Intrarosa

The active ingredient in Intrarosa is prasterone. Prasterone (DHEA) is converted inside the vaginal cells into small amounts of estrogen and androgens. These hormones help restore healthy vaginal tissue by:

• Improving elasticity and thickness.
• Enhancing natural lubrication.
• Reducing vaginal pH.

-Relieving dryness and discomfort.

This local mechanism of action makes Intrarosa effective for treating vaginal atrophy and severe dyspareunia without raising systemic hormone levels in a significant way.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Intrarosa. However, the following is a synopsis of the general guidelines for the use of Intrarosa:

• Use one vaginal insert once daily, preferably at bedtime.
• Wash your hands before and after placing the insert.
• Peel open the blister pack to remove the insert.
• Use the provided applicator to place the insert high inside the vagina.
• After inserting, wash the applicator with mild soap and warm water for future use.
• Do not use the product if the packaging is damaged.
• If you miss a dose, use it the next day at the regular time. Do not use more than one insert per day.

Some mild or most common side effects of Intrarosa seen in clinical trials include:

• Vaginal discharge.

Some individuals may experience serious side effects while using Intrarosa. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

Signs of an allergic reaction, such as swelling, hives, or difficulty breathing.

• Abnormal results on a Pap smear.
• Increased risk of breast cancer.

These are not all of the possible side effects of Intrarosa. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Intrarosa, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• A history of breast cancer.
• Unexplained vaginal bleeding.
• A history of endometrial hyperplasia.
• Liver disease.
• A history of abnormal Pap smears.
• Vaginal or vulvar irritation or inflammation.
• A known allergy to prasterone or any ingredient in the insert.

Intrarosa should not be used in individuals who:

• Have undiagnosed abnormal genital bleeding.
• Have a known allergy to prasterone or any inactive ingredients in the insert.

Most women begin to notice improvement within 6 to 12 weeks of daily use. Changes such as increased lubrication and reduced vaginal pain during intercourse were seen in clinical trials around week 12.

Some women may experience symptom relief earlier, depending on the severity of their vaginal atrophy.

When Intrarosa is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Vaginal products containing estrogen or moisturizers (may alter vaginal pH or irritation risk).
• Lubricants and spermicides.
• Herbal supplements that affect hormones.
• Medications that influence androgen or estrogen metabolism.

Intrarosa is available as a 6.5 mg vaginal insert used once daily.

It comes individually sealed in a blister pack along with a reusable applicator for insertion.

Store at room temperature and keep out of reach of children.

Intrarosa is manufactured by Endoceutics, Inc.

At this time, no generic version of Intrarosa (prasterone) is available.

Do not stop using Intrarosa without speaking to your healthcare provider. If you discontinue treatment, symptoms such as vaginal dryness and painful intercourse may return.

If you experience allergic reactions, unexplained vaginal bleeding, or persistent discomfort, stop using the insert and contact your healthcare provider for medical advice.

Intrarosa is approved only for use in postmenopausal women and is not intended for premenopausal women. Your healthcare provider will recommend what is safest for you.

Since Intrarosa is intended for postmenopausal women, breastfeeding is unlikely. However, if you are breastfeeding for any reason, speak with your doctor before using the medication. Small amounts of hormone metabolites may enter the bloodstream and breast milk.