testosterone injection

Pronunciation

Generic Name: testosterone injection (tes TOS ter one)
Brand Name: Aveed, Delatestryl, Depo-Testosterone, Testosterone Cypionate, Testosterone Enanthate

What is testosterone injection?

Testosterone is a naturally occurring sex hormone that is produced in a man's testicles. Small amounts of testosterone are also produced in a woman's ovaries and adrenal system.

Testosterone injection is used in men and boys to treat conditions caused by a lack of this hormone, such as delayed puberty, impotence, or other hormonal imbalances.

Testosterone injection is also used in women to treat breast cancer that has spread to other parts of the body.

Testosterone injection may also be used for purposes not listed in this medication guide.

What is the most important information I should know about testosterone injection?

Do not use this medicine if you are pregnant or may become pregnant.

You should not receive testosterone if you have prostate cancer, male breast cancer, a serious heart condition, or severe liver or kidney disease.

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What should I discuss with my healthcare provider before receiving testosterone injection?

You should not receive testosterone if you are allergic to it, or if you have:

  • prostate cancer;

  • male breast cancer;

  • a serious heart condition;

  • severe liver disease;

  • severe kidney disease; or

  • if you are pregnant or may become pregnant.

To make sure testosterone is safe for you, tell your doctor if you have:

  • diabetes;

  • enlarged prostate;

  • a history of heart disease or coronary artery disease;

  • high cholesterol or triglycerides (a type of fat in the blood);

  • breast cancer (in men, or in women who have hypercalcemia);

  • liver or kidney disease;

  • if you are bedridden or otherwise debilitated; or

  • if you take a blood thinner (warfarin, Coumadin, Jantoven).

FDA pregnancy category X. This medicine can harm an unborn baby or cause birth defects. Do not use testosterone if you are pregnant or may become pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are receiving testosterone.

It is not known whether testosterone injection passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How is testosterone injection given?

Testosterone is injected into a muscle. A healthcare provider will give you this injection. Testosterone injection is usually given every 2 to 4 weeks.

The length of treatment with testosterone injection will depend on the condition being treated.

Testosterone will not enhance athletic performance and should not be used for that purpose.

While receiving testosterone, you will need frequent blood tests.

Testosterone can affect bone growth in boys who are treated for delayed puberty. Bone development may need to be checked with x-rays every 6 months during treatment.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your testosterone injection.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving testosterone injection?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Testosterone injection side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • nausea or vomiting;

  • changes in skin color;

  • increased or ongoing erection of the penis;

  • impotence, ejaculation problems, decreased amounts of semen, decrease in testicle size;

  • painful or difficult urination;

  • shortness of breath (even with mild exertion);

  • swelling in your ankles or feet, rapid weight gain;

  • high levels of calcium in the blood--stomach pain, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless; or

  • liver problems--upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Women receiving testosterone may develop male characteristics, which could be irreversible if treatment is continued. Call your doctor at once if you notice any of these signs of excess testosterone:

  • acne;

  • changes in menstrual periods;

  • male-pattern hair growth (such as on the chin or chest);

  • hoarse or deepened voice; or

  • enlarged clitoris.

Common side effects (in men or women) may include:

  • breast swelling;

  • headache, anxiety;

  • increased facial or body hair growth, male-pattern baldness;

  • increased or decreased interest in sex;

  • numbness or tingly feeling; or

  • pain or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Testosterone injection dosing information

Usual Adult Dose for Hypogonadism -- Male:

Parenteral: Short-acting (testosterone solution and propionate): 25 mg to 50 mg IM 2 to 3 times a week.
Long-acting (enanthate and cypionate): 50 to 400 mg IM every 2 to 4 weeks.
Subcutaneous implant: 2 to 6 pellets (75 mg each) implanted subcutaneously every 3 to 6 months.

Topical:
Transdermal Film: 2.5 to 5 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 daily, preferably in the morning. May increase as needed to a maximum of 10 g once a day.

Buccal: 30 mg patch to the gum region twice daily; morning and evening (about 12 hours apart). Patch should be placed just above the incisor tooth. With each application, the patch should be rotated to alternate sided of the mouth.

Testosterone 30 mg/1.5 mL transdermal solution:
Starting dose is 60 mg of testosterone (1 pump actuation of 30 mg of testosterone to each axilla), applied once daily, at the same time each morning. The dose of testosterone may be decreased from 60 mg (2 pump actuations) to 30 mg (1 pump actuation) or increased from 60 mg to 90 mg (3 pump actuations) or from 90 mg to 120 mg (4 pump actuations) based on the serum testosterone concentration from a single blood draw 2 to 8 hours after applying the solution and at least 14 days after starting treatment or following dose adjustment.

Testosterone 10 mg/0.5 g transdermal gel:
Starting dose is 40 mg of testosterone (4 pump actuations of 30 mg to clean, dry intact skin of the front and inner thighs), applied once daily, at the same time each morning. Let application site dry before putting on pants or shorts. The dose can be adjusted between a minimum of 10 mg of testosterone (1 pump actuation) and a maximum of 70 mg of testosterone (7 pump actuations) on the basis of total serum testosterone concentrations 2 hours post application. The dose should be titrated based on the serum testosterone concentration from a single blood draw 2 hours after applying and at approximately 14 days and 35 days after starting treatment or following dose adjustment. In addition, serum testosterone concentration should be assessed periodically thereafter.

Testosterone 20.25 mg/1.25 g transdermal gel:
Starting dose 40.5 mg of testosterone (2 pump actuations), applied topically to the shoulders and upper arms once daily in the morning. The dose can be adjusted between a minimum of 20.25 mg of testosterone (1 pump actuation) and a maximum of 81 mg of testosterone (4 pump actuations). The dose should be titrated based on the pre dose morning serum testosterone concentration at approximately 14 days and 28 days after starting treatment or following dose adjustment. Additionally, serum testosterone concentration should be assessed periodically thereafter.

Usual Adult Dose for Breast Cancer--Palliative:

Parenteral: Short-acting (testosterone solution and propionate): 50 mg to 100 mg IM 2 to 3 times a week.
Long-acting (enanthate and cypionate): 200 to 400 mg IM every 2 to 4 weeks.
Subcutaneous implant: 2 to 6 pellets (75 mg each) implanted subcutaneously every 3 to 6 months

Testosterone is approved by the FDA for the palliation of androgen responsive metastatic breast cancer in women who are 1 to 5 years postmenopausal or who are proven to have a hormone-dependent tumor noted by previous beneficial response to castration.

Female patients should be observed for signs of virilization. Women should be instructed to report any hoarseness, acne, changes in menstrual periods, or increases in facial hair. Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization. A decision may be made by the patient and the physician that some virilization will be tolerated during the treatment for malignant disease.

Usual Adult Dose for Postpartum Breast Pain:

Parenteral: Short-acting (testosterone solution and propionate): 25 mg to 50 mg IM for 3 to 4 days, starting at the time of delivery.

Usual Pediatric Dose for Delayed Puberty -- Male:

Parenteral:
Initiation of pubertal growth: Long-acting (enanthate and cypionate): 40 to 50 mg/square meter IM monthly until the growth rate falls to prepubertal levels.
Terminal growth phase: Long-acting (enanthate and cypionate): 100 mg/square meter IM monthly until the growth ceases.
Maintenance virilizing dose: Long-acting (enanthate and cypionate): 100 mg/square meter intramuscular twice monthly.

Subcutaneous implant: 2 to 6 pellets (75 mg each) implanted subcutaneously every 3 to 6 months.

Dosages used to treat delayed puberty are generally started at the lower end of the dosing range and titrated according to patient response and tolerance. The duration of therapy should be limited to 4 to 6 months. Serum concentrations of testosterone should be determined following 3 to 4 weeks of daily use. If desired results have not been achieved at 6 to 8 weeks an alternative testosterone regimen should be considered.

Wrist and hand bone age should be assessed prior to initiation of testosterone therapy and every 6 months to monitor bone maturation. Exogenous androgen therapy can accelerate bone maturation without producing a compensatory gain in linear growth. Use over long periods can result in fusion of the epiphyseal growth centers and termination of the growth process.

What other drugs will affect testosterone injection?

Other drugs may interact with testosterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about testosterone injection.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.02. Revision Date: 2014-05-01, 1:14:12 PM.

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