Twirla vs Xulane: How do they compare?
Twirla and Xulane are weekly birth control patches or transdermal systems used to prevent pregnancy.
They are both used the same way in a four week cycle. Each patch is applied and worn for 7 days. Three patches are used over three weeks. When the third patch is removed after 7 days, a patch-free fourth week begins before the four week cycle repeats all over again.
Twirla and Xulane are combination patches containing an estrogen and a progestin. The both contain ethinyl estradiol, but the progestin in Twirla is levonorgestrel, while the progestin in Xulane is called norelgestromin.
Other differences between the two products include slight differences in their appearance, efficacy and adverse reactions profile (see table below for details).
Xulane is a generic version of a previously marketed product called Ortho Evra, whereas Twirla has been approved by the FDA as a new drug product. Zafemy is another generic version of Ortho Evra.
How does Twirla compare with Xulane?
(ethinyl estradiol and levonorgestrel)
(ethinyl estradiol and norelgestromin)
Generic or new drug
|New drug||Generic version of Ortho Evra, which has been discontinued|
|Approval date||2020||2014 - following the approval of the original version called Ortho Evra in 2001|
|Indications / uses||Birth control patch / contraceptive to prevent pregnancy in women with a body mass index (BMI) ﹤30 mg/m2||Birth control patch / contraceptive to prevent pregnancy in women with a body mass index (BMI) ﹤30 mg/m2|
|Mechanism of action||Primarily works by suppressing ovulation||Primarily works by suppressing ovulation|
|Type of drug||Combination estrogen + progestin contraceptive||Combination estrogen + progestin contraceptive|
|Active ingredients and strength||
Ethinyl estradiol 2.30 mg - estrogen
Levonorgestrel 2.60 mg - progestin
Ethinyl estradiol 0.53 mg- estrogen
Norelgestromin 4.86 mg - progestin
|Daily drug delivery rate||
Ethinyl estradiol 30 mcg/day
Levonorgestrel 120 mcg/day
Ethinyl estradiol 35 mcg/day
Norelgestromin 150 mcg/day
|Pharmacokinetic profile of ethinyl estradiol per day*||
Approximately 30 mcg/per day
Comparable to a low-dose oral contraceptive
Approximately 56 mcg/per day
This is approximately 60 percent higher than for an oral contraceptive containing ethinyl estradiol 35 mcg.
Increased estrogen exposure may increase the risk of adverse events including venous thromboembolism (VTE). However, studies have not confirmed whether use of the Xulane patch is associated with an increased risk of VTE compared with use of oral contraceptives tablets containing 30-35 mcg of ethinyl estradiol
|Surface area of patch||28 cm2||14 cm2|
|Appearance||Twirla is a circular, beige colored transdermal system or patch that has “TWIRLA Levonorgestrel 120 mcg/day Ethinyl Estradiol 30 mcg/day” etched on it.||Xulane comes as a square-shaped patch or transdermal system with rounded edges. They are peach in color. The patch has “Xulane (norelgestromin and ethinyl estradiol) 150/35 mcg per day” written on it in brown ink.|
Consists of five layers and a release liner removed prior to use.
Consists of two layers and a release liner removed prior to use.
|Application and schedule||
The most common adverse reactions (≥ 2%) are:
The most common adverse reactions (≥ 2%) are:
|Drug interactions||Enzyme inducers can decrease how effective Twirla is and increase breakthrough bleeding. Alternative methods of contraception are needed if enzyme inducers are used.||Enzyme inducers can decrease how effective Xulane is and increase breakthrough bleeding. Alternative methods of contraception are needed if enzyme inducers are used.|
|Efficacy||The overall Pearl Index (PI) defined as the pregnancy rate per 100 woman-years of Twirla use was 5.8 (95% CI 4.5, 7.2) in a clinical trial. Twirla was found to be more effective in women with a lower BMI.||The pregnancy rate per 100 woman-years of Xulane use was 1.07 (95% CI 0.6-, 1.76). Xulane is thought to be less effective in women with a higher BMI.|
|Adhesion||In a year-long phase 3 trial, 5% of all the Twirla patches (55,900) worn fully detached. Full detachment was more common in patches exposed to water. Patients found the abdomen was the best site to apply the patch.||In clinical trials 2% of Xulane patches completely detached, which affected 2-6% of study participants.|
|Warnings and precautions||
|Special patient populations||
* A study directly comparing the pharmacokinetic profiles of Twirla and Xulane has not been conducted.
- Food and Drug Administration (FDA). Twirla. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204017s000lbl.pdf. [Accessed March 31, 2021].
- Food and Drug Administration (FDA). Ortho Evra. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021180s048lbl.pdf. [Accessed March 31, 2021].
- Agile Therapeutics. FDA APPROVES AGILE THERAPEUTICS, INC.’S TWIRLA® (LEVONORGESTREL AND ETHINYL ESTRADIOL) TRANSDERMAL SYSTEM – A NEW WEEKLY CONTRACEPTIVE PATCH DELIVERING A 30 MCG DAILY DOSE OF ESTROGEN AND 120 MCG DAILY DOSE OF PROGESTIN. February 14, 2020. Available from: https://ir.agiletherapeutics.com/news-releases/news-release-details/fda-approves-agile-therapeutics-incs-twirlar-levonorgestrel-and. [Accessed November 27, 2020].
- Xulane. Available from: https://www.xulane.com/. [Accessed November 27, 2020].
- Twirla. Available from: https://www.twirla.com/. [Accessed November 27, 2020].
- 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(6):595-601. doi:10.1016/j.contraception.2011.10.006.
- United States Securities and Exchange Commission. Agile Therapeutics Form 10-K. Year Ended December 31, 2020. March 1, 2021. Available from: https://sec.report/Document/0001558370-21-002163/. [Accessed March 31, 2021].
- DailyMed. Xulane - norelgestromin and ethinyl estradiol patch. Updated February 4, 2021. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo. [Accessed March 31, 2021].
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