Generic Name: Testosterone Undecanoate Injection (tes TOS ter one)
Brand Name: Aveed
- A very bad lung problem has happened with testosterone undecanoate injection. Allergic reactions have also happened with this medicine. Sometimes, allergic reactions have been life-threatening. These reactions have happened while testosterone undecanoate injection was given and right after. These reactions can happen with any dose of this medicine.
- You will be watched closely by your doctor for 30 minutes after each dose. Call your doctor right away if you have chest pain, cough or the need to cough, dizziness, passing out, shortness of breath, sweating, or throat tightness.
- You can only get testosterone undecanoate injection through the Aveed REMS Program.
Uses of Testosterone Undecanoate Injection:
- It is used to treat low testosterone levels.
What do I need to tell my doctor BEFORE I take Testosterone Undecanoate Injection?
- If you have an allergy to testosterone or any other part of this medicine.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you are male and have breast or prostate cancer.
- If you have any of these health problems: Heart disease, kidney disease, or liver disease.
- If you are a woman. This medicine is not approved for use in women. If you are a woman using testosterone undecanoate injection, talk with your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding.
This is not a list of all drugs or health problems that interact with this medicine.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take testosterone undecanoate injection with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Testosterone Undecanoate Injection?
- Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
- If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
- There may be a higher chance of prostate cancer. Talk with the doctor.
- If you have an enlarged prostate, your signs can get worse while you use testosterone undecanoate injection. Call your doctor if this happens to you.
- High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
- Treatment with this medicine may lead to higher cholesterol and triglycerides. The effect of these changes on heart health is not known. Talk with the doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
- This medicine is an anabolic steroid. Anabolic steroid drugs have been abused and misused before. Anabolic steroid abuse can lead to dependence and very bad health problems. These health problems include heart or blood vessel problems, stroke, liver problems, and mental or mood problems. Talk with the doctor.
- If you are 65 or older, use testosterone undecanoate injection with care. You could have more side effects.
- This medicine is not approved for treating low testosterone levels caused by getting older. Talk with your doctor.
- This medicine may affect sperm in men. This may affect being able to father a child. Talk with the doctor.
- This medicine is not approved for use in children. Talk with the doctor.
How is this medicine (Testosterone Undecanoate Injection) best taken?
Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take testosterone undecanoate injection.
- If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this medicine.
- Wash your hands before and after use.
- It is given as a shot into a muscle.
- Your doctor will give testosterone undecanoate injection.
What do I do if I miss a dose?
- Call your doctor to find out what to do.
See also: Dosage Information (in more detail)
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Signs of high calcium levels like weakness, confusion, feeling tired, headache, upset stomach and throwing up, hard stools (constipation), or bone pain.
- For males, erections (hard penis) that happen often or that last a long time.
- Passing urine more often.
- Trouble passing urine.
- Passing urine in a weak stream or drips.
- Not able to control passing urine.
- Mood changes.
- Low mood (depression).
- Change in how you act.
- Enlarged breasts.
- Breast pain.
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- Upset stomach or throwing up.
- Trouble breathing when sleeping.
- Feeling sleepy during the day.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Change in color of skin.
- Change in size or shape of testicles.
- Very bad irritation where this medicine is used.
- For females, a deep voice, facial hair, pimples, or period changes.
- Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.
- Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
What are some other side effects of Testosterone Undecanoate Injection?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Pimples (acne).
- Loose stools (diarrhea).
- Emotional ups and downs.
- Change in sex interest.
- Not able to get or keep an erection.
- Feeling tired or weak.
- Not able to sleep.
- Irritation where testosterone undecanoate injection is used.
- Pain where the shot was given.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
See also: Side effects (in more detail)
If OVERDOSE is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Testosterone Undecanoate Injection?
- If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.
Consumer Information Use and Disclaimer
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time testosterone undecanoate injection is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Disclaimer: This information should not be used to decide whether or not to take testosterone undecanoate injection or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to testosterone undecanoate injection. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Review Date: February 7, 2018
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