Important Safety Information about Natazia

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.


 

Consider Natazia® — the only oral contraceptive FDA approved to also treat heavy menstrual bleeding (HMB) in women without organic pathology who choose to use an oral contraceptive as their method of contraception

Natazia was studied in two multi-regional, multicenter, double-blind, randomized, placebo-controlled clinical trials

The primary efficacy variable was the proportion of subjects who were completely relieved of symptoms, which was defined by the number of subjects with the absence of any dysfunctional bleeding symptom and who met up to 8 strictly defined criteria for success during the 90-day efficacy assessment phase.

  • HMB was defined as menstrual blood loss of 80 mL or more in at least 2 bleeding episodes.
Complete symptom relief was comprised of 8 strictly defined criteria2,3:
  1. No bleeding episodes lasting >7 days
  2. ≤4 bleeding episodes overall
  3. No bleeding episodes with a blood loss volume of ≥80 mL or more
  4. ≤1 bleeding episode increase from baseline
  5. ≤24 days of bleeding overall
  6. No increase from baseline in subject’s total number of bleeding days
  7. In women with prolonged bleeding, decrease of ≥2 days in maximum duration of bleeding episode
  8. For participants with heavy bleeding, the blood loss volume for each episode had to be <80 mL and had to represent a decrease of at least 50% from the average of the qualifying bleeding episodes

Statistically, significantly more patients in the Natazia group experienced complete symptom relief compared with placebo (intent-to-treat).2,3

Natazia Symptom Relief

Study design:
The efficacy and safety of Natazia were evaluated in two multi-regional, multi-center, double-blind, randomized, placebo-controlled clinical trials. Study 1 was performed in the United States and Canada and Study 2 was performed in Australia and 9 European countries. The studies were identical in design. The studies enrolled women, 18 years of age or older, with a diagnosis of dysfunctional uterine bleeding characterized as heavy, prolonged and/or frequent bleeding without organic pathology. Heavy menstrual bleeding (HMB) was defined as menstrual blood loss of 80mL or more in at least 2 bleeding episodes. The diagnosis of HMB was documented through the collection of used sanitary protection (pads and tampons) to quantify blood loss assessed by the alkaline hematin method. Overall, about 85% of the subjects qualified for the study because they had heavy menstrual bleeding symptoms. A total of 421 women with a mean age of 38.2 and a mean BMI of 25.5 were randomized to the two clinical studies, for a total of 269 women in the Natazia group and 152 women in the placebo group, and treated for seven 28-day cycles. Approximately 81% were Caucasian, 13% were Black, and 6% were Hispanic or Asian or Other.

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%).

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.

Median Reduction in Menstrual Blood Volume at Cycle Seven

Natazia Menstrual Blood Volume Reduction

Study design:
Two multicenter, double-blind, randomized, placebo-controlled trials. Women ≥18 years of age and diagnosed with dysfunctional uterine bleeding (DUB), characterized as heavy, prolonged, and/or frequent bleeding without organic pathology, received Natazia (n=269) or placebo (n=152), for seven 28-day cycles. HMB was defined as menstrual blood loss (MBL) ≥80 mL in ≥2 bleeding episodes. The primary endpoint was the proportion of women who achieved complete symptom relief (absence of any dysfunctional bleeding symptom and who met up to 8 strictly defined criteria for success) during the 90-day efficacy assessment phase.

Common Adverse Reactions (≥2%) in contraception (n=1867) and HMB (n=264) studies:

  • Headache (including migraines) (12.7%), breast pain, discomfort or tenderness (7.0%), menstrual disorders (metrorrhagia, menstruation irregular, menorrhagia, vaginal hemorrhage, dysfunctional uterine bleeding, genital hemorrhage, abnormal withdrawal bleeding, uterine hemorrhage) (6.9%), nausea or vomiting (6.0%), acne (3.9%), mood changes (depression, mood swings, depressed mood, mood altered, affect lability, dysthymic disorder, crying) (3.0%) and increased weight (2.9%).

Natazia® — the only oral contraceptive approved by the FDA to treat HMB in women without organic pathology who choose to use an oral contraceptive as their method of contraception

Median Menstrual Blood Loss Volume by Cycle (Study 1)

Natazia Menstrual Blood Loss Volume Study 1

Median Menstrual Blood Loss Volume by Cycle (Study 2)

Natazia Menstrual Blood Loss Volume Study 2

Serious Adverse Reactions in contraception (n=1867) and HMB (n=264) studies:

  • Myocardial infarction (2 cases), ruptured ovarian cyst (2 cases), deep vein thrombosis, focal nodular hyperplasia of the liver, uterine leiomyoma, acute cholecystitis, and chronic acalculous cholecystitis.

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.

Important Safety Information about Natazia

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 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

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, 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 now leaving the www.natazia.com Website.

Bayer is not responsible for the content presented by any independent Website, including any advertising claims, special offers, illustrations, names or endorsements.

Thank you for visiting www.natazia.com.

OK Cancel

You are leaving a Bayer HealthCare Pharmaceuticals, Inc. website...

and going to a third party site to activate or download the Bayer Savings Card. That site may have a privacy policy different from Bayer.

Do you want to go to the third party site to activate or download a Bayer Savings Card?

Yes I want to activate/download my Bayer Savings Card Cancel