FDA approved Twirla (levonorgestrel/ethinyl estradiol) Transdermal System for ContraceptionFDA approved new birth control patch Twirla for women with lower BMI.

FDA From the archive Source published February 14, 2020 Summary added June 25, 2026 DOI ↗ Editorial oversight: Dr. Sofia Müller, MD · Lifespan & Whole-Person Care

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Key Takeaway

Consider reduced contraceptive effectiveness of Twirla in women with BMI ≥25 to <30 kg/m² before prescribing.

The FDA has approved Twirla (levonorgestrel/ethinyl estradiol) transdermal system for contraception in women of reproductive potential with a BMI less than 30 kg/m² for whom a combined hormonal contraceptive is appropriate. The approval includes a limitation of use: clinicians should consider Twirla's reduced effectiveness in women with a BMI between 25 and 30 kg/m² before prescribing. Twirla is contraindicated in women with a BMI of 30 kg/m² or higher. The transdermal system delivers a combination of the progestin levonorgestrel and the estrogen ethinyl estradiol. It is applied weekly for three weeks, followed by a patch-free week. The approval provides an additional contraceptive option for women who prefer a transdermal route, but with important BMI-based restrictions on use.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Not reported in label.

Indication & Patient Population

Twirla is indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m² for whom a combined hormonal contraceptive is appropriate. Limitation of Use: Consider Twirla's reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m² before prescribing. Twirla is contraindicated in women with a BMI ≥ 30 kg/m².

Dosing & Administration

For transdermal use only. Apply one Twirla transdermal system (TDS) every week for three consecutive weeks. Apply to one of the following sites: abdomen, buttock, or upper torso (excluding breasts). Do not cut or alter the TDS. A new TDS is applied and worn for seven days for three consecutive weeks (Weeks 1, 2, and 3). No TDS is worn during Week 4 (the TDS-Free Week). On the day after Week 4 ends, a new 28-day cycle is started. Under no circumstances should there be more than a 7-day TDS-free interval between dosing cycles. For women with no current use of hormonal contraception, the first TDS should be applied during the first 24 hours of menstruation (Day 1 Start). If applied after the first 24 hours, non-hormonal back-up contraception is needed for the first 7 days. Instructions for switching from other contraceptive methods are provided in the label.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Contraindicated in women with a BMI ≥ 30 kg/m². Consider reduced effectiveness in women with BMI ≥ 25 to < 30 kg/m².

Place in Therapy

Twirla is a transdermal contraceptive option for women with BMI < 30 kg/m². Its use is limited by BMI considerations, with reduced effectiveness in overweight women and contraindication in obesity.

The FDA has approved a new birth control patch called Twirla. It is a weekly patch that releases two hormones, levonorgestrel and ethinyl estradiol, to prevent pregnancy. Twirla is for women of reproductive age who have a body mass index (BMI) less than 30 and who can safely use combined hormonal contraception.

This approval gives women another option for birth control that is applied to the skin once a week for three weeks, followed by a patch-free week. However, the FDA notes that Twirla may be less effective in women with a BMI between 25 and 30. It should not be used by women with a BMI of 30 or higher.

If you are considering Twirla, talk to your doctor. They can help you decide if this patch is right for you based on your health and BMI. Remember, no birth control method is 100% effective, and this patch does not protect against sexually transmitted infections.

What this means for you:

Twirla is a new weekly birth control patch for women with BMI under 30, but may be less effective for those with BMI 25-30.

Study Details

Study typeFda approval

PublishedFeb 2020

View Original Abstract ↓

1 INDICATIONS AND USAGE TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. Limitation of Use Consider TWIRLA’s reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m 2 before prescribing TWIRLA [see Use in Specific Populations ( 8.9 ) and Clinical Studies ( 14 )] . TWIRLA is contraindicated in women with a BMI ≥ 30 kg/m 2 [see Contraindications ( 4 )] . TWIRLA is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. ( 1 ) Limitation of Use Consider TWIRLA’s reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m 2 before prescribing. ( 4 , 8.9 , 14 )

FDA approved Twirla (levonorgestrel/ethinyl estradiol) Transdermal System for ContraceptionFDA approved new birth control patch Twirla for women with lower BMI.

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FDA approved Twirla (levonorgestrel/ethinyl estradiol) Transdermal System for ContraceptionFDA approved new birth control patch Twirla for women with lower BMI.

Study Details

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