Evra

Follow the instructions in the package insert or those given to you by your doctor.

A patch is worn every day for 3 weeks. The patch is changed each week and is worn for 7 days. During the 4th week, no patch is worn and menstruation will occur. Always change the patch on the same day of the week. Never be without a patch for longer than 7 days at a time – you may not be protected against pregnancy.

Only one patch should be worn at a time. Apply the patch to clean, dry, healthy skin. It should be applied to the buttock, abdomen, upper outer arm, or upper torso in a spot that will not be rubbed by clothing. Do not apply it to the breast. Do not apply the patch on red, irritated, or cut skin. Do not use creams or other skin products on the area where the patch is currently applied or where you will be soon placing the patch.

Patches must be applied whole, do not cut or damage the patch. Cutting the patch changes the amount of medication that can be absorbed and may change the effectiveness of this medication.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones given here, do not change the way you are using the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you make a dosing error (e.g., forget to change your patch), or if your patch becomes loose or falls off, check the instructions that came with the medication. If you are not sure what to do, contact your doctor and use a backup method of birth control.

There is still active medication in the patch when it is removed at the end of the week. To prevent children and pets from coming into contact with the medication, fold it in half, with the sticky sides together before discarding the patch safely.

Store this medication at room temperature. Each patch should be stored in its protective pouch inside the original box. Keep this medication out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each transdermal system sealed within a protective pouch and heat-stamped "EVRA™" contains 6 mg of norelgestromin and 0.60 mg of ethinyl estradiol in the middle layer, releasing approximately 200 µg of norelgestromin and 35 µg of ethinyl estradiol every 24 hours. Nonmedicinal ingredients: backing layer: low-density pigmented polyethylene outer layer and a polyester inner layer; middle layer inactive components: polyisobutylene/polybutene adhesive, crospovidone, non-woven polyester fabric, lauryl lactate; release liner: polyethylene terephthalate film with polydimethylsiloxane coating on one side. The EVRA transdermal system does not contain any metal components.

Do not use norelgestromin - ethinyl estradiol if you:

• are allergic to norelgestromin or ethinyl estradiol or any other ingredients of the medication

• are immobilized for prolonged periods

• are known or suspected to be pregnant

• have or have had blood clots (in the legs, lungs, eyes, or anywhere else) or have severe or multiple risk factors for them

• have or have had a stroke or TIA ("mini-stroke")

• have or have had a heart attack or chest pain (angina)

• have or have had valvular heart disease with complications

• have severe high blood pressure (always >160/100 mmHg)

• have diabetes with blood vessel involvement

• have very high cholesterol

• have health conditions that increase the risk of blood clots (such as certain inherited blood clotting diseases; talk to your doctor for more information)

• smoke and are over the age of 35

• have active liver disease

• have or have had liver tumours (benign or malignant)

• have or are suspected to have breast cancer

• have or are suspected to have cancer of the reproductive organs (e.g., endometrium)

• have undiagnosed abnormal vaginal bleeding

• have yellowing of the skin (jaundice) due to steroids or blocked bile ducts

• have yellowing of the eyes or skin during pregnancy

• have vision problems due to vascular eye disease

• have migraine with focal aura

• have had major surgery associated with an increased risk of blood clots

• are taking the following medication combination used to treat Hepatitis C: paritaprevir, ritonavir, ombitasvir with or without dasabuvir

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who uses this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people using this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain

• acne

• appetite changes

• bleeding between periods

• breast discomfort

• changes in menstrual periods

• changes in skin pigmentation

• diarrhea

• discomfort or difficulty wearing contact lenses

• dizziness

• gas

• gain or loss of body or facial hair

• flu-like illness

• headache (unless it is sudden, severe, or worsening)

• nausea

• painful menstrual periods

• rash

• skin irritation, redness, or rash where the patch was applied

• stuffy or runny nose

• tiredness

• vomiting

• weight changes

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abnormal swelling of arms or legs

• back pain

• breast lumps

• headaches or migraines

• muscle pain

• nervousness

• severe pain or a lump in the abdomen

• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

• swelling of the feet, ankles, or lower leg

• symptoms of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)

• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)

• vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge

• unexpected vaginal bleeding

Stop using the medication and seek immediate medical attention if any of the following occur:

• convulsions

• loss of vision or change in vision (sudden)

• pains in chest, groin, or leg (especially in calf of leg)

• signs of a blood clot in the lung (e.g., coughing up blood, sudden/unexplained shortness of breath)

• signs of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

The information provided here results from studies of combination oral contraceptives; the patch contraceptive is thought to have similar risks. Oral combination contraceptives increase the risk of the following serious conditions:

• blood clots

• gallbladder disease

• heart attack

• liver tumours

• stroke

The risk of disease or death from these conditions greatly increases if a woman has other risk factors such as high blood pressure, high cholesterol, obesity, or diabetes.

Smoking while using hormonal contraceptives increases the risk of side effects that affect the heart and blood vessels (e.g., blood clots). This risk is greatest for those 35 years and older. You should not take this medication if you smoke and are 35 years or older.

Blood clots: This medication may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities. If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.

You should stop using the patch immediately if you develop any of the following:

• blood clot disorders and cardiovascular disorders (e.g., inflammation of a vein due to blood clot, blood clot in your lung)

• a condition that makes you immobile for a long period of time (e.g., recovering from major surgery, being bedridden due to a long-term illness)

• vision or eye problems (e.g., double vision, certain eye conditions) – check with your doctor

• severe headache without known cause, or worsening of preexisting migraine

**Blood pressure: **You should not take this medication if you have high blood pressure that is not controlled by medication. If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Body weight: For those weighing 90 kg (198 lbs.) or more, the patch may be less effective. Check with your doctor for more information.

Breast cancer: Increasing age and a strong family history are the most significant risk factors for the development of breast cancer. Other established risk factors include obesity, not having had children, and a late age at first full-term pregnancy. The identified groups of people that may be at increased risk of developing breast cancer before menopause are those who have used birth control pills for more than 8 years or who started using them at an early age. For a few people, the use of birth control pills may accelerate the growth of an existing but undiagnosed breast cancer.

People taking this medication should do regular breast self-exams and have yearly physical exams done by their doctor. Notify your doctor any time you detect a lump because, if a breast cancer should develop, medications that contain estrogen may cause the cancer to grow more quickly.

Depression: Hormones, such as estrogen, have been known to cause mood swings and symptoms of depression. If you have had clinical depression in the past, you may be more likely to experience it again while taking this medication. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication contact your doctor as soon as possible.

Heat sources: Do not expose the patch area to heat sources such as heating pads, electric blankets, saunas, hot tubs, or heat lamps. This may increase the amount of medication that enters your body through the skin.

Eye disorders: People who are using hormonal birth control may experience fluid buildup in the cornea of the eye that may cause visual disturbances and changes in tolerance to rigid (i.e., hard) contact lenses. Soft contact lenses usually do not cause disturbances. If visual changes or alterations in tolerance to contact lenses occur, you may need to stop wearing them.

Fibroids: This medication may worsen fibroids, causing sudden enlargement, pain, or tenderness. If you notice these effects, contact your doctor.

Gall bladder disease: This medication can cause gall bladder disease to become worse. If you have gall bladder disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver problems:  If you have active liver disease, decreasing liver function, or liver tumours, you should not take this medication. If you have a history of liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
If you experience symptoms of liver problems such as sudden, sharp abdominal pain, fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Migraine and headache: The onset or worsening of migraines or the development of new types of recurrent, persistent, or severe headaches should be reported to your doctor. Hormonal birth control may increase the risk of stroke for women who experience migraine headaches.

Return to fertility: After stopping birth control therapy, you should delay pregnancy until at least one normal menstrual cycle has occurred in order to date the pregnancy. An alternative birth control method (e.g., condoms) should be used during this time.

**Seizures: **Seizures have been reported by a small number of people using this medication. If you have a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience a seizure or increased frequency of seizures, let your doctor know immediately.

Sexually transmitted infections: Birth control patches do not protect against sexually transmitted infections, including HIV/AIDS. For protection against these, use latex condoms.

Pregnancy: This medication should not be taken during pregnancy. You should stop using this medication if you become pregnant and contact your doctor.

Breast-feeding: This medication passes into breast milk and may affect your baby. Adverse effects on the baby, such as jaundice and breast enlargement, have been reported. Talk to your doctor about whether you should continue breast-feeding.

Children: This medication is not recommended for use before the start of menstruation in puberty.

There may be an interaction between norelgestromin - ethinyl estradiol patch and any of the following:

• anastrozole

• anticonvulsants (e.g., carbamazepine, clobazam, phenobarbital, phenytoin, primidone, rufinamide, topiramate)

• apalutamide

• aprepitant

• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)

• bosentan

• celecoxib

• CF transmembrane regulators (e.g., elexacaftor, lumacaftor)

• cholestyramine

• clarithromycin

• clozapine

• cobicistat

• colesevelam

• colestipol

• corticosteroids (e.g., dexamethasone, prednisone)

• cyclosporine

• dantrolene

• darolutamide

• deferasirox

• diabetes medications (e.g., acarbose, canagliflozin, gliclazide, liraglutide, insulin, metformin, sitagliptin)

• echinacea

• elagolix

• enzalutamide

• flibanserin

• fostemsavir

• folic acid

• glecaprevir

• grapefruit juice

• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine)

• HIV protease inhibitors (e.g., atazanavir, darunavir, ritonavir)

• lenalidomide

• lomitapide

• levothyroxine

• liothyronine

• lomitapide

• mavacamten

• melatonin

• mifepristone

• modafinil

• morphine

• mycophenolate

• nirmatrelvir and ritonavir

• octreotide

• ospemifene

• perampanel

• pitolisant

• pomalidomide

• protein kinase inhibitors (e.g., ceritinib, dabrafenib, idelalisib)

• rifabutin

• rifampin

• roflumilast

• ropinirole

• sarilumab

• St. John's wort

• selegiline

• siltuximab

• tacrolimus

• tecovirimat

• telotristat

• theophyllines (e.g., aminophylline, theophylline)

• tizanidine

• tocilizumab

• tranexamic acid

• tretinoin

• ulipristal

• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Evra