A new FDA approval is set to bring clearer dosing information to women using the TWIRLA birth control patch, a once-weekly hormonal contraceptive designed for women with a BMI under 30.
TWIRLA was first approved by the FDA on February 14, 2020, as a low-dose combined hormonal contraceptive patch for birth control.
Exeltis USA, Inc. announced that the agency has approved an update to the labeled strength of the patch to better reflect the amount of hormone actually delivered to the body.
The updated strength — expected to appear on the market in September or October 2026 — is based on findings from Study ATI-CL28, which measured the residual drug left in the patch after use. According to Exeltis, the change aligns with FDA draft guidance for Transdermal and Topical Delivery Systems and is intended to provide a more accurate representation of hormone transfer to the user.
Importantly, the company emphasized that nothing about the patch's formulation, composition or its manufacturing process is changing. The update is related only to the labeling.
Women may continue to see the previous 120 mcg/30 mcg per-day strength on pharmacy shelves until existing supply is depleted, but the dose and clinical effect remain the same regardless of which label appears on the box.
What TWIRLA is Used For
TWIRLA is a combination hormonal contraceptive (CHC) containing levonorgestrel and ethinyl estradiol. It is approved for women with BMI under 30 kg/m2, though it is less effective in women with a BMI of 25-30 and not indicated for women with a BMI above 30. The patch delivers hormones through the skin and is applied weekly for three weeks, followed by one patch-free week.
Important Safety Information
The FDA-approved update does not change TWIRLA's safety profile. The patch should not be used by women who:
-Smoke and are over age 35
-Have a history of blood clots, stroke, heart attack, or certain heart rhythm problems
-Have uncontrolled high blood pressure
-Have liver disease, unexplained vaginal bleeding, or hormone-sensitive cancers.
-Are pregnant or think they may be pregnant -Have a BMI greater than or equal to 30 kg/m2
Serious risks include blood clots, liver problems, high blood pressure, and gallbladder issues. Common side effects include skin reactions at the patch site, nausea, headaches, menstrual cramps, and weight gain.
Women are advised to avoid lotions, oils or other cosmetics on the patch site, as well as prolonged swimming or water exposure, which may affect adhesion. Those prone to chloasma should limit sun exposure and use sunscreen while on TWIRLA.
Source: FDA
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