Generic Name: prasterone
Dosage Form: Vaginal Inserts
Date of Approval: November 16, 2016
Company: Endoceutics Inc.
Treatment for: Dyspareunia in Postmenopausal Women
FDA Approves Intrarosa
The U.S. Food and Drug Administration has approved Intrarosa (prasterone), a vaginally administered steroid indicated to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
Read this Patient Information before you start treatment. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is Intrarosa?
Intrarosa vaginal inserts is a prescription medicine used in women after menopause to treat moderate to severe pain during sexual intercourse caused by changes in and around the vagina that happen with menopause. It is not known if the vaginal inserts are safe and effective in children.
Do not use the vaginal inserts if you have vaginal bleeding that has not been checked by your healthcare provider.
Before using the vaginal inserts, tell your healthcare provider about all of your medical conditions, including if you:
- have, have had, or think you may have had breast cancer. Prasterone, the active ingredient in Intrarosa vaginal inserts, is changed in your body to estrogen. Estrogen medicines are not for use in women who have, have had, or think they may have had breast cancer.
- are pregnant or plan to become pregnant. Intrarosa vaginal inserts are only for use in women who are past menopause. It is not known if the vaginal inserts will harm your unborn baby.
- are breastfeeding or plan to breastfeed. Intrarosa vaginal inserts are only for use in women who are past menopause. It is not known if the active ingredient passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use Intrarosa vaginal inserts?
- See the Instructions for Use at the end of this Patient Information for detailed instructions about the right way to use the vaginal inserts.
- Use the vaginal inserts exactly how your healthcare provider tells you to use them.
- Place one vaginal insert in your vagina one time each day at bedtime, using the applicator provided.
Intrarosa side effects
The most common side effects of Intrarosa are vaginal discharge and changes on Pap smear.
These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store the vaginal inserts?
- Store the vaginal inserts between 41°F to 86°F (5°C to 30°C). They can be stored at room temperature or in the refrigerator.
Keep all medicines out of the reach of children and pets.
General Information about the safe and effective use of Intrarosa vaginal inserts.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Intrarosa for a condition for which it was not prescribed. Do not give the vaginal inserts to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information that is written for health professionals.
What are the ingredients?
Active ingredient: prasterone
Inactive ingredient: off-white hard fat (W itepsol)
Instructions for Use
Intrarosa is a vaginal insert that is placed in your vagina with a single-use applicator provided. Use one insert, one time each day at bedtime.
Empty your bladder and wash your hands before handling the vaginal insert and applicator.
Tear off one vaginal insert along the perforations from the 7-vaginal insert strip.
1a. Remove one applicator from the package.
1b. Pull back on the plunger until it stops to activate the applicator. The applicator must be activated before use. Place the applicator on a clean surface.
Slowly pull the plastic tabs on the vaginal insert away from each other while keeping the vaginal insert still between your fingers. Carefully remove the vaginal insert from the plastic wrap. If a vaginal insert falls on an unsanitary surface, replace it with a new one.
Place the flat end of the vaginal insert into the open end of the activated applicator. You are now ready to insert the vaginal insert into your vagina.
Hold the applicator between your thumb and middle finger. Leave your index (pointer) finger free to press the applicator plunger after the applicator is inserted into your vagina.
Select the position for insertion (lying or standing) of the vaginal insert that is most comfortable for you.
Gently slide the vaginal insert end of the applicator into your vagina as far as it will comfortably go. Do not use force.
Press the applicator plunger with your index (pointer) finger to release the vaginal insert. Remove the applicator and throw it away after use.