Generic Name: testosterone injection (tes TOS ter one)Brand Names: Andro LA 200, Delatestryl, Depandro 100, Depo-Testosterone, Testosterone Cypionate, Testosterone Enanthate
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 other purposes not listed in this medication guide.What is the most important information I should know about testosterone injection?This medication can cause birth defects in an unborn baby if it is used by a woman during pregnancy. Do not receive testosterone injection if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Do not receive this medication if you have prostate cancer, male breast cancer, if you are pregnant, or if you have ever had an allergic reaction to a hormone treatment.
Before receiving testosterone injection, tell your doctor if you have benign prostatic hypertrophy (BPH), a bleeding or blood clotting disorder, high cholesterol, any type of cancer, liver or kidney disease, or heart disease, coronary artery disease, or a history of heart attack.What should I discuss with my healthcare provider before receiving testosterone injection?You should not receive this medication if you have:
male breast cancer;
if you are pregnant; or
if you have ever had an allergic reaction to a hormone treatment.
Before receiving testosterone injection, tell your doctor if you are allergic to any drugs, or if you have:
benign prostatic hypertrophy (BPH);
any type of cancer;
a bleeding or blood clotting disorder;
liver or kidney disease; or
heart disease, coronary artery disease (hardened arteries), congestive heart failure, or a history of heart attack.
If you have any of these conditions, you may need a dose adjustment or special tests to safely use testosterone injection.FDA pregnancy category X. This medication can cause birth defects. Do not receive testosterone injection if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are receiving this medication. It is not known whether testosterone injection passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.
Testosterone injection is given as an shot into a muscle of your buttocks. Your doctor, nurse, or other healthcare provider will give you this injection. Testosterone injection is usually given every 2 to 4 weeks.
The number of months you need to use testosterone injection will depend on the condition being treated.
To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.Testosterone injection 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.
Call your doctor if you miss an appointment for your testosterone injection.
An overdose of testosterone injection is not expected to produce life-threatening symptoms.
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using testosterone injection.
swelling, rapid weight gain;
increased or ongoing erection of the penis;
bone pain, increased thirst, memory problems, restless feeling, confusion, nausea, loss of appetite, increased urination, weakness, muscle twitching; or
nausea, vomiting, stomach pain, loss of appetite, and jaundice (yellowing of the skin or eyes).
changes in your menstrual periods;
male-pattern hair growth (such as on the chin or chest);
male pattern baldness;
increase or decrease in sex drive.
Less serious side effects may include:
breast swelling in men;
headache, anxiety, depressed mood;
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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
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 film: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 grams applied once daily, preferably in the morning. May increase as needed to a maximum of 10 grams 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.
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 monthsTestosterone 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.
Before receiving testosterone injection, tell your doctor if you are using any of the following drugs:
the blood thinner warfarin (Coumadin);
insulin or diabetes medication you take by mouth such as glimepiride (Amaryl, Duetact, Avandaryl), glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glynase), metformin (Actoplus Met, Avandamet, Fortamet, Glucophage Janumet), rosiglitazone (Avandia), and others; or
steroid medicine such as methylprednisolone (Depo-Medrol, Medrol, Solu-Medrol), prednisone (Deltasone, Orasone, others), and others.
This list is not complete and there may be other drugs that can interact with testosterone injection. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.