Intrarosa

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Before taking Intrarosa, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Intrarosa or to any of its ingredients
• have, have had, or think you may have had breast cancer
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Intrarosa is indicated only in postmenopausal women. There are no data with Intrarosa use in pregnant women regarding any drug-associated risks. Animal reproduction studies have not been conducted with Intrarosa.

Follow all directions on the product label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

An overdose of prasterone vaginal is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

It is not likely that other drugs you take orally or inject will have an effect on prasterone used in the vagina. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

General

Prasterone is available in the following dosage form(s) and strength(s):

Vaginal insert: 6.5 mg of prasterone.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

One vaginal insert, once daily at bedtime.1

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional 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 indicated for use in the pediatric population.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Intrarosa™ in the elderly.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell 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—Should not be used in patients with these conditions.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

It is unlikely that a postmenopausal woman may become pregnant. But you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become 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 (eg, Pap smear).

• It is used to treat vaginal pain during sex caused by changes that happen with menopause.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature or in a refrigerator. Do not freeze.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Undiagnosed abnormal genital bleeding: Any postmenopausal woman with undiagnosed, persistent or recurring genital bleeding should be evaluated to determine the cause of the bleeding before consideration of treatment with Intrarosa.

Intrarosa (prasterone) vaginal insert is a vaginally administered steroid. Prasterone is identified chemically as 3β-hydroxyandrost-5-en-17-one. It has the empirical formula C 19H 28O 2 with a molecular weight of 288.424 g/mol. Prasterone is a white to off-white crystalline powder insoluble in water and soluble in sodium lauryl sulfate (SLS). The structural formula is:

Each Intrarosa (prasterone) vaginal insert contains 6.5 mg of prasterone in 1.3 ml of off-white hard fat (Witepsol).

You should not use Intrarosa if you are allergic to prasterone, or if you have:

• abnormal vaginal bleeding that has not been checked by a doctor.

To make sure Intrarosa is safe for you, tell your doctor if you have ever had breast cancer.

Although this medicine is for use only in postmenopausal women, Intrarosa should not be used by a women who is pregnant or breast-feeding.

This medicine is not approved for use by anyone younger than 18 years old.