IMPORTANT SAFETY INFORMATION

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 and effective for use 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 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 use 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 to any TLANDO ingredients; or have low testosterone without certain medical conditions. For example, do not take TLANDO if you have low testosterone due to age.

What should I tell my healthcare provider before using TLANDO?

Before you use TLANDO, tell your healthcare provider about all of your medical conditions, including if you have: high blood pressure or are being treated for high blood pressure; heart problems; high red blood cell count (hematocrit) or high hemoglobin laboratory value; urinary problems due to an enlarged prostate; kidney or liver problems; problems breathing while you sleep (sleep apnea); or a history of mental illness including suicidal thoughts or actions, depression, anxiety or mood disorder.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using TLANDO with other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines. Know the medicines you take. Ask your healthcare provider or pharmacist for a list of all your medicines if you are not sure. Show your list to your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of TLANDO?

TLANDO can cause serious side effects including:

• Increase in red blood cell count, hematocrit or hemoglobin. High red blood cell counts increase the risk of clots, strokes, and heart attacks. You may need to stop TLANDO if your red blood cell count increases.
• If you already have an enlarged prostate, your signs and symptoms may get worse while using TLANDO.These may include: increased nighttime urination; trouble starting urination; more frequent urination; feeling an urge to urinate, having a urine accident; and being unable to pass urine or weak urine flow.
• Increased risk of prostate cancer.
• Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
• Increase in blood pressure. TLANDO can increase your blood pressure. Increases in blood pressure can increase the risk of heart attack or stroke over time. If you experience an increase in blood pressure while on TLANDO, you may need to start taking blood pressure medication. If you are already taking blood pressure medication, your dose may need to be adjusted, or you may need to start taking additional blood pressure medication. If your blood pressure cannot be controlled with medication, you may need to stop taking TLANDO.
• 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.
• 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; or pain on the right side of your stomach area (abdominal pain).
• Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney or liver disease.
• Enlarged or painful breasts.
• Problems breathing 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 blood prolactin, high blood pressure, increased red blood cell count, common cold, increased weight, headache, and 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. 

For more information, go to www.TLANDO.com or call 1-844-996-7833.

Please see the full Prescribing Information and Medication Guide.