Fluoxymesterone

Fluoxymesterone
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Fluoxymesterone is an androgen that is FDA approved for the treatment of Primary hypogonadism (congenital or acquired), Hypogonadotropic hypogonadism (congenital or acquired), Delayed puberty, and Metastatic mammary cancer.. Common adverse reactions include Acne, Hirsutism, Male pattern alopecia, Seborrhea, Electrolyte imbalance, Gynecomastia, Nausea, Headache, Anxiety, Depression, Amenorrhea, Irregular periods.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Males ANDROXY™ Tablets are indicated for replacement therapy in conditions associated with a 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 luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.)

If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.

Delayed puberty

ANDROXY™ (Fluoxymesterone Tablets, USP) may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. An X-ray of the hand and wrist to determine bone age should be obtained every six months to assess the effect of treatment on the epiphyseal centers (see WARNINGS).

Females Metastatic mammary cancer

ANDROXY™ (Fluoxymesterone Tablets, USP) may be used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal. Primary goals of therapy in these women include ablation of the ovaries. Other methods of counteracting estrogen activity are adrenalectomy, hypophysectomy, and/or antiestrogen therapy. This treatment has been used in premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor. Judgment concerning androgen therapy should be made by an oncologist with expertise in this field.

Dosage

ANDROXY™ (Fluoxymesterone Tablets, USP), for oral administration, may be given as a single daily dose or in divided doses. Dosage and duration of therapy will depend on age, sex, diagnosis, patient's response to treatment, and appearance of adverse effects. The following recommendations will serve as a guide to therapy with ANDROXY™ Tablets.

In males with delayed puberty Various dosage regimens have been used, some call for lower dosages initially with gradual increases as puberty progresses, with or without a decrease to maintenance levels. Other regimens call for higher dosage to induce pubertal changes and lower dosage for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose. Dosage is within the range of 2.5 to 20 mg daily, although generally in the lower range of 2.5 to 10 mg daily, and for a limited duration, for example 4 to 6 months. X-rays should be taken at appropriate intervals to determine the amount of bone maturation and skeletal development (see INDICATIONS AND USAGE, and WARNINGS).

Male hypogonadism As replacement therapy, i.e., for eunuchism, a daily dose of 5 to 20 mg is suggested. It is usually preferable to start therapy at a higher level within the range (e.g., 10 mg), with subsequent adjustment as required.

Palliation of inoperable mammary cancer in women A daily dose of 10 to 40 mg, given in divided doses, is recommended. To determine if there will be an objective response, treatment should be continued for three months or more. Patients must be followed closely because androgen therapy occasionally appears to accelerate the disease. Thus, many experts prefer to use a shorter acting androgen preparation, such as ANDROXY™ Tablets, rather than those with prolonged activity, particularly during the early stages of androgen therapy.

In palliation of advanced mammary carcinoma Hormone therapy is adjunctive to and not a replacement for conventional therapy. Duration of therapy will depend on the response of the condition and the appearance of adverse reactions.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Fluoxymesterone in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Fluoxymesterone in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Fluoxymesterone in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Fluoxymesterone in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Fluoxymesterone in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Fluoxymesterone in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Fluoxymesterone in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Fluoxymesterone in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Fluoxymesterone during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Fluoxymesterone with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Fluoxymesterone with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Fluoxymesterone with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Fluoxymesterone with respect to specific gender populations.

Race

There is no FDA guidance on the use of Fluoxymesterone with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Fluoxymesterone in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Fluoxymesterone in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Fluoxymesterone in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Fluoxymesterone in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Fluoxymesterone in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Fluoxymesterone in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Fluoxymesterone in the drug label.

Pharmacology

There is limited information regarding Fluoxymesterone Pharmacology in the drug label.

Mechanism of Action

Structure

File:Fluoxymesterone01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Fluoxymesterone in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Fluoxymesterone in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Fluoxymesterone in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Fluoxymesterone in the drug label.

How Supplied

Storage

There is limited information regarding Fluoxymesterone Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Fluoxymesterone in the drug label.

Precautions with Alcohol

• Alcohol-Fluoxymesterone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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