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Natazia (estradiol valerate and estradiol valerate/dienogest) tablets
2015-10-15 03:32:27 来源: 作者: 【 】 浏览:452次 评论:0
  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use Natazia safely and effectively. See full prescribing information for Natazia. Natazia (estradiol valerate and estradiol valerate/dienogest) tablets for oral use Initial U.S. Approval: 2010
    WARNING: CIGARETTE SMOKING AND
    SERIOUS CARDIOVASCULAR EVENTS

    See full prescribing information for complete boxed warning
    • Women who are over 35 years old and smoke should not use Natazia.
    • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.

    INDICATIONS AND USAGE

    • Natazia is an estrogen/progestin COC indicated for use by women to prevent pregnancy. (1)
    • The efficacy of Natazia in women with a body mass index (BMI) of
      >30 kg/m2 has not been eva luated. (1, 8.8)

    DOSAGE AND ADMINISTRATION

    • Take one tablet daily by mouth at the same time every day. (2.1)
    • Tablets must be taken in the order directed on the blister pack. (2.1)
    • Do not skip or delay intake by more than 12 hours. (2.1)
    DOSAGE FORMS AND STRENGTHS

    Natazia consists of 28 film-coated, unscored tablets in the following order:

    • 2 dark yellow tablets each containing 3 mg estradiol valerate
    • 5 medium red tablets each containing 2 mg estradiol valerate and 2 mg dienogest
    • 17 light yellow tablets each containing 2 mg estradiol valerate and 3 mg dienogest
    • 2 dark red tablets each containing 1 mg estradiol valerate
    • 2 white tablets (inert) (3)

    CONTRAINDICATIONS

    • A high risk of arterial or venous thrombotic diseases (4)
    • Undiagnosed abnormal genital bleeding (4)
    • Breast cancer or other estrogen- or progestin-sensitive cancer (4)
    • Liver tumors or liver disease (4)
    • Pregnancy (4

    WARNINGS AND PRECAUTIONS

    • Vascular risks: Stop Natazia if a thrombotic event occurs. Stop Natazia at least 4 weeks before and through 2 weeks after major surgery. Start Natazia no earlier than 4 weeks after delivery, in women who are not breastfeeding. (5.1)
    • Liver disease: Discontinue Natazia if jaundice occurs. (5.3)
    • High blood pressure: Do not prescribe Natazia for women with uncontrolled hypertension or hypertension with vascular disease. (5.4)
    • Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking Natazia. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. (5.6)
    • Headache: eva luate significant change in headaches and discontinue Natazia if indicated. (5.7)
    • Uterine bleeding: eva luate irregular bleeding or amenorrhea. (5.8)
    • CYP3A4 induction: Women taking strong CYP3A4 inducers (for example, carbamazepine, phenytoin, rifampicin, and St. John’s wort) should not choose Natazia as their oral contraceptive due to the possibility of decreased contraceptive efficacy. (5.13)
     
    ADVERSE REACTIONS

    The most common adverse reactions (≥2%) in clinical trials for Natazia are headaches, irregular uterine bleeding, breast tenderness, nausea/vomiting, acne and increased weight. (6)

    To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    DRUG INTERACTIONS

    Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with COCs. (7.1)

    Women taking strong CYP3A4 inducers (for example, carbamazepine, phenytoin, rifampicin, and St. John’s wort) should not choose Natazia as their oral contraceptive due to the possibility of decreased contraceptive efficacy. (7.1)

    USE IN SPECIFIC POPULATIONS
    • Nursing mothers: Not recommended for nursing mothers; can decrease milk production. (8.3)
    • Body Mass Index: The safety and efficacy of Natazia in women with a body mass index (BMI) of >30 kg/m2 has not been eva luated. (8.8)
     
    See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

    Revised: 10/2010

  • FULL PRESCRIBING INFORMATION: CONTENTS*

    1 INDICATIONS AND USAGE

    2 DOSAGE AND ADMINISTRATION

    2.1 How to take Natazia

    2.2 How to start Natazia

    2.3 Advice in case of Gastrointestinal Disturbances

    3 DOSAGE FORMS AND STRENGTHS

    4 CONTRAINDICATIONS

    5 WARNINGS AND PRECAUTIONS

    5.1 Thrombotic and Other Vascular Events

    5.2 Carcinoma of the Breasts and Reproductive Organs

    5.3 Liver Disease

    5.4 High Blood Pressure

    5.5 Gallbladder Disease

    5.6 Carbohydrate and Lipid Metabolic Effects

    5.7 Headache

    5.8 Bleeding Irregularities

    5.9 COC Use Before or During Early Pregnancy

    5.10 Emotional Disorders

    5.11 Interference with Laboratory Tests

    5.12 Monitoring

    5.13 Drug Interactions

    5.14 Other Conditions

    6 ADVERSE REACTIONS

    6.1 Clinical Trials Experience

    7 DRUG INTERACTIONS

    7.1 Effects of Other Drugs on Combined Hormonal Contraceptives

    7.2 Effects of Combined Hormonal Contraceptives on Other Drugs

    8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    8.3 Nursing Mothers

    8.4 Pediatric Use

    8.5 Geriatric Use

    8.6 Renal Impairment

    8.7 Hepatic Impairment

    8.8 Body Mass Index

    10 OVERDOSAGE

    11 DESCRIPTION

    12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    12.2 Pharmacodynamics

    12.3 Pharmacokinetics

    13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    13.2 Animal Toxicology and/or Pharmacology

    14 CLINICAL STUDIES

    14.1 Oral Contraceptive Clinical Trials

    16 HOW SUPPLIED/STORAGE AND HANDLING

    16.1 How Supplied

    16.2 Storage Conditions

    17 PATIENT COUNSELING INFORMATION

    17.1 Information for Patients

    *
    Sections or subsections omitted from the full prescribing information are not listed.
  • 1 INDICATIONS AND USAGE

    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 eva luated.

  • 2 DOSAGE AND ADMINISTRATION

    Enter section text here

    2.1 How to take Natazia

    To achieve maximum contraceptive effectiveness, Natazia must be taken exactly as directed. Take one tablet by mouth the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or intake delayed by more than 12 hours. For patient instructions for missed pills, see FDA-Approved Patient Labeling.

    2.2 How to start Natazia

    Instruct the patient to begin taking Natazia on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding) [see FDA-Approved Patient Labeling]. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 9 days.

    For postpartum women who do not breastfeed or after a second trimester abortion, Natazia may be started no earlier than 4 weeks postpartum. Recommend use of a non-hormonal back-up method for the first 9 days. When combined oral contraceptives (COCs) are used during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. The possibility of ovulation and conception before starting COCs should also be considered.

    If the patient is switching from a combination hormonal method such as:

      • Another pill
      • Vaginal ring
      • Patch
    • Instruct her to take the first dark yellow pill on the first day of her withdrawal bleed. She should not continue taking the pills from her previous birth control pack. If she does not have a withdrawal bleed, rule out pregnancy before starting Natazia.
    • If she previously used a vaginal ring or transdermal patch, she should start using Natazia on the day the ring or patch is removed.
    • Instruct the patient to use a non-hormonal back-up method such as a condom or spermicide for the first 9 days.

    If the patient is switching from a progestin-only method such as a:

      • Progestin-only pill
      • Implant
      • Intrauterine system
      • Injection
    • Instruct her to take the first dark yellow pill on the day she would have taken her next progestin-only pill or on the day of removal of her implant or intrauterine system or on the day when she would have had her next injection.
    • Instruct the patient to use a non-hormonal back-up method such as a condom or spermicide for the first 9 days.

    2.3 Advice in case of Gastrointestinal Disturbances

    In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3-4 hours after taking a colored tablet, this can be regarded as a missed tablet. [See FDA-Approved Patient Labeling.]

  • 3 DOSAGE FORMS AND STRENGTHS

    Natazia (estradiol valerate and estradiol valerate/dienogest) tablets are available in blister packs.

    Each blister pack (28 film-coated tablets) contains in the following order:

    • 2 dark yellow tablets each containing 3 mg estradiol valerate
    • 5 medium red tablets each containing 2 mg estradiol valerate and 2 mg dienogest
    • 17 light yellow tablets each containing 2 mg estradiol valerate and 3 mg dienogest
    • 2 dark red tablets each containing 1 mg estradiol valerate
    • 2 white tablets (inert)
  • 4 CONTRAINDICATIONS

    Do not prescribe Natazia to women who are known to have the following:

    • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
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