Androfeme

Androfeme is a steroid sex hormone found in both men and women. In men, Androfeme is produced primarily by the Leydig (interstitial) cells of the testes when stimulated by luteinizing hormone (LH). It functions to stimulate spermatogenesis, promote physical and functional maturation of spermatozoa, maintain accessory organs of the male reproductive tract, support development of secondary sexual characteristics, stimulate growth and metabolism throughout the body and influence brain development by stimulating sexual behaviors and sexual drive. In women, Androfeme is produced by the ovaries (25%), adrenals (25%) and via peripheral conversion from androstenedione (50%). Testerone in women functions to maintain libido and general wellbeing. Androfeme exerts a negative feedback mechanism on pituitary release of LH and follicle-stimulating hormone (FSH). Androfeme may be further converted to dihydrotestosterone or estradiol depending on the tissue.

Males

Androfeme® (Androfeme Enanthate Injection, USP) is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous Androfeme.

Primary hypogonadism (congenital or acquired) – Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy.

Hypogonadotropic hypogonadism (congenital or acquired) – 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 Androfeme deficiency after puberty.

Safety and efficacy of Androfeme in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

Delayed puberty – Androfeme® (Androfeme Enanthate Injection, 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.

Females

Metastatic mammary cancer – Androfeme® (Androfeme Enanthate Injection, 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 also 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.

Androfeme injection is used for the treatment of men whose bodies do not make enough natural Androfeme, a condition called hypogonadism. Androfeme is a male hormone responsible for the growth and development of the male sex organs and maintenance of secondary sex characteristics.

Androfeme injection is also used in women with breast cancer that has spread to other parts of the body (metastatic).

Androfeme injection is also used to stimulate delayed puberty in male teenagers.

This medicine is to be given only by or under the direct supervision of your doctor. The Aveed® brand is only available under a restricted distribution program called the Aveed® REMS program. Xyosted™ is available only with your doctor's prescription.

Androfeme (Androfeme (transdermal)) TTS

One system is applied at about the same time each day. The adhesive side of the Androfeme (Androfeme (transdermal)) TTS system should be placed on a clean, dry area of skin on the arm, back or upper buttocks immediately upon removal from the protective pouch. DO NOT APPLY TO THE SCROTUM. The area selected should not be oily, damaged, or irritated. The system should be pressed firmly in place with the palm of the hand for about 10 seconds, making sure there is good contact, especially around the edges. In the event that a system should fall off, the same system may be reapplied. If the system comes off after it has been worn for more than 12 hours and it cannot be reapplied, a new system may be applied at the next routine application time. In either case, the daily treatment schedule should be continued. The Androfeme (Androfeme (transdermal)) TTS system should be worn approximately 24 hours and then replaced. To ensure proper dosing, serum Androfeme concentration may be measured 2-4 hours after an application of Androfeme (Androfeme (transdermal)) TTS. If the serum Androfeme concentrations are low, the dosing regimen may be increased to 2 systems. Because of variability in analytical values among diagnostic laboratories, all Androfeme measurements should be performed at the same laboratory.

Androfeme (Androfeme (transdermal)) and Androfeme (Androfeme (transdermal)) WITH ADHESIVE

Patients should start therapy with a 6 mg/d system of either Androfeme (Androfeme (transdermal)) or Androfeme (Androfeme (transdermal)) WITH ADHESIVE applied daily; if the scrotal area cannot accommodate a 6 mg/d system, a 4 mg/d Androfeme (Androfeme (transdermal)) system should be used. One Androfeme (Androfeme (transdermal)) or Androfeme (Androfeme (transdermal)) WITH ADHESIVE system should be placed on clean, dry, scrotal skin. Scrotal hair should be dry-shaved for optimal skin contact. Chemical depilatories should not be used. Androfeme (Androfeme (transdermal)) or Androfeme (Androfeme (transdermal)) WITH ADHESIVE should be worn 22-24 hours.

After 3-4 weeks of daily system use, blood should be drawn 2-4 hours after system application for determination of serum total Androfeme. Because of variability in analytical values among diagnostic laboratories, this laboratory work and later analyses for assessing the effect of the Androfeme (Androfeme (transdermal)) and Androfeme (Androfeme (transdermal)) WITH ADHESIVE therapy should be performed at the same laboratory.

If patients have not achieved desired results by the end of 6-8 weeks of treatment with any of the Androfeme (Androfeme (transdermal)) products, another form of Androfeme replacement therapy should be considered.

How supplied

Androfeme (Androfeme (transdermal)) TTS, Androfeme (Androfeme (transdermal)), and Androfeme (Androfeme (transdermal)) WITH ADHESIVE Androfeme transdermal systems contain a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.

Androfeme (Androfeme (transdermal)) TTS

Androfeme (Androfeme (transdermal)) TTS systems are supplied as individually pouched systems, 30 per carton. Androfeme (Androfeme (transdermal)) TTS 5 mg/d (Androfeme Transdermal System) -- each 60 cm2 system contains 328 mg Androfeme USP for nominal dose of 5 mg/day

Carton of 30 Androfeme (Androfeme (transdermal)) TTS 5 mg/d systemsNDC 17314-4717-3

Androfeme (Androfeme (transdermal)) and Androfeme (Androfeme (transdermal)) WITH ADHESIVE

Androfeme (Androfeme (transdermal)) and Androfeme (Androfeme (transdermal)) WITH ADHESIVE systems are supplied as individually pouched systems, 30 per carton.

Androfeme (Androfeme (transdermal)) 4 mg/d (Androfeme Transdermal System) -- each 40 cm2 system contains 10 mg Androfeme USP for nominal delivery of 4 mg for one day.

Carton of 30 Androfeme (Androfeme (transdermal)) 4 mg/d systems. NDC 17314-4608-3

Androfeme (Androfeme (transdermal)) and Androfeme (Androfeme (transdermal)) WITH ADHESIVE

6 mg/d (Androfeme Transdermal System) -- each 60 cm2 system contains 15 mg Androfeme USP for nominal delivery of 6 mg for one day.

Carton of 30 Androfeme (Androfeme (transdermal)) 6 mg/d systems. NDC 17314-4609-3

Carton of 30 Androfeme (Androfeme (transdermal)) WITH ADHESIVE 6 mg/d systemsNDC 17314-2836-3

Storage

Androfeme (Androfeme (transdermal)) TTS

Store at controlled room temperature below 25oC (77oF).

Androfeme (Androfeme (transdermal)) and Androfeme (Androfeme (transdermal)) WITH ADHESIVE

Store at room temperature 15-30oC (59-86oF).

Disposal

Androfeme (Androfeme (transdermal)) products should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

Caution: Federal law prohibits dispensing without prescription.

REFERENCE

See also:
What is the most important information I should know about Androfeme?

• Androfeme% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate.
• Androfeme% is contraindicated in women who are or may become pregnant, or who are breastfeeding. Androfeme% may cause fetal harm when administered to a pregnant woman. Androfeme% may cause serious adverse reactions in nursing infants. Exposure of a fetus or nursing infant to androgens may result in varying degrees of virilization. Pregnant women or those who may become pregnant need to be aware of the potential for transfer of Androfeme from men treated with Androfeme%. If a pregnant woman is exposed to Androfeme%, she should be apprised of the potential hazard to the fetus.

Use Androfeme solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Androfeme solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Androfeme solution refilled.
• Prime this product before the first use. To prime it, depress the pump 3 times and wash any product that is dispensed down the sink.
• Depress the pump once to fill the applicator cup. Holding the applicator upright, wipe Androfeme solution steadily up and down onto clean, dry skin in the armpit. If Androfeme solution drips or runs, it can be wiped back up with the applicator cup. Do NOT apply Androfeme solution to other parts of your body (eg, scrotum, penis, stomach, shoulders, upper arms). Do NOT apply it over open sores, wounds, or irritated skin.
• Do NOT use your fingers or hand to rub the medicine into the skin.
• You may need to alternate between armpits when applying Androfeme solution. Be sure you understand how to apply Androfeme solution. Contact your doctor or pharmacist if you have questions or concerns about how to apply Androfeme solution.
• Wash your hands with soap and water immediately after using Androfeme solution.
• Allow Androfeme solution to dry completely before dressing.
• After Androfeme solution has dried, cover the application site (eg, with a shirt) to prevent others from coming into contact with Androfeme solution. If direct skin-to-skin contact with another person is expected, wash the application site well with soap and water to remove the medicine.
• After using Androfeme solution, rinse the applicator with room temperature water and pat it dry with a tissue. Replace the applicator and cap on the bottle for storage.
• Do NOT get Androfeme solution in your eyes. If you do, rinse thoroughly with water. If eye irritation persists, contact your doctor.
• Apply Androfeme solution at the same time every morning after showering or bathing, unless your doctor tells you otherwise.
• If you are also using an antiperspirant or deodorant (stick or roll-on), apply it at least 2 minutes before you apply Androfeme solution.
• For best results, wait 2 hours after applying Androfeme solution before you wash the application site or swim.
• If you miss a dose of Androfeme solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Androfeme solution.

Androfeme is a male hormone primarily used to treat deficiency or absence of naturally produced hormone Androfeme in men (hypogonadal disorders). The conditions include,

• Testicular diseases (primary hypogonadism) - diseases or conditions of testes, the organ that produces Androfeme affecting secretion of Androfeme.
• Pituitary diseases (secondary hypogonadism) - diseases or conditions of pituitary gland or hypothalamus that produce hormones (gonadotropins) which stimulate release of Androfeme.

See also:
What other drugs will affect Androfeme?

Drug Interactions

Anticoagulants: C-17 substituted derivatives of Androfeme, such as methandrostenolone, have been reported to decrease the anticoagulant requirements of patients receiving oral anticoagulants. Patients receiving oral anticoagulant therapy require close monitoring, especially when androgens are started or stopped.

Oxyphenbutazone: Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.

Insulin: In diabetic patients, the metabolic effects of androgens may decrease blood glucose and therefore, insulin requirements.

Propranolol: In a published pharmacokinetic study of an injectable Androfeme product, administration of Androfeme cypionate led to an increased clearance of propranolol in the majority of men tested.6

Corticosteroids: The concurrent administration of Androfeme with ACTH or corticosteroids may enhance edema formation; thus these drugs should be administered cautiously, particularly in patients with cardiac or hepatic disease.7

Drug/Laboratory Test Interactions

Androgens may decrease levels of thyroxin-binding globulin, resulting in decreased total T. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

The Androfeme (Androfeme (transdermal)) products contain a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.

Androfeme (Androfeme (transdermal)) TTS is designed for application to arm, back or upper buttocks skin.

Androfeme (Androfeme (transdermal)) and Androfeme (Androfeme (transdermal)) WITH ADHESIVE are designed for application to scrotal skin only. Because scrotal skin is at least five times more permeable to Androfeme than other skin sites, Androfeme (Androfeme (transdermal)) or Androfeme (Androfeme (transdermal)) WITH ADHESIVE will not produce adequate serum Androfeme concentrations if applied to non-scrotal skin.

Ingestion of Androfeme, or the contents of any of the Androfeme (Androfeme (transdermal)) products will not result in clinically significant serum Androfeme concentrations due to extensive first-pass metabolism. In addition, an intramuscular injection of Androfeme from any of the Androfeme (Androfeme (transdermal)) products will not produce adequate serum Androfeme levels due to its short half-life (about 10 minutes).

See also:
What are the possible side effects of Androfeme?

Adverse events are reported in this section by product. Adverse events reported during use of a given product may occur in patients who are treated with any Androfeme (Androfeme (transdermal)) product.

Adverse Events with Androfeme (Androfeme (transdermal)) TTS

In clinical studies of 457 participants (116 hypogonadal males and 341 healthy adult males) treated for up to 6 weeks with Androfeme (Androfeme (transdermal)) TTS, the most commonly reported adverse events were application site reactions of transient itching (12%) and moderate or severe erythema (3%).

Adverse events reported by less than 1% of Androfeme (Androfeme (transdermal)) TTS users in clinical trials that were of probable or unknown relationship to drug were:

Topical Reactions

Of 457 study participants, 3 men (1%) discontinued prematurely because of application site reactions.

There were no clinically significant differences in skin tolerability in younger (<65 years old) and older (³ 65 years old) subjects.

A contact sensitization rate of 0.5% for Androfeme (Androfeme (transdermal)) TTS was observed in a 6-week study of 233 normal male volunteers.

In one study with 14 days of daily use, 42% of patients reported 3 or more detachments of their Androfeme (Androfeme (transdermal)) TTS; of these detachments, 33% occurred during exercise.

Adverse Events with Androfeme (Androfeme (transdermal))

In clinical studies of 104 patients treated with Androfeme (Androfeme (transdermal)), the most common adverse effects reported were local effects. In US clinical trials, most of the 72 patients filling out a daily questionnaire reported scrotal itching, discomfort, or irritation at some time during therapy. Of all the daily questionnaire responses, 7% reported itching, 4% discomfort, and 2% irritation. All topical reactions decreased with duration of use.

The following adverse effects (greater than 1%) were reported in association with Androfeme (Androfeme (transdermal)) therapy in 104 patients using the product for up to three years. These effects are listed in decreasing frequency of occurrence with the percentages of patients reporting the effect in parentheses: Gynecomastia (5%), acne (4%), prostatitis/urinary tract infection (4%), breast tenderness (3%), stroke (2%). For this same patient population, the following adverse effects were reported by 1% of users: memory loss, pupillary dilation, abnormal liver enzymes, scrotal cellulitis, deep vein phlebitis, benign prostatic hyperplasia, rectal mucosal lesion over prostate, hematuria/bladder cancer, papilloma on scrotum, and congestive heart failure.

Adverse Events with Androfeme (Androfeme (transdermal)) WITH ADHESIVE

In a pharmacokinetic study in 50 normal men, skin assessment scores following a single 24-hour application of Androfeme (Androfeme (transdermal)) WITH ADHESIVE to scrotal skin were similar to those for Androfeme (Androfeme (transdermal)). Other adverse events reported during the study were headache (6%), dizziness (6%), back pain, pain, nausea, and pustular rash (1% each).

General Adverse Events with Androgen Replacement Therapy

Skin and Appendages: Hirsutism, male pattern baldness, seborrhea, and acne.

Endocrine and Urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high doses.

Fluid and Electrolyte Disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.

Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests. Rare instances of hepatocellular neoplasms and peliosis hepatis have occurred.

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.

Metabolic: Increased serum cholesterol.

Miscellaneous: Rarely, anaphylactoid reactions.

DRUG ABUSE AND DEPENDENCE

The Androfeme (Androfeme (transdermal)) products contain a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.

Androfeme (Androfeme (transdermal)) TTS is designed for application to arm, back or upper buttocks skin.

Androfeme (Androfeme (transdermal)) and Androfeme (Androfeme (transdermal)) WITH ADHESIVE are designed for application to scrotal skin only. Because scrotal skin is at least five times more permeable to Androfeme than other skin sites, Androfeme (Androfeme (transdermal)) or Androfeme (Androfeme (transdermal)) WITH ADHESIVE will not produce adequate serum Androfeme concentrations if applied to non-scrotal skin.

Ingestion of Androfeme, or the contents of any of the Androfeme (Androfeme (transdermal)) products will not result in clinically significant serum Androfeme concentrations due to extensive first-pass metabolism. In addition, an intramuscular injection of Androfeme from any of the Androfeme (Androfeme (transdermal)) products will not produce adequate serum Androfeme levels due to its short half-life (about 10 minutes).