dienogest/estradiol valerate (Rx)

Brand and Other Names:Natazia
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • Contains 4 phases of doses for estrogen or combined estrogen/progestin throughout the 28-day cycle
  • Days 1-2: estradiol valerate 3 mg
  • Days 3-7: estradiol valerate 2 mg and dienogest 2 mg
  • Days 8-24: estradiol valerate 2 mg and dienogest 3 mg
  • Days 25-26: estradiol valerate 1 mg
  • Days 27-28: inert tablets
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Contraception

1 tab PO qDay; take at same time each day and in precise order as directed on blister pack

Do not skip tablets or delay intake by more than 12 hr

Initiate by beginning pack on day 1 of menstrual cycle and use nonhormonal contraceptive back-up method (eg, condoms and foam) during first 9 days

Initiating after pregnancy

  • Increased risk for venous thromboembolism (VTE) following delivery with combined hormonal contraceptives; risk declines rapidly after 21 days, but does not return to normal until 42 days after delivery
  • CDC guidelines recommend waiting 3-6 weeks in postpartum women without additional VTE risks (MMWR July 7, 2011)
  • Initiating after vaginal birth: Wait at least 3 weeks
  • Initiating after caesarean section birth: Wait at least 6 weeks
  • Women with other risk factors for VTE in addition to postpartum: Do not use combined hormonal contraceptives

Dosage Forms & Strengths

tablet

  • Contains 4 phases of doses for estrogen or combined estrogen/progestin throughout the 28-day cycle
  • Days 1-2: estradiol valerate 3 mg
  • Days 3-7: estradiol valerate 2 mg and dienogest 2 mg
  • Days 8-24: estradiol valerate 2 mg and dienogest 3 mg
  • Days 25-26: estradiol valerate 1 mg
  • Days 27-28: inert tablets
more...

Contraception

Safety and efficacy established in women of reproductive age; efficacy is expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older

Adolescents requiring contraception: As adults

1 tab PO qDay; take at same time each day and in precise order as directed on blister pack

Do not skip tablets or delay intake by more than 12 hr

Initiate by beginning pack on day 1 of menstrual cycle and use nonhormonal contraceptive back-up method (eg, condoms and foam) during first 9 days

Initiating after pregnancy

  • Increased risk for venous thromboembolism (VTE) following delivery with combined hormonal contraceptives; risk declines rapidly after 21 days, but does not return to normal until 42 days after delivery
  • CDC guidelines recommend waiting 3-6 weeks in postpartum women without additional VTE risks (MMWR July 7, 2011)
  • Initiating after vaginal birth: Wait at least 3 weeks
  • Initiating after caesarean section birth: Wait at least 6 weeks
  • Women with other risk factors for VTE in addition to postpartum: Do not use combined hormonal contraceptives
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Interactions

Interaction Checker

and dienogest/estradiol valerate

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache, including migraines (13.2%)

            1-10%

            Metrorrhagia and irregular menstruation (8%)

            Breast pain, discomfort, or tenderness (6.6%)

            Nausea or vomiting (6.5%)

            Acne (3.9%)

            Weight gain (2.85)

            <1%

            Venous thromboembolism

            Jaundice or cholestasis

            Gallbladder disease

            Depression

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            Warnings

            Black Box Warnings

            Cigarette smoking

            • Cigarette smoking increases risk of serious cardiovascular adverse effects from combination hormonal contraceptive use
            • This risk increases with age (>35 yr) and heavy smoking (15 or more cigarettes/day)
            • Advise women who use hormonal oral contraceptives not to smoke

            Contraindications

            Pregnancy

            Hypersensitivity

            Breast Cancer, or other estrogen- or progestin-sensitive cancer

            A high risk of arterial or venous thromboembolic disorders

            Undiagnosed uterine bleeding

            Cautions

            Poorly metabolized with hepatic impairment

            Use caution in patients with history of migraine, seizure disorder,

            Not recommended for women smokers >35 years

            Oral contraceptives can reduce production of milk in breastfeeding mothers

            Evaluate significant change in headaches and discontinue therapy if indicated

            Women taking strong CYP3A4 inducers (for example, carbamazepine, phenytoin, rifampicin, and St. John’s wort) should choose an alternate oral contraceptive due to the possibility of decreased contraceptive efficacy

            Discontinue therapy if jaundice occurs

            Not for administration for women with uncontrolled hypertension or hypertension with vascular disease

            Monitor prediabetic and diabetic women receiving therapy

            Consider an alternate contraceptive method for women with uncontrolled dyslipidemia

            Evaluate uterine bleeding or amenorrhea

            Thromboembolic disease may occur; stop therapy for at least 4 weeks before and through 2 weeks after major surgery; initiate therapy no sooner than 4 weeks after delivery, in women who are not breastfeeding

            Safety and efficacy not established for BMI >30 kg/m²

            CDC guidelines recommend waiting at least 3 weeks following vaginal birth or 6 weeks after cesarean section to decrease risk for venous thromboembolism before initiating combined hormonal contraceptives; women with additional risk factors for VTE (besides postpartum) should not use combined hormonal contraceptives (MMWR July 7, 2011)

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            Pregnancy & Lactation

            Pregnancy considerations: There is little or no increased risk of birth defects in women who inadvertently use combined oral contraceptives (COCs) during early pregnancy; epidemiologic studies and meta-analyses have not found increased risk of genital or non-genital birth defects following exposure to low dose COCs prior to conception or during early pregnancy; the administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy; COCs should not be used during pregnancy to treat threatened or habitual abortion; women who do not breastfeed may start COCs no earlier than four weeks postpartum.

            Lactation: May decrease breast milk production; enters milk; not recommended

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Estrogen/progestin combined oral contraceptive; decreases risk of becoming pregnant primarily by suppressing ovulation May also cause cervical mucus changes that inhibit sperm penetration and endometrial changes that decrease ability for implantation

            Pharmaockinetics

            Bioavailability: 91% (dienogest)

            Vd: 1.2 L/kg (estradiol IV)

            Peak Plasma Time: 6 hr (17-beta estradiol); 11 hr (dienogest)

            Peak Plasma Concentration: 73.3 pg/mL (17-beta estradiol); 91.7 ng/mL (dienogest)

            Protein Bound: 60% (estradiol); 90% (dienogest)

            Half-life elimination

            • estradiol: 14 hr
            • dienogest: 1 hr

            Excretion

            • estradiol and its metabolites: feces (10%), urine (90%)
            • dienogest: predominantly via urine as metabolites and unchanged dienogest
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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