Important Safety Information About Natazia
Prescribing Information, including Boxed WARNING

WARNING TO WOMEN WHO SMOKE: Do not use Natazia if you smoke and are over age 35. Smoking increases your risk of serious side effects from the Pill, which can be life-threatening, including blood clots, stroke, or heart attack. This risk increases with age and number of cigarettes smoked.
See additional important risk information below


 

How Well Does Natazia® Work to Help Treat Heavy Periods?

When taken as directed, prescription Natazia is highly effective at preventing pregnancy. But that’s not all. Natazia is also highly effective at reducing heavy periods that are not caused by any diagnosed conditions of the uterus.

About the clinical studies

Two clinical studies compared Natazia with placebo (inactive hormone-free pill) in women suffering from irregular bleeding symptoms: heavy, frequent, and/or prolonged bleeding not caused by any diagnosed conditions of the uterus. The effectiveness of Natazia was evaluated during the 90-day observation phase (efficacy phase).

For women taking Natazia during this 90-day phase, 29.2% in one study and 29.5% in the other reported “complete symptom relief” (defined as having no more irregular bleeding symptoms). In comparison, 2.9% and 1.2% of women who were given a placebo reported “complete symptom relief”.

In 2 clinical studies, women with heavy menstrual bleeding who took Natazia had significantly lighter periods than women who took a placebo.

Results in women with heavy periods

Most women in the two studies described above suffered from heavy bleeding specifically (85%). For these women with heavy periods who took Natazia, menstrual bleeding was reduced over 90 days by an average of 72% in one study and 78% in the other. In comparison, women who took a placebo saw an average of 14% and 32% bleeding reduction in the two studies (see chart).

What are the most common side effects in Natazia clinical trials?

The most common side effects were headache/migraine, breast pain/discomfort/tenderness, menstrual irregularities, nausea/vomiting, acne, mood changes, and weight gain.

Average Reduction in Bleeding

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IMPORTANT SAFETY INFORMATION ABOUT NATAZIA®, INCLUDING BOXED WARNING

What is Natazia® prescribed for?
Natazia is a birth control pill approved to prevent pregnancy. Natazia can also be used for the treatment of heavy menstrual bleeding that is not caused by any diagnosed conditions of the uterus (womb) in women who decide to use the Pill for birth control.

Natazia has not been studied for pregnancy prevention in women who are obese (body mass index >30).

Who should not take Natazia?

Do not use Natazia if you smoke and are over age 35. Smoking increases your risk of serious side effects from the Pill, which can be life-threatening, including blood clots, stroke, or heart attack. This risk increases with age and number of cigarettes smoked.

Do not use Natazia if you have or have had blood clots, certain cancers, history of heart attack or stroke, or if you are or may be pregnant.

What are the most serious risks of taking Natazia?
Natazia increases the risk of serious conditions including blood clots, stroke, and heart attack. The risk of blood clots is highest during the first year of use. This risk is greatest when first starting the Pill and when restarting the same or a different Pill after a 4 week or greater break.

Call your healthcare provider right away if you have:
Persistent leg pain; sudden shortness of breath; sudden blindness, partial or complete; severe pain in your chest; sudden, severe headache unlike your usual headaches; weakness or numbness in an arm or leg, or trouble speaking; yellowing of the skin or eyes.

What are the most common side effects in Natazia clinical trials?
The most common side effects were headache/migraine, breast pain/discomfort/tenderness, menstrual irregularities, nausea/vomiting, acne, mood changes, and weight gain.

Tell your healthcare provider about all medicines and herbal products you take including daily long-term treatment for chronic conditions such as seizures or cardiovascular disease.

Natazia does not protect against HIV infection (AIDS) or other STDs.

Please see full Prescribing Information about Natazia (estradiol valerate and estradiol valerate/dienogest) tablets, including boxed warning.

Bayer®, the Bayer Cross®, and Natazia® are trademarks of Bayer. All other trademarks are the property of their respective owners.

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.

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