Testosterone Skin Solution

What is this medication?

TESTOSTERONE (tes TOS ter one) is used to increase testosterone levels in your body. It belongs to a group of medications called androgen hormones.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): AXIRON

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Breast cancer
• Breathing problems while you sleep (sleep apnea)
• Diabetes
• Heart disease
• If a female partner is pregnant or trying to get pregnant
• Kidney disease
• Liver disease
• Lung disease
• Prostate cancer, enlargement
• An unusual or allergic reaction to testosterone, other medications, foods, dyes, or preservatives
• If a female partner is pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is applied at the same time every day (preferably in the morning) to clean, dry, intact skin of the armpit. Follow the directions on the prescription label. If you take a bath or shower in the morning, apply the medication after the bath or shower. If you use deodorants or antiperspirants, use them at least 2 minutes before applying this medication. Only apply this medication to the armpits. Do not use on any other body part. To use, remove the cap and the applicator cup from the pump. Fully depress the pump once to dispense solution into the applicator cup. With the applicator cup held upright, wipe the solution down and up into the armpit. Do not use your fingers or hand to rub the medication into the skin. Allow the skin to dry a few minutes before putting on clothing. The skin solution is flammable. Avoid fire, flame, or smoking until the solution has dried. Wash your hands after use. Avoid bathing or swimming for at least 2 hours after you apply the medication.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team regarding the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medication?

• Certain medications for diabetes
• Certain medications that treat or prevent blood clots like warfarin
• Oxyphenbutazone
• Propranolol
• Steroid medications like prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. They will need to check the level of testosterone in your blood.

This medication is only approved for use in men who have low levels of testosterone related to certain medical conditions. Heart attacks and strokes have been reported with the use of this medication. Notify your care team and seek emergency treatment if you develop breathing problems; changes in vision; confusion; chest pain or chest tightness; sudden arm pain; severe, sudden headache; trouble speaking or understanding; sudden numbness or weakness of the face, arm or leg; loss of balance or coordination. Talk to your care team about the risks and benefits of this medication.

This medication can transfer from your body to others. If a person or pet comes in contact with the area where this medication was applied to your skin, they may have a serious risk of side effects. If you cannot avoid skin-to-skin contact with another person, make sure the site where this medication was applied is covered with clothing. If accidental contact happens, the skin of the person or pet should be washed right away with soap and water. Also, a female partner who is pregnant or trying to get pregnant should avoid contact with the gel or treated skin.

This medication may affect blood sugar levels. If you have diabetes, check with your care team before you change your diet or the dose of your diabetic medication.

This medication is banned from use in athletes by most athletic organizations.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Mood swings, irritability, or hostility
• Prolonged or painful erection
• Sleep apnea—loud snoring, gasping during sleep, daytime sleepiness
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Swelling of the ankles, hands, or feet
• Thoughts of suicide or self-harm, worsening mood, feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Acne
• Change in sex drive or performance
• Irritation at application site
• Unexpected breast tissue growth

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep your medication in a safe place to protect it from theft. Do not share this medication with anyone. Selling or giving away this medication is dangerous and against the law.

Store upright at room temperature between 15 and 30 degrees C (59 to 86 degrees F). Keep closed until use. Protect from heat and light. This medication is flammable. Avoid exposure to heat, fire, flame, and smoking. Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.