fluoxymesterone

Adult Dosing

Male hypoganadism

5-20 mg PO qd; alt divided doses tid-qid
In general, therapy is initiated with full therapeutic dose with subsequent adjustments
Note: If priapism occurs, temporarily discontinue therapy and reinstitute at a lower dose

Palliation of inoperable mammary cancer in women

10-40 mg/day PO divided tid-qid x 3 months or more depending upon patient response

Pediatric Dosing

[Outline]

Indications ⬆ ⬇

Male

Replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone
Primary hypogonadism (congenital or acquired) testicular failure
Hypogonadotropic hypogonadism (congenital or acquired)
Delayed puberty

Females

Metastatic mammary cancer; who are 1-5 years postmenopausal
Treatment in premenopausal women with breast CA who have benefited from oophorectomy and are considered to have a hormone-responsive tumor

Contraindications ⬆ ⬇

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Hepatic Dose Adjustment

Warnings/Precautions ⬆ ⬇

Fluoxymesterone may cause hypercalcemia in patients with breast cancer; discontinue treatment if this occurs
Prolonged use of high doses can cause potentially life-threatening complications including hepatic adenomas, hepatocellular carcinoma, and peliosis hepatis
Cholestatic hepatitis and jaundice may occur with fluoxymesterone, if such conditions occur consider discontinuation of therapy
Geriatric patients are at an increased risk of developing prostatic hypertrophy and prostatic carcinoma
Edema with or without congestive heart failure is a serious complication in patients with preexisting cardiac, renal, or hepatic disease
Gynecomastia may occur and persist in patients being treated for hypogonadism
Use cautiously in males with delayed puberty. Monitor effect on bone maturation by assessing bone age of the wrist and hand every 6 months. Fluoxymesterone may accelerate bone maturation without producing compensatory gain in linear growth
Avoid use for enhancement of athletic performance
Observe women for development of signs of virilization; discontinue use if such signs are noted
Determine urine and serum calcium levels in women with disseminated breast carcinoma during the course of therapy
Monitor Hg, HCT, LFTs, and periodic (every 6 months) X-ray examinations of bone age in prepubertal males

Cautions: Use cautiously in

Supplemental Patient Information

Instruct patient to report if there are frequent or persistent erections of the penis
Advise male patients receiving androgens for delayed puberty to have bone development evaluated every six months
Instruct female patients to report if hoarseness, acne, changes in menstrual periods or increased hair on the face occurs
Advise patient to report if nausea, vomiting, changes in skin color or ankle swelling occurs

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:X

Breastfeeding: Safety unknown; Not recommended during nursing

Adverse Reactions ⬆ ⬇

CNS: Headache
NEURO: Generalized paresthesia
PSYCHIATRY: Anxiety, depression
GI: Nausea, cholestatic jaundice, alterations in liver function tests
HEMA: Suppression of clotting factors II, V, VII, and X, bleeding, polycythemia
DERM: Hirsutism, male pattern of baldness, seborrhea, acne
EENT: Deepening of voice
GU: Amenorrhea, menstrual irregularities, virilization, clitoral enlargement, gynecomastia, penile erections, oligospermia, priapism
METABOLIC: Retention of (sodium, chloride, water, potassium, calcium, and inorganic phosphates), increased serum cholesterol
REPRODUCTIVE: Increased/decreased libido
HYPERSENSITIVITY: Anaphylactoid reactions

Clinical Pharmacology ⬆ ⬇

Androgen; binds to the androgen receptor. Promotes growth and development of male reproductive organs, maintains secondary sex characteristics. It produces retention of nitrogen, sodium, potassium, and phosphorus; increase protein anabolism, decrease protein catabolism and urinary excretion of calcium
Metabolized by liver; CYP450: Unknown
Excreted in urine
Half-life: 9.2 hrs

Brands and Availability ⬆ ⬇