Important Safety Information — Testosterone Cypionate

Indications

Testosterone cypionate is an injectable androgen indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

Contraindications

• Males with known or suspected carcinoma of the prostate gland
• Males with carcinoma of the breast
• Women who are or may become pregnant (testosterone can cause fetal harm, including virilization of the female fetus)
• Patients with serious cardiac, hepatic, or renal disease
• Known hypersensitivity to testosterone cypionate or any component of the formulation

Warnings and Precautions

• Cardiovascular risk: Increased risk of myocardial infarction, stroke, and cardiovascular death. Monitor cardiovascular health throughout treatment.
• Polycythemia: Testosterone can increase red blood cell mass and may increase the risk of thromboembolic events. Monitor hematocrit prior to and during treatment. If hematocrit becomes elevated, stop therapy until it decreases to an acceptable level.
• Venous thromboembolism: Cases of deep vein thrombosis and pulmonary embolism have been reported. Discontinue treatment and initiate appropriate workup if a venous thromboembolic event is suspected.
• Sleep apnea: Treatment may potentiate sleep apnea, particularly in patients with risk factors such as obesity or chronic lung diseases.
• Hepatic effects: Prolonged use of high doses has been associated with hepatic adverse effects, including peliosis hepatis, hepatic neoplasms, and cholestatic hepatitis. Monitor liver function.
• Edema: Testosterone may cause fluid retention. Use with caution in patients with pre-existing cardiac, renal, or hepatic disease. In addition to discontinuation, diuretic therapy may be required.
• Gynecomastia: May occur, particularly with excess dosing or in patients who convert testosterone to estrogen at higher rates.
• Lipid changes: Changes in serum lipid profile may occur, including decreases in HDL cholesterol.
• Prostate monitoring: Patients should be monitored for signs of prostate enlargement or cancer. Check PSA and perform digital rectal exams at baseline and periodically.

Common Side Effects

• Injection site pain, redness, or swelling
• Acne or oily skin
• Increased body hair growth
• Male pattern hair loss
• Mood changes, including irritability or anxiety
• Headache
• Increased red blood cell count (polycythemia)
• Fluid retention and weight gain
• Changes in libido

Serious Side Effects

Seek medical attention immediately if you experience any of the following:

• Chest pain or pressure, shortness of breath, or signs of a heart attack or stroke
• Leg pain or swelling, sudden shortness of breath (signs of blood clot)
• Painful or prolonged erections lasting 4 hours or more
• Difficulty breathing, especially during sleep
• Yellowing of the skin or eyes (jaundice)
• Unusual swelling, especially in the ankles or feet
• Breast enlargement or tenderness
• Signs of allergic reaction (rash, hives, difficulty breathing)

Drug Interactions

• Oral anticoagulants (e.g., warfarin): Testosterone may increase anticoagulant activity. Frequent monitoring of INR and prothrombin time is required, and anticoagulant dose adjustment may be needed.
• Corticosteroids: Concurrent use may increase fluid retention. Monitor for edema.
• Insulin and oral hypoglycemics: Testosterone may decrease blood glucose; diabetic patients may require dose adjustments of their diabetes medications.
• ACTH (adrenocorticotropic hormone): Enhanced tendency toward edema. Use with caution.

Use in Specific Populations

• Pregnancy: Contraindicated. Testosterone is a Pregnancy Category X drug and can cause virilization of the external genitalia of a female fetus.
• Lactation: Not recommended for use in nursing women.
• Pediatric use: Safety and effectiveness in pediatric patients below the age of 12 years have not been established. Use in children may accelerate bone maturation without producing compensatory gain in linear growth, compromising adult height.
• Geriatric use: Elderly patients may be at increased risk for prostatic hyperplasia and prostatic carcinoma. Monitor accordingly.
• Hepatic/Renal impairment: Use with caution due to risk of fluid retention and hepatic adverse effects.