Description
Norelgestromin and ethinyl estradiol combination is used to prevent pregnancy in patients 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.
This patch allows more estrogen into the blood than oral birth control containing the same amount of estrogen.
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 with your doctor your options for birth control.
This medicine will not prevent HIV or other sexually transmitted diseases. It will not prevent hepatitis B. It will not help as emergency contraception, such as after unprotected sexual contact.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Patch, Extended Release
Before Using
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.
Pediatric
Appropriate studies on the relationship of age to the effects of norelgestromin 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.
Geriatric
Appropriate studies on the relationship of age to the effects of norelgestromin and ethinyl estradiol combination have not been performed in the geriatric population. This medicine is not indicated for use in elderly women.
Breastfeeding
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Drug Interactions
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
- Ensitrelvir
- Fezolinetant
- 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.
- Alclometasone
- Aldosterone
- Alfentanil
- Amcinonide
- Amifampridine
- Amobarbital
- Amoxicillin
- Ampicillin
- Amprenavir
- Anagrelide
- Apalutamide
- Aprepitant
- Armodafinil
- Avapritinib
- Bacampicillin
- Beclomethasone
- Belzutifan
- Betamethasone
- Bexarotene
- Boceprevir
- Bosentan
- Budesonide
- Bupropion
- Butabarbital
- Butalbital
- Carbamazepine
- Carbenicillin
- Cefaclor
- Cefadroxil
- Cefdinir
- Cefditoren
- Cefixime
- Cefpodoxime
- Cefprozil
- Ceftazidime
- Ceftibuten
- Cefuroxime
- Cenobamate
- Ceritinib
- Chlortetracycline
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.
- Amitriptyline
- Atazanavir
- Atorvastatin
- Diazepam
- Doxepin
- Etoricoxib
- Ginseng
- Imipramine
- Kratom
- Lamotrigine
- Leflunomide
- Levothyroxine
- Licorice
- Liothyronine
- Lorazepam
- Parecoxib
- Roflumilast
- Selegiline
- Temazepam
- Teriflunomide
- Tipranavir
- Triazolam
- Valdecoxib
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 is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.
- Tobacco
Using this medicine with any of the following is usually not recommended, 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.
- Grapefruit Juice
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, or history of or
- Cervical cancer, or history of 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
- Heart rhythm problems (eg, atrial fibrillation) or
- Hypertension (high blood pressure), uncontrolled or
- Liver disease, including tumors or cancer or
- Major surgery with a long period of inactivity or
- Migraine headache or
- Stroke, history of or
- Tumors (estrogen-dependent), 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 of or
- Dyslipidemia (high cholesterol or fats in the blood) or
- Edema (fluid retention or body swelling) or
- Gallbladder disease or
- Hereditary angioedema, history of or
- High cholesterol, uncontrolled or
- Hypertension (high blood pressure)—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).
- Obesity—Use of the transdermal patch may be less effective in women with body weight greater than or equal to 198 pounds (90 kilograms).
Proper Use
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 a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have questions.
This transdermal patch system is to be used for 28 days (four-week) cycle. A new patch is applied each week for 3 weeks (21 days), and week four is patch-free.
When you begin using norelgestromin and ethinyl estradiol combination transdermal, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception (eg, condoms, spermicides, diaphragms) for the first 7 days of your first patch cycle.
To use this patch:
- Keep each patch in the package until you are ready to use it.
- Wash your hands with soap and water before and after applying a patch.
- Tear open the pouch at the top edge and one side edge.
- You may apply the patch on your upper outer arm, stomach, buttocks, or back. Do not put the new patch on the same place you wore the last one. Do not put the patch on the waistline, straps, on the breasts, or cut or irritated skin.
- Avoid using creams, lotions, oils, or powders.
- Hold the patch with the clear plastic facing you. Peel away one piece of the clear plastic. Do not touch the sticky surface.
- Apply the patch to clean, dry skin. Remove the other piece of clear plastic. Press the patch firmly on the skin for 10 seconds. The patch should be flat and smooth without wrinkles.
- Check the patch every day and after any water exposure including bathing or showering to make sure 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, press it down firmly for 10 seconds to make sure it sticks on your skin or replace with a new patch right away.
- If the patch starts to lift or partially falls off for less than 1 day, try to reapply. If it does not completely stick, apply a new patch. An additional form of birth control is not needed.
- If the patch starts to lift or partially falls off for more than 1 day or if you are not sure for how long, 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 want to move your Patch Change Day to a different day of the week, finish your current cycle. Remove the third patch on the correct day. During week 4, the Patch Free Week (Days 22 to 28), you may apply the patch on the day you prefer. The day you apply a new patch is your new Day 1 and new Patch Change Day.
If the patch is not sticky or has stuck to material or itself, remove it and apply a new patch. Do not hold the patch in place with tape or wraps.
If you are switching from another birth control method to using Gwyn Lo™:
- Birth control pill, transdermal system, or vaginal ring—Complete the current pill, transdermal, or vaginal ring cycle and apply on the day that the next pill, transdermal, or vaginal ring cycle would normally start. Check with your doctor if your menses does 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 Gwyn Lo™.
- Injection or progestin-only pill—Apply Gwyn Lo™ on the day the next injection or progestin-only pill would normally start.
- Intrauterine system—Apply Gwyn Lo™ on the day of intrauterine system removal. If the IUS is not removed on the first day of menstruation, use another form of birth control (eg, condoms, spermicide, diaphragm) during the first week of using Gwyn Lo™.
- Implant—Apply Gwyn Lo™ on the day of implant removal.
If you are switching from a contraceptive pill or vaginal ring to using the patch, start the patch on the first day of your period on the day that you would usually use your next pill or vaginal ring for Xulane®. If your period does not start after 1 week for Xulane®, you should see your doctor for a pregnancy test. If you apply Xulane® more than 1 week after using your last pill or vaginal ring, use a second method of birth control with the patch for the first 7 days.
If you have a miscarriage or an abortion in the first trimester of your pregnancy, you may start norelgestromin and ethinyl estradiol combination transdermal right away. You do not need a second form of birth control. If you start this medicine 5 days or more after the miscarriage or abortion, you should use a second form of birth control with the patch for the first 24 hours during the start of your menstrual period or for the first 7 days on the first Sunday of your menstruation. If you have a miscarriage or abortion after the first trimester, you should wait for 4 weeks before starting this medicine.
If you use this patch after giving birth and choose not to breastfeed, you may start after 4 weeks to prevent the risk of having blood clots. If your menses does not occur before using the patch, use another form of birth control (eg, condoms, spermicide, diaphragm) for the first 7 days.
If you have bleeding with the patch in place, continue to use the patches as usual. If the bleeding continues for 2–3 cycles, call your doctor. If you do not have your period during the time the patch is off, stay on your regular schedule and call your doctor.
If the patch is uncomfortable or causes irritation, change to a new patch in a new location. Change the patch again on your regular schedule. Do not use more than one patch at a time.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.
If you are using colesevelam, take it 4 or more hours before using norelgestromin and ethinyl estradiol combination.
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 your 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.
- For transdermal dosage form (skin patch):
- For contraception (to prevent pregnancy):
- Adults—Apply one patch to the skin once a week for 3 weeks (Weeks 1, 2, and 3). Always change the patch on the same day of the week. 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.
- For contraception (to prevent pregnancy):
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.
Xulane®:
- If you forget to apply your patch during the 1st week, apply it as soon as possible and start a new cycle. Use a second form of birth control for the first week of the new cycle. You will now have a new patch start day.
- If you forget to change your patch in the 2nd or 3rd week for one or two days, change it as soon as you remember. No other form of birth control is needed. If you forget to change your patch in the 2nd or 3rd week for more than two days, change to a new patch and start a new cycle. Use a second form of birth control for the first week of the new cycle. If you forget to remove your patch at the end of the 3rd week, remove it as soon as possible and then start a new patch on your regular start day. You should never have the patch off for more than 7 days in a row.
Gwyn Lo™:
- If you forget to change your patch at the start of any cycle (Week 1, 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 (Week 2 or Week 3):
- If you forget to change your patch for 1 or 2 days, apply a new patch. 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 2 days, 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, take the patch off as soon as you remember. Start your next patch cycle on the usual Patch Change Day, the day after Day 28. An additional form of birth control is not needed.
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.
Ask your healthcare professional how you should dispose of any medicine you do not use.
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
It is very important that your doctor check your progress at regular visits to 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 have had a baby within 4 weeks before you start using this medicine.
If you think that you may be pregnant, check with your doctor right away.
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.
Norelgestromin and ethinyl estradiol transdermal may not work as well for you if you weigh more than 198 pounds (98 kilograms). Talk to your doctor about the kind of birth control that is best for you.
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 7 days in a row, call your doctor’s office.
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.
This medicine will not protect you from getting HIV/AIDS, herpes, or other sexually transmitted diseases. Tell your doctor if you or your partner begin 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.
Check with your doctor if you miss a menstrual period so that the cause may be determined. Missed periods may occur if you have not used the patch exactly as scheduled or the medicine is not the right strength or type for your needs. You might need a pregnancy test.
Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using this birth control, 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 the type of diet and exercise to control your weight and blood cholesterol level.
You will be exposed to more estrogen if you use this medicine than if you use a typical birth control pill. Increased estrogen exposure may increase the risk of side effects. Talk to your doctor about this risk.
Using this medicine may increase your risk of having blood clots, stroke, or heart attack. This risk may continue even after you stop using the medicine. Your risk for these serious problems is even greater if you have high blood pressure, high cholesterol in your blood, diabetes, overweight, or you smoke cigarettes. Contact your doctor immediately if you experience confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscles, or an inability to speak.
Check with your doctor immediately if you wear contact lenses or if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Using this medicine may increase your risk of breast cancer or cervical cancer. Talk with your doctor about this risk. Check with your doctor immediately if you experience abnormal vaginal bleeding or a lump in the breast or underarm.
Check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine or pale stools, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may increase your risk for 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.
Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.
Use with caution around small children. The contraceptive patch may be a choking hazard if swallowed by a child.
Make sure any doctor who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.
This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
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
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:
More common
- Body aches or pain
- chills
- cough
- difficulty with breathing
- ear congestion
- fever
- headache
- loss of voice
- nasal congestion
- runny nose
- sneezing
- sore throat
- unusual tiredness or weakness
Incidence not known
- Anxiety
- changes in skin color
- chest pain or discomfort
- confusion
- dark urine
- diarrhea
- dizziness
- eye pain
- fainting
- inability to speak
- itching
- lack or loss of appetite
- light-colored stools
- lightheadedness
- nausea
- numbness in the hands
- pain in the stomach
- pain in the chest, groin, or legs, especially the calves
- pain or discomfort in the arms, jaw, back, or neck
- pain, tenderness, or swelling of the foot or leg
- pounding in the ears
- rash
- seizures
- slow or fast heartbeat
- slurred speech
- sudden headache
- sudden loss of coordination
- sudden, severe weakness or numbness in the arm or leg on one side of the body
- sweating
- swelling, pain, or tenderness in the upper abdominal or stomach area
- temporary blindness
- unpleasant breath odor
- vision changes
- vomiting of blood
- 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, or redness of the skin
- menstrual cramps
- pain, soreness, swelling, or discharge from the breast or breasts
- swelling or soreness at the patch site
Incidence not known
- Absent, missed, or irregular menstrual periods
- bloody vaginal discharge
- brown, blotchy spots on exposed skin
- change in amount of vaginal discharge
- change in menstrual flow
- decreased amount of breast milk
- discouragement
- dry mouth
- feeling sad or empty
- increase or decrease in weight
- increased hunger or thirst
- increased urination
- irritability
- itching of the vagina or outside of the genitals
- light vaginal bleeding between periods and after sexual intercourse
- loss of interest or pleasure
- pain during sexual intercourse
- stomach cramps or bloating
- stopping of menstrual bleeding
- swelling
- thick, white curd-like vaginal discharge without odor or with mild odor
- trouble concentrating
- trouble sleeping
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.
DRG-20062923
