Twirla vs Xulane: How do they compare?

Answers by TheMediTary.Com - Last updated: 13-Jul-2023

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.

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