Testosterone-intramuscular

Nausea, vomiting, headache, skin color changes, increased/decreased sexual interest, oily skin, hair loss, and acne may occur. Pain and redness at the injection site may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects when it is used at normal doses.Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as anxiety, depression, increased anger), trouble sleeping/snoring, signs of serious liver disease (such as persistent abdominal pain/nausea, unusual tiredness, yellowing eyes/skin, dark urine).If you are male, tell your doctor immediately if any of these unlikely but serious side effects occur: trouble urinating, breast swelling/tenderness, too frequent/prolonged erections.Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and seek immediate medical attention, or permanent problems could occur.This medication can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.If you are female, tell your doctor immediately if any of these unlikely but serious side effects occur: deepening of the voice, hoarseness, unusual facial/body hair growth, enlarged clitoris, irregular menstrual periods.This medication can cause your body to hold on to extra body water (edema). This can increase your risk of heart failure. Tell your doctor immediately if any of these unlikely but serious signs of water retention or heart failure occur: decreased exercise ability, hands/ankles/feet swelling, unusual tiredness, shortness of breath while lying down.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: "blood thinners" (such as warfarin).Corticosteroids (such as hydrocortisone, prednisone) may increase the risk of edema and heart failure.This medication may interfere with certain laboratory tests (including thyroid tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Do not share or sell this medication to others. It is against the law.Laboratory and/or medical tests (such as blood testosterone levels, red blood cell counts, liver function tests, blood cholesterol levels, PSA test) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Reviewed on 4/16/2014 References

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

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

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

testosterone 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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For testosterone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to testosterone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Depo®-Testosterone in children younger than 12 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Aveed® in the pediatric population. Safety and efficacy have not been established.

Although Delatestryl® may be used for short periods of time in certain male teenagers to treat delayed puberty, X-ray exams of the hands and wrists of male teenagers should be made every 6 months while receiving testosterone.

Geriatric

Appropriate studies on the relationship of age to the effects of testosterone injection have not been performed in the geriatric population. However, elderly patients are more likely to have heart or prostate problems (including enlarged prostate), which may require caution in patients receiving testosterone.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using testosterone.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving testosterone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using testosterone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Anisindione
• Bupropion
• Dasabuvir
• Dicumarol
• Paclitaxel
• Paclitaxel Protein-Bound
• Phenprocoumon
• Warfarin

Using testosterone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Licorice

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of testosterone. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to benzyl benzoate or refined castor oil or
• Breast cancer (males) or
• Prostate cancer, known or suspected—Aveed® and Delatestryl® should not be used in patients with these conditions.

• Blood clotting problems (eg, deep vein thrombosis, pulmonary embolism) or
• Coronary artery disease or
• Diabetes or
• Drug abuse or dependence, or history of or
• Enlarged prostate or
• Heart attack, or history of or
• Hypercalcemia (high calcium in the blood) or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Liver problems or
• Problems in passing urine or
• Sleep apnea (breathing problem)—Use with caution. May make these conditions worse.

• Blood disorder (eg, polycythemia)—May increase risk for thromboembolic diseases.

• Heart disease (eg, congestive heart failure) or
• Kidney disease or
• Liver disease—Use with caution. Testosterone may cause edema (fluid retention) in patients with these conditions.

• Heart disease, severe or
• Kidney disease, severe or
• Liver disease, severe—Depo®-Testosterone should not be used in patients with these conditions.