• Patient Info
  • Prescribing Info
  • Instructions for Use
  • For HCPs
Gwyn Lo (norelogestromin and ethinyl estradiol transdermal system) 220/20 mcg per day

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IMPORTANT SAFETY INFORMATION
 
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What is the most important information I should know about Gwyn Lo?

  • Do not use Gwyn Lo 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 Gwyn Lo if your Body Mass Index (BMI) is 30 kg/m2 or more. Women with a BMI of 30 kg/m2 or more who use Gwyn Lo may be at a higher risk of developing blood clots compared to women with a BMI lower than 30 kg/m2.

Do not use Gwyn Lo 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 that you were born with (inherited) or that has happened for other reasons such as medicines, surgery or injuries (acquired).
  • have high blood pressure that is not controlled.
  • have diabetes with kidney, eye, nerve, or blood vessel damage.
  • have had certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, 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.
  • have or have had breast cancer or any cancer that is sensitive to female hormones.
  • take any Hepatitis C drug combination-containing ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin, or with glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir. This may increase levels of the liver enzyme called alanine aminotransferase (ALT) in the blood.

Gwyn Lo may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes).

Before you use Gwyn Lo, tell your healthcare provider about all your medical conditions.
Gwyn Lo does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Gwyn Lo may affect the way other medicines work, and other medicines may affect how well Gwyn Lo works.

  • Some medicines and herbal products may make Gwyn Lo less effective or cause breakthrough bleeding. Use another birth control method (such as a condom and spermicide or diaphragm and spermicide) when you take medicines that may make Gwyn Lo less effective and for 28 days after stopping the medicine.
  • Some medicines and grapefruit juice may increase your level of the hormone ethinyl estradiol if used together.
  • Gwyn Lo may affect the way that lamotrigine, a medicine used to treat seizures, works and may increase the risk of seizures. Your healthcare provider may need to adjust the dose of lamotrigine while you are on Gwyn Lo.
  • If you are scheduled for any laboratory tests, tell your healthcare provider that you are using Gwyn Lo. Certain blood tests may be affected by CHC methods.
  • Women on thyroid replacement therapy may need increased doses of thyroid replacement medicine or corticosteroid replacement medicine.

Ask your healthcare provider if you are not sure if you take any of the medicines listed above.

What should I avoid while taking Gwyn Lo?

  • Smoking
  • The following can cause the patch to not stick the right way making Gwyn Lo 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.
    • Contact with water 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 sunlight, tanning booths, and under sun lamps while using Gwyn Lo. Use sunscreen if you have to be in the sunlight.

What are the possible side effects of Gwyn Lo?
Gwyn Lo may cause serious side effects, including:

  • blood clots. It is possible to die or be permanently disabled from a problem caused by a blood clot, such as a heart attack or a stroke. Call your healthcare provider right away if you have:
    • leg pain that will not go away
    • sudden shortness of breath
    • sudden changes to your vision or blindness
    • severe pain or pressure in your chest
    • sudden, severe headache unlike your usual headaches
    • weakness or numbness in an arm or leg
    • trouble speaking
  • liver problems, including liver tumors. Stop using Gwyn Lo and tell your healthcare provider right away if you have yellowing of your skin or eyes (jaundice).
  • high blood pressure.
  • gallbladder problems or worsening of a gallbladder problem you already have.
  • headaches. Tell your healthcare provider if you have new headaches that keep coming back, that do not go away or are severe. Also tell your healthcare provider if your migraine headaches happen more often or are more severe than normal.
  • irregular or unusual vaginal bleeding and spotting between your menstrual periods or absence of menstrual periods (amenorrhea). Tell your healthcare provider if you miss 2 or more menstrual cycles.
  • depression.
  • swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare provider or get emergency medical care right away if you have a swollen face, lips, mouth, tongue or throat as this may lead to difficulty swallowing or breathing.
  • dark patches of skin on your forehead, cheeks, upper lip, and chin (chloasma).

The most common side effects of Gwyn Lo include skin irritation, redness, itching or rash at the patch application site, bleeding between periods and heavy periods, and nausea.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of Gwyn Lo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Gwyn Lo?
Gwyn Lo is a birth control patch for women with a BMI less than 30 kg/m2 who can become pregnant. It contains two female hormones, a progestin called norelgestromin, and an estrogen called ethinyl estradiol.

Please see the Full Prescribing Information, including Boxed WARNING, Patient Information, and Instructions for Use.

Gwyn Lo is available by prescription only.
Patients should always ask their doctors for medical advice about adverse events.
You are encouraged to report adverse events related to Viatris products by calling 1-877-446-3679 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088.

This site is intended only for U.S. residents. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only and is not intended to replace discussions with a healthcare provider.

Viatris
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Gwyn Lo and the Gwyn Lo Logo are trademarks of Mylan
Pharmaceuticals Inc., a Viatris Company.
VIATRIS and the Viatris Logo are trademarks of Mylan Inc., a Viatris
Company.
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