Natazia™ Receives FDA Approval
Available NOW by prescription only.
Natazia™ (estradiol valerate and estradiol valerate/dienogest) is a combined oral contraceptive (COC) indicated for use by women to prevent pregnancy.
Natazia receivesFDA approval
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Indication
Natazia is indicated for use by women to prevent pregnancy.
The efficacy of Natazia in women with a body mass index (BMI) of >30 kg/m2 has not been evaluated.
Important Safety Information About Natazia, Including Boxed Warning
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 genital 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
Cigarette smoking increases the risk of serious cardiovascular side effects from combination oral contraceptive (COC) use. The risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.
Thrombotic and Other Vascular Events: Stop COCs if an arterial or deep venous thrombotic event occurs. The excess risk is highest during first year of use. 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 COCs at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism. Start COCs 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 COCs if jaundice develops. Hepatic adenomas are associated with COC use.
High Blood Pressure: For women with well-controlled hypertension, monitor blood pressure and stop COCs 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 COC user develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue COCs 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 OCs do not protect against HIV infection and other sexually transmitted diseases.
Serious adverse reactions in the clinical trials included: Deep vein thrombosis, myocardial infarction, focal nodular hyperplasia of the liver, uterine leiomyoma, and ruptured ovarian cyst.
Most common adverse reactions (≥2%) in Natazia clinical trials
Headache (including migraines) (13.2%), metrorrhagia and irregular menstruation (8.0%), breast pain, discomfort, or tenderness (6.6%), nausea or vomiting (6.5%), acne (3.9%), and increased weight (2.8%).
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.
Please see full prescribing information about Natazia, including
boxed warning.
Bayer®, the Bayer Cross® and Natazia™ are trademarks of Bayer. All other trademarks are property of their respective owners.
