Glossary

Bioidentical estradiol

Compounding

The custom mixing of hormones by a pharmacist.

DOT Matrix technology

A delivery system built into Minivelle® (estradiol transdermal system) patches that is designed to continuously release estradiol through the skin.

Estrogen

A female hormone made primarily in the ovaries. Not having enough estrogen can cause symptoms of menopause, like hot flashes, as well as cause osteoporosis.

Estrogen therapy (ET)

A treatment that helps relieve menopause symptoms. ET helps provide a woman's body with estrogen that she may have lost as a result of entering menopause. ET comes in several forms: pills, transdermal patches, topical gels, and vaginal rings.

Estrogen can help slow the bone loss associated with osteoporosis. The goal of treatment with estrogen is to prevent bone loss and lower the risk of breaking bones.

Hormones

Chemical substances produced in the body that controls and regulates the activity of certain cells or organs.

Hot flashes

Sudden feelings of intense heat in the body.

Hysterectomy

When the uterus is surgically removed.

Menopause

A normal part of life when a woman stops getting her period and can no longer become pregnant. If a woman has not had a period for 12 months in a row, she may be in menopause.

Natural menopause

When a woman's ovaries produce less estrogen and progesterone. This can prevent a woman from getting her period and from getting pregnant, and is typically confirmed after a woman has missed her period for 12 months in a row.

Night sweats

Hot flashes with excessive sweating that occur at night and may be strong enough to wake a woman up.

Oophorectomy

Surgical removal of one or both ovaries. A woman who has had an oophorectomy may enter menopause as a result of the surgery.

Ovaries

Two organs located on either side of the uterus that serve as the main source of female hormones before menopause. They help regulate the menstrual cycle.

Postmenopausal Osteoporosis

A largely preventable disease in which the bones become weak and are more likely to fracture. When women reach menopause, the estrogen hormone that protects bones decreases sharply, which can cause bone loss. That is why the risk of developing osteoporosis increases as women reach menopause.

Progesterone

A female hormone made primarily in the ovaries. Not having enough progesterone can cause symptoms of menopause.

Surgical menopause

Surgical menopause, often called induced menopause, can take place at any age and occurs due to an unusual event which affects ovary function. This can happen when the ovaries are surgically removed (oophorectomy) or when the ovaries are severely damaged by radiation, chemotherapy or other medications. Because the ovaries are the body's main source of estrogen production, a woman enters menopause (sometimes at a premature age) when they are removed.

In some cases, a woman may have her uterus removed (hysterectomy) and not her ovaries. It is still possible in these cases for the woman to experience a decrease in blood supply to her ovaries. This decrease may also increase her chances of experiencing menopause earlier than if she had not had the hysterectomy.

Uterus

The small, hollow, pear-shaped organ (womb) in a woman's pelvis where menstrual bleeding originates and in which a fetus develops.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about MINIVELLE® (an estrogen hormone)?

  • Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using MINIVELLE as vaginal bleeding after menopause may be a warning sign of cancer of the uterus. Your healthcare provider should check any unusual vaginal bleeding to find out the cause.

  • Do not use estrogen-alone or estrogen with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function).

  • Using estrogen-alone may increase your chances of getting strokes or blood clots, while using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.

  • Using estrogen-alone or estrogen with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older.

  • You and your healthcare provider should talk regularly about whether you still need treatment with MINIVELLE.

MINIVELLE should not be used if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack, currently have or have had blood clots, currently have or have had liver problems, have been diagnosed with a bleeding disorder, are allergic to MINIVELLE or any of its ingredients, or think you may be pregnant.

Before you take MINIVELLE, tell your healthcare provider if you have unusual vaginal bleeding, have any other medical conditions, are going to have surgery or will be on bed rest, are breast feeding, and about all of the medicines you take.

The most common side effects that may occur with MINIVELLE are headache, breast tenderness, back and limb pain, common cold, upset stomach, nausea, inflammation of the sinuses and irregular vaginal bleeding or spotting.

MINIVELLE should be used at the lowest effective dose and for the shortest duration consistent with your treatment goals and risks.

These are not all the possible side effects of MINIVELLE. Please read the Patient Information section within the full Prescribing Information before taking MINIVELLE. For more information ask your healthcare provider or pharmacist for advice about side effects.

INDICATION

MINIVELLE® (estradiol transdermal system) is a prescription medicine patch that contains estradiol (an estrogen hormone). MINIVELLE is used to reduce moderate to severe hot flashes due to menopause and to help prevent postmenopausal osteoporosis (thin weak bones). The 0.025 mg/day dose is only approved for the prevention of postmenopausal osteoporosis.

If you use MINIVELLE only to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you.

Click here for the full Prescribing Information, including Boxed WARNING.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.


DOT Matrix™ is a trademark of Noven Pharmaceuticals, Inc.

MINIVELLE® and the Minivelle Logo are trademarks of Noven Therapeutics, LLC.

Vivelle-Dot® is a registered trademark of Novartis AG.

For information, call 1-800-455-8070.

©2017-2018 Noven Therapeutics, LLC. All rights reserved. For U.S. Audience Only. MINI-3530-16 10/18

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about MINIVELLE® (an estrogen hormone)?

  • Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using MINIVELLE as vaginal bleeding after menopause may be a warning sign of cancer of the uterus. Your healthcare provider should check any unusual vaginal bleeding to find out the cause.

  • Do not use estrogen-alone or estrogen with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function).

  • Using estrogen-alone may increase your chances of getting strokes or blood clots, while using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.

  • Using estrogen-alone or estrogen with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older.

  • You and your healthcare provider should talk regularly about whether you still need treatment with MINIVELLE.

MINIVELLE should not be used if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack, currently have or have had blood clots, currently have or have had liver problems, have been diagnosed with a bleeding disorder, are allergic to MINIVELLE or any of its ingredients, or think you may be pregnant.

Before you take MINIVELLE, tell your healthcare provider if you have unusual vaginal bleeding, have any other medical conditions, are going to have surgery or will be on bed rest, are breast feeding, and about all of the medicines you take.

The most common side effects that may occur with MINIVELLE are headache, breast tenderness, back and limb pain, common cold, upset stomach, nausea, inflammation of the sinuses and irregular vaginal bleeding or spotting.

MINIVELLE should be used at the lowest effective dose and for the shortest duration consistent with your treatment goals and risks.

These are not all the possible side effects of MINIVELLE. Please read the Patient Information section within the full Prescribing Information before taking MINIVELLE. For more information ask your healthcare provider or pharmacist for advice about side effects.

INDICATION

MINIVELLE® (estradiol transdermal system) is a prescription medicine patch that contains estradiol (an estrogen hormone). MINIVELLE is used to reduce moderate to severe hot flashes due to menopause and to help prevent postmenopausal osteoporosis (thin weak bones). The 0.025 mg/day dose is only approved for the prevention of postmenopausal osteoporosis.

If you use MINIVELLE only to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you.

Click here for the full Prescribing Information, including Boxed WARNING.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.