Important Safety Information for Oral Testosterone

• ny symptoms of cardiovascular problems immediately

Who Should Not Use Oral Testosterone Undecanoate?

Do not use this medication if you:

• Have known or suspected prostate cancer
• Have male breast cancer
• Have uncontrolled high blood pressure
• Are allergic to testosterone undecanoate or any ingredient in the formulation
• Are female, pregnant, or breastfeeding
• Have serious heart problems, including heart failure
• Have severe liver disease
• Have severe kidney disease

Warnings and Precautions

1. Cardiovascular RiskEven small increases in blood pressure can raise the risk of heart attack and stroke. Your provider will monitor your blood pressure regularly, typically around 3 weeks after starting treatment or after dose adjustments. Those with pre-existing cardiovascular disease or risk factors may be at higher risk.

2. Polycythemia (Elevated Red Blood Cells)Testosterone can increase red blood cell counts (hematocrit), which may lead to blood clots, heart attack, or stroke. Hematocrit levels should be checked before starting treatment, approximately 3 months after starting, and periodically thereafter. Treatment may need to be paused if levels become too high.

3. Blood ClotsDeep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported with testosterone products. Stop treatment and seek immediate medical care if you develop leg pain/swelling/redness or sudden shortness of breath/chest pain.

4. Prostate EffectsTestosterone may worsen symptoms of benign prostatic hyperplasia (BPH) and may increase prostate cancer risk. PSA levels should be monitored. Do not use if you have known or suspected prostate cancer.

5. Sleep ApneaTestosterone may cause or worsen sleep apnea. Inform your provider if you develop symptoms like loud snoring, breathing pauses during sleep, or excessive daytime sleepiness.

6. Edema (Fluid Retention)Fluid retention may occur, potentially worsening heart failure, kidney disease, or liver disease. Report swelling in your legs, ankles, or feet.

7. Decreased Sperm ProductionTestosterone replacement suppresses the body's natural hormone production, which can decrease sperm count and cause infertility. Discuss fertility concerns with your provider before starting treatment.

8. Liver ConsiderationsAlthough this formulation is designed to minimize liver toxicity by using lymphatic absorption, periodic liver function monitoring may be recommended.

Controlled Substance Warning

Oral testosterone undecanoate is a Schedule III controlled substance with potential for abuse, misuse, and dependence. Misusing testosterone can cause:

• Heart attack and heart failure
• Stroke
• Depression and psychosis
• Liver damage
• Abnormal drug-seeking behavior

Use only as prescribed by your healthcare provider.

Common Side Effects

Side effects reported in clinical trials included:

• Polycythemia (elevated red blood cells)
• Diarrhea
• Nausea
• Indigestion (dyspepsia)
• Belching (eructation)
• Swelling in legs/feet (peripheral edema)
• Headache
• Prostate enlargement
• High blood pressure (hypertension)
• Increased hematocrit

Serious Side Effects

Seek immediate medical attention for:

• Signs of heart attack (chest pain, shortness of breath, sweating, pain radiating to arm or jaw)
• Signs of stroke (sudden weakness, numbness, confusion, vision changes, difficulty speaking)
• Signs of blood clot (leg pain, swelling, warmth, or redness; sudden breathing difficulty)
• Severe allergic reaction (rash, hives, swelling, difficulty breathing)

Drug Interactions

Tell your healthcare provider about all medications you take, including:

• Insulin and diabetes medications – May need dose adjustments as testosterone can affect blood sugar
• Blood thinners (anticoagulants) – May alter anticoagulant effects
• Corticosteroids – May increase fluid retention
• Blood pressure medications – Monitor for effectiveness

Dosing Information

• Take with food to ensure proper absorption
• Typical starting dose: 237 mg twice daily (morning and evening)
• Dose may be adjusted based on blood testosterone levels
• Minimum dose: 158 mg twice daily
• Maximum dose: 396 mg twice daily
• Swallow capsules whole; do not crush or chew

Monitoring Recommendations

Your healthcare provider should monitor:

• Blood pressure (before starting and periodically during treatment)
• Testosterone levels (6 hours after morning dose)
• Hematocrit/hemoglobin (before treatment, at 3 months, then periodically)
• PSA levels
• Lipid profile
• Liver function tests (periodically)

Storage

Store at room temperature (68°F to 77°F / 20°C to 25°C). Protect from moisture. Keep out of reach of children.

When to Seek Emergency Care

Get immediate medical help if you experience:

• Chest pain or tightness
• Sudden numbness or weakness
• Trouble speaking or confusion
• Severe headache
• Leg pain, swelling, or redness
• Difficulty breathing
• Signs of severe allergic reaction

Reporting Side Effects

Report side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

Consult your healthcare provider for complete prescribing information about oral testosterone undecanoate.