Prasterone Vaginal Insert

What is this medication?

PRASTERONE (PRAS ter one), also known as DEHYDROEPIANDROSTERONE (DHEA) reduces vaginal pain during sex due to menopause. It works by increasing levels of the hormone estrogen in the body.

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

COMMON BRAND NAME(S): INTRAROSA

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

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

• Cancer, such as breast, uterine, or other cancer
• History of vaginal bleeding
• An unusual or allergic reaction to prasterone, DHEA, other hormones, medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for vaginal use only. Do not take by mouth. Follow the directions on the prescription label. Read package directions carefully before using. Wash hands before and after use. Use this medication at bedtime. Do not use it more often than directed. Do not stop using except on your care team's advice.

Talk to your care team about the use of this medication in children. This medication is not approved for use in children.

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?

Interactions are not expected. Do not use any other vaginal products without telling your care team.

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 a regular check on your progress. This medication may cause changes on a cervical Pap smear. You will receive regular pelvic exams.

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
• Unusual vaginal discharge, itching, or odor
• Vaginal bleeding after menopause, pelvic pain

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

• Vaginal discharge
• Vaginal irritation at application site

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.

Store at room temperature or in a refrigerator between 5 and 30 degrees C (41 and 86 degrees F). 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.