Transdermal Contraceptive Patch

Introduction

We offer 2 different transdermal contraceptive options:

The first generic version of this birth control is Ethinyl estradiol 0.035 mg and norelgestromin 0.15 mg per day. Similar brand names to this medication are: Xulane®, and Zafemy®

The second formulation of birth control, Twirla®, is Ethinyl estradiol 0.035mg and levonorgestrel 0.012mg per day. There are no generic equivalents at this time.

This birth control plan reviews the risks and benefits of the treatment we are recommending. Please make sure to read it and the manufacturer's pamphlet that comes with the medicine. The manufacturer's pamphlet contains the full information on interactions, side effects, and other important information you should know about the medicine before you start.

Important: This medication is less effective in individuals weighing over 198 pounds (90 kg) or a BMI of 30* or more based on clinical trials. If you fall within these categories please reach out to your Wisp provider for an appropriate contraceptive option.

*Twrila has shown reduced effectiveness in people with a BMI of 25 or over

Active Ingredient

• Ethinyl estradiol (Estrogen analog)
• Norelgestromin [NGMN] (Progestin) OR
• Levonorgestrel (Progestin)
  

Storage

• Your transdermal contraceptive patches should be stored at room temperature between 68°F to 77°F
• Do not store the transdermal contraceptive patches above 86°F
• Avoid direct sunlight.
• When discarding the transdermal patch you should fold the sticky sides of the patch together and place in the trash. Do not flush down the toilet.
  
  

Instructions

You have stated that you wish to take a transdermal contraceptive patch to prevent pregnancy, and in some instances improve menstrual symptoms. It contains 2 hormones: Norelgestromin OR Levonorgestrel depending on your prescription (progestins) and ethinyl estradiol (an estrogen). It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle.

The transdermal contraceptive patch will be placed one time each week on the same day for 3 weeks (21 total days) then you will allow one full patch free week (7 total days) to allow a cycle. Ensure to apply each new patch on the same day of the week- this will be your “patch change day”. Your patch should never be off for more than 7 days in a row. Once you’ve completed your patch free week you’ll apply a new patch to restart your 4 week cycle.

When and How to Start

This treatment can be started on the day of pick up or delivery. You do not need to start this treatment at any particular point within your menstrual cycle. You will need to use a backup method, like condoms, for the first week if you're having reproductive intercourse before pregnancy prevention will begin.

Your patch can be placed on your upper outer arm, abdomen, buttock or back in a place where it won’t be rubbed by tight clothing. Check the patch every day to make sure all edges are sticking correctly. Only apply to clean, dry skin. Your new patch MUST stick securely to your skin to work properly.

Do NOT:

• Place on your breasts, cut, or irritated skin
• Apply on your waistline or near clothing or undergarment seams
• Use lotions, creams, oils, powders, or make up at your patch site
• Try to reapply a patch if it is no longer sticky
• Tape or wrap the patch to your skin
  
  

Application

• Make sure your skin is clean and dry. Don’t use lotions, creams, oils, powders, or makeup at the patch site
• Tear open the pouch at the top edge. Peel open the pouch and gently remove the contents
• Peel away half of the clear plastic. Avoid touching the sticky surface with your fingers
• Apply the sticky side of the patch on your clean, dry skin. Remove the other half of the clear plastic and attach to your skin
  • Application sites: upper outer arm, abdomen, buttock, back, or in a place where it won’t be rubbed by tight clothing
  • NOT on breasts, cut or irritated skin, or near undergarment seams
• Press firmly on the patch with the palm of your hand for 10 seconds making sure the patch sticks to your skin. Smooth out any wrinkles around the outer edges
• Check your patch daily to make sure all edges are sticking correctly
• Wear only one patch at a time. Remove your old patch before applying a new patch
  
  

Switching from a different contraceptive

Oral, patch, or ring contraceptive: Start your new transdermal contraceptive patch the day after your last contraceptive pill, patch, or ring was taken. Use a backup method for one week if any doses were missed.

Injection: Start your transdermal contraceptive patch up to 15 weeks after your last injection. You should use a backup method for one week if it's been 15 weeks or over since your last injection.

**IUD or implant: ** Start your transdermal contraceptive patch 7 days prior to your IUD or implant removal. If you start your transdermal contraceptive patch after IUD or implant removal or less than a week before removal ensure to use a backup method for the first week.

Refills

You will automatically be sent a refill every 90 days (subject to a refill visit to help screen for side effects). You may request a refill early by logging into your Account (Subscriptions > Next Refill) or placing a new one-time order. If you decide to stop treatment prior to using your complete subscription please contact us for further guidance.

Allergies/Contraindications

True anaphylactic allergic reactions to hormonal contraception are extremely rare because the active ingredients in these medications mimic naturally occurring hormones in your body. However these medications do have other ingredients that may cause allergic reactions. If you experience any of the symptoms below, you should immediately go to the emergency room or call 911.

This list is not all inclusive

• Allergic reaction like: rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
• Liver problems like: dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of a blood clot like: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, change of color, or pain in a leg or arm, trouble speaking, or swallowing

There are several contraindications to taking hormonal combined contraception. If you have any of the following conditions please let your doctor know prior to starting medication:

• Adrenal insufficiency
• Current or history of estrogen or progesterone sensitive cancer
• Hepatic tumors
• Pregnancy
• Renal impairment
• Liver disease
• Undiagnosed abnormal uterine bleeding
• Taking hepatitis c drugs (ombitasvir/paritaprevir/ritonavir with or without dasabuvir)
• Prolonged immobilization
• Lupus with unknown of positive antiphospholipid antibody status
• Diabetes with a history of vascular disease or diabetes history >20 years
• Current gallbladder disease without surgical intervention
• Postpartum less than 6 weeks
• Recipient of organ transplant
• Porphyria
• Inflammatory bowel disease
• Advised by a healthcare provider to not take hormones Menopause
• Pancreatitis initiated on contraceptives in the past

Use is also contraindicated in women at high risk of having a blood clot or arterial or venous thrombotic diseases including:

• Cerebrovascular disease or history of strokes
• Coronary artery disease or history of heart attack
• Diabetes with a history of vascular disease or diabetes history >20 years
• Current or history of DVT (deep vein thrombosis) or PE (pulmonary Embolism)
• Hyper Coagulopathies (easy to make blood clots) (inherited or acquired),
• Hypertension or high blood pressure (uncontrolled)
• Headaches with focal neurological symptoms or migraines headaches with aura (with or without aura in >35 years old)
• Thrombogenic valvular or rhythm diseases of the heart (eg, subacute bacterial endocarditis with valvular disease or atrial fibrillation)
• 35+ years old who smoke
  
  

Conditions

We have evaluated your health history and the specific health information you provided us, however if anything changes and you develop or discover that one of these conditions applies to you please stop taking this medicine and call or message us immediately.

Pregnancy and Breastfeeding

Use is contraindicated in pregnant women. Combination hormonal contraceptives are used to prevent pregnancy; treatment should be discontinued if pregnancy occurs. In general, the use of combination hormonal contraceptives, when inadvertently used early in pregnancy, have not been associated adverse fetal or maternal effects

Due to the increased risk of blood clots in legs postpartum, combination hormonal contraceptives should not be started in breastfeeding women <21 days following delivery. The risk of getting a blood clot decreases to population baseline by postpartum day 42. Use of combination hormonal contraceptives in women between 21 and 42 days after delivery should take into consideration the individual woman's risk factors for Getting a blood clot (eg, age ≥35 years, previous blood clot, thrombophilia, immobility, preeclampsia, transfusion at delivery, cesarean delivery, peripartum cardiomyopathy, BMI ≥30 kg/m2, postpartum hemorrhage, or smoking). The risks, benefits, and alternatives to combination hormonal contraception should be evaluated when initiating treatment in breastfeeding women. This should be discussed with your doctor who delivered your child prior to starting treatment.

Combination based birth controls with estrogen may impact your milk supply. If you would like an alternative contraceptive that won't impact your milk supply we recommend a progestin only pill.

Emergency Side Effects

This medicine can cause dangerous and potentially life threatening side effects. If any of the emergency side effects listed in the manufacturer's pamphlet happen to you please stop taking the medicine and call 911 or seek immediate medical help in person. This list can include (but are not limited to):

• Anaphylaxis/anaphylactoid reaction (shortness of breath, difficulty breathing, facial swelling or edema, tongue swelling)
• Jaundice (yellowing of skin and eyes)
• Chest pain
• Visual changes
• Sudden severe headache
• One sided or persistent leg pain
• Weakness or numbness in your extremities
• Trouble speaking
  
  

Other Side Effects

• Edema (swelling in legs)
• Worsening of varicose veins
• Depression
• Melasma (brownish skin, on the forehead, nose, upper lip, and cheeks)
• Amenorrhea (loss of period)
• Breast Changes: breast enlargement, discharge, tenderness, pain
• Increased or decreased Weight
• Changes in menstrual flow
• Abdominal cramps, bloating, nausea, vomiting
• Breakthrough bleeding, spotting, changes in secretions
• Yeast infection
• Change in sexual drive
• Acne
• Headaches
• Bloating
• Vaginal discharge
• Skin irritation: redness, pain, swelling, itching, or rash at patch application site- try a new application site
  
  

Medicines, Supplements, and Foods

We have evaluated your health history and the specific health information you provided us, however if anything changes and you start or discover that you are taking any of the medicines, foods, or supplements listed below call or message us before you take the medicine. Some of these can cause your birth control to be less effective and cause more severe or dangerous side effects. Alternative method of contraceptive (male condoms) Should be used if you are taking these medications (This list is not all inclusive):

• Antibiotics: Rifampin, cefixime, ciprofloxacin, fluconazole, metronidazole nitrofurantoin macrocrystal oral.
• Anticonvulsants or anti-seizure medications such as carbamazepine (Tegretol®), phenytoin (Dilantin®), oxcarbazepine (Trileptal®), primidone, Lamotrigine (Lamictal®) or topiramate (Topamax®)
• Antifungal medications such as griseofulvin (Gris-PEG®), ketoconazole (Extina®, Nizoral®, Xolegel®)
• Antiretrovirals: ritonavir, ombitasvir, paritaprevir, dasabuvir
• Herbal medications such as St. John’s wort & DIM
• HIV Medications
• Modafinil (Provigil®)
  
  

Accurate Information

We have evaluated the specific health information you provided and are making our recommendations based on it. If you forgot to provide or incorrectly provided that information we may misdiagnose or fail to diagnose conditions that you may have which could affect our recommendation for treatment. If you need to clarify or update any information about your health you can message or call us anytime.

Treatment Failure/Missed Doses

The effectiveness of hormonal contraception is very high when it is consistently used and doses are not missed. Approximately 1 to 2 women out of 100 women may get pregnant using a transdermal contraceptive patch for the first year. The biggest cause of pregnancy is missed doses or not following dosing schedules with the transdermal contraceptive patch.

Missed Doses

Week 1 or Day 1: You may not be protected from pregnancy. Apply a new patch as soon as you remember, this will be your “new patch day.” Use a back-up method, like condoms, for 7 days if engaging in reproductive intercourse.

**In the middle of the cycle- Days 8-15 ** Up to 48 hours: Replace the patch immediately. Keep the same “patch change day.” No back-up contraception is needed if no other doses were missed More than 48 hours: You may not be protected from pregnancy. Place a new contraceptive patch immediately to restart your 4 week cycle. This will be your new “patch change day” and the first day of your 4 week cycle. Use a back-up method, like condoms, for 7 days if engaging in reproductive intercourse.

Forgetting to remove your patch after week 3: Take your patch off as soon as you remember. The next cycle should be started on your usual “patch change day.” No back-up is needed if you haven’t missed any days previously.

Managing Partial or Complete patch detachments

If an edge lifts up

• Press firmly down on the patch with the palm of the hand for 10 seconds to ensure the entire patch is adhered to the skin. Smooth any wrinkles around the edges
• If the patch doesn’t stick completely after attempted re-adhesion the patch should be removed and a new patch should be applied

If the patch has been off partially

• Less than one day: Try to reapply the patch. If it doesn’t adhere completely, apply a new patch immediately. No back-up method is needed and the “patch change day” will be the same.
• More than one day or unsure of time frame: You may not be protected from pregnancy. Apply a new patch and restart your new 4 week cycle. This will be your new “patch change day.” You will need to use a back-up method, like condoms, for 7 days if engaging in reproductive intercourse

Accepting or Declining Our Recommendation

We are recommending this treatment for you because the potential benefits of treatment outweigh the risks. You should evaluate this information as well as the manufacturer's pamphlet, and any input from your in-person healthcare team, or other relevant information to decide if this treatment plan is appropriate for you. You are free to decline our treatment recommendations.

Alternative Treatment

We have based our recommendation on your specific case and current medical guidelines, but there may be alternative treatments or strategies that may be helpful to you. Some may be more or less effective than what we provide. Some treatments may require an in-person exam or procedure which we can't provide. Message us or talk to your doctor in-person to discuss alternative treatments. Here are some other treatments or strategies that you might consider:

• Implanon implant contraceptives
• Intrauterine device (IUD)
• Intermittent injections
• Transdermal patches
• Oral contraceptive pills
• Male or female condoms
• Diaphragm
• Spermicide
• Sterilization
• Sponge
• Cap
• Diaphragm
• Fertility Awareness Method
• Phexxi
  
  

Share with Your In-Person Healthcare Team

You can access your records anytime. We strongly recommend that you update your in-person doctor, pharmacist, and the rest of your healthcare team to let them know about any new medicines you are taking or other changes in your health. You can also ask us questions anytime and we are happy to help you share any information about your health with your in-person healthcare team.