KYZATREX® (Testosterone Undecanoate Capsules)

BLACK BOX WARNING

WARNING: BLOOD PRESSURE INCREASES. POSSIBLE INCREASED RISK OF HEART ATTACK OR STROKE.

See full prescribing information for complete boxed warning.

Important Safety Information for KYZATREX^® (Testosterone Undecanoate) Capsules

What is the most important information I should know about KYZATREX?

KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase 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.

1. If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.
2. If your blood pressure cannot be controlled, KYZATREX may need to be stopped.
3. Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX.

Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age).

Before you take KYZATREX, 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 a history of diabetes; 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; or 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.

Taking KYZATREX 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; or medicines that increase blood pressure, such as some cold medicine and pain medicines.

KYZATREX may cause other serious side effects including:

1. Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases.
2. If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX. 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.
3. Increased risk of prostate cancer
4. 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.
5. 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.
6. In large doses, KYZATREX may lower your sperm count
7. 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).
8. Swelling of your ankles, feet, or body (edema), with or without heart failure
9. Enlarged or painful breasts
10. 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 effect of KYZATREX is high blood pressure. Other side effects may include: headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.

Contraindications

KYZATREX is contraindicated in patients with carcinoma of the breast or known or suspected carcinoma of the prostate; women who are pregnant (testosterone may cause fetal harm); patients with known hypersensitivity to KYZATREX or any of its ingredients; and men with hypogonadal conditions that are not associated with structural or genetic etiologies, as KYZATREX has not been established for these conditions and there is a risk of increased BP that can increase the risk of MACE.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include "blood thinners" (such as warfarin).

This medication may interfere with certain lab tests (including thyroid function tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Lab and/or medical tests (such as blood pressure, testosterone levels, blood counts, liver function, cholesterol levels, PSA) should be done while you are taking this medication. Keep all medical and lab appointments.

Is it possible to abuse or misuse testosterone?

Abuse and misuse of testosterone has been seen in both male and female adults and children. Drug abuse is defined as the intentional and non-therapeutic use of any drug in order to feel the rewarding psychological and physiological effects. Drug abuse can occur once or over repeated use over any length of time.

Testosterone may be abused by athletes and bodybuilders in particular, often in combination with other anabolic androgen steroids (AAS) and/or obtained by methods other than by prescription from a pharmacy. There are reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and/or continuing testosterone despite adverse events or against medical advice.

Individuals who abuse testosterone or other AAS have reported serious adverse reactions including:

• Cardiac arrest
• Myocardial infarction
• Hypertrophic cardiomyopathy
• Congestive heart failure
• Cerebrovascular accident
• Hepatotoxicity
• Serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility, and aggression

Men in particular have reported:

• Transient ischemic attacks
• Convulsions
• Hypomania
• Irritability
• Dyslipidemias
• Testicular atrophy
• Subfertility
• Infertility

Women have reported:

• Hirsutism
• Virilization
• Deepening of voice
• Clitoral enlargement
• Breast atrophy
• Malepattern baldness
• Menstrual irregularities

Male and female adolescents have reported the premature closure of bony epiphyses with termination of growth, and precocious (early onset) puberty.

Why is there an FDA label warning about hypogonadism (low testosterone)?

The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The FDA recommends that health care professionals prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. The benefit and safety of such medications have not been established for treating low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone. As such, the FDA requires the manufacturers of all approved prescription testosterone products to change their labeling to clarify the approved uses of these medications and to add information on the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone.

The FDA approves testosterone for replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism. Examples of these disorders include failure of the testicles to produce testosterone because of genetic problems, or damage from chemotherapy or infection.

In addition, based on the available evidence from published studies and expert input from an Advisory Committee, the FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not.

The FDA recommends that health care professionals make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy. Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as:

• Chest pain
• Shortness of breath or trouble breathing
• Weakness in one part or one side of the body
• Slurred speech

What is KYZATREX?

KYZATREX (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions.

KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women.

These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist.

KYZATREX is a prescription medication. Keep KYZATREX and all medicines out of the reach of children.

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. In case of emergencies, please call 911 or go to the nearest emergency room.

Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions and additional information.

This information is not comprehensive. Please see the full Prescribing Information and Medication Guide for KYZATREX.

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