Fluoxymesterone (Androxy) is an anabolic androgenic synthetic steroid. It is five times more potent than natural methyltestosterone.

Fluoxymesterone (Androxy) Uses:

• Metastatic breast cancer in females:

  • It is indicated as a salvage therapy for inoperable metastatic breast cancer in postmenopausal females

• Delayed puberty in males:

  • For the treatment of delayed puberty in males as a replacement therapy.

• Hypogonadism in males:

  • For the treatment of primary or secondary hypogonadism in males.

Fluoxymesterone (Androxy) Dose in Adults

Note: Androxy has been discontinued in the US for more than a year.

Fluoxymesterone (Androxy) Dose in the treatment of metastatic Breast cancer in females: 

• Manufacturer labeling:

  • 10 to 40 mg orally once  day in divided doses for 3 months or more.

Fluoxymesterone (Androxy) Dose in the treatment of Delayed puberty in males:

• 2.5 to 20 mg orally daily for 4 - 6 months

Fluoxymesterone (Androxy) Dose in the treatment of primary or secondary (hypogonadotropic) Hypogonadism in males:

• 5 to 20 mg orally once a day.

Fluoxymesterone (Androxy) Dose in Childrens

Note: Androxy is no more available in the US (It has been discontinued in the US for more than a year).

Fluoxymesterone (Androxy) Dose in the treatment of Delayed puberty:

• Adolescent Males:

  • Typically avoid its use in individuals younger than 14 years of age.
  • Usual range:
    • 2.5 mg to 10 mg orally daily.
    • The dose may be administered once a day or in divided doses.
  • The reported range:
    • 2.5 to 20 mg per day.
  • A daily dose of 2.5 mg for 6 to 60 months (depending on the clinical response) is recommended by most experts.
  • With concomitant testosterone therapy, the response may be evaluated every 3 - 6 months and the dose titrated if required.

Fluoxymesterone (Androxy) Dose in the treatment of Male hypogonadism:

• Children older than 12 years and Adolescents:

  • 2.5 to 20 mg orally daily.
  • The dose may be administered once a day or in divided doses for four to six months.
  • To prevent rapid over-virilization, initiate the treatment at a lower dose, and titrate the dose gradually upwards.

• Dosing adjustment for toxicity:

  • Children older than 12 years and Adolescents:

    • Edema:
      • Reinitiate the treatment at a lower dose, if the drug was stopped because of edema.
    • Hypogonadism in adult males:
      • Hematocrit (HCT) greater than 50%:
        • Avoid its use.
      • if HCT greater than 54% during therapy:
        • Discontinue treatment until the hematocrit falls to a safe level.
        • Assess for hypoxemia and sleep apnea
      • Reinitiate at a reduce dose.

Pregnancy Risk Factor X

• It is not recommended for pregnant women and women who are at risk of becoming pregnant.
• It has been linked to clitoral hypertrophy and labial fusion in pregnancy, as well as vaginal atresia and ambiguous female genitalia.

Fluoxymesterone use during breastfeeding:

• It is unknown if the drug will be excreted into breastmilk.
• Manufacturers recommend that you stop taking the drug and/or breastfeed to evaluate the risks and benefits of therapy.

Fluoxymesterone (Androxy) Dose in Kidney Disease:

• Use with caution.
• The manufacturer has not recommended any adjustments in the dose.

Fluoxymesterone (Androxy) Dose in Liver disease:

• Hepatic impairment before treatment initiation:

  • Use with caution.
  • The manufacturer has not recommended any adjustments in the dose.

• Hepatic impairment during treatment:

  • Discontinue the treatment if the patient develops cholestatic hepatitis with jaundice or has abnormal liver functions.

Side effects of Fluoxymesterone (Androxy):

• Cardiovascular:

  • Edema

• Central Nervous System:

  • Anxiety
  • Depression
  • Headache
  • Paresthesia

• Dermatologic:

  • Acne Vulgaris
  • Androgenetic Alopecia

• Endocrine & Metabolic:

  • Change In Libido (Decreased Libido Or Increased Libido)
  • Electrolyte Disturbance (Calcium
  • Chloride
  • Inorganic Phosphate
  • Potassium
  • And Sodium Retention)
  • Fluid Retention
  • Gynecomastia (Males)
  • Hirsutism
  • Hypercholesterolemia
  • Menstrual Disease (Females; Including Amenorrhea)

• Gastrointestinal:

  • Gastrointestinal Irritation
  • Nausea
  • Vomiting

• Genitourinary:

  • Benign Prostatic Hypertrophy (Males)
  • Oligospermia (Males; At Higher Doses)
  • Priapism (Males)
  • Testicular Atrophy (Males)
  • Virilization (Females; Including Clitoromegaly
  • Deepening Of The Voice In Females)

• Hematologic & Oncologic:

  • Clotting Factors Suppression
  • Polycythemia
  • Prostate Carcinoma (Males)

• Hepatic:

  • Abnormal Hepatic Function Tests
  • Cholestatic Jaundice
  • Hepatic Insufficiency

• Hypersensitivity:

  • Anaphylactoid Reaction (Non-Immunologic Anaphylaxis)
  • Hypersensitivity Reaction

Contraindications to Fluoxymesterone (Androxy):

• Patients with prostate or breast cancer in men
• Females and pregnant women who could become pregnant.

Warnings and precautions

• Dyslipidemia:

  • Anabolic steroids can adversely affect the lipid profile. Patients with ischemic heart disease should not use it.

• Gynecomastia

  • Gynecomastia may develop from prolonged use.

• Hepatic effects

  • High doses of oral estrogens can have serious adverse liver effects. These include jaundice, hepatic tumors and peliosis.
  • If the patient experiences cholestatasis, abnormal liver function tests or other symptoms, discontinue treatment.

• Carbohydrate intolerance:

  • Patients with diabetes and prediabetes should use it with caution due to its effects on glucose tolerance.

• Conditions that are edematous:

  • Fluid retention can occur and should be avoided in patients who are at risk of fluid overload, such as those suffering from renal failure or heart failure.

• Heart failure:

  • Patients with hypogonadism or poorly controlled or uncontrolled cardiac failure should avoid it.

• Hepatic impairment

  • Patients with liver disease should use it with caution.

• Hypercalcemia:

  • It can stimulate osteolysis and cause hypercalcemia.
  • Patients with breast cancer and women who are immobilized should be cautious about using it because of the risk of hypercalcemia. 
  • Assess for bony metastasis if hypercalcemia is suspected.

• Renal impairment

  • Patients with impaired renal function should not use it.
  • This should not be done in hypogonadism males who have symptoms of lower bladder obstruction and an IPSS score of greater than 19.

• Sleep Apnea

  • It is not recommended to treat hypogonadism among male patients suffering from severe obstructive sleeping apnea.

Fluoxymesterone: Drug Interaction

Monitoring parameters:

• Liver function tests at baseline and periodically thereafter,
• lipid profile
• Serum glucose levels in diabetic patients
• Hemoglobin and hematocrit at baseline and then periodically during the treatment. In males, Hemoglobin and hematocrit may be monitored at baseline, at 3 - 6 months, and annually thereafter when used as androgen-replacement therapy.
• Monitor urinary and serum calcium and the clinical features of virilization in females who are being treated for breast cancer.
• In prepubertal males, monitor the bone age by examining the x-rays of the wrists and hands every 6 months.
• Monitor the response to treatment and its side effects at 3 to 6 months intervals initially and then annually thereafter in males.
• Monitor for edema, sleep apnea, and signs of heart failure.

How to administer Fluoxymesterone (Androxy)?

• In males, it may be administered as a single dose or in divided doses.
• In females, administer the drug in divided doses.

Mechanism of action of Fluoxymesterone (Androxy):

• It is a synthetic version oftestosteroneThis is responsible for the growth and development of secondary sexual characteristics and male sex organs.
• It suppresses testosterone's endogenous production when taken in large amounts.

Absorption:

• Rapid

Protein binding:

• 98%

Metabolism:

• It is metabolized by the liver the enterohepatic circulation.

Half-life elimination:

• 10 hours (range: 10-100 minutes)

Excretion:

• Urine (90%);
• feces (6%)

International Brands of Fluoxymesterone:

• Androxy
• Afluteston
• Baojen
• Fuloan
• Halotestin
• Oralsterone
• Sidomon
• Vewon

Fluoxymesterone Brand Names in Pakistan:

No Brands Available in Pakistan.