Pronunciation:

lee-voe-nor-JES-trel, ETH-i-nil es-tra-DYE-ol

Brand Names:

• Twirla

Dosage Forms:

• Patch, Extended Release

Warnings:

Warning: Cigarette Smoking and Serious Cardiovascular Events and Contraindicated in Women with BMI greater than or equal to 30 kg/m(2)Cigarette Smoking and Serious Cardiovascular EventsCigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including levonorgestrel/ethinyl estradiol, are contraindicated in women who are over 35 years of age and smoke.Contraindicated in Women with a BMI greater than or equal to 30 kg/m(2)Levonorgestrel/ethinyl estradiol is contraindicated in women with a BMI greater than or equal to 30 kg/m(2). Compared to women with a lower BMI, women with a BMI greater than or equal to 30 kg/m(2) had reduced effectiveness and may have a higher risk for venous thromboembolism events (VTEs) .

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Progestin

Uses of This Medicine:

Levonorgestrel and ethinyl estradiol combination is used to prevent pregnancy in women who can get pregnant with a BMI less than 30 kilograms (kg) per square meter (m2). It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control patches. Discuss your options for birth control with your doctor.

This medicine will not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies on the relationship of age to the effects of levonorgestrel and ethinyl estradiol combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females with a BMI of less than 30 kg/m2, but should not be used before the start of menstruation.

Older adults—

No information is available on the relationship of age to the effects of levonorgestrel and ethinyl estradiol combination in geriatric patients. This medicine is not indicated for use in elderly women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amifampridine
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Anagrelide
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethasone
• Bexarotene
• Boceprevir
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Cobicistat
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dipyrone
• Donepezil
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Felbamate
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fostemsavir
• Glecaprevir
• Grazoprevir
• Griseofulvin
• Guar Gum
• Indinavir
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mephobarbital
• Methohexital
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Nirmatrelvir
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Paclitaxel
• Paclitaxel Protein-Bound
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pibrentasvir
• Piperaquine
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Ritonavir
• Rufinamide
• Saquinavir
• Secobarbital
• Simeprevir
• Somatrogon-ghla
• St John's Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thiopental
• Thioridazine
• Ticarcillin
• Tigecycline
• Tirzepatide
• Tizanidine
• Topiramate
• Troglitazone
• Ulipristal
• Valproic Acid
• Voxilaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acitretin
• Amitriptyline
• Atazanavir
• Atorvastatin
• Clomipramine
• Diazepam
• Doxepin
• Etoricoxib
• Ginseng
• Imipramine
• Lamotrigine
• Levothyroxine
• Licorice
• Liothyronine
• Lorazepam
• Parecoxib
• Perampanel
• Roflumilast
• Selegiline
• Tacrine
• Temazepam
• Tipranavir
• Triazolam
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
• Breast cancer, known or suspected or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Heart attack, history of or
• Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), or history of or
• Hypertension (high blood pressure), uncontrolled or
• Jaundice during pregnancy or from using hormonal treatment in the past or
• Liver disease, including tumors or cancer or
• Migraine headache or
• Stroke, history of or
• Tumors (estrogen or progestin-sensitive), known or suspected or
• Women with a BMI of 30 kg/m2 or more—Should not be used in patients with these conditions.

• Chloasma gravidarum (dark patches in the face during pregnancy), history of or
• Depression, history or
• Gallbladder disease or
• Hereditary angioedema, history of or
• High cholesterol, uncontrolled—Use with caution. May make these conditions worse.

• Hypertriglyceridemia (high cholesterol in the blood) or family history of—Use with caution. May increase risk for pancreatitis (swelling of the pancreas).

• Women with a BMI greater than 25 kg/m2 but less than 30 kg/m2—Use of the medicine in these patients may not work as well. Talk to your doctor if you have concerns.

Proper Use of This Medicine:

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

To use the patch:

• Wash your hands with soap and water before and after you use this medicine.
• Carefully tear open the pouch when you are ready to put the patch on your skin. Do not cut it.
• The patient instructions will show the body areas where you can wear the patch. When you put on a 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 you apply 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.

If you are switching from another birth control method to using Twirla®:

• Birth control pill, transdermal system, or vaginal ring—Complete the current pill, transdermal, or vaginal ring cycle and apply Twirla® on the day that the next pill, transdermal, or vaginal ring cycle would normally start. Check with your doctor if your menses do not occur within a week after using the last active pill, transdermal, or vaginal ring. If you applied the patch more than a week after using the last active pill, transdermal, or vaginal ring, use another form of birth control (eg, condoms, spermicide, diaphragm) during the first week of using Twirla®.
• Injection or progestin-only pill—Apply Twirla® on the day the next injection or progestin-only pill would normally start.
• Intrauterine system or implant—Apply Twirla® on the day of intrauterine system or implant removal.

If you are using colesevelam, take it 4 or more hours before using levonorgestrel and ethinyl estradiol combination.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the 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 start after Day 1 of your menstrual period, use another form of birth control (including condoms, spermicide, diaphragm) during the first week of the new patch cycle.

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.

• For transdermal dosage form (patch):
  • For contraception (to prevent pregnancy):
    • Adults—Apply 1 patch to the lower stomach area, buttocks, or upper part of the body once a week for 3 weeks (Weeks 1, 2, and 3) in a row. Do not apply a patch during Week 4. After Week 4 ends, apply a new patch to start a new 28-day cycle. The patch should never be off more than 7 days in a row.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

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 (eg, 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.

Storage—

Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visitsto make sure this medicine is working properly. Blood and urine tests may also be needed to check for unwanted effects. Your doctor may also want to check your blood pressure while taking this medicine.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you had given birth within 4 weeks before you start using this medicine.

If you suspect that you may be pregnant, check with your doctor right away.

Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®). You may restart treatment with this medicine at least 2 weeks after completing treatment for hepatitis C infection.

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 a few days in a row, call your doctor’s office.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using ethinyl estradiol and norgestrel combination, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, a sudden loss of coordination, or vision changes while using this medicine.

Check with your doctor right away if you have pain or tenderness in the stomach, dark urine, pale stools, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.

This medicine may increase the cholesterol levels in the blood, which can lead to pancreatitis (swelling of the pancreas). Check with your doctor right away if you have bloating, chills, constipation, darkened urine, fast heartbeat, fever, indigestion, loss of appetite, nausea, pains in the stomach, side, or abdomen, possibly radiating to the back, vomiting, or yellow eyes or skin.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors, such as feeling sad or hopeless, getting upset easily, or feeling nervous or hostile. It may also cause some people to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

Using this medicine may increase your risk of having cancer of the cervix. Talk with your doctor about this risk. Check with your doctor right away if you experience abnormal vaginal bleeding.

Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine.

This patch will not protect you from getting HIV/AIDS, herpes, or other sexually transmitted diseases. Tell your doctor if you or your partner begins to have sexual intercourse with other people, or you or your partner tests positive for a sexually transmitted disease. If this is a concern for you, talk with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Difficulty breathing

pain in the chest, groin, or legs, especially the calves

severe, sudden headache

slurred speech

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

vision changes

Rare

Bloating

changes in behavior

chest pain

chills

confusion

cough

discouragement

dizziness

fast, weak pulse

feeling sad or empty

gaseous stomach pain

indigestion

irritability

lack of appetite

lightheadedness

loss of interest or pleasure

nausea

pale, cold clammy skin

recurrent fever

severe cramping

severe nausea

severe vomiting

sneezing

sore throat

stomach fullness or pain

sudden increase in abdominal or shoulder pain

sweating

thoughts of killing oneself

tightness in the chest

tiredness

trouble concentrating

trouble sleeping

unusual or large amount of vaginal bleeding

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Burning, itching, redness, skin rash, swelling, or soreness at the application site

Less common

Diarrhea

heavy bleeding

increased weight

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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