Testosterone Injection

IMPORTANT WARNING:

Testosterone undecanoate injection (Aveed) may cause serious breathing problems and allergic reactions, during or immediately after the injection. The injection should be given by a doctor or nurse in a healthcare setting where these problems or reactions can be treated. You will need to remain in the healthcare setting for at least 30 minutes after you receive your injection. Tell your doctor or nurse immediately if you experience any of the following symptoms during or after your injection: tightening of your throat, difficulty breathing, difficulty swallowing, shortness of breath, cough or urge to cough, chest pain, dizziness, fainting, sweating, rash, hives, or itching.

A program has been set up to limit the use of testosterone undecanoate injection (Aveed) and to inform people about the increased risk of breathing problems and allergic reactions while receiving this medication. The program also makes sure that everyone who received this medication understands the risks and benefits from this medication and receives the medication in a setting where they can be monitored for serious reactions.

Testosterone enanthate injection (Xyosted) and other testosterone products may cause an increase in blood pressure which can increase your risk of having a heart attack or stroke that may be life-threatening. Tell your doctor if you have or have ever had high blood pressure, heart disease, a heart attack, or a stroke. Tell your doctor and pharmacist if you are taking medications for blood pressure, pain, or cold symptoms. If you experience any of the following symptoms, call your doctor immediately: chest pain; shortness of breath; pain in the arms, back, neck, or jaw; slow or difficult speech; dizziness or faintness; or weakness or numbness of an arm or leg.

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with testosterone undecanoate injection or testosterone enanthate injection (Xyosted). Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine prescribed?

Testosterone cypionate (Depo-Testosterone), testosterone enanthate (Xyosted, available generically), testosterone undecanoate (Aveed), and testosterone pellet (Testopel) are forms of testosterone injection used to treat symptoms of low testosterone in men who have hypogonadism (a condition in which the body does not produce enough natural testosterone). Testosterone is used only for men with low testosterone levels caused by certain medical conditions, including disorders of the testicles, pituitary gland (a small gland in the brain), or hypothalamus (a part of the brain) that cause hypogonadism. Your doctor will order certain lab tests to check your testosterone levels to see if they are low before you begin to use testosterone injection. Testosterone enanthate (available generically) and testosterone pellet (Testopel) are also used to stimulate puberty in males with delayed puberty. Testosterone enanthate (available generically) injection may be used in certain women with a type of breast cancer called mammary cancer that has spread to other parts of the body. Testosterone should not be used to treat the symptoms of low testosterone in men who have low testosterone due to aging ('age related hypogonadism'). Testosterone is in a class of medications called androgenic hormones. Testosterone is a hormone produced by the body that contributes to the growth, development, and functioning of the male sexual organs and typical male characteristics. Testosterone injection works by supplying synthetic testosterone to replace the testosterone that is normally produced naturally in the body. When used to treat breast cancer, testosterone works by stopping the release of estrogen.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Testosterone cypionate, testosterone enanthate (available generically), and testosterone undecanoate injection come as a solution (liquid) to be injected into a muscle and as a pellet to be injected under the skin by a doctor or nurse in an office setting or clinic. Testosterone enanthate injection (Xyosted) comes as a solution (liquid) to be injected subcutaneously (under the skin) once a week by yourself or a caregiver.

Testosterone injection may control your symptoms but will not cure your condition. Your doctor may adjust your dose of testosterone depending on the amount of testosterone in your blood during your treatment and your reaction to the medication.

Always look at your testosterone enanthate (Xyosted) solution before you inject it. It should be clear to light yellow in color and free of visible particles. Do not use it if it is cloudy, contains visible particles, or if the expiration date on the package has passed.

You can inject testosterone enanthate injection (Xyosted) in the left or right side of your abdomen (stomach) except your navel and the area 2 inches around it. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars, tattoos, or stretch marks.

Your healthcare provider will show you how to use testosterone enanthate injection (Xyosted). Be sure that you understand these directions, and ask your healthcare provider if you have any questions.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving testosterone injection,

• tell your doctor and pharmacist if you are allergic to testosterone, any other medications, or any of the ingredients in testosterone injection products. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven); insulin (Apidra, Humalog, Humulin, others); medications for diabetes; and oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• if you are male, tell your doctor if you have breast cancer or have or may have prostate cancer. Also tell your doctor if you have heart, liver, or kidney disease. Your doctor may tell you that you should not receive testosterone injection.

• tell your doctor if you have or have ever had sleep apnea (breathing stops for short periods of time during sleep); benign prostate hyperplasia (BPH; an enlarged prostate); high blood levels of calcium; cancer; diabetes; depression or other mental illness; or lung disease.

• you should know that some testosterone products should not be used in women (Aveed, Xyosted). Otherwise, women should not receive this medication if they are or may become pregnant or are breastfeeding. Testosterone may harm the baby.

• you should know that there have been reports of serious side effects in people who use testosterone at higher doses, along with other male sex hormone products, or in ways other than directed by a doctor. These side effects may include a heart attack, heart failure, or other heart problems; stroke and mini-stroke; liver disease; seizures; or mental health changes such as depression, mania (frenzied, abnormally excited mood), aggressive or unfriendly behavior, hallucinations (seeing things or hearing voices that do not exist), or delusions (having strange thoughts or beliefs that have no basis in reality). People who use higher doses of testosterone than recommended by a doctor may also experience withdrawal symptoms such as depression, extreme tiredness, craving, irritability, restlessness, loss of appetite, inability to fall asleep or stay asleep, or a decreased sex drive, if they suddenly stop using testosterone. Be sure to use testosterone injection exactly as directed by your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Testosterone injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• acne
• breast enlargement or pain
• hoarseness
• deepening of voice
• pain, redness, bruising, bleeding, or hardness at injection site
• tiredness
• difficulty falling asleep or staying asleep
• mood swings
• weight gain
• headache
• joint pain
• back pain

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• lower leg pain, swelling, warmth, or redness
• nausea or vomiting
• swelling of the hands, feet, ankles, or lower legs
• difficulty breathing, especially during sleep
• erections that happen too often or that last too long
• difficulty urinating, weak urine flow, frequent urination, sudden need to urinate right away, blood in the urine
• yellowing of the skin or eyes
• pain in the upper right part of the stomach
• mood changes including depression, anxiety, or becoming suicidal (thinking about harming or killing oneself or planning or trying to do so)

Testosterone injection may cause a decrease in the number of sperm (male reproductive cells) produced, especially if it is used at high doses. Talk to your doctor about the risks of using this medication if you are a man and would like to have children.

Testosterone may increase the risk of developing prostate cancer. Talk to your doctor about the risks of receiving this medication.

Testosterone injection may cause the bones to mature more quickly than normal in children who receive the medication. This means that the children may stop growing sooner than expected and may have a shorter than expected adult height.

Testosterone injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep testosterone enanthate injection (Xyosted) in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom). Do not refrigerate or freeze.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to testosterone injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving testosterone injection.

Do not let anyone else use your testosterone enanthate injection (Xyosted). Testosterone is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.