etonogestrel/ethinylestradiol (Rx)

Brand and Other Names:NuvaRing
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

etonogestrel/ethinyl estradiol

vaginal ring

  • 0.12mg/0.015mg released per day
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Contraception

Indicated for use by females of reproductive age to prevent pregnancy

One NuvaRing is inserted in the vagina and is to remain in place continuously for 3 weeks

It is removed for a one-week break, during which a withdrawal bleed usually occurs, THEN

A new ring is inserted 1 week after the last ring was removed

See Adminstration for details regarding when to insert ring

Dosage Forms & Strengths

etonogestrel/ethinyl estradiol

vaginal ring

  • 0.12mg/0.015mg released per day
more...

Contraception

Indicated for use by females of reproductive age to prevent pregnancy

One NuvaRing is inserted in the vagina and is to remain in place continuously for 3 weeks

It is removed for a 1-week break, during which a withdrawal bleed usually occurs, THEN

A new ring is inserted 1 week after the last ring was removed

See Adminstration for details regarding when to insert ring

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Interactions

Interaction Checker

and etonogestrel/ethinylestradiol

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     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Vaginitis (13.8%)

            Headache (including migraine) (11.2%)

            1-10%

            Mood changes (6.4%)

            Device-related events (eg, expulsion/discomfort/foreign body sensation) (6.3%)

            Nausea/vomiting (5.9%)

            Vaginal discharge (5.7%)

            Increased weight (4.9%)

            Vaginal discomfort (4%)

            Breast pain/discomfort/tenderness (3.8%)

            Dysmenorrhea (3.5%)

            Abdominal pain (3.2%)

            Acne (2.4%)

            Decreased libido (2%)

            Postmarketing Reports

            Immune system disorders: Hypersensitivity

            Nervous system disorders: Stroke/cerebrovascular accident

            Vascular disorders: Arterial events (including arterial thromboembolism and myocardial infarction), aggravation of varicose veins

            Skin and subcutaneous tissue disorders: urticaria, chloasma

            Reproductive system and breast disorders: penile disorders, including local reactions on penis (in male partners of women using NuvaRing), galactorrhea

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            Warnings

            Black Box Warnings

            Cigarette smoking & risk of cardiovascular disease

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

            Contraindications

            Documented hypersensitivity

            Arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease

            Estrogen-dependent neoplasia (current or history of)

            Cerebrovascular disease, coronary artery disease

            Headaches with focal neurological symptoms

            Liver disease, liver tumors

            Undiagnosed abnormal vaginal bleeding

            Uncontrolled hypertension

            Women >35 years who smoke

            Major surgery with prolonged immobilization

            Diabetes mellitus with vascular involvement, jaundice with prior oral contraceptive use

            Cautions

            Avoid using diaphragm concomitantly; may interfere with ring placement

            Family history of breast cancer and or DVT/PE

            Current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy)

            Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significang blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery

            Discontinue 4 week before major surgery or prolonged immobilization

            Discontinue if an arterial thrombotic or venous thromboembolic event occurs

            Estrogens may cause retinal vascular thrombosis; discontinue therapy if visual disturbances occur including migraine, loss of vision, diplopia, or proptosis

            Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted)

            Some studies link OCP use with increased risk of breast cancer, whereas other studies have not shown a change in risk; woman's risk depends on conditions where naturally high hormone levels persist for long periods of time including early onset menstruation before age 12, late onset menopause, after age 55, first child after age 30, nulliparity

            Increased risk of cervical cancer with OCP use, however HPV remains as main risk factor for this cancer, evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk

            Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use

            Combination of hormonal contraceptives may affect lipoprotein levels and serum triglycerides

            Increased risk of gallbladder disease reported (dose dependent)

            Use caution in patients with diseases that may be exacerbated by fluid retention including migraine, diabetes, renal dysfunction, and epilepsy

            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 Category: X

            Lactation: Small amounts of steroids are excreted in breast milk; estrogens may reduce quality/quantity of milk; may be prudent to use other forms of birth control until full weaning (AAP Committee states compatible w/ nursing)

            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

            Ethinyl estradiol (EE): Reduces LHRH release from hypothalamus, reduces gonadotropin release from pituitary; increases synthesis of DNA, RNA, and various proteins in target tissues

            Etonogestrel: Progestin; inhibits gonadotropin secretion from pituitary; prevents follicular maturation & ovulation, stimulates growth of mammary tissues

            Pharmacokinetics

            Half-life: 44.7 hr (ethinyl estradiol); 29.3 hr (etonogestrel)

            Excretion: Urine, bile, and feces (ethinyl estradiol and etonogestrel)

            Bioavailability: 56% (ethinyl estraiol); 100% (etonogestrel)

            Metabolism: Liver (ethinyl estradiol and etonogestrel form metabolites)

            Protein binding 98% (ethinyl estradiol); 32% (etonogestrel; sex hormone binding globulin and 66% to albumin)

            Absorption: Rapid (ethinyl estradiol and etonogestrel; tampons do not interfere with absorption)

            Duration: Serum levels decrease after 3 weeks of continuous use

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            Administration

            Intravaginal Administration

            Consider possibility of ovulation and conception before the first use of etonogestrel/ethinyl estradiol intravaginal ring

            One NuvaRing is inserted in the vagina and is to remain in place continuously for 3 weeks

            It is removed for a 1-week break, during which a withdrawal bleed usually occurs, THEN

            A new ring is inserted 1 week after the last ring was removed

            To prevent loss of contraceptive efficacy, advise women not to deviate from the recommended regimen

            No hormonal contraceptive use in preceding cycle

            • Insert ring on the first day of menstrual bleeding
            • May also be started on Days 2-5 of the woman’s cycle, but in this case a barrier method (eg, male condoms with spermicide) should be used for the first 7 days of the ring’s use in the first cycle

            Changing from other combination hormonal contraceptive (CHC)

            • May switch from previous CHC on any day, but at the latest on the day following the usual hormone-free interval
            • Ensure that the previous hormonal method was used consistently and correctly, and it is reasonably certain the woman is not pregnant

            Changing from progestin-only contraceptive

            • Progestin-only contraceptives vary (eg, oral, implant, long-acting injection, intrauterine system)
            • Progestin-only pill (POP): May switch on any day; instruct to insert the ring on the day after she took her last POP
            • Intrauterine system (IUS): Switch from an implant or the IUS on the day of its removal
            • Injection: Switch from injection when the next injection would be due
            • In all of these cases, the woman should use an additional barrier method (eg, male condom with spermicide) for the first 7 days

            Use after abortion or miscarriage

            • Complete first trimester abortion or miscarriage
              • May start using the ring within the first 5 days; no need to use an additional method of contraception
              • If not started within 5 days, follow the instructions for “no hormonal contraceptive use in the preceding cycle”
              • In the meantime, use a nonhormonal contraceptive method
            • Second trimester abortion or miscarriage
              • Do not start earlier than 4 weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolism

            Following childbirth

            • Initiated use of ring no sooner than 4 weeks postpartum in women who elect not to breastfeed, due to the increased risk of thromboembolism in the postpartum period
            • Also instruct her to use an additional method of contraception (eg, male condoms with spermicide) for the first 7 days
            • Advise women who are breastfeeding not to use NuvaRing but to use other forms of contraception until the child is weaned

            Inadvertent removal or expulsion

            • If the ring is accidentally expelled and is left outside of the vagina for <3 hr, contraceptive efficacy is not reduced
            • Rinse ring with cool to lukewarm (not hot) water and reinserted as soon as possible, but at the latest within 3 hr
            • If the ring is lost, a new vaginal ring should be inserted and the regimen should be continued without alteration
            • If ring out of vagina >3 hr
              • During weeks 1 and 2: Contraceptive efficacy may be reduced; reinsert the ring as soon as possible and use a barrier method (eg, condoms with spermicides) until the ring has been used continuously for 7 days
              • During week 3: Discard that ring, and either insert a new ring immediately to start the next 3-week use period, OR insert a new ring no later than 7 days from the time the previous ring was expelled/removed and use barrier method for 7 days

            Prolonged ring-free interval

            • If the ring-free interval has been extended beyond 1 week, consider the possibility of pregnancy, and an additional method of contraception (eg, male condoms with spermicide) MUST be used until the ring has been used continuously for 7 days

            Prolonged use or ring

            • Left in place for up to 1 extra week (ie, up to 4 weeks total): The woman will remain protected; remove ring and insert a new ring after a 1-week ring-free interval
            • Left in place for >4 weeks: Instruct the woman to remove the ring, and rule out pregnancy; if pregnancy is ruled out, the ring may be restarted, and an additional method of contraception MUST be used until the new ring has been used continuously for 7 days

            Ring breakage

            • There have been reported cases of the disconnecting at the weld joint; this is not expected to affect the contraceptive effectiveness
            • Vaginal discomfort or expulsion (slipping out) is more likely to occur
            • Discard the ring and replace it with a new ring

            Missed menstrual period

            • If the woman has not adhered to the prescribed regimen consider the possibility of pregnancy at the time of the first missed period and discontinue the ring if pregnancy is confirmed
            • If the woman has adhered to the prescribed regimen and misses 2 consecutive periods, rule out pregnancy
            • If the woman has retained 1 ring for >4 weeks, rule out pregnancy

            Use with other vaginal products

            • The ring may interfere with the correct placement and position of a diaphragm; a diaphragm is therefore not recommended as a back-up contraceptive method
            • Pharmacokinetic data show that the use of tampons has no effect on the systemic absorption of the hormones released by the ring
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            Formulary

            FormularyPatient Discounts

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            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.
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            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.
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