FLORHAM PARK, N.J., June 19, 2026 (GLOBE NEWSWIRE) -- Exeltis USA, Inc. (Exeltis), a global pharmaceutical company specializing in women’s health, announced that the U.S. Food and Drug Administration (FDA) has approved an update to the labeled strength of TWIRLA® (levonorgestrel and ethinyl estradiol) transdermal system. The new labeled strength will begin to appear on the market in September or October of 2026.
This change is to provide a more accurate representation of the amount of levonorgestrel and ethinyl estradiol delivered (or transferred) to the user from TWIRLA. The revised labeled strength is based on the residual drug results from Study ATI-CL28. This is consistent with the recommendations of the FDA draft guidance for industry-- Transdermal and Topical Delivery Systems - Product Development and Quality Considerations (2019) at: https://www.fda.gov/media/132674/download.
The change is in the label strength only. There is no change to the formulation, composition, or manufacturing process of TWIRLA due to this labeled strength change.
Until the supply of 120 mcg/30 mcg per day is depleted, patients may receive TWIRLA labeled with either strength, but the dose (1 transdermal system) and its effects are unchanged.
What is TWIRLA?
TWIRLA is a birth control patch for women with Body Mass Index (BMI) less than 30 kg/m2 who can become pregnant. It contains two female hormones, a progestin called levonorgestrel, and an estrogen called ethinyl estradiol. Birth control methods that have both an estrogen and progestin are called combination hormonal contraceptives (CHCs).
TWIRLA is less effective in women with a BMI of 25 kg/m2 and is not indicated for women with a BMI of more than 30 kg/m2.
Important Risk Information
What is the most important information I should know about TWIRLA?
- Do not use TWIRLA if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from combination hormonal contraceptives (CHCs), including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
- Do not use TWIRLA if your BMI is 30 kg/m2 or more. If you do not know what your BMI is, please talk to your healthcare provider. Women with a BMI of 30 kg/m2 or more who use CHCs may have a higher risk for developing side effects like blood clots compared to women with a BMI lower than 30 kg/m2.
Do not use TWIRLA if you:
- smoke and are over 35 years old
- have or have had blood clots in your arms, legs, eyes or lungs
- have had a stroke
- have had a heart attack
- have certain heart valve problems or heart rhythm problems that can cause blood clots to form in the heart
- have a problem that makes your blood clot more than normal
- have high blood pressure that is not controlled
- have diabetes and are over the age of 35, have high blood pressure or have kidney, eye, nerve, or blood vessel damage, or have had diabetes for more than 20 years
- have had certain kinds of severe migraine headaches or have any migraine headaches if you are over age 35
- have a BMI of 30 kg/m2 or more
- have liver problems including liver tumors, hepatitis, cirrhosis, or liver disease
- have unexplained vaginal bleeding
- are pregnant or think you may be pregnant
- have had breast cancer or any cancer that is sensitive to female hormones
- are allergic to any of the ingredients in TWIRLA
- take any Hepatitis C drug combination containing ombitasvir, paritaprevir, ritonavir, with or without dasabuvir as this may increase levels of a liver enzyme in the blood
TWIRLA may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy or related to previous use of hormonal birth control.
Tell your healthcare provider if you have ever had any of the above conditions. Your healthcare provider may recommend another method of birth control.
TWIRLA may cause serious side effects, including:
- blood clots
- liver problems, including liver tumors
- high blood pressure
- gallbladder problems or worsening of a gallbladder problem you already have
- headaches
- irregular or unusual bleeding and spotting or absence of menstrual periods
- depression
- swelling of your skin, especially around your mouth, eyes, and in your throat
- dark patches of skin on your forehead, cheeks, upper lip, and chin
Most common side effects of TWIRLA include:
- skin reactions at the patch site
- nausea
- headache
- menstrual cramps
- weight gain
These are not all the possible side effects of TWIRLA. Talk to your healthcare provider for medical advice about side effects.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines and herbal products may make TWIRLA less effective or cause breakthrough bleeding.
Use another birth control method (such as condoms, spermicide, or diaphragm) when you take medicines that may make TWIRLA less effective and for 28 days after stopping the medicine.
Tell your healthcare provider if you drink grapefruit juice, take lamotrigine, are scheduled for any laboratory tests, or on thyroid or corticosteroid replacement medicine.
If you are not sure if you take any of the medicines described above, talk to your healthcare provider.
What should I avoid while using TWIRLA?
- Smoking
- The following can cause the patch to not stick the right way making TWIRLA less effective:
- Avoid using makeup, creams, lotions, oils, powders or any other products on the skin area where you put or plan to put the patch.
- Swimming or contact with water often or for long periods of time (30 minutes or more). Talk with your healthcare provider about the best method of birth control if you are a swimmer or you often come in contact with water for 30 minutes or more.
- Women who tend to get chloasma should avoid spending a long time in the sunlight, tanning booths, and under sun lamps while using TWIRLA. Use sunscreen if you have to be in the sunlight.
You may report side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088, or Exeltis at 1-877-324-9349.
About Exeltis USA, Inc.
Exeltis is part of the global Insud Pharma group, a family-owned pharmaceutical co with over 40 years of experience.
Everett Laboratories Inc. (Now Exeltis USA, Inc.) was founded in 1971 and entered the women’s health market in the mid 1990’s, with a focus on pre-natal supplementation. Since then, Exeltis USA, Inc. has brought other important women’s health products to market, building a strong reputation with the healthcare professionals specializing in Women’s Health.
About Insud Pharma
Insud Pharma is a pharmaceutical group with more than 45 years of history, presence in around 50 countries, 9,000 employees worldwide and 20 manufacturing plants.
Insud Pharma operates throughout the value chain of the pharmaceutical industry, offering specialized knowledge in scientific research, development, manufacturing, sale and marketing of a wide range of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs) and pharmaceutical products of brand for the care of humans and animals and biopharmaceuticals.
Insud Pharma seeks to improve health throughout the world by providing accessible, effective, safe and quality pharmacological treatments through its different business units, with continuous investment in R&D and the latest technology.
Media Contact:
Randi Rievman
Vice President, Marketing and Strategic Communications, Exeltis USA
rrievman@exeltis.com
(973) 803-5505
