TRANSDERMAL HORMONE DELIVERY

Twirla® delivers 30 mcg of estrogen per day, the lowest exposure of estrogen in a transdermal contraceptive option.1

Twirla is the first and only contraceptive patch that combines levonorgestrel and ethinyl estradiol.

Estrogen delivery over 7 days without the daily serum highs and lows of oral delivery.

EE=ethinyl estradiol, NGM=norgestimate.

In a phase 1, head-to-head study of Twirla (30 mcg of EE daily) and an oral contraceptive (35 mcg of EE daily)2,3:

  • The total estrogen concentration for Twirla over 1 week was 10% lower than the pill
    (AUC0-168 6.26 ng·h/mL vs 6.97 ng·h/mL; P = 0.0532)

  • The peak estrogen concentration for Twirla was 60% lower than the pill
    (Cmax 51.3 pg/mL vs 131 pg/mL; P ≤ 0.0001)

  • The steady-state concentration for Twirla was 14% lower than the pill
    (Css 35.7 pg/mL vs 41.5 pg/mL; P < 0.05)

References: 1. Xulane [prescribing information]. Morgantown, WV: Mylan Pharmaceuticals; 2020. 2. Archer DF, Stanczyk FZ, Rubin A, Foegh M. Ethinyl estradiol and levonorgestrel pharmacokinetics with a low-dose transdermal contraceptive delivery system, AG200-15: a randomized controlled trial. Contraception. 2012;85:595-601. 3. Archer DF, Stanczyk FZ, Feogh M. Pharmacokinetic profile of AG200-15, a transdermal contraceptive delivery system, in healthy women. Poster presented at: American College of Obstetrics & Gynecologists 59th Annual Clinical Meeting; April 30-May 4, 2011; Washington, DC. https://www.acog.org/patient-resources/faqs/contraception/combined-hormonal-birth-control-pill-patch-and-ring. Accessed October 10, 2020.

IMPORTANT SAFETY INFORMATION

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WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥30 kg/m2

Cigarette Smoking and Serious Cardiovascular Events
Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including TWIRLA, are contraindicated in women who are over 35 years of age and smoke.
Contraindicated in Women with a BMI ≥30 kg/m2
TWIRLA is contraindicated in women with a BMI ≥30 kg/m2. Compared to women with a lower BMI, women with a BMI ≥30 kg/m2 had reduced effectiveness and may have a higher risk for venous thromboembolic events (VTEs).