Ethinyl Estradiol (ETH-i-nil es-tra-DYE-ol), Levonorgestrel (lee-voe-nor-JES-trel)

Prevents pregnancy in patients with a BMI less than 30 kilograms (kg) per square meter (m2).

Brand Name(s):

Twirla

When This Medicine Should Not Be Used:

How to Use This Medicine:

Patch

• Your doctor will tell you how many patches to use, where to apply them, and how often to apply them. Do not use more patches or apply them more often than your doctor tells you to. Use only 1 patch at a time.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Carefully follow your doctor's instructions about when to start using your medicine. You may begin using the patch during the first 24 hours of your menstrual period. This will be your Patch Change Day every week.
• If you want to change your Patch Change Day, complete your current patch cycle first, removing the third patch on the correct day. Apply a new patch on your chosen day during the patch free week.
• To use the patch:
  • Wash your hands with soap and water before and after applying a patch.
  • Leave the patch in its sealed wrapper until you are ready to put it on. Tear the wrapper open carefully. NEVER CUT the wrapper or the patch with scissors. Do not use any patch that has been cut by accident.
  • The patient instructions will show the body areas where you can wear the patch. When putting on each new patch, choose a different place within these areas. Do not put the new patch on the same place you wore the last one. Be sure to remove the old patch before applying a new one. You may apply the patch on the lower stomach area, buttocks, or upper part of the body. Make sure the application site is clean and dry before you use the patch. Do not put the patch on the waistline, near clothing, or undergarment seams, on the breasts, or cut or irritated skin.
  • Avoid using make up, creams, lotions, oils, powders, or any other products on the skin where you plan to apply the patch.
  • The patch should be flat and smooth without wrinkles or folds when you apply it on the skin.
  • Check the path everyday and after any water exposure, including bathing. showering, or swimming, to make sure it is in the right place.
  • Put on a new patch if the old one has fallen off and cannot be reapplied.
    • If the patch starts to lift or completely falls off for less than 24 hours, try to put it on again or replace with a new patch right away. An additional form of birth control is not needed.
    • If the patch starts to lift or completely falls off for more than 24 hours, you may not be protected from pregnancy. Start over on a new patch cycle right away. The day you apply a new patch is now your new Day 1 and new Patch Change Day. You must use another form of birth control (including condoms, spermicide, diaphragm) during the first week of the new patch cycle.
• Missed dose: This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully, and call your doctor if you have any questions.
• If you forget to change your patch at the start of any cycle (Day 1), apply a new patch as soon as you remember. This is now your new Day 1 and new Patch Change Day. You must use another form of birth control (including condoms, spermicide, diaphragm) during the first week of the new patch cycle.
• If you forget to change your patch in the middle of the cycle (Day 8 or 15), apply a new patch during the first 48 hours. The next patch should be applied on your usual Patch Change Day. An additional form of birth control is not needed.
• If you forget to change your patch for more than 48 hours, start over a new 4-week patch cycle right away. The day you apply a new patch is now your new Day 1 and new Patch Change Day. You must use another form of birth control during the first week of the new patch cycle.
• If you forget to remove your patch for the patch free week:
  • Past Day 22: Take the patch off as soon as you remember. Start your next patch cycle on the usual Patch Change Day.
  • If you go more than 7 days without a patch, use another form of birth control to keep from getting pregnant. The patch should never be off more than 7 days in a row.
• Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. You may restart treatment with this medicine at least 2 weeks after completing treatment for hepatitis C infection.
• Some medicines can affect how levonorgestrel/ethinyl estradiol works. Tell your doctor if you are using any of the following:
  • Acetaminophen, aprepitant, ascorbic acid, atorvastatin, bosentan, cyclosporine, lamotrigine, morphine, prednisolone, rosuvastatin, salicylic acid, St John's wort, theophylline, tizanidine
  • Medicine to treat HIV/AIDS (including amprenavir/ritonavir, atazanavir/ritonavir, boceprevir, darunavir/ritonavir, efavirenz, etravirine, fosamprenavir/ritonavir, indinavir, lopinavir/ritonavir, nelfinavir, nevirapine, telaprevir, tipranavir/ritonavir)
  • Medicine to treat infection (including fluconazole, griseofulvin, itraconazole, ketoconazole, rifabutin, rifampin, rufinamide, voriconazole)
  • Medicine to treat seizures (including carbamazepine, felbamate, oxcarbazepine, phenytoin, topiramate)
  • Thyroid medicine
• If you are using colesevelam, take it 4 or more hours before using levonorgestrel/ethinyl estradiol.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you have recently been pregnant. Tell your doctor if you have gallbladder disease, uncontrolled high cholesterol, or a history of depression, hereditary angioedema, or dark patches in the face during pregnancy (chloasma gravidarum). Tell your doctor if you smoke, have a BMI greater than 25 kg/m2 but less than 30 kg/m2, or if you are having surgery that requires inactivity for a long time.
• This medicine may cause the following problems:
  • Increased risk of heart attack, stroke, or blood clots
  • Liver problems (including liver tumor or cancer)
  • High blood pressure
  • Gallbladder disease
  • High cholesterol in the blood, which can lead to swelling of the pancreas (pancreatitis)
  • Changes in mood or behavior
  • Increased risk of cancer (including cancer of the cervix)
• You might have some light bleeding or spotting, especially during the first 3 months of using this medicine. This is usually normal and should not last long. However, if you have heavy bleeding or the bleeding lasts more than seven days in a row, call your doctor's office.
• This medicine will not protect you from getting HIV/AIDS or other sexually transmitted diseases.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests. Do not use this medicine at least 4 weeks before and 2 weeks after a surgical procedure.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Fold the used patch in half with the sticky sides together. Throw any used patch away so that children or pets cannot get to it. You will also need to throw away old patches after the expiration date has passed.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Chest pain or tightness, trouble breathing, coughing up blood
• Dark urine, pale stools, loss of appetite, yellow skin or eyes
• Heavy vaginal bleeding
• Irregular, late, or missed menstrual periods
• Numbness or weakness in your arm or leg, or on one side of your body
• Pain in your lower leg (calf)
• Sudden and severe stomach pain, nausea, vomiting, lightheadedness
• Sudden or severe headache, problems with vision, speech, or walking
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual changes in mood or behavior

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, or a lump under your skin where the patch is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088