Twirla vs Xulane: How do they compare?

Medically reviewed by Nicole France, BPharm. Last updated on March 31, 2021.

Official answer

by Drugs.com

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?

	Twirla (ethinyl estradiol and levonorgestrel)	Xulane (ethinyl estradiol and norelgestromin)
Company	Agile	Mylan Technologies
Generic or new drug (FDA approval)	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
Inactive ingredients	Acrylic adhesives Capric acid Copovidone Crospovidone Dimethyl sulfoxide Ethyl lactate Lauryl lactate Polybutene Polyester internal membrane Polyester release liner Polyisobutylene adhesives Woven polyester backing membrane	Polyisobutene adhesive Crospovidone Mineral oil Non-woven polyester fabric Oleyl alcohol Dipropylene glycol
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.
Description	Consists of five layers and a release liner removed prior to use. The outer layer is a woven peripheral backing layer. The next layer is an inactive peripheral acrylic adhesive layer. The layer after that is an inactive peripheral polyisobutylene adhesive layer. The final two layers are an internal membrane to separate the active adhesive matrix from the inactive adhesive laminate, and the active adhesive matrix layer. Ethinyl estradiol and levonorgestrel are contained in the two final/innermost layers, along with inactive ingredients.	Consists of two layers and a release liner removed prior to use. The outer backing layer is a peach colored flexible film made up of a pigmented polyethylene router layer and a polyester inner layer. The inner layer consists of a non-woven polyester fabric containing the active ingredients - ethinyl estradiol and norelgestromin - inactive ingredients and ethinyl.
Application and schedule	A Twirla patch is applied to clean, dry skin on the first day of your menstrual period. The day of the week you first apply Twirla becomes your patch change day. The patch can be applied to the lower stomach area, a buttock or the upper torso. Each Twirla patch is worn for seven days. 28 day system - one patch is applied weekly for three weeks and on the fourth week no patch is worn.	A Xulane patch is applied to clean, dry skin on the first day of your menstrual period, or on the first Sunday after your period begins (with additional contraception, such as condoms, used for the first seven days) The patch can be applied to the upper outer arm, the abdomen, a buttock or the back where it won’t be rubbed by clothing. 28 day system - one patch is applied weekly for three weeks and on the fourth week no patch is worn.
Adverse reactions	The most common adverse reactions (≥ 2%) are: Application site disorders Nausea Headache Dysmenorrhea Weight gain	The most common adverse reactions (≥ 2%) are: Application site disorder Nausea/vomiting Headache Dizziness Migraine Fatigue Dysmenorrhea Abdominal pain Diarrhea Vaginal bleeding and menstrual disorders Mood, affect and anxiety disorders Breast symptoms Acne Vaginal yeast infection Weight gain
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	Not for use in women over 35 who smoke Not for use in women with a BMI ≥ 30 kg/m² because use may be associated with a higher risk of venous thromboembolism (VTE) or blood clots Vascular risk Liver disease Hypertension Adverse Carbohydrate and lipid metabolic effect Headache Uterine bleeding	Not for use in women over 35 who smoke Not for use in women with a BMI ≥ 30 kg/m² because use may be associated with a higher risk of venous thromboembolism (VTE) or blood clots Vascular risk Liver disease Hypertension Adverse Carbohydrate and lipid metabolic effect Headache Uterine bleeding
Special patient populations	Twirla can decrease breast milk production and should be avoided by breastfeeding mothers. Twirla has shown reduced efficacy in women with a BMI ≥ 25 kg/m².	Xulane can decrease breast milk production and should be avoided by breastfeeding mothers.

^{* A study directly comparing the pharmacokinetic profiles of Twirla and Xulane has not been conducted.}

References

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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