Prasterone (Vaginal)

Prasterone is used to treat women who have moderate to severe dyspareunia (painful intercourse) caused by menopause. Low estrogen levels can cause changes in the vulvar and vaginal areas, leading to atrophy (shrinking of tissues) and dryness. Prasterone is a steroid medicine.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress during regular visits. This will help your doctor see if the medicine is working properly and decide if you should keep using it.

It is unlikely that a postmenopausal woman may become pregnant. However, using this medicine while you are pregnant could harm your unborn baby. If you think you may be pregnant while using the medicine, tell your doctor right away.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests (e.g., Pap smear).

In deciding to use this medicine, you and your doctor need to consider the risks compared to the benefits. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any strange or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Intrarosa™ is not meant for use in children.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of Intrarosa™.

Interactions with Medicines

Some medicines should never be used together. However, in some cases, two different medicines can be used together even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with specific types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Breast cancer, known or suspected, or a history of—This medicine should not be used in patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common or rare

• White or brownish vaginal discharge

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Intrarosa

Available Dosage Forms:

• Suppository

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Androgen

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.

This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

This medicine comes with a disposable applicator. Place the vaginal insert in the applicator and then insert it into your vagina. Use each applicator only once, and then throw it away.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For vaginal dosage form (suppository):For dyspareunia: Adults—6.5 milligrams (mg) once a day, at bedtime. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

You may also store the medicine in the refrigerator.