Fluoxymesterone

Fluoxymesterone is a male hormone (androgen) used as replacement therapy in conditions associated with symptoms of deficiency or absence of endogenous testosterone and in delayed puberty in men. It is also used for the treatment of metastatic breast cancer in women.

• Fluoxymesterone is available under the following different brand names: Androxy, Halotestin

Common side effects of Fluoxymesterone include:

• nausea
• vomiting
• headache
• skin color changes
• increased/decreased sexual interest
• oily skin
• hair loss
• acne

Serious side effects of Fluoxymesterone include:

• 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

Rare side effects of Fluoxymesterone include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet: Schedule III

• 2 mg
• 5 mg
• 10 mg

Hypogonadism, males

Adult and pediatric dosage

• 5-20 mg orally once a day

Metastatic breast cancer, females

Adult dosage

• Palliative adjunctive therapy: 10-40 mg/day orally in divided doses ×3 months or longer

Delayed puberty, males

Pediatric dosage

• 2.5-20 mg orally once a day for 4-6 months

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Fluoxymesterone has severe interactions with no other drugs.
• Fluoxymesterone has serious interactions with the following drugs:
  • pexidartinib
  • pretomanid
  • warfarin
• Fluoxymesterone has moderate interactions with the following drugs:
  • carbamazepine
  • valoctocogene roxaparvovec
• Fluoxymesterone has minor interactions with at least 37 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Severe cardiac, hepatic, or renal disease, men with breast or prostate cancer, hypersensitivity
• Pregnancy

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Fluoxymesterone?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Fluoxymesterone?”

Cautions

• Benign prostatic hypertrophy, men with delayed puberty, geriatric patients, pediatric patients
• Hypercalcemia may occur in patients with breast cancer and immobilized patients
• Halogenated derivative of testosterone with up to five times the activity of methyltestosterone

Pregnancy and Lactation

• Do not use during pregnancy
• Lactation
  • Excretion in milk unknown; contraindicated