Aveed Vial

GENERIC NAME(S): Testosterone Undecanoate

OTHER NAME(S): Aveed Solution

FDA WARNING: The FDA is asking that all testosterone drugs carry a warning that they may increase the risk of heart attacks and strokes. Read More

WARNINGS:

This medication can rarely cause a certain serious lung problem (pulmonary oil microembolism-POME), caused by tiny droplets of oil that have traveled to the lungs. Symptoms may include cough/urge to cough, difficulty breathing, sweating, tightening of the throat, chest pain, dizziness, or fainting. Most of the time, symptoms last only a few minutes and improve with medical help. However, symptoms have sometimes lasted up to several hours, or worsened and required treatment in a hospital. Serious (rarely fatal) allergic reactions may also occur. These side effects may happen during or right after each injection. To be sure that you do not have a serious reaction, you will need to stay in a health care setting for 30 minutes after each injection so your doctor can carefully monitor you and provide medical help if needed.

This medication is available only through a restricted program called the Aveed REMS Program. Only doctors enrolled in the program may prescribe or give this medication. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Who should not take Aveed Vial?

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Uses

Uses

This medication is used in men who do not make enough of a natural substance called testosterone. Testosterone belongs to a class of drugs known as androgens. Testosterone helps the body to develop and maintain male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire.

Testosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty.

This product should not be used in women.

How to use Aveed Vial

Read the Medication Guide provided by your pharmacist before you start using this medication and each time you receive an injection. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into the buttock muscle as directed by your doctor. After the first dose, it is usually given 4 weeks later, then every 10 weeks. The dosage is based on your medical condition, testosterone blood levels, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, use a calendar to mark the days you will receive an injection.

Misuse or abuse of testosterone can cause serious side effects such as heart disease (including heart attack), stroke, liver disease, mental/mood problems, abnormal drug-seeking behavior, or improper bone growth (in adolescents). Do not increase your dose or use this drug more often or for longer than prescribed. When testosterone is misused or abused, you may have withdrawal symptoms (such as depression, irritability, tiredness) when you suddenly stop using the drug. These symptoms may last from weeks to months.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

Side Effects

See also Warning section.

Nausea, vomiting, headache, skin color changes, increased/decreased sexual interest, oily skin, hair loss, and acne may occur. Pain or 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: breast swelling/tenderness, mental/mood changes (such as depression, agitation, hostility), unusual snoring or difficulty breathing during sleep, swelling hands/ankles/feet, symptoms of liver problems (such as loss of appetite, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin, dark urine), trouble urinating, increased urination (especially at night), too frequent/prolonged erections, fast/irregular heartbeat.

Get medical help right away if you have any very serious side effects, including: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, get medical help right away, or permanent problems could occur.

This medication can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.

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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Precautions

Before using testosterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as benzyl benzoate, refined castor oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer (especially prostate or breast cancer), prostate problems (such as enlarged prostate), heart problems (such as heart failure, previous heart attack), stroke, kidney problems, liver problems, high cholesterol, difficulty breathing during sleep (sleep apnea), blood clots (such as in the leg, lungs).

If you have diabetes, this product may lower your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of low blood sugar, such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug. In children, it may affect bone growth. Check your child's height periodically.

Some men, particularly older adults, are at a higher risk for developing enlarged prostate or prostate cancer while using this medication. Your risk of prostate problems should be checked by your doctor before you start testosterone.

This medication should not be used in women, especially during pregnancy or breast-feeding. It may harm an unborn or breast-feeding baby. Consult your doctor for more details.

Interactions

Interactions

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).

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.

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Laboratory and/or medical tests (such as testosterone levels, blood cell counts, liver function, cholesterol levels, PSA) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor right away to establish a new dosing schedule.

Storage

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.Information last revised October 2016. Copyright(c) 2016 First Databank, Inc.

Images

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.