Zafemy Patches
WARNING: Smoking cigarettes while using this drug raises the chance of severe heart and blood-related side effects. This chance is raised with age (mainly older than 35 years of age). It is also raised with the number of cigarettes smoked. It is strongly advised not to smoke. Do not use this drug if you smoke and are older than 35 years of age.Be sure you know your body mass index (BMI). If you do not know, talk with your doctor. Do not use this drug if your BMI is 30 or more. The risk of blood clots may be higher with a BMI of 30 or more. @ COMMON USES: It is used to prevent pregnancy. If you have been given this drug for some other reason, talk with your doctor for more information.
Drug Class
Contraceptive, Hormonal
Pharmacologic Class
Estrogen/Progestin Combination
Pregnancy Category
Category X
FDA Approved
Jul 2019
DEA Schedule
Not Controlled
Overview
What is this medicine?
Zafemy is a transdermal patch that contains two types of female hormones, an estrogen (ethinyl estradiol) and a progestin (norelgestromin). It is used to prevent pregnancy by stopping ovulation (the release of an egg from the ovary) and by changing the cervical mucus and uterine lining. You wear one patch for a week, then replace it with a new one for two more weeks, followed by one week without a patch.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Apply one patch once a week for three weeks, on the same day each week. Do not apply a patch during the fourth week.
Applying the Patch
Apply the patch to clean, dry, healthy skin on the buttock, belly, upper arm, or back. Choose a different site for each patch to avoid skin irritation. Avoid applying the patch to the breast, waistline, or skin that is irritated, damaged, or has folds. Also, avoid areas that will be rubbed by tight clothing.
Important Application Instructions
Do not cut or divide the patches.
Do not use damaged patches.
Do not use adhesives or wraps to hold the patch in place.
Do not apply the patch to skin where you have recently used creams, oils, lotions, powder, or other skin products, as this may affect the patch's adhesion.
Additional Contraceptive Measures
After starting this medication, you may need to use a non-hormone type of birth control, such as condoms, to prevent pregnancy for a period of time. Follow your doctor's instructions regarding the use of additional birth control methods.
Missed Doses and Patch Replacement
Do not skip doses, even if you do not have sex frequently.
Do not apply more than one patch at a time.
If you miss two periods in a row, take a pregnancy test before starting a new dosing cycle.
If you have not used the medication correctly and miss one monthly period, take a pregnancy test.
If the patch falls off and has been off for less than 24 hours, reapply the same patch to the same site.
If the patch is no longer sticky or is sticking to itself or another surface, apply a new patch.
* If a patch has been off for more than 24 hours, you may not be protected from pregnancy. Apply a new patch to start a new four-week cycle, and use an additional type of birth control, such as a condom, during the first week of the new cycle.
Interactions and Precautions
If you consume grapefruit juice or eat grapefruit regularly, consult your doctor.
Storage and Disposal
Store the medication at room temperature, away from refrigeration and freezing.
Missed Dose Instructions
If you miss a dose, refer to the package insert or consult your doctor for guidance. If you are using this medication for contraception, you may need to use a non-hormone form of birth control, such as condoms, for a period of time to prevent pregnancy.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Apply one patch once a week for three weeks, on the same day each week. Do not apply a patch during the fourth week.
Applying the Patch
Apply the patch to clean, dry, healthy skin on the buttock, belly, upper arm, or back. Choose a different site for each patch to avoid skin irritation. Avoid applying the patch to the breast, waistline, or skin that is irritated, damaged, or has folds. Also, avoid areas that will be rubbed by tight clothing.
Important Application Instructions
Do not cut or divide the patches.
Do not use damaged patches.
Do not use adhesives or wraps to hold the patch in place.
Do not apply the patch to skin where you have recently used creams, oils, lotions, powder, or other skin products, as this may affect the patch's adhesion.
Additional Contraceptive Measures
After starting this medication, you may need to use a non-hormone type of birth control, such as condoms, to prevent pregnancy for a period of time. Follow your doctor's instructions regarding the use of additional birth control methods.
Missed Doses and Patch Replacement
Do not skip doses, even if you do not have sex frequently.
Do not apply more than one patch at a time.
If you miss two periods in a row, take a pregnancy test before starting a new dosing cycle.
If you have not used the medication correctly and miss one monthly period, take a pregnancy test.
If the patch falls off and has been off for less than 24 hours, reapply the same patch to the same site.
If the patch is no longer sticky or is sticking to itself or another surface, apply a new patch.
* If a patch has been off for more than 24 hours, you may not be protected from pregnancy. Apply a new patch to start a new four-week cycle, and use an additional type of birth control, such as a condom, during the first week of the new cycle.
Interactions and Precautions
If you consume grapefruit juice or eat grapefruit regularly, consult your doctor.
Storage and Disposal
Store the medication at room temperature, away from refrigeration and freezing.
Missed Dose Instructions
If you miss a dose, refer to the package insert or consult your doctor for guidance. If you are using this medication for contraception, you may need to use a non-hormone form of birth control, such as condoms, for a period of time to prevent pregnancy.
Lifestyle & Tips
- Do not smoke while using Zafemy, especially if you are over 35 years old, as this significantly increases your risk of serious side effects like blood clots, heart attack, and stroke.
- Zafemy does not protect against HIV/AIDS or other sexually transmitted infections (STIs). Use condoms to protect against STIs.
- Maintain regular physical activity and a healthy diet to support overall cardiovascular health.
- Attend all scheduled follow-up appointments with your healthcare provider for blood pressure checks and annual exams.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One transdermal patch applied once a week for 3 consecutive weeks, followed by a patch-free week in Week 4. A new cycle begins on Day 1 of the next week (the day after Week 4 ends).
Condition-Specific Dosing:
first_time_use:
Apply the first patch on the first day of menstruation (Day 1 Start) or on the first Sunday after menstruation begins (Sunday Start).
missed_patch:
Refer to package insert for specific instructions based on when the patch was missed and for how long.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established for pre-menarcheal girls. Post-menarcheal adolescents follow adult dosing guidelines.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
Use with caution; no specific studies have been conducted in this population.
Dialysis:
Not available
Hepatic Impairment:
Mild:
Use with caution.
Moderate:
Use with caution.
Severe:
Contraindicated in women with acute or chronic liver disease or hepatic adenomas/carcinomas.
Pharmacology
Mechanism of Action
Zafemy acts by suppressing gonadotropins (follicle-stimulating hormone and luteinizing hormone) through the combined actions of ethinyl estradiol and norelgestromin. The primary mechanism is the inhibition of ovulation. Other mechanisms include changes in the cervical mucus (making it more difficult for sperm to penetrate) and changes in the endometrium (making it less receptive to implantation).
Pharmacokinetics
Absorption:
Bioavailability:
Norelgestromin: Approximately 60-70% (transdermal). Ethinyl Estradiol: Approximately 40-50% (transdermal).
Tmax:
Norelgestromin: Approximately 48 hours. Ethinyl Estradiol: Approximately 48 hours.
FoodEffect:
Not applicable for transdermal patch.
Distribution:
Vd:
Norelgestromin: Approximately 3.1 L/kg. Ethinyl Estradiol: Approximately 4.4 L/kg.
ProteinBinding:
Norelgestromin: >99% (primarily to albumin and sex hormone-binding globulin [SHBG]). Ethinyl Estradiol: >98% (primarily to albumin and SHBG).
CnssPenetration:
Limited
Elimination:
HalfLife:
Norelgestromin: Approximately 28 hours. Ethinyl Estradiol: Approximately 17 hours.
Clearance:
Norelgestromin: Approximately 6.4 L/hr. Ethinyl Estradiol: Approximately 10 L/hr.
ExcretionRoute:
Renal (urine) and fecal (bile).
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Contraceptive efficacy begins after the first 7 consecutive days of patch use in the first cycle.
PeakEffect:
Steady-state concentrations are generally reached within 2 weeks of continuous patch application.
DurationOfAction:
One week per patch application.
Safety & Warnings
BLACK BOX WARNING
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS: Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combined hormonal contraceptives, including Zafemy, are contraindicated in women who are over 35 years of age and smoke. Zafemy is associated with a higher risk of venous thromboembolism (VTE) than oral contraceptives containing 30-35 mcg of ethinyl estradiol and levonorgestrel.
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of gallbladder problems, including:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Changes in stools
+ Dark urine or yellow skin or eyes
+ Fever with chills
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Depression or other mood changes
Feeling very tired or weak
Eyesight changes or loss
Bulging eyes
Changes in how contact lenses feel
A lump in the breast, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Severe or persistent vaginal bleeding or spotting
This medication may also cause fluid retention, leading to swelling or weight gain. If you experience any of the following symptoms, contact your doctor:
Swelling
Weight gain
Trouble breathing
Seek immediate medical attention if you notice signs of a blood clot, such as:
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
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to contact your doctor if you notice any of the following:
Weight gain
Headache
Upset stomach or vomiting
Stomach pain or cramps
Bloating
Enlarged breasts
Breast soreness
Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles
Decreased interest in sex
* Irritation where the medication is applied
If you have any questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of gallbladder problems, including:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Changes in stools
+ Dark urine or yellow skin or eyes
+ Fever with chills
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Depression or other mood changes
Feeling very tired or weak
Eyesight changes or loss
Bulging eyes
Changes in how contact lenses feel
A lump in the breast, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Severe or persistent vaginal bleeding or spotting
This medication may also cause fluid retention, leading to swelling or weight gain. If you experience any of the following symptoms, contact your doctor:
Swelling
Weight gain
Trouble breathing
Seek immediate medical attention if you notice signs of a blood clot, such as:
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
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to contact your doctor if you notice any of the following:
Weight gain
Headache
Upset stomach or vomiting
Stomach pain or cramps
Bloating
Enlarged breasts
Breast soreness
Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles
Decreased interest in sex
* Irritation where the medication is applied
If you have any questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- A: Abdominal pain (severe)
- C: Chest pain (severe), cough, shortness of breath
- H: Headaches (severe, sudden, or worse than usual), dizziness, weakness, numbness
- E: Eye problems (blurred vision, loss of vision, bulging eyes)
- S: Severe leg pain (calf or thigh), swelling, warmth, redness
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Describe the allergic reaction and its symptoms.
A history of certain health problems, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Chest pain (angina) or heart attack
+ Stroke or high blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical or vaginal cancer, or unexplained vaginal bleeding.
Eyesight problems, such as loss of vision due to blood vessel disorders in the eye.
* Recent use (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
Additionally, certain medications, herbal products, or health conditions may interfere with the effectiveness of hormone-based birth control. Be sure to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor. You may need to use a non-hormonal form of birth control, such as condoms, in addition to this medication.
If you have experienced jaundice (yellowing of the skin and eyes) during pregnancy or while using estrogen-containing products, such as hormonal birth control, inform your doctor.
Do not take this medication if you are pregnant or think you may be pregnant.
This is not an exhaustive list of all potential interactions. Therefore, it is crucial to inform your doctor and pharmacist about all your medications and health problems to ensure safe use of this medication. Never start, stop, or change the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Describe the allergic reaction and its symptoms.
A history of certain health problems, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Chest pain (angina) or heart attack
+ Stroke or high blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical or vaginal cancer, or unexplained vaginal bleeding.
Eyesight problems, such as loss of vision due to blood vessel disorders in the eye.
* Recent use (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
Additionally, certain medications, herbal products, or health conditions may interfere with the effectiveness of hormone-based birth control. Be sure to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor. You may need to use a non-hormonal form of birth control, such as condoms, in addition to this medication.
If you have experienced jaundice (yellowing of the skin and eyes) during pregnancy or while using estrogen-containing products, such as hormonal birth control, inform your doctor.
Do not take this medication if you are pregnant or think you may be pregnant.
This is not an exhaustive list of all potential interactions. Therefore, it is crucial to inform your doctor and pharmacist about all your medications and health problems to ensure safe use of this medication. Never start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will instruct you on when to resume taking it after the surgery or procedure.
Blood Clot Risk
This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this risk with your doctor. Additionally, because this medication contains a higher dose of estrogen compared to some other birth control pills, the risk of blood clots may be higher. Talk to your doctor about this potential risk.
Prolonged Immobility
If you will be stationary for extended periods, such as during long trips, bedrest after surgery, or illness, inform your doctor. Prolonged immobility may increase your risk of developing blood clots.
Weight and Effectiveness
If you weigh 198 pounds (90 kilograms) or more, this medication may be less effective in preventing pregnancy. Consult your doctor to discuss alternative options.
Diabetes
If you have high blood sugar (diabetes), inform your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as directed by your doctor, and report any signs of high blood sugar, such as confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Cholesterol and Triglyceride Levels
This medication may cause high cholesterol and triglyceride levels. Discuss this risk with your doctor and have your blood work checked as directed.
Blood Pressure
Drugs like this one may cause high blood pressure. Have your blood pressure checked regularly as advised by your doctor.
Regular Check-Ups
Regular breast exams, gynecology check-ups, and breast self-exams are crucial while taking this medication. Follow your doctor's recommendations for these exams.
Lab Tests
Inform all your healthcare providers and lab workers that you are taking this medication, as it may affect certain lab tests.
Sexually Transmitted Diseases
This medication does not protect against diseases like HIV or hepatitis that are transmitted through sexual contact. Use a latex or polyurethane condom during sex to reduce the risk of transmission. If you have questions, consult your doctor.
Cancer Risks
Some studies suggest that taking hormone-based birth control, like this medication, may increase the risk of cervical cancer, although this may be due to other factors. Additionally, there is conflicting evidence about the risk of breast cancer associated with long-term use of hormone-based birth control. Discuss any concerns with your doctor.
Skin Darkening
This medication may cause dark patches on your face. Avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing to minimize this risk.
Pediatric Use
This medication is not intended for use in children who have not had their first menstrual period.
Pregnancy
If you suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately.
Breastfeeding
If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will instruct you on when to resume taking it after the surgery or procedure.
Blood Clot Risk
This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this risk with your doctor. Additionally, because this medication contains a higher dose of estrogen compared to some other birth control pills, the risk of blood clots may be higher. Talk to your doctor about this potential risk.
Prolonged Immobility
If you will be stationary for extended periods, such as during long trips, bedrest after surgery, or illness, inform your doctor. Prolonged immobility may increase your risk of developing blood clots.
Weight and Effectiveness
If you weigh 198 pounds (90 kilograms) or more, this medication may be less effective in preventing pregnancy. Consult your doctor to discuss alternative options.
Diabetes
If you have high blood sugar (diabetes), inform your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as directed by your doctor, and report any signs of high blood sugar, such as confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Cholesterol and Triglyceride Levels
This medication may cause high cholesterol and triglyceride levels. Discuss this risk with your doctor and have your blood work checked as directed.
Blood Pressure
Drugs like this one may cause high blood pressure. Have your blood pressure checked regularly as advised by your doctor.
Regular Check-Ups
Regular breast exams, gynecology check-ups, and breast self-exams are crucial while taking this medication. Follow your doctor's recommendations for these exams.
Lab Tests
Inform all your healthcare providers and lab workers that you are taking this medication, as it may affect certain lab tests.
Sexually Transmitted Diseases
This medication does not protect against diseases like HIV or hepatitis that are transmitted through sexual contact. Use a latex or polyurethane condom during sex to reduce the risk of transmission. If you have questions, consult your doctor.
Cancer Risks
Some studies suggest that taking hormone-based birth control, like this medication, may increase the risk of cervical cancer, although this may be due to other factors. Additionally, there is conflicting evidence about the risk of breast cancer associated with long-term use of hormone-based birth control. Discuss any concerns with your doctor.
Skin Darkening
This medication may cause dark patches on your face. Avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing to minimize this risk.
Pediatric Use
This medication is not intended for use in children who have not had their first menstrual period.
Pregnancy
If you suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately.
Breastfeeding
If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Withdrawal bleeding (in females)
What to Do:
There is no specific antidote. Treatment is symptomatic and supportive. In case of suspected overdose, contact a poison control center or seek immediate medical attention. Call 1-800-222-1222 for Poison Control.
Drug Interactions
Contraindicated Interactions
- Hepatitis C virus (HCV) drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (due to potential for ALT elevations).
Major Interactions
- CYP3A4 inducers (e.g., rifampin, barbiturates, carbamazepine, oxcarbazepine, phenytoin, topiramate, felbamate, griseofulvin, St. John's Wort): May decrease contraceptive efficacy and increase breakthrough bleeding.
- Aromatase inhibitors (e.g., anastrozole, letrozole): May reduce efficacy of the aromatase inhibitor.
- Selective estrogen receptor modulators (SERMs) (e.g., tamoxifen, raloxifene): May reduce efficacy of the SERM.
- Protease inhibitors (e.g., ritonavir, nelfinavir): May alter plasma concentrations of ethinyl estradiol and norelgestromin.
- Non-nucleoside reverse transcriptase inhibitors (NNRTIs) (e.g., efavirenz, nevirapine): May alter plasma concentrations of ethinyl estradiol and norelgestromin.
Moderate Interactions
- Lamotrigine: Combined hormonal contraceptives may significantly decrease lamotrigine plasma concentrations, potentially leading to loss of seizure control.
- Thyroid hormone replacement therapy: Estrogens can increase thyroid-binding globulin (TBG), leading to increased total thyroid hormone levels and potentially requiring an increase in thyroid hormone dose.
- Cyclosporine: Combined hormonal contraceptives may increase cyclosporine plasma concentrations.
- Corticosteroids: Combined hormonal contraceptives may increase plasma concentrations of corticosteroids.
Minor Interactions
- Not typically clinically significant for this class, but some antibiotics (e.g., ampicillin, tetracycline) have been anecdotally associated with reduced efficacy, though evidence is limited. Advise backup method.
Monitoring
Baseline Monitoring
Complete medical history (including family history)
Rationale: To identify risk factors for cardiovascular disease, thromboembolic disorders, certain cancers, and other contraindications.
Timing: Prior to initiation of therapy.
Blood pressure measurement
Rationale: To identify pre-existing hypertension, a contraindication or risk factor for cardiovascular events.
Timing: Prior to initiation of therapy.
Physical examination (including breast and pelvic exam, Pap test)
Rationale: To rule out contraindications (e.g., undiagnosed abnormal genital bleeding, breast cancer) and establish baseline health status.
Timing: Prior to initiation of therapy, or as clinically indicated per current guidelines.
Routine Monitoring
Blood pressure measurement
Frequency: Annually, or more frequently if clinically indicated.
Target: <140/90 mmHg
Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may warrant discontinuation or change in contraceptive method.
Annual physical examination (including breast and pelvic exam, Pap test)
Frequency: Annually, or as clinically indicated per current guidelines.
Target: Normal findings
Action Threshold: Abnormal findings (e.g., new breast lump, abnormal bleeding) require further investigation.
Lipid profile (optional)
Frequency: Periodically, especially in patients with risk factors for cardiovascular disease.
Target: Within normal limits
Action Threshold: Significant adverse changes may warrant re-evaluation of contraceptive choice.
Symptom Monitoring
- Severe abdominal pain (possible liver tumor, blood clot)
- Severe chest pain, shortness of breath, coughing up blood (possible pulmonary embolism, myocardial infarction)
- Severe headaches, dizziness, weakness or numbness, speech problems, vision changes (possible stroke)
- Eye problems (e.g., blurred vision, loss of vision, bulging eyes) (possible blood clot in eye)
- Severe leg pain, swelling, warmth, redness (possible deep vein thrombosis)
- Jaundice (yellowing of skin or eyes), dark urine, light-colored stools (possible liver problems)
- Depression or mood changes
- Unusual vaginal bleeding or spotting
Special Patient Groups
Pregnancy
Zafemy is contraindicated during pregnancy. If pregnancy occurs during use, Zafemy should be discontinued immediately. There is no evidence of teratogenicity from inadvertent exposure to combined hormonal contraceptives during early pregnancy, but data are limited.
Trimester-Specific Risks:
First Trimester:
Contraindicated. No increased risk of birth defects reported from inadvertent exposure.
Second Trimester:
Contraindicated. Not applicable for continued use.
Third Trimester:
Contraindicated. Not applicable for continued use.
Lactation
Use of combined hormonal contraceptives during lactation may decrease the quantity and quality of breast milk and may be transferred to the infant. It is generally not recommended for use in nursing mothers until weaning or at least 6 weeks postpartum.
Infant Risk:
Small amounts of hormonal steroids and/or their metabolites may be excreted in breast milk. Potential for adverse effects on the infant (e.g., jaundice, breast enlargement) is low but possible. Long-term effects on breastfed infants have not been established.
Pediatric Use
Safety and efficacy have been established in women of reproductive age. Use is not indicated before menarche. Post-menarcheal adolescents should follow adult dosing guidelines.
Geriatric Use
Zafemy is not indicated for use in postmenopausal women. Contraception is not required in this population.
Clinical Information
Clinical Pearls
- Adherence is crucial for efficacy; missing or delaying patch changes significantly increases the risk of pregnancy.
- The patch may be less effective in women weighing 198 lbs (90 kg) or more.
- Patients should be advised on proper patch application and removal, including rotating application sites to avoid irritation.
- Counsel patients on the 'ACHES' warning signs of serious adverse events and when to seek immediate medical attention.
- Zafemy has a higher risk of venous thromboembolism (VTE) compared to oral contraceptives containing 30-35 mcg of ethinyl estradiol and levonorgestrel. This risk should be discussed with patients, especially those with additional VTE risk factors.
- Not all antibiotics are proven to reduce contraceptive efficacy, but for patient reassurance and to minimize risk, a backup method (e.g., condoms) is often advised during and for 7 days after antibiotic use (especially rifampin).
Alternative Therapies
- Progestin-only pills (mini-pills)
- Progestin-only injectable (e.g., Depo-Provera)
- Progestin-only implant (e.g., Nexplanon)
- Intrauterine devices (IUDs) (hormonal and non-hormonal)
- Barrier methods (e.g., condoms, diaphragm, cervical cap)
- Spermicides
- Natural family planning methods
- Sterilization (tubal ligation, vasectomy)
Cost & Coverage
Average Cost:
$100 - $200 per 3 patches (1-month supply)
Generic Available:
Yes
Insurance Coverage:
Often Tier 1 or Tier 2 on most commercial insurance plans, due to generic availability. May be covered without cost-sharing under the Affordable Care Act for preventive services.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.