(floo oks i MES te rone)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Androxy: 10 mg [scored; contains fd&c blue #1 aluminum lake, fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake]
Brand Names: U.S.
Synthetic derivative of testosterone; responsible for the normal growth and development of male sex hormones, male sex organs, and maintenance of secondary sex characteristics; large doses suppress endogenous testosterone release
Hepatic; enterohepatic recirculation
Urine (90%); feces (6%)
10 hours (range: 10-100 minutes)
Use: Labeled Indications
Replacement therapy in the treatment of delayed male puberty; male hypogonadism (primary or hypogonadotropic); inoperable metastatic female breast cancer
Males with carcinoma of the breast or the prostate (known or suspected); women who are or may become pregnant
Hypogonadism: 5-20 mg daily
Delayed puberty: 2.5-20 mg daily for 4-6 months
Female: Inoperable breast carcinoma: 10-40 mg daily in divided doses for ≥3 months
Dosage adjustment in renal impairment: No dosage adjustment provided in manufacturer's labeling; use with caution.
Dosage adjustment in hepatic impairment: No dosage adjustment provided in manufacturer's labeling; use with caution.
Males: May be administered in single or divided doses. Females: Administer in divided doses.
Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 2]).
Store between 15°C to 30°C (59°F to 86°F); protect from light.
Blood Glucose Lowering Agents: Androgens may enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy
C1 inhibitors: Androgens may enhance the thrombogenic effect of C1 inhibitors. Monitor therapy
Corticosteroids (Systemic): May enhance the fluid-retaining effect of Androgens. Monitor therapy
CycloSPORINE (Systemic): Androgens may enhance the hepatotoxic effect of CycloSPORINE (Systemic). Androgens may increase the serum concentration of CycloSPORINE (Systemic). Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Androgens may enhance the anticoagulant effect of Vitamin K Antagonists. Consider therapy modification
Decreased levels of thyroxine-binding globulin; decreased total T4 serum levels; increased resin uptake of T3 and T4
Frequency not defined.
Male: Gynecomastia, oligospermia (at higher doses), priapism, prostatic carcinoma, prostatic hypertrophy, testicular atrophy
Female: Menstrual irregularities (including amenorrhea), virilism (including deepening of the voice, clitoris hypertrophy)
Central nervous system: Anxiety, depression, headache
Dermatologic: Acne, hirsutism, “male pattern” baldness
Endocrine & metabolic: Electrolyte abnormalities (sodium, chloride, calcium, potassium, and inorganic phosphate retention), hypercholesterolemia, libido changes (increased or decreased), water retention
Gastrointestinal: GI irritation, nausea, vomiting
Genitourinary: Prostatic hyperplasia
Hematologic: Clotting factor suppression, polycythemia
Hepatic: Cholestatic jaundice, hepatic coma (rare), hepatic dysfunction, hepatocellular neoplasms (rare), liver function tests abnormal, peliosis hepatitis (rare)
Neuromuscular & skeletal: Paresthesia
Miscellaneous: Hypersensitivity, nonimmunologic anaphylaxis (formerly known as anaphylactoid reaction)
Postmarketing and/or case reports (Limited to important or life-threatening): Hepatotoxicity (idiosyncratic) (Chalasani, 2014)
Concerns related to adverse effects:
• Dyslipidemia: Anabolic steroids may alter serum lipid profile; use caution in patients with history of myocardial infarction or coronary artery disease.
• Gynecomastia: May cause gynecomastia.
• Hepatic effects: Prolonged use of high doses of oral androgens has been associated with serious hepatic effects (eg, peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, jaundice). Discontinue use in patients with cholestatic hepatitis with jaundice or abnormal liver function tests.
• Carbohydrate intolerance: May have adverse effects on glucose tolerance; use caution in patients with diabetes.
• Edematous conditions: Use with caution in patients with conditions influenced by edema (eg, cardiovascular disease, migraine, seizure disorder, renal impairment); may cause fluid retention.
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• Hypercalcemia: Use with caution in patients with breast cancer or immobilization; may cause hypercalcemia by stimulating osteolysis. Discontinue use if hypercalcemia occurs; may indicate bony metastasis.
• Elderly: Elderly patients may be at greater risk for prostatic hyperplasia and prostate cancer; use with caution.
• Pediatric: May accelerate bone maturation without producing compensatory gain in linear growth in children. In prepubertal children, perform radiographic examination of the hand and wrist every 6 months to determine the rate of bone maturation and to assess the effect of treatment on the epiphyseal centers.
• Women: During treatment for metastatic breast cancer, women should be monitored for signs of virilization (eg, deepening of voice, hirsutism, acne, clitoromegaly, menstrual irregularities); discontinue use with evidence of mild virilization to prevent irreversible symptoms.
• Hazardous agent: Use appropriate precautions for handling and disposal (NIOSH 2014 [group 2])
Periodic liver function tests, lipid panel, hemoglobin, and hematocrit (prior to therapy, at 3-6 months, then annually); radiologic examination of wrist and hand every 6 months (when using in prepubertal children). Withhold initial treatment with hematocrit >50% (discontinue therapy if hematocrit exceeds 54% [Bhasin, 2010]), hyperviscosity, untreated obstructive sleep apnea, or uncontrolled severe heart failure. Monitor urine and serum calcium and signs of virilization in women treated for breast cancer. Serum glucose (may be decreased by testosterone; monitor patients with diabetes). Evaluate males for response to treatment and adverse events 3-6 months after initiation and then annually.
Pregnancy Risk Factor
Use is contraindicated in women who are or may become pregnant. May cause androgenic effects to the female fetus; clitoral hypertrophy, labial fusion, urogenital sinus defect, vaginal atresia, and ambiguous genitalia have been reported.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience male macromastia, decreased libido, anxiety, or headache. Have patient report immediately to prescriber signs of hypercalcemia, dyspnea, excessive weight gain, edema of extremities, skin discoloration, ecchymosis, hemorrhaging, depression, paresthesia, penile pain, signs of virilization, or signs of hepatic impairment (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.