Ferring Pharmaceuticals Inc. (Page 3 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

Each MILPROSA (progesterone) vaginal system is a white to off-white, flexible, non-biodegradable silicone ring (toroidal-shaped), which contains 1.78 grams of progesterone and releases an average of 11 mg/day of progesterone over a 7-day period of use. MILPROSA vaginal system has an inner and outer diameter of approximately 38 mm and 55 mm, respectively, and a cross-sectional diameter of approximately 8.5 mm.

Each MILPROSA is packed individually in a sealed foil pouch. These pouches are available in cartons packed:

  • 2 vaginal systems per carton (NDC 55566-9400-1)

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Do not refrigerate or freeze and avoid excessive heat.

After use, place in pouch and discard via a drug take-back option if available; otherwise, mix with something undesirable, such as used coffee grounds, dirt, or cat litter to make it less appealing to children and pets. Place the mixture in something that can be closed (a re-sealable zipper storage bag, empty can, or other container) and discard in the household trash. DO NOT flush down toilet. See drug disposal information at www.fda.gov/drugdisposal for more information.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Instructions for Use).

Inform women:

  • Of the importance of reporting irregular vaginal bleeding to their doctor as soon as possible.
  • Of the possible side effects of progesterone therapy such as headaches, abdominal pain, breast tenderness, bloating, mood swings, irritability, and drowsiness.
  • To leave the vaginal system in place continuously (for a minimum of 23 hours per day) [see Dosage and Administration (2.2)]. It may be removed for sexual intercourse, although this is not necessary.
  • MILPROSA is not recommended for use with other vaginal products (such as antifungal products, vaginal lubricants, diaphragms, and condoms) as this concomitant use has not been studied and may alter the progesterone release and absorption from the vaginal system [see Warnings and Precautions (5.4) and Drug Interactions (7)].

MANUFACTURED FOR:
Ferring Pharmaceuticals Inc.
100 Interpace ParkwayParsippany, NJ 07054 USA

This Patient Information has been approved by the U.S. Food and Drug Administration Issued: 04/2020
Patient InformationMILPROSA (mil-PRO-sah) (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:
  • blood clots. MILPROSA can increase your chance of getting blood clots. Blood clots can be serious and lead to death. Serious blood clots can happen in the:
  • legs (thrombophlebitis)
  • lungs (pulmonary embolus)
  • eyes (loss of eyesight)
  • heart (heart attack)
  • brain (stroke)
Call your healthcare provider or get medical help right away if you have:
  • leg pain that does not go away
  • sudden shortness of breath
  • sudden changes in vision or blindness
  • severe pain or pressure in your chest
  • blood in your spit when you cough
  • sudden severe headache
  • vomiting
  • dizziness or feeling faint
  • weakness in an arm or leg
  • trouble speaking
  • yellowing of the skin or the white of the eyes
  • depression. Tell your healthcare provider if your symptoms of depression get worse while using MILPROSA.
  • toxic shock syndrome (TSS). Call your healthcare provider or get emergency medical help right away if you have the following symptoms:
  • fever
  • nausea
  • vomiting
  • diarrhea
  • muscles pain
  • dizziness
  • fainting
  • a sunburn-like rash on your face and body
Common side effects of MILPROSA include:
  • headache
  • vaginal discharge
  • nausea
  • breast tenderness
  • discomfort after inserting the vaginal system
  • stomach bloating
  • stomach pain
  • pelvic pain
  • constipation
Other side effects of progesterone use include:
  • mood swings
  • irritability
  • drowsiness
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.For more information call Ferring Pharmaceuticals Inc. at 1-888-FERRING (1-888-337-7464).

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