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  • Dosing Regimen
  • Contraceptive Efficacy & Safety
  • Heavy Menstrual Bleeding
  • Savings & Resources
  • Important Safety Information
  • Full Prescribing Information
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An OC that improves HMB symptoms and reduces menstrual blood loss9,10 

For pregnancy prevention and the treatment of heavy menstrual bleeding (HMB) in women without organic pathology who choose to use an oral contraceptive (OC) as their method of contraception1

Significantly more women with HMB experienced complete symptom relief with Natazia® compared with placebo (intent to treat)9,10

Study Design: The efficacy and safety of Natazia were evaluated in 2 multiregional, multicenter, double-blind, randomized, placebo-controlled clinical trials, which were identical in design. Study 1 was performed in the United States and Canada, and Study 2 was performed in Australia and 9 European countries. The studies enrolled women aged 18 years or older with a diagnosis of dysfunctional uterine bleeding characterized as heavy, prolonged, and/or frequent bleeding without organic pathology. 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 HMB symptoms. A total of 421 women (mean age: 38.2 years) and a mean body mass index (BMI) of 25.5 kg/m2 were randomized to the 2 clinical studies, for a total of 269 women in the Natazia group and 152 women in the placebo group. They were treated for seven 28-day cycles. Approximately 81% were Caucasian, 13% were Black, and 6% were Hispanic, Asian, or other.

The primary efficacy variable was the proportion of subjects who were completely relieved of symptoms. This was defined by: 

 

  • The number of subjects with the absence of any dysfunctional bleeding symptom

  • Those who met up to 8 strictly defined criteria for success during the 90-day efficacy assessment phase

HMB was defined as menstrual blood loss (MBL) ≥80 mL in ≥2 bleeding episodes

 

Complete symptom relief was achieved by more women treated with Natazia compared with placebo9,10

Natazia complete symptom relief bar chart

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%).

What is HMB?

HMB was defined as MBL of 80 mL 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 HMB symptoms. 

Natazia significantly reduced median menstrual blood loss in women with HMB versus placebo at cycle 7

In 2 studies, women with HMB taking Natazia experienced a statistically significant reduction in median menstrual blood volume (MBV) at cycle 7 from baseline compared with placebo (P<0.0001 for both studies)

Natazia median MBL chart

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.

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Consider Natazia:
The ONLY FDA-approved OC for HMB
in women without organic pathology who choose to use an OC as their method of contraception1

Important Safety Information

More Important Safety Information More 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.

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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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