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


 

Natazia® Is Indicated for Use by Women to Prevent Pregnancy

Natazia is also indicated for treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive for birth control.

The contraceptive efficacy of Natazia in women with a body mass index (BMI) of
> 30 kg/m2 has not been evaluated.

IMPORTANT SAFETY INFORMATION ABOUT NATAZIA®

Patients who should not take Natazia

Natazia should not be used in women with a high risk of arterial or venous thrombotic diseases, undiagnosed abnormal uterine bleeding, breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors (benign or malignant) or liver disease, or who are pregnant.

Know the most serious risks

Women over 35 years old who smoke should not use Natazia. Smoking increases the risk of serious cardiovascular side effects from Natazia use. This risk increases with age and the number of cigarettes smoked.

Thromboembolic and Other Vascular Events: Stop Natazia if an arterial or venous thrombotic event occurs. The risk of venous thromboembolism (VTE) is highest during the first year of combination oral contraceptive (COC) use. This increased risk is greatest after initially starting a COC or restarting the same or a different COC following a 4 week or greater Pill-free interval.

COC use also increases the risk of arterial thromboses (eg, stroke and myocardial infarction) especially in women with other risk factors for these events. If feasible, stop Natazia at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism. Start Natazia no earlier than 4 weeks after delivery, in women who are not breastfeeding. COCs must be used with caution in women with cardiovascular disease risk factors.

Liver Disease: Discontinue Natazia if jaundice develops. Hepatic adenomas are associated with COC use.

High Blood Pressure (BP): For women with well-controlled hypertension, monitor blood pressure and stop Natazia if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs. An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women and with extended duration of use.

Carbohydrate and Lipid Metabolic Effects: Carefully monitor prediabetic and diabetic COC users. Consider alternative contraception for women with uncontrolled dyslipidemia.

Headache: If a Natazia user develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Natazia if indicated. Increased frequency or severity of migraines may be reason for immediate discontinuation.

Bleeding Irregularities: If irregular bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. Rule out pregnancy in the event of amenorrhea occurring in 2 or more consecutive cycles.

Drug Interactions: Women taking strong CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampicin, and St. John’s wort) should not use Natazia during and for at least 28 days after discontinuation of these inducers due to the possibility of decreased contraceptive efficacy.

Counsel patients that Natazia does not protect against HIV infection and other sexually transmitted diseases.

Serious adverse reactions in clinical trials

Myocardial infarction, ruptured ovarian cyst, deep vein thrombosis, focal nodular hyperplasia of the liver, uterine leiomyoma, acute cholecystitis, and chronic acalculous cholecystitis.

Most common adverse reactions (≥2%) in clinical trials

Headache (including migraines) (12.7%), breast pain, discomfort or tenderness (7.0%), menstrual disorders (6.9%), nausea or vomiting (6.0%), acne (3.9%), mood changes (3.0%), and increased weight (2.9%).

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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