laboratory value. have urinary problems due to an enlarged prostate. have liver or kidney problems. have a history of mental health illness including suicidal thoughts or actions, depression, anxiety or mood disorder. have problems breathing while you sleep (sleep apnea). Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using TLANDO with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin. medicines that decrease blood clotting (blood thinners). corticosteroids. medicines that increase blood pressure such as some cold medicines and pain medicines. Know the medicines you take. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. How should I take TLANDO? Take TLANDO exactly as your healthcare provider tells you take it. Take TLANDO by mouth two times daily. Take 2 capsules in the morning and take 2 capsules in the evening. Take TLANDO with food. What are the possible side effects of TLANDO? TLANDO may cause serious side effects including: See “ What is the most important information I should know about TLANDO?” Increase in red blood cell count (hematocrit) or hemoglobin. TLANDO increases red blood cell counts in some people. High red blood cell counts increase the risk of blood clots, strokes, and heart attacks. You may need to stop TLANDO if your red blood cell count increases. Your healthcare provider should check your red blood cell count and hemoglobin while you use TLANDO. If you already have an enlarged prostate, your signs and symptoms may worsen while using TLANDO. These may include: increased urination at night trouble starting your urine stream urinating many times during the day urge to go to the bathroom right away a urine accident inability to pass urine or weak urine flow Increased risk of prostate cancer . Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use TLANDO. Blood clots in the legs or lungs . Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain. Abuse . Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects. Your healthcare provider should check you for signs of abuse before and during treatment with TLANDO. In large doses TLANDO may lower your sperm count. Liver problems. Symptoms of liver problems may include: nausea or vomiting yellowing of your skin or whites of your eyes dark urine pain on the right side of your stomach area (abdominal pain) Swelling of your ankles, feet, or body (edema), with or without heart failure. Enlarged or painful breasts. Breathing problems while you sleep (sleep apnea). Call your healthcare provider right away if you have any of the serious side effects listed above. The most common side effects of TLANDO include: increased prolactin in your blood high blood pressure increased red blood cell count common cold increased weight headache joint and muscle pain Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TLANDO. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store TLANDO? Store TLANDO at room temperature between 68°F to 77°F (20°C to 25°C). Store TLANDO in a dry place. Keep TLANDO and all medicines out of the reach of children. How should I throw away (dispose of) TLANDO? Throw away unused TLANDO via a take-back option. If a take-back option is unavailable, follow FDA instructions at www.fda.gov/drugdisposal for properly throwing away medicine. General information about the safe and effective use of TLANDO Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TLANDO for a condition for which it was not prescribed. Do not give TLANDO to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TLANDO that is written for health professionals. What are the ingredients in TLANDO? Active ingredient: testosterone undecanoate Inactive ingredients:  ascorbyl palmitate, glyceryl monolinoleate, polyethylene glycol 8000, and polyoxyl 40 hydrogenated castor oil. Capsule shell: contains black iron oxide, gelatin, and titanium dioxide and imprint ink (ammonium hydroxide, black iron oxide, propylene glycol, and shellac). Manufactured for: Antares Pharma, Inc. Ewing, NJ 08628 Manufactured in the United Kingdom For more information, go to www.TLANDO.com or call 1-844-996-7833.

Capsules: 112.5 mg, white opaque body imprinted with “112” in black ink and grey opaque cap, banded with a colorless gelatin band.

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).

There is insufficient data to characterize an exposure-response relationship or time course of pharmacodynamic response.

Geriatric Patients: Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and hypertension ( 8.5 ).

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 ).

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

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 )].

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 ) ] .

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 ).

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.

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 )] .

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 ).

Advise the patients to read the FDA-approved patient labeling ( Medication Guide ).

The safety and effectiveness of TLANDO 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.

There have not been sufficient numbers of geriatric patients in controlled clinical studies with TLANDO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. Of the 95 patients enrolled in Study 16-002, the 24-day major safety and effectiveness study utilizing TLANDO, 16 (16.8%) were over 65 years of age.  Additionally, there is insufficient long-term safety data in geriatric patients utilizing TLANDO 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 and hypertension [see Warnings and Precautions ( 5.1 )] and 5.4 ].

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 .

TLANDO contains testosterone undecanoate, a schedule III controlled substance.

Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice.

There is one report of acute overdosage with use of an approved injectable testosterone product: this subject had serum testosterone levels of up to 11,400 ng/dL with a cerebrovascular accident. Treatment of overdosage consists of discontinuation of TLANDO and appropriate symptomatic and supportive care.

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.

TLANDO is not substitutable with other oral testosterone undecanoate products.

This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 03/2022 MEDICATION GUIDE TLANDO ® (Tee-lan-doh) (testosterone undecanoate) capsules, for oral use CIII What is the most important information I should know about TLANDO? TLANDO can cause serious side effects, including: • Increase in blood pressure. TLANDO can increase your blood pressure, which can increase your risk of having a heart attack or stroke and can increase your risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke. If your blood pressure increases while on TLANDO, blood pressure medicines may need to be started. If you are taking blood pressure medicines, new blood pressure medicines may need to be added or your current blood pressure medicines may need to be changed to control your blood pressure. If your blood pressure cannot be controlled, TLANDO may need to be stopped. Your healthcare provider will monitor your blood pressure while you are being treated with TLANDO. What is TLANDO? TLANDO is a prescription medicine that contains testosterone. TLANDO is used to treat adult men who have low or no testosterone due to certain medical conditions. It is not known if TLANDO is safe or effective in children younger than 18 years old. Improper use of TLANDO may affect bone growth in children. TLANDO is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your TLANDO in a safe place to protect it. Never give your TLANDO to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law. TLANDO is not meant for use by women. Do not take TLANDO if you: have breast cancer. have or might have prostate cancer. are a woman who is pregnant. TLANDO may harm your unborn baby. are allergic to TLANDO or any ingredients in TLANDO. See the end of this Medication Guide for a complete list of ingredients in TLANDO. have low testosterone without certain medical conditions. For example, do not take TLANDO if you have low testosterone due to age. Before you take TLANDO, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure. have heart problems. have high red blood cell count (hematocrit) or high hemoglobin laboratory value. have urinary problems due to an enlarged prostate. have liver or kidney problems. have a history of mental health illness including suicidal thoughts or actions, depression, anxiety or mood disorder. have problems breathing while you sleep (sleep apnea). Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using TLANDO with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin. medicines that decrease blood clotting (blood thinners). corticosteroids. medicines that increase blood pressure such as some cold medicines and pain medicines. Know the medicines you take. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. How should I take TLANDO? Take TLANDO exactly as your healthcare provider tells you take it. Take TLANDO by mouth two times daily. Take 2 capsules in the morning and take 2 capsules in the evening. Take TLANDO with food. What are the possible side effects of TLANDO? TLANDO may cause serious side effects including: See “ What is the most important information I should know about TLANDO?” Increase in red blood cell count (hematocrit) or hemoglobin. TLANDO increases red blood cell counts in some people. High red blood cell counts increase the risk of blood clots, strokes, and heart attacks. You may need to stop TLANDO if your red blood cell count increases. Your healthcare provider should check your red blood cell count and hemoglobin while you use TLANDO. If you already have an enlarged prostate, your signs and symptoms may worsen while using TLANDO. These may include: increased urination at night trouble starting your urine stream urinating many times during the day urge to go to the bathroom right away a urine accident inability to pass urine or weak urine flow Increased risk of prostate cancer . Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use TLANDO. Blood clots in the legs or lungs . Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain. Abuse . Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects. Your healthcare provider should check you for signs of abuse before and during treatment with TLANDO. In large doses TLANDO may lower your sperm count. Liver problems. Symptoms of liver problems may include: nausea or vomiting yellowing of your skin or whites of your eyes dark urine pain on the right side of your stomach area (abdominal pain) Swelling of your ankles, feet, or body (edema), with or without heart failure. Enlarged or painful breasts. Breathing problems while you sleep (sleep apnea). Call your healthcare provider right away if you have any of the serious side effects listed above. The most common side effects of TLANDO include: increased prolactin in your blood high blood pressure increased red blood cell count common cold increased weight headache joint and muscle pain Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TLANDO. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store TLANDO? Store TLANDO at room temperature between 68°F to 77°F (20°C to 25°C). Store TLANDO in a dry place. Keep TLANDO and all medicines out of the reach of children. How should I throw away (dispose of) TLANDO? Throw away unused TLANDO via a take-back option. If a take-back option is unavailable, follow FDA instructions at www.fda.gov/drugdisposal for properly throwing away medicine. General information about the safe and effective use of TLANDO Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TLANDO for a condition for which it was not prescribed. Do not give TLANDO to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TLANDO that is written for health professionals. What are the ingredients in TLANDO? Active ingredient: testosterone undecanoate Inactive ingredients:  ascorbyl palmitate, glyceryl monolinoleate, polyethylene glycol 8000, and polyoxyl 40 hydrogenated castor oil. Capsule shell: contains black iron oxide, gelatin, and titanium dioxide and imprint ink (ammonium hydroxide, black iron oxide, propylene glycol, and shellac). Manufactured for: Antares Pharma, Inc. Ewing, NJ 08628 Manufactured in the United Kingdom For more information, go to www.TLANDO.com or call 1-844-996-7833.

Capsules: 112.5 mg, white opaque body imprinted with “112” in black ink and grey opaque cap, banded with a colorless gelatin band.

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).

There is insufficient data to characterize an exposure-response relationship or time course of pharmacodynamic response.

Geriatric Patients: Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and hypertension ( 8.5 ).

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 ).

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