(progesterone) vaginal system
Read this Patient Information before you start using MILPROSA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Your healthcare provider may do a physical examination before prescribing MILPROSA.
What is MILPROSA?
- MILPROSA is a vaginal system that contains the hormone progesterone. MILPROSA is for infertile women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) program. Progesterone is one of the hormones essential for helping you to become and to stay pregnant. If you are undergoing ART treatment, your healthcare provider may prescribe MILPROSA to provide the progesterone your body needs.
- It is not known if MILPROSA is safe and effective in children.
- It is not known if MILPROSA is effective in women 35 years of age and older.
- It is not known if MILPROSA is safe and effective in women with a high body mass index (BMI) greater than 38 kg/m2.
Do not use MILPROSA if you:
- are allergic to progesterone or any ingredients in MILPROSA. See the end of this leaflet for a complete list of ingredients.
- have unusual vaginal bleeding that has not been evaluated by your healthcare provider.
- have or have had liver disease.
- have known or suspected breast cancer.
- have or have had blood clots in the legs, lungs, eyes, or anywhere else in your body.
Before you use MILPROSA, tell your healthcare provider about all of your medical conditions, including if you:
- have a history of heart problems or heart disease including a heart attack, stroke, and blood clots.
- have a history of depression.
- are breastfeeding or plan to breastfeed. MILPROSA may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use MILPROSA.
Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements. Some medicines may affect MILPROSA.
Especially tell your healthcare provider if you:
- use other vaginal products, such as antifungal products, vaginal lubricants, diaphragms, and condoms.
- take CYP inducers such as rifampin and carbamazepine.
Talk with your healthcare provider if you are not sure if you take these medicines. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I use MILPROSA?
- Read the Instructions for Use at the end of this Patient Information that comes with MILPROSA for information about the right way to insert, remove, and throw away MILPROSA.
- Use MILPROSA exactly as prescribed. The usual dose of MILPROSA is 1 system placed in your vagina for 7 continuous days, and replaced weekly for a total of 10 weeks, unless your healthcare provider tells you something different.
- MILPROSA should remain in place for a minimum of 23 hours each day. It may be removed for sexual intercourse, although this is not necessary.
- Do not use any other vaginal products such as antifungal products, vaginal lubricants, diaphragms, and condoms when using the MILPROSA vaginal system.
What are the possible side effects of MILPROSA?
MILPROSA may cause serious side effects, including:
Common side effects of MILPROSA include:
- vaginal discharge
- breast tenderness
- discomfort after inserting the vaginal system
- stomach bloating
- stomach pain
- pelvic pain
Other side effects of progesterone use include:
- mood swings
Call your healthcare provider immediately if you have abnormal vaginal bleeding.
These are not all the possible side effects of MILPROSA. For more information, ask your healthcare provider or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.
How should I store MILPROSA?
- Store MILPROSA at room temperature between 68° to 77°F (20° to 25°C).
- Do not put MILPROSA in the refrigerator.
- Do not freeze MILPROSA.
- Avoid excessive heat.
- Keep MILPROSA and all medicines out of the reach of children.
General information about the safe and effective use of MILPROSA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use MILPROSA for a condition for which it was not prescribed. Do not give MILPROSA to other women, even if they have the same condition as you do. It may harm them.
You can ask your pharmacist or healthcare provider for information about MILPROSA that is written for healthcare professionals.
What are the ingredients in MILPROSA?
Active ingredient: progesterone.
Inactive ingredients: light mineral oil, silicone elastomer.
Instructions for Use
(progesterone) vaginal system
Read this Instructions for Use carefully before you use MILPROSA and each time you get a refill. This information does not take the place of talking with your healthcare provider who specializes in women’s health. If you have any questions about MILPROSA, ask your healthcare provider.
Follow the steps below to insert MILPROSA:
You do not need to use anything else to place MILPROSA in the correct position. MILPROSA will change shape to fit your body. The exact position of MILPROSA is not important. The muscles of your vagina will keep MILPROSA securely in place. If you have difficulty inserting MILPROSA, it is fine to rinse the MILPROSA with cool to lukewarm (not hot) water before inserting it.
- Wash and dry your hands.
- Remove the MILPROSA vaginal system from its foil pouch. Keep the foil pouch so you can place your used MILPROSA in it before you throw it away. See “To throw away (dispose of) MILPROSA” instructions at the end of this Instructions for Use.
- Choose the position that is most comfortable for you such as lying down, squatting, or standing with 1 leg up.
- Hold MILPROSA between your thumb and index finger and gently squeeze the sides of MILPROSA together.
- Use your other hand and hold open the folds of skin around your vagina.
- Place the tip of MILPROSA in the vaginal opening and then use your index finger to push the folded MILPROSA gently into your vagina. Push MILPROSA up towards your lower back as far as you can. If you can feel MILPROSA, it may not be placed back far enough in your vagina. Use your index finger to push MILPROSA back a bit further. Put MILPROSA where it is comfortable for you. There is no danger of MILPROSA being pushed too far up in the vagina or getting lost.
In 7 days remove the old MILPROSA and replace with a new MILPROSA.
MILPROSA should remain in place for a minimum of 23 hours each day. You can remove MILPROSA for sexual intercourse, although this is not necessary.
If MILPROSA is expelled, removed, or dropped, it should be rinsed with cool to lukewarm (not hot) water and reinserted as soon as possible, except if MILPROSA touches or has feces on it. If MILPROSA touches or has feces on it, replace it with a new MILPROSA.
To remove MILPROSA:
- Wash your hands.
- Choose the position that is the most comfortable for you such as lying down, squatting, or standing with 1 leg up.
- Put a finger into your vagina and hook it through MILPROSA.
- Gently pull downwards and forward to remove MILPROSA.
To throw away (dispose of) MILPROSA:
- Place the used MILPROSA in the foil pouch. If available, throw it away through a drug take-back option.
- Place the used MILPROSA in the foil pouch and mix it with coffee grounds, dirt or cat litter.
- Place the foil pouch mixture in something that can be closed like a zipper storage bag, empty can, or other container and throw it away in your household trash out of the reach of children and pets.
- Do not flush the foil pouch down the toilet.
For more information on drug disposal see www.fda.gov/drugdisposal.
If you have other questions call your healthcare provider.
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.