Usual Adult Dose for Hypogonadism - Male

IM INJECTION:

• Testosterone Undecanoate: 750 mg (3 mL) IM injection followed by 750 mg (3 mL) injected after 4 weeks, then 750 mg (3 mL) every 10 weeks thereafter
• Testosterone Enanthate and Cypionate: 50 to 400 mg IM injection every 2 to 4 weeks

IMPLANT:

• 2 to 6 pellets (75 mg each) implanted subcutaneously every 3 to 6 months.
• The number of pellets to be implanted depends upon the minimal daily requirements of testosterone propionate administered parenterally. Thus, implant two 75 mg pellets for each 25 mg testosterone propionate required weekly.

Comments:

• The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose.
• This drug should be used only if the benefits outweigh the serious risks of pulmonary oil microembolism and anaphylaxis.
• Injections more frequently than every two weeks are not recommended.
• Adequate effect of the implants (pellets) continues for three to four months, sometimes as long as six months.

BUCCAL:

• Mucoadhesive Oral Patch: Apply a 30 mg patch to the gum region twice a day; morning and evening (about 12 hours apart).

TOPICAL:

• Transdermal Film: 2 to 6 mg applied to the back, abdomen, upper arm, or upper thigh once a day, preferably at night.
• Gel (in tubes, packets or spray): 5 g applied once a day, preferably in the morning. Consult the manufacturer product information for specific dosage and additional instructions of use.
• Transdermal Solution: Initial dose is 60 mg of testosterone (1 pump actuation of 30 mg of testosterone to each axilla), applied once a day, at the same time each morning. Consult the manufacturer product information for specific dosage and additional instructions of use.

Comments: Prior to initiating therapy with this drug, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days, and that these serum testosterone concentrations are below the normal range.

Uses:

• Primary hypogonadism (congenital or acquired): Testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter Syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above the normal range.
• Hypogonadotropic hypogonadism (congenital or acquired): Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.

Usual Adult Dose for Breast Cancer-Palliative

Testosterone Enanthate:

• 200 to 400 mg IM injection every 2 to 4 weeks

Comments:

• Androgen therapy can accelerate the disease. Close monitoring is recommended.
• Report any hoarseness, acne, changes in menstrual periods, or more facial hair.

Uses:

• This drug may be used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal.
• Premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor.

Usual Pediatric Dose for Delayed Puberty - Male

IM INJECTION:

• Testosterone Enanthate: 50 to 200 mg every 2 to 4 weeks for 4 to 6 months

IMPLANT:

• 2 pellets (each pellet contain 75 mg of testosterone) implanted subcutaneously every 3 to 6 months
• Duration of therapy: 4 to 6 months

Comments:

• The chronological and skeletal ages should be taken into consideration when determining the initial dose and when adjusting the dose.
• 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.
• Report frequent or persistent erections.
• Androgen therapy should be used very cautiously in children and only by specialists who are aware of the adverse effects on bone maturation.

Use: To stimulate puberty in selected males with clearly delayed puberty

Renal Dose Adjustments

Testosterone Cypionate IM injection: Contraindicated in renal disease

Liver Dose Adjustments

Testosterone Cypionate IM injection: Contraindicated in liver disease

Dose Adjustments

The doses of this drug should be adjusted according to the patient's response and the appearance of adverse reactions.

IMPLANTS:
The number of pellets to be implanted depends upon the minimal daily requirements of testosterone propionate determined by a gradual reduction of the amount administered parenterally. The usual dosage is as follows:

• Implant two 75 mg pellets for each 25 mg testosterone propionate required weekly.
• Thus, for a weekly injection of 75 mg of testosterone propionate, implant six 75 mg pellets (450 mg); for weekly injections of 50 mg of testosterone propionate, implant four 75 mg pellets (300 mg) may suffice for approximately three months.
• With lower requirements by injection, correspondingly lower amounts may be implanted.

TOPICAL:

• To ensure proper dosing, serum testosterone concentrations should be measured after initiation of therapy to ensure that the desired concentrations (300 ng/dL-1050 ng/dL) are achieved.
• The topical dose can be adjusted based on the serum testosterone concentration from a single blood draw 2 to 8 hours after applying this drug and at least 14 days after starting treatment or following dose adjustment.
• If the measured serum testosterone concentration is below 300 ng/dL, the daily testosterone dose may be increased. Consult the manufacturer product information for specific dose adjustment.
• If the serum testosterone concentration exceeds 1050 ng/dL, the daily testosterone dose should be decreased. Consult the manufacturer product information for specific dose adjustment.
• If the serum testosterone concentration consistently exceeds 1050 ng/dL at the lowest daily dose therapy should be discontinued.

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) medication guide for Testosterone. For Testosterone Undecanoate, REMS includes elements to assure safe use and implementation system . For additional information: www.fda.gov/REMS

US BOXED WARNINGS:
Pulmonary Oil Microembolism (POME) Reactions And Anaphylaxis:

• Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including life-threatening reactions, have been reported to occur during or immediately after the administration of testosterone undecanoate injection. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose.
• Following each injection of testosterone undecanoate observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis.

Secondary Exposure To Topical Testosterone:

• Virilization has been reported in children who were secondarily exposed to topical testosterone products.
• Children should avoid contact with unwashed or unclothed application sites in men using testosterone topical.
• Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

Safety and efficacy have not been established in patients younger than 18 years.

Testosterone Enanthate and Testosterone Implant are indicated for delayed puberty in adolescent patients.

Testosterone Cypionate: Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
Mucoadhesive Oral Patch:

• It should be placed just above the incisor tooth.
• With each application, the patch should be rotated to the alternate side of the mouth.

IM Injection:

• Testosterone cypionate should not be used interchangeably with testosterone propionate because of differences in duration of action.
• Inject deeply into the gluteal muscle following guidelines for intramuscular administration to minimize the risk of intravascular injection.
• Special care must be taken to avoid intravasal injection.
• Following IM injection, observe patients in the healthcare setting for 30 minutes to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis.
• This drug should be inspected visually for particulate matter and discoloration prior to administration.

Topical:

• Patients should wash their hands immediately with soap and water after application.
• Patients should cover the application site(s) with clothing, such as a T-shirt, after the solution has dried.
• If direct skin-to-skin contact is anticipated, patients should wash the application site thoroughly with soap and water to remove any testosterone residue.
• Apply this drug after washing, bathing, or showering to clean, dry, intact skin of the shoulders and/or upper arms, abdomen, and the sides of the body (just below the armpits).
• It is preferable to apply this drug to areas with minimal hair and body fat.

General:

• Therapy with this drug should be adjusted to the response of the individual patient.
• A detailed examination should be performed prior starting therapy with this drug to confirm testosterone insufficiency and to exclude risks of prostatic cancer.

Limitations of use:

• Safety and efficacy of drug in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.
• Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.

Monitoring:

• Serum testosterone levels should be measured before start of treatment and periodically during treatment.

Patient advice:

• Report any of the following: nausea, vomiting, changes in skin color, ankle swelling, too frequent or persistent erections, hoarseness, acne, changes in menstrual periods, or more facial hair.
• Avoid smoking, fire or flame until the dose of applied topical testosterone has completely dried.
• Patients should not wash, shower or swim for at least 2 hours after applying topical testosterone.
• If unwashed or unclothed skin that has been applied with topical testosterone comes in direct contact with the skin of another person, the contact area on the other person should be washed with soap and water as soon as possible.
• Follow strictly the recommended instructions for the use of this drug.

Frequently asked questions

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