Important Safety Information
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.
Patients who should not take Natazia
Natazia is contraindicated in females with a high risk of arterial or venous thrombotic diseases, undiagnosed abnormal uterine bleeding, current diagnosis of, or history of, breast cancer which may be hormone sensitive, liver tumors (benign or malignant) or liver disease, or who are pregnant.
Know the most serious risks
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%).
INDICATIONS
Natazia is indicated for use by women to prevent pregnancy.
Natazia is also indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of birth control.
The contraceptive efficacy of Natazia in women with a body mass index (BMI) of >30 kg/m2 has not been evaluated.
Please see full Prescribing Information about Natazia, including Boxed Warning.
You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.
You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.
For Bayer products, you can report these directly to Bayer by clicking here.
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Site Last Modified 5/2022
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