Treatment with Testosterone Cypionate

Treatment is recommended for these conditions:

• Symptoms of deficiency or absence of endogenous testosterone.
• Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.
• Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.

You should avoid treatment if...

• You have a known hypersensitivity to the drug
• You are male with carcinoma of the breast
• You are a male with known or suspected carcinoma of the prostate gland
• You have serious cardiac, hepatic or renal disease

Warnings

• Hypercalcemia may occur in immobilized patients. If this occurs, the drug should be discontinued.
• Prolonged use of high doses of androgens (principally the 17-α alkyl-androgens) has been associated with development of hepatic adenomas, hepatocellular carcinoma, and peliosis hepatis – all potentially life-threatening complications.
• Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking.
• Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease.
• Gynecomastia may develop and occasionally persists in patients being treated for hypogonadism.
• This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal “Gasping Syndrome” in premature infants.
• Androgen therapy should be used cautiously in healthy males with delayed puberty. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months. In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child, the greater the risk of compromising final mature height.
• This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk of serious adverse health effects, this drug should not be used for such purpose.

Seek Medical Attention

You 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

Precautions

Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism or excessive sexual stimulation may develop. Oligospermia may occur after prolonged administration or excessive dosage. If any of these effects appear, the androgen should be stopped and if restarted, a lower dosage should be utilized. Testosterone Cypionate should not be used interchangeably with testosterone propionate because of differences in duration of action. Testosterone Cypionate is not for intravenous use.

Information for Patients

Patients should be instructed to report any of the following: nausea, vomiting, changes in skin color, ankle swelling, too frequent or persistent erections of the penis.

Adverse Reactions

The following adverse reactions in the male have occurred with some androgens:

• Endocrine and urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages.
• Skin and appendages: Hirsutism, male pattern of baldness, seborrhea, and acne.
• Fluid and electrolyte disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.
• Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis (see WARNINGS).
• Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.
• Nervous system: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.
• Allergic: Hypersensitivity, including skin manifestations and anaphylactoid reactions.
• Miscellaneous: Inflammation and pain at the site of intramuscular injection.