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WARNING
BLOOD PRESSURE INCREASES
No Information Provided
TLANDO is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Safety and efficacy of TLANDO in males less than 18 years old have not been established [see Use In Specific Populations] .
TLANDO is not substitutable with other oral testosterone undecanoate products.
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.
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.
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:
112.5 mg, white opaque body imprinted with “112” in black ink and grey opaque cap, banded with a colorless gelatin band.
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 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled RoomTemperature].
Dispose of unused TLANDO via a take-back option. If a take-back option is unavailable, follow FDA instructions at www.fda.gov/drug disposal.
Manufactured for: Antares Pharma, Inc. Ewing, NJ 08628. Revised: Mar 2022
The following clinically significant adverse reactions are discussed elsewhere in the labeling:
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) 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% 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) 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.
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 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 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.
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] .
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:
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.
Included as part of the "PRECAUTIONS" Section
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] .
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.
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 TLANDOpermanently. An increase in red blood cell mass may increase the risk of thromboembolic events [ see Venous Thromboembolism ] .
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 BOX WARNING and Increase In Blood Pressure] .Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO.
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] .
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] .
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.
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] .
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] . Patients should be informed of this possible risk when deciding whether to use or to continue to useTLANDO.
Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyl testosterone) 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 hepaticadenomas. 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.
Androgens, including TLANDO, may promote retention of sodium and water. Edema, with or without congestive heart failure, maybe a serious complication in patients with preexisting cardiac, renal, or hepatic disease [ see ADVERSE REACTIONS] . In addition to discontinuation of the drug, appropriate work up and management of edema may be required.
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.
Gynecomastia may develop and persist in patients being treated for hypogonadism.
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.
Androgens, including TLANDO, should be used with caution in cancer patients at risk of hypercalcemia (and associated). Monitor serum calcium concentrations periodically in these patients.
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.
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 [ see ADVERSE REACTIONS] .
Advise the patients to read the FDA-approved patient labeling (Medication Guide).
Advise patients that TLANDO can increase blood pressure (BP) which can result in an increase in the risk of major adverse cardiovascular events (MACE), including myocardial infarction, stroke, and cardiovascular death. This risk is greater in patients with established cardiovascular disease or risk factors for cardiovascular disease. Advise patients about the importance of monitoring BPperiodically while on TLANDO. Advise patients to report to their healthcare provider the use of concomitant prescription or non prescription medication, including cough and cold medications which can also increase BP [ see WARNINGS AND PRECAUTIONS] .
Advise patients that TLANDO can cause an increase in hematocrit levels that may increase the risk of thromboembolic events.Advise patients about the importance of completing laboratory testing as instructed by their health care provider while on TLANDO. [see WARNINGS AND PRECAUTIONS].
Advise patients that TLANDO can cause increased symptoms of BPH and can increase the risk for prostate cancer. Advise patients to contact their health care provider if they have any prostate-related symptoms [see WARNINGS AND PRECAUTIONS].
Advise patients with preexisting cardiac, renal, or hepatic disease that TLANDO can cause edema. Advise patients to notify their health care provider if edema develops or worsens [see WARNINGS AND PRECAUTIONS].
Advise patients that TLANDO can worsen sleep apnea especially in patients with risk factors such as obesity or chronic lung diseases [see WARNINGS AND PRECAUTIONS].
Advise patients that TLANDO can cause gynecomastia. [see WARNINGS AND PRECAUTIONS].
Advise patients to take TLANDO with food [see DOSAGE AND ADMINISTRATION].
Testosterone has been tested by subcutaneous injection and implantation in mice and rats. In mice, the implant induced cervical-uterine tumors, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.
Mutagenic effects of testosterone undecanoate were not detected in a battery of in vitro tests including bacterial mutation assays(Ames test) and chromosomal aberration tests in human lymphocytes. Testosterone undecanoate was also negative in an in vivo bonemarrow micronucleus assay in rats. Testosterone was negative in the in vitro Ames and in the in vivo mouse micronucleus assays.
The administration of exogenous testosterone has been reported to suppress spermatogenesis in the rat, dog and non-human primates, which was reversible on cessation of the treatment.
TLANDO is contraindicated in pregnant women and not indicated for use in females [ see CONTRAINDICATIONS] . Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies (see Data) and its mechanism of action [ see CLINICAL PHARMACOLOGY] . Exposure of a female fetus to androgens may result in varying degrees of virilization. In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies did not meet current standards for nonclinical development toxicity studies.
Animal Data
In developmental studies conducted in rats, rabbits, pigs, sheep and rhesus monkeys, pregnant animals received intramuscular injection of testosterone during the period of organogenesis. Testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. Structural impairments observed in females included increased a no genital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. Structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen. Increased pituitary weight was seen in both sexes.
Testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring. Hypertension was observed in pregnant females and offspring in rats exposed to doses approximately twice those used for testosterone replacement therapy.
TLANDO is not indicated for use in females.
Males
During treatment with large doses of exogenous androgens, including TLANDO, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis [ see WARNINGS AND PRECAUTIONS] . Reduced fertility is observe din some men taking testosterone replacement therapy. The impact on fertility may be irreversible. Testicular atrophy, sub fertility, and infertility have also been reported in men who abuse anabolic androgenic steroids [ see Drug Abuse And Dependence] .
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-daymajor 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].
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 contraindicated in:
No Information Provided
TLANDO®
(Tee-lan-doh)
(testosterone undecanoate) capsules, for oral use
What is the most important information I should know about TLANDO?
TLANDO can cause serious side effects, including:
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:
Before you take TLANDO, tell your healthcare provider about all of your medical conditions, including if you:
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:
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?
What are the possible side effects of TLANDO?
TLANDO may cause serious side effects including:
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:
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?
Keep TLANDO and all medicines out of the reach of children.
How should I throw away (dispose of) TLANDO?
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 castoroil.
Capsule shell:contains black iron oxide, gelatin, and titanium dioxide and imprint ink (ammonium hydroxide, black iron oxide, propylene glycol, and shellac).
This Medication Guide has been approved by the U.S. Food and Drug Administration
