Brand Names: U.S.
Androderm; AndroGel; AndroGel Pump; Aveed; Axiron; Depo-Testosterone; First-Testosterone; First-Testosterone MC; Fortesta; Striant; Testim; Testopel
Brand Names: Canada
Andriol; Androderm; AndroGel; Andropository; Delatestryl; Depotest 100; Everone 200; PMS-Testosterone; Testim
- A very bad lung problem has happened with this drug. Allergic reactions have also happened with this drug. Sometimes, allergic reactions have been life-threatening. These reactions have happened while this drug was given and right after. These reactions can happen with any dose of this drug.
- 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 this drug through the Aveed REMS Program.
Gel and solution:
- Do not let your skin that the gel or solution was used on touch any children’s or women’s skin. Cover treated part with clothes. Signs of puberty may happen in children.
What is this drug used for?
- It is used to treat breast cancer in women.
- It is used to treat low testosterone levels.
- It is used in certain children when puberty is delayed.
What do I need to tell my doctor BEFORE I take this drug?
- If you have an allergy to testosterone or any other part of this drug.
- 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 are a woman. This drug is not approved for use in women.
- Do not give to a child. Talk with your doctor.
All other products:
- If you are pregnant or may be pregnant. Do not take this drug if you are pregnant.
- If you are breast-feeding. Do not breast-feed while you take this drug.
This is not a list of all drugs or health problems that interact with this drug.
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 this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
- If you have any of these health problems: Heart disease, kidney disease, or liver disease.
What are some things I need to know or do while I take this drug?
- Tell dentists, surgeons, and other doctors that you use this drug.
- 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 your doctor.
- Have your blood pressure checked often. Talk with your doctor.
- Have your blood work checked often. Talk with your doctor.
- This drug may affect certain lab tests. Be sure your doctor and lab workers know you take this drug.
- If you are 65 or older, use this drug with care. You could have more side effects.
- This drug may affect sperm in men. This may affect being able to father a child. Talk with the doctor.
- This drug may cause harm to the unborn baby if you take it while you are pregnant. If you get pregnant while taking this drug, call your doctor right away.
- 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.
Gel and solution:
- Tell the doctor right away if a child or woman touches the gel or solution and has any bad effects. In children, these are forceful actions, enlarged sex organs, and early growth of pubic hair. In women, these are a deep voice, change in body hair, or pimples.
- If a pregnant woman touches the gel or solution, call the doctor right away.
- Some products have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn. Talk with the doctor to see if this product has benzyl alcohol in it.
- Some drugs may be used in children. Use care if this drug is given to a child. Talk with the doctor to see if this drug may be used in children. Talk with the doctor if you have questions about giving this drug to a child.
- This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
- The patch may have metal. Take off the patch before an MRI.
- Be sure to inspect your gums where you put this drug on a regular basis. Talk with your doctor.
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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- For men, erections (hard penis) that happen often or that last a long time.
- Passing urine often.
- Not able to pass urine or change in how much urine is passed.
- Mood changes.
- Enlarged breasts.
- Breast pain.
- 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.
- Shortness of breath, a big weight gain, swelling in the arms or legs.
- Upset stomach or throwing up.
- Any bruising or bleeding.
- Trouble breathing when you sleep.
- If you are very sleepy.
- Very bad headache.
- Chest pain.
- Coughing up blood.
- Swelling, warmth, or pain in the leg or arm.
- Change in color of skin.
- Change in size or shape of testicles.
- If you have an enlarged prostate, your signs can get worse while you use this drug. Call your doctor if this happens to you.
- Gum changes.
- Very bad mouth irritation.
- Very bad irritation where the shot was given.
- For women, a deep voice, facial hair, pimples, or period changes.
What are some other side effects of this drug?
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.
- Lowered interest in sex.
- Change in sex ability.
- Feeling tired or weak.
- Not able to sleep.
All skin products:
- Gum irritation or pain.
- Mouth irritation.
- Bad taste in your mouth.
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 your national health agency.
- Pain where the shot was given.
- Irritation where the shot is given.
How is this drug best taken?
Use this drug as ordered by your doctor. Read and follow the dosing on the label closely.
- Wash your hands before and after use.
Gel and solution:
- Not all products are the same strength. Read and follow label carefully.
- Do not get this drug on other parts of your body or on other people.
- Do not put on the genitals.
- Keep out of your eyes.
- Some products come in pumps. Some products come in packets. If you are using a pump, you will need to prime it before you use it the first time. Prime the pump as you are told in the package insert.
- Put on clean, dry, healthy skin.
- Certain products are to be put on certain parts of the body. Be sure you know where to put this drug. Read the package insert for more details.
- After putting this drug on, you will need to wait some time before you bathe, shower, or swim. Be sure you know how long you need to wait. Read the package insert for more details.
- Let dry before covering with clothing.
- Avoid fire, flames, or smoking until dry.
- If a woman or child touches the gel, she/he needs to wash the skin with soap and water.
- Wash the site where the drug was used before it touches anyone else’s skin.
- Use one finger to gently rub gel onto skin.
- Do not put on a spot on the thigh where this drug might get onto the scrotum.
- Put on clean, dry, healthy skin using the applicator under the arm.
- Do not use your fingers or hand to rub this drug into the skin.
- Change armpits with each dose.
- Allow skin to dry between uses.
- If you use deodorant, put on at least 2 minutes before you put on this drug.
- Do not use patches that are cut or do not look right.
- Put patch on clean, dry, healthy skin on back, belly, thigh, or upper arm.
- Do not put on the genitals.
- Put on a new patch at the same time every night. Be sure to take off the old patch before you put on the new one.
- Move the patch site with each new patch. Do not put on the same site for 7 days.
- Do not bathe, shower, or swim for 3 hours after putting on.
- Do not cover the patch with other bandages or tape. If the patch does not stick well, talk with your doctor or pharmacist.
- If your patch falls off before noon, put on a new patch and wear it until you put on a new patch at your normal time.
- If your patch falls off after noon, do not put on a new one. Wait and put on a new patch at your normal time.
- After you take off a skin patch, be sure to fold the sticky sides of the patch to each other.
- Do not remove the tablet from the tablet pack until you are ready to take this drug. Take the tablet right away after opening the blister pack. Do not store the removed tablet for future use.
- Dry your hands and place the tablet in your mouth above the incisor tooth between the upper cheek and gum. Let it melt during the day.
- Do not chew or swallow.
- Change the side of mouth with each dose.
- Do not take out until it is time for your next dose.
- Make sure drug is still in place after eating, drinking, brushing your teeth, or using mouthwash.
- If the drug does not stick or falls out within the first 8 hours, put in a new one. This still counts as your first dose. Change the tablet again at your next normal time.
- To remove tablet, gently slide it down from the gum toward the tooth to keep from scratching the gum.
All shot products:
- It is given as a shot into a muscle.
- Your doctor will give this drug.
All other shot products:
- Your doctor may teach you how to give this drug.
- Follow how to use carefully.
- Do not use if the solution is cloudy, leaking, or has particles.
- Do not use if solution changes color.
- Throw away needles in a needle/sharp disposal box. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
- This drug is given as an implant.
What do I do if I miss a dose?
- Call your doctor to find out what to do.
All other products:
- Use a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not use 2 doses or extra doses.
How do I store and/or throw out this drug?
- Most of the time, this drug will be given in a hospital or doctor’s office. If stored at home, follow how to store as you were told by your doctor.
- This drug will be given to you in a hospital or doctor’s office. You will not store it at home.
All other products:
- Store at room temperature. Do not freeze.
- Store in a dry place. Do not store in a bathroom.
Gel and solution:
- Protect from heat or open flame.
- Store in pouch until ready for use.
- Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
General drug facts
- 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.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, pharmacist, or other health care provider.
Consumer Information Use and Disclaimer
This information should not be used to decide whether or not to take this medicine or any other medicine. Only your healthcare provider has the knowledge and training to decide which medicines are right for you. 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 this medicine. This information is not specific medical advice and does not replace information you receive from your healthcare provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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