Testosterone Enanthate, Injection

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KEY POINTS

• This medicine is given by injection to treat conditions caused by a lack of the hormone testosterone in males. This medicine is also used to treat advanced breast cancer in postmenopausal women. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may raise cholesterol, increase the risk of blood clots, or cause other serious side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: androgen; male hormone

Generic and brand names: testosterone enanthate, injection; Delatestryl

What is this medicine used for?

This medicine is given by injections (shots) to treat conditions caused by a lack of the hormone testosterone in men. It is used to stimulate the growth of the male sex organs in adolescent males.

This medicine is also used to treat advanced breast cancer in postmenopausal women (women who have stopped having monthly periods).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine, hormone, or to sesame oil
• A stroke or transient ischemic attack (TIA)
• Blood clots in your legs, lungs, brain, or eyes
• Diabetes
• Heart disease or a heart attack
• High cholesterol
• Kidney or liver disease
• Lung or breathing problems such as asthma, COPD, or sleep apnea
• Male breast cancer
• Prostate cancer
• Trouble urinating or an enlarged prostate gland

Females of childbearing age: Do not take this medicine if you are pregnant or may become pregnant. This medicine has been reported to cause birth defects. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

How do I use it?

Your dosage, how often you will receive the shots, and how long the treatment will last, depend on the condition being treated, your sex and age, and your response to the medicine.

Your healthcare provider will give you these shots. Sometimes you may be able to give yourself these shots or have someone at home give them to you. Check the label on the medicine for directions about your specific dose. Be sure you know when to use the medicine and how much medicine you should use. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in children.

What if I miss a dose?

Ask your healthcare provider what to do if you miss a dose.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine may affect bone growth in children. Children being treated for delayed puberty, should have their bone development checked every 6 months. Talk with your healthcare provider about this.

This medicine may:

• Raise your cholesterol.
• Increase your risk for prostate cancer or an enlarged prostate.
• Increase your risk of blood clots.
• Make breast cancer worse.
• Worsen heart failure symptoms by causing you to retain fluid.

Your healthcare provider will watch you closely. You may need to have blood tests regularly to see how this medicine affects you. Keep all appointments for follow-up care.

This medicine is a controlled substance. It is illegal for you to give it to anyone else.

Rarely, this medicine may cause a painful erection of the penis that will not return to normal. If this happens, contact your healthcare provider or get medical care right away. It can lead to permanent erectile dysfunction if not treated.

This medicine may lower the sperm count in men. Talk with your healthcare provider about this.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicine you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Nausea; vomiting; yellowing of eyes or skin; dark urine; light-colored bowel movements; severe nausea, vomiting, or stomach pain; redness, warmth, or swelling in your lower legs, ankles, or feet; sudden shortness of breath; chest pain; breathing problems, especially while sleeping; dizziness; fainting; trouble urinating; unusual bruising or bleeding. In males: too frequent or persistent erections; enlarged breasts. In females: hoarseness, acne, changes in menstrual periods, more facial hair.

Other: Headache, anxiety, depression, pain at injection site.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Diabetes medicines such as glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• Saw palmetto
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.