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Ethinyl Estradiol/Levonorgestrel Transdermal

    Brands

    DEA Class; Rx

    Common Brand Names; Twirla

    • Contraceptives, Transdermal

    Combination hormonal contraceptives lower the risk of becoming pregnant primarily by suppressing ovulation

    Ethinyl estradiol: Reduces LHRH release from hypothalamus and reduces gonadotropin release from pituitary; increases synthesis of DNA, RNA, and various proteins in target tissues; other possible mechanisms include changes in cervical mucus that cause inhibition of sperm penetration and endometrial changes that reduce likelihood of implantation

    Levonorgestrel transdermal: Synthetic progestin; ovulation is inhibited from a negative feedback mechanism on hypothalamus, leading to reduced secretion of FSH and LH

    Indicated for contraception in females of reproductive potential with a BMI <30 kg/m2 for whom a combined hormonal contraceptive is appropriate

    Have headaches with focal neurological symptoms, migraine headaches with aura

    Women aged >35 yr with any migraine headache

    BMI ≥30 kg/m2; reduced effectiveness and may have higher risk for VTEs compared with women with lower BMI

    Liver tumors (benign or malignant), acute viral hepatitis, severe (decompensated) cirrhosis, or liver disease

    Undiagnosed abnormal uterine bleeding

    Pregnancy, given there is no reason to use CHCs during pregnancy

    Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past

    Hypersensitivity to any components; observed reactions include itching and irritation at application site

    Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, owing to potential for elevated ALT

    • Application site disorder (6.2%)
    • Nausea (4.1%)
    • Headache (3.6%)
    • Dysmenorrhea (2.3%)
    • Increased weight (2%)
    • Cholelithiasis
    • Cholecystitis
    • Major depression
    • Suicidal ideation
    • Appendicitis
    • Ectopic pregnancy
    • Pneumonia
    • Gastroenteritis

    Contraindicated with benign or malignant liver tumors, acute viral hepatitis, or severe cirrhosis; discontinue if jaundice occurs

    Increased ALT observed in women taking ethinyl estradiol-containing medications with certain hepatitis C drug regimens (ie, ombitasvir/paritaprevir/ritonavir, with or without dasabuvir)

    Contraindicated with uncontrolled hypertension or hypertension with vascular disease; if administered to women with well-controlled hypertension, monitor blood pressure; discontinue immediately if blood pressure increases significantly

    Consider age-related risk factors for CV disease (eg, hypertension, diabetes, dyslipidemia, obesity)

    Increase risk of gall bladder disease among CHC users

    Contraindicated in diabetic women aged ≥35 yr, or women who have diabetes with hypertension, nephropathy, retinopathy, or neuropathy, other vascular disease, or women with diabetes >20 yr duration

    Contraindicated in women who have headaches with focal neurological symptoms or have migraine headaches with aura, and women aged ≥35 yr who have migraine headaches with or without aura

    Carefully observe women with history of depression; discontinue if depression recurs to a serious degree

    Some studies suggest that CHCs are associated with increased risk of cervical cancer or intraepithelial neoplasia; controversial whether these findings are caused by CHCs or sexual behavior and other factors

    Estrogen may raise serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin, and cortisol-binding globulin; dose of replacement thyroid hormone or cortisol therapy may need to be increased

    Exogenous estrogens may induce or exacerbate symptoms of angioedema

    Chloasma may occur, especially in women with a history of chloasma gravidarum; avoid sun exposure or ultraviolet radiation

    Contraindicated

    Discontinue if pregnancy occurs

    Contraceptive hormones and/or metabolites are present in human milk

    CHCs can reduce milk production in breastfeeding women, but this is less likely to occur once breastfeeding is well established

    Adults

    28day (4-week) cycle

    • 1 new transdermal system (TDS) is applied and worn for 7 days for 3 consecutive weeks (Weeks 1, 2, and 3); no TDS is worn during Week 4 when withdrawal bleeding is expected
    • Every new TDS should be applied on the same day of the week
    • On the day after Week 4 ends, a new 28-day cycle is started by applying a new TDS
    • Under no circumstances should there be >7-day TDS-free interval between dosing cycles
    • If there are >7 TDS-free days, women may not be protected from pregnancy and nonhormonal back-up contraception (eg, condoms and spermicide, diaphragm and spermicide) must be used for 7 days
    • See Administration for how to initiate dosing if no contraception is currently used or if switching from another form of contraception

    Ethinyl estradiol/levonorgestrel

    transdermal patch

    • (30mcg/120mcg)/day