MIAMI and NEW YORK, Feb. 12, 2015 /PRNewswire/ -- Noven Pharmaceuticals, Inc. today announced that the new 0.025 mg/day dosage strength for Minivelle^® (estradiol transdermal system) is now available by prescription nationwide for only the prevention of postmenopausal osteoporosis. The FDA initially approved Minivelle in October 2012 to treat moderate to severe vasomotor symptoms (VMS) due to menopause, commonly known as hot flashes. In September 2014, the FDA approved a new indication for prevention of postmenopausal osteoporosis for all doses of Minivelle. The new 0.025 mg/day low dose was approved for this indication only.

The new 0.025 mg/day patch is 33% smaller than Minivelle 0.0375 mg/day, already about the size of a dime, making the 0.025 mg/day patch the world's smallest estrogen therapy patch ever. Minivelle is now available with five dosing options – 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day, with the newly available lower dose of 0.025 mg/day indicated for the prevention of postmenopausal osteoporosis only. The higher doses are indicated to treat moderate to severe VMS as well. If a patient uses Minivelle only to prevent osteoporosis from menopause, they should talk with their healthcare provider about whether a different treatment or medicine without estrogens might be better for them.

Bioidentical Hormones-Allvia Progesterone Allvia pharmaceuticals use natural plant compounds to create the bioidentical hormone progesterone. The percentage used is 1.6% or 20mg per dispensing transdermal dose. 20 mg has been found to be the appropriate dose for women needing to supplement with progesterone. For Healthcare Providers. Plant based and similar to the estrogen women make naturally 2 Simple dosing—One pump, once a day 1 Very low incidence of skin irritation—0.6% incidence of application-site reaction reported in clinical studies 1 Estrogen therapy alone or with progestin should not be used for the prevention of cardiovascular disease or dementia.

'The journey of menopause is unique for each woman, and this additional indication and new dosage strength of Minivelle – for the prevention of osteoporosis only – allow women and their doctors to individualize treatment to best fit each woman's needs,' said Joel Lippman, MD, FACOG, Noven's Executive Vice President – Product Development and Chief Medical Officer. 'As the world's smallest estrogen therapy patch, Minivelle is an example of an innovative product tailored to women's active and busy lifestyles.'

Noven offers a savings program to help reduce Minivelle co-pays for eligible patients. On co-pays up to $70, patients pay no more than $15 for a one-month supply. On co-pays in excess of $70, patients may qualify for up to $55 in savings for a one-month supply. Patients can take advantage of this offer each month, for up to 12 uses. Restrictions apply. Physicians and patients should review the full terms and conditions at www.minivelle.com

About Minivelle^®
Minivelle is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause, commonly known as hot flashes, and the prevention of postmenopausal osteoporosis. If a patient uses Minivelle only to prevent osteoporosis from menopause, they should talk with their healthcare provider about whether a different treatment or medicine without estrogens might be better for them.

Minivelle is bioequivalent to Vivelle^® (estradiol transdermal system), which demonstrated safety and efficacy for the treatment of moderate to severe vasomotor symptoms due to menopause, commonly known as hot flashes. Efficacy and safety of Vivelle in the prevention of postmenopausal osteoporosis have been demonstrated in a 2-year double-blind, randomized, placebo-controlled, parallel group study. No clinical trials were conducted with Minivelle. The most commonly reported adverse events for Vivelle (greater than or equal to 5 percent) were headache, breast tenderness, back and limb pain, common cold, upset stomach, nausea, inflammation of the sinuses, and irregular vaginal bleeding or spotting.

Minivelle contains bioidentical estradiol, a plant-based estrogen that is chemically identical to the estrogen produced naturally by a woman's body. Noven's transdermal drug-delivery of estrogens by Minivelle allows for efficient delivery of estradiol through the skin, bypassing first-pass metabolism. The clinical significance of this has not been established and this does not mean that Minivelle is safer or more effective than other hormone therapies.

Minivelle is round with smooth, curved edges that may help prevent lifting or snagging associated with everyday wear and stays in place during showering and exercising. It leaves almost no sticky residue and causes almost no skin irritation. During clinical pharmacology studies with Minivelle, 35 percent or less of subjects experienced barely perceptible erythema.

At 1.65 cm², the new 0.025 mg/day patch is 33% smaller than Minivelle 0.0375 mg/day that is already only about the size of a dime. Minivelle is now approved with five dosing options – 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day with the newly approved, lower dose of 0.025 mg/day indicated for the prevention of postmenopausal osteoporosis only.

Please read the Important Safety Information below and for more information, including the full Prescribing Information, visit www.MINIVELLE.com.

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).

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.

IMPORTANT SAFETY INFORMATION

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.

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.

/zone-of-the-enders-artbook-pdf-converter.html. About Noven
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of prescription pharmaceutical products. Noven's mission is to develop and offer pharmaceutical products that meaningfully benefit patients around the world, with a commitment to advancing patient care through transdermal drug delivery. Noven is a stand-alone operating subsidiary of Japan-based Hisamitsu Pharmaceutical Co., Inc., and serves as Hisamitsu's U.S. growth platform in prescription pharmaceuticals. For more information about Noven, visit www.noven.com. For information about Hisamitsu, visit www.hisamitsu.co.jp/english.

Minivelle^® is a registered trademark of Noven Therapeutics, LLC.
Vivelle^® is a registered trademark of Novartis AG.

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SOURCE Noven Pharmaceuticals, Inc.

Related Links

http://www.noven.com

Generic Name:estradiol transdermal (ES tra DYE ole tranz DERM al)
Brand Names:Alora, Climara, Estraderm, Estradiol Patch, Menostar, Minivelle, Vivelle, Vivelle-Dot

Medically reviewed by P. Thornton, DipPharm Last updated on Jun 4, 2019.

• Overview

What is Menostar?

Menostar is a skin patch that contains estradiol, a form of estrogen. Estradiol is a female sex hormone produced by the ovaries that regulates many processes in the body.

Plant Based Estrogen Patch

Menostar skin patches are used to prevent postmenopausal osteoporosis.

Menostar may also be used for purposes not listed in this medication guide.

Important information

You should not use Menostar if you have: liver disease, a bleeding disorder, unusual vaginal bleeding, history of a hormone-dependent cancer (such as breast, uterine, ovarian, or thyroid cancer), or if you have ever had a heart attack, stroke, a blood clot, or if you will be having major surgery.

Do not use Menostar if you are pregnant.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to help lower this risk. Report any unusual vaginal bleeding right away.

Using Menostar can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries. Estradiol should not be used to prevent heart disease, stroke, or dementia.

Your doctor should check your progress on a regular basis to determine whether you should continue treatment with Menostar.

Before taking this medicine

You should not use Menostar if you are allergic to estradiol, if you are pregnant, or if you have:

• unusual vaginal bleeding that a doctor has not checked;

• liver disease;

• a bleeding or blood-clotting disorder;

• a recent history of heart attack or stroke;

• a history of hormone-dependent cancer (such as breast, uterine, ovarian, or thyroid cancer); or

• if you have ever had a blood clot (especially in your lung or your lower body).

Menostar should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

To make sure Menostar is safe for you, tell your doctor if you have:

• heart disease;

• risk factors for coronary artery disease (such as diabetes, lupus, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, or if you have had a hysterectomy);

• a history of jaundice caused by pregnancy or birth control pills;

• hereditary angioedema (an immune system disorder);

• a thyroid disorder;

• kidney disease;

• asthma;

• epilepsy or other seizure disorder;

• migraines;

• lupus;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

• endometriosis or uterine fibroid tumors;

• gallbladder disease;

• high or low levels of calcium in your blood; or

• if you have had your uterus removed (hysterectomy).

Using estradiol may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using Menostar long term.

FDA pregnancy category X. Do not use Menostar if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using Menostar.

See also:

Menostar pregnancy and breastfeeding warnings (in more detail)

Estradiol can pass into breast milk. Menostar may slow breast milk production. Do not use if you are breast-feeding a baby.

How should I use Menostar?

Use Menostar patches exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to help lower this risk. Report any unusual vaginal bleeding right away.

Menostar comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

The adhesive side of Menostar should be placed on a clean, dry area of the lower abdomen or the upper quadrant of the buttock.

• Menostar should not be applied to or near the breasts.
• The sites of application must be rotated, with an interval of at least 1-week allowed between applications to a same site.
• The area selected should not be oily, damaged, or irritated. The waistline should be avoided, since tight clothing may rub the transdermal system off.
• Application to areas where sitting would dislodge Menostar should also be avoided.

Application

• Menostar should be applied immediately after opening the pouch and removing the protective liner.
• Menostar should be pressed firmly in place with the fingers for at least 10 seconds, making sure there is good contact, especially around the edges.
• If the system lifts, apply pressure to maintain adhesion.
• In the event that a system should fall off reapply it to a different location. If the system cannot be reapplied, a new system should be applied for the remainder of the 7-day dosing interval.
• Only one system should be worn at any one time during the 7-day dosing interval.
• Swimming, bathing, or using a sauna while using Menostar has not been studied, and these activities may decrease the adhesion of the system and the delivery of estradiol.

Removal of the Menostar Transdermal System

• Removal of the system should be done carefully and slowly to avoid irritation of the skin.
• Should any adhesive remain on the skin after removal of the system, allow the area to dry for 15 minutes. Then gently rubbing the area with an oil-based cream or lotion should remove the adhesive residue.
• Used patches still contain some active hormones. Each patch should be carefully folded in half so that it sticks to itself before throwing it away.

If you need surgery or medical tests or if you will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using Menostar.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms while using Menostar.

Store Menostar patches at room temperature away from moisture and heat. Keep each patch in its pouch until you are ready to use it.

See also:

Menostar dosage information (in more detail)

What happens if I miss a dose?

If you forget to change your patch, change it as soon as you remember or wait until your next scheduled patch change. Do not apply two patches at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Plant Based Estrogen Patches

What should I avoid while using Menostar?

Grapefruit and grapefruit juice may interact with estradiol and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Menostar side effects

Get emergency medical help if you have any of these signs of an allergic reaction to the Menostar patch: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Remove the skin patch and call your doctor at once if you have:

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• increased blood pressure - severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed;

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot - sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;

• swelling or tenderness in your stomach;

• jaundice (yellowing of the skin or eyes);

• unusual vaginal bleeding, pelvic pain;

• a breast lump;

• memory problems, confusion, unusual behavior; or

• high levels of calcium in your blood - nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common Climara side effects may include:

• headache, back pain;

• stuffy nose, sinus pain, sore throat;

• vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;

• bloating, stomach cramps, nausea, vomiting;

• breast pain;

• redness or irritation where the patch was worn;

• thinning scalp hair; or

• fluid retention (swelling, rapid weight gain).

Does Plant Based Estrogen Cause Cancer

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Menostar?

Other drugs may interact with estradiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

See also:

Menostar drug interactions (in more detail)

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Menostar only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Plant Based Estrogen Patch

Copyright 1996-2019 Cerner Multum, Inc. Version: 18.03.

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