Fluoxymesterone

WHY is this medicine prescribed?

Fluoxymesterone is used to treat symptoms of low testosterone in adult men who have hypogonadism (a condition in which the body does not produce enough natural testosterone). Fluoxymesterone 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. Fluoxymesterone is also used to stimulate puberty in men with delayed puberty. Fluoxymesterone may also be used alone or along with other medications in certain women with breast cancer that has spread to other parts of the body and can not be removed with surgery. Fluoxymesterone is in a class of medications called androgenic hormones. It works by supplying testosterone to replace the testosterone that is normally produced naturally in the body. 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. When used to treat breast cancer, testosterone works by blocking the release of estrogen to stop or slow the growth of breast cancer..

HOW should this medicine be used?

Fluoxymesterone comes as a tablet to take by mouth. It usually is taken with or without food once a day or three or four times a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fluoxymesterone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take fluoxymesterone even if you feel well. Do not stop taking fluoxymesterone without talking to your doctor.

Are there OTHER USES for this medicine?

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

What SPECIAL PRECAUTIONS should I follow?

Before taking fluoxymesterone,

• tell your doctor and pharmacist if you are allergic to fluoxymesterone, any other medications, or any of the ingredients in fluoxymesterone tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, or nutritional supplements you are taking or plan to take while taking fluoxymesterone. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you are a man and you have breast cancer or if you have or may have prostate cancer. Your doctor will probably tell you not to take fluoxymesterone.
• tell your doctor if you are not able to walk around, or if you have or have ever had diabetes; a heart attack; coronary artery disease (clogged blood vessels leading to the heart); or heart, liver, or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant or are breast-feeding. If you become pregnant while taking fluoxymesterone, call your doctor immediately. Fluoxymesterone can harm the fetus. Do not breastfeed while taking fluoxymesterone.
• you should know that there have been reports of serious side effects in people who take androgenic hormones similar to fluoxymesterone 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; stroke; liver disease; 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 androgenic hormones than recommended by a doctor may also experience withdrawal symptoms such as depression, extreme tiredness, irritability, loss of appetite, inability to fall asleep or stay asleep, or a decreased sex drive, if they suddenly stop taking the androgenic hormone. Be sure to take fluoxymesterone exactly as directed by your doctor.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

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

• changes in sex drive
• enlargement of the breast
• headache
• anxiety
• depression
• tingling, prickling, or burning sensations

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment:

• enlargement of the clitoris, deepening of voice, increase in facial hair, acne, and baldness (in women)
• abnormal or absent menstrual periods
• erections of the penis that happen too often or do not go away
• rash, itching, or hives
• difficulty breathing
• yellowing of skin or eyes
• pain in the upper right part of the stomach
• nausea or vomiting
• unusual or excessive bleeding
• swelling or fluid retention

Fluoxymesterone may prevent normal growth in children. Children who take fluoxymesterone may be shorter as adults then they would have been if they had not taken the medication. Fluoxymesterone is more likely to interfere with the growth of younger children than older children. Your child's doctor will take x-rays regularly to be sure your child is growing normally. Talk to your child's doctor about the risks of giving this medication to your child.

Fluoxymesterone may decrease fertility in men. Talk to your doctor about the risks of taking this medication.

Fluoxymesterone may cause other side effects. Call your doctor if you have any unusual problems while taking 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, and excess heat and moisture (not in the bathroom).

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 (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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. https://www.upandaway.org

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 will order certain lab tests to check your response to fluoxymesterone.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking fluoxymesterone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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 report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: May 24, 2017.