Testosterone Undecanoate, 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 men.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause a life-threatening allergic reaction or a serious lung problem called a pulmonary oil microembolism reaction. It may cause other unwanted 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 undecanoate, injection; Aveed

What is this medicine used for?

This medicine is given by injections (shots) to treat various conditions caused by a lack of the hormone testosterone in men. You must be enrolled in a special program before you can receive this medicine. Talk with your healthcare provider about this.

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, benzyl benzoate, or to castor oil
• A blood disorder, such as polycythemia
• A stroke or transient ischemic attack (TIA)
• Blood clots in your legs, lungs, brain, or eyes
• Diabetes
• Heart disease, heart failure, or a heart attack
• High cholesterol
• High levels of calcium in the blood
• 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: This medicine is not for use in women. 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.

Males: This medicine may lower sperm counts. This may affect being able to father a child. Talk with your healthcare provider about this.

How do I use it?

Read the Medication Guide provided by your healthcare provider before you begin treatment with this medicine and before each injection.

This medicine is given by your healthcare provider in a clinic or hospital. You will be monitored closely while receiving this medicine and for at least 30 minutes after each treatment. The schedule for these shots depends on your condition. Be sure you understand when you need your treatments, and keep all your appointments.

What if I miss a dose?

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

What should I watch out for?

This medicine may cause a life-threatening allergic reaction or a serious lung problem called a pulmonary oil microembolism (POME) reaction. POME is caused by tiny droplets of oil that have traveled to the lungs. Contact your healthcare provider right away if you have:

• Cough or urge to cough
• Trouble breathing
• Sweating
• Tightening of your throat
• Chest pain
• Dizziness
• Fainting

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

This medicine may increase your risk of prostate cancer. Talk with your healthcare provider about this.

Rarely, this medicine may cause a painful erection of the penis that will not return to normal. If you have an erection that lasts more than 4 hours, contact your healthcare provider or get medical care right away. It can lead to permanent erectile dysfunction if not treated.

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.): Cough; chest pain; nausea; vomiting; breathing problems, especially while sleeping; dizziness; fainting; yellowing of eyes or skin; unusual bruising or bleeding; pain, swelling, warmth, or redness in the legs or ankles or any unexplained swelling; sudden shortness of breath; trouble urinating; increased urination; too frequent or persistent erections; enlarged breasts.

Other: Headache, mood swings, irritability, tiredness, trouble sleeping, acne, 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)
• 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.

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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.