Axiron Warnings and Precautions
Warnings and precautions to be aware of prior to using this drug include the following:
- Axion is not approved for use in women. It has not been adequately studied in women and can cause virilization (the development of male characteristics, such as a deep voice or body hair) in women. Other signs of virilization include acne, early development of pubic hair in children, or abnormal changes in genital size in children.
- Axiron can rub off onto others with skin-to-skin contact, even hours after it is applied (it stays on the surface of the skin until washed off). Take measures to avoid exposing women and children to the drug, as virilization may occur.
If skin-to-skin contact is anticipated, you should wash the area thoroughly before any contact occurs. If accidental contact occurs, the woman or child should wash the skin immediately to remove any of the medication that may have been transferred.
- Let your healthcare provider know if any women or children that may have come into direct or indirect contact with Axiron are showing signs of virilization. Stop using the drug until the exact cause of the virilization can be determined.
- Axiron can cause or worsen an enlarged prostate. It also appears to increase the risk of prostate cancer. Your healthcare provider should evaluate you for prostate cancer before you start the medication and periodically thereafter.
- Axiron can potentially decrease sperm count, thereby decreasing fertility, although it can also help with certain causes of infertility related to low testosterone. Consult your healthcare provider if you experience difficulty conceiving a child while using this product.
- This medication can cause increased red blood cells. Your healthcare provider should do a routine blood test (called a "hematocrit" test) to check for this problem. If your hematocrit increases too much, you may need to stop using Axiron, as a high hematocrit may be associated with an increased risk for blood clots.
- Androgens can increase the risk of liver problems, including liver cancer. Although these problems have not been reported with Axiron, they cannot be completely ruled out.
- Androgens can cause fluid retention, which can be dangerous for people with liver, heart, or kidney disease.
- Breast enlargement can occur in men using Axiron.
- Axiron can worsen (or possibly even cause) sleep apnea.
- This medicine can cause cholesterol changes, high blood calcium (hypercalcemia), and changes in thyroid levels. Your healthcare provider may need to check for these problems.
- Axiron can potentially react with a few other medications (see Axiron Drug Interactions).
- Axiron is considered a pregnancy Category X medication. This means it is definitely not safe for use during pregnancy (see Axiron and Pregnancy).
- This medication is not safe for use while breastfeeding (see Axiron and Breastfeeding).