Medical Editor: John P. Cunha, DO, FACOEP
What Is Tlando?
Tlando (testosterone undecanoate) is testosterone replacement therapy (“TRT”) indicated for conditions associated with a deficiency or absence of endogenous testosterone or hypogonadism in adult males.
What Are Side Effects of Tlando?
Side effects of Tlando include:
- increased blood prolactin,
- high blood pressure (hypertension),
- increased hematocrit,
- upper respiratory tract infection,
- weight gain,
- headache, and
- musculoskeletal pain.
Tlando may cause serious side effects including:
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- high red blood cell counts,
- increased urination at night,
- difficulty urinating,
- frequent urination,
- frequent urge to urinate,
- leaking urine,
- inability to urinate or weak flow,
- leg pain, redness or swelling,
- chest pain or pressure,
- yellowing of your eyes or skin (jaundice),
- dark urine,
- abdominal pain (right side),
- swelling of your ankles or feet,
- enlarged or painful breasts,
- difficulty breathing in your sleep (sleep apnea), and
- low sperm count
Get medical help right away, if you have any of the symptoms listed above.
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Tlando
No information provided.
Tlando In Children
Safety and efficacy of Tlando in males less than 18 years old have not been established.
What Drugs, Substances, or Supplements Interact with Tlando?
Tlando may interact with other medicines such as:
- corticosteroids, and
- prescription drugs and nonprescription analgesic and cold
- medications that can increase blood pressure.
Tell your doctor all medications and supplements you use.
Tlando During Pregnancy and Breastfeeding
Tlando is contraindicated in pregnant women and not indicated for use in females and thus is not intended for use during pregnancy or while breastfeeding.
Our Tlando (testosterone undecanoate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following clinically significant adverse reactions are discussed elsewhere in the labeling:
- Increase in Blood Pressure [see WARNINGS AND PRECAUTIONS]
- Polycythemia [see WARNINGS AND PRECAUTIONS]
- Cardiovascular Risk [see WARNINGS AND PRECAUTIONS]
- Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer [see WARNINGS AND PRECAUTIONS]
- Venous Thromboembolism [see WARNINGS AND PRECAUTIONS]
- Hepatic Adverse Effects [see WARNINGS AND PRECAUTIONS]
- Edema [see WARNINGS AND PRECAUTIONS]
- Sleep Apnea [see WARNINGS AND PRECAUTIONS]
- Gynecomastia [see WARNINGS AND PRECAUTIONS]
- Lipid Changes [see WARNINGS AND PRECAUTIONS]
- Hypercalcemia [see WARNINGS AND PRECAUTIONS]
- Decreased Thyroxine-binding Globulin [see WARNINGS AND PRECAUTIONS]
- Increases in Prolactin [see WARNINGS AND PRECAUTIONS]
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].
In Study 18-001, an uncontrolled ambulatory blood pressure monitoring (ABPM) study, 138 hypogonadal males were treated withTLANDO 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/m2 ), 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)
|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% wereWhite, 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/m2 ), 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)
|Blood prolactin increased||6 (6.3)|
|Weight increased||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 BPwas 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% CI1.0, 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.
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
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.
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.
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.
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] .
Drug Abuse And Dependence
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.
Abuse-Related Adverse Reactions
Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression.
The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, sub fertility, and infertility.
The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities.
The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.
Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Behaviors Associated with Addiction
Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors:
- Taking greater dosages than prescribed
- Continued drug use despite medical and social problems due to drug use
- Spending significant time to obtain the drug when supplies of the drug are interrupted
- Giving a higher priority to drug use than other obligations
- Having difficulty in discontinuing the drug despite desires and attempts to do so
- Experiencing withdrawal symptoms upon abrupt discontinuation of use
Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supra therapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism.
Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.
Read the entire FDA prescribing information for Tlando (Testosterone Undecanoate Capsules)
© Tlando Patient Information is supplied by Cerner Multum, Inc. and Tlando Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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