Norelgestromin and ethinyl estradiol transdermal system

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Norelgestromin and ethinyl estradiol transdermal system
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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Black Box Warning

WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING, RISK OF VENOUS THROMBOEMBOLISM, AND PHARMACOKINETIC PROFILE OF ETHINYL ESTRADIOL
See full prescribing information for complete Boxed Warning.
* Cigarette Smoking and Serious Cardiovascular Risks
  • Cigarette smoking increases the risk of serious cardiovascular events from 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, hormonal contraceptives, including ORTHO EVRA, should not be used by women who are over 35 years of age and smoke.
  • Risk of Venous Thromboembolism
  • The risk of venous thromboembolism (VTE) among women aged 15–44 who used the ORTHO EVRA patch compared to women who used several different oral contraceptives was assessed in five U.S. epidemiologic studies using electronic healthcare claims data. The relative risk estimates ranged from 1.2 to 2.2; one of the studies found a statistically significant increased relative risk of VTE for current users of ORTHO EVRA.
  • Pharmacokinetic (PK) Profile of Ethinyl Estradiol (EE)
  • The PK profile for the ORTHO EVRA patch is different from the PK profile for oral contraceptives in that it has a higher steady state concentrations and a lower peak concentration. Area under the time-concentration curve (AUC) and average concentration at steady state (Css) for EE are approximately 60% higher in women using ORTHO EVRA compared with women using an oral contraceptive containing 35 mcg of EE. In contrast, the peak concentration (Cmax) for EE is approximately 25% lower in women using ORTHO EVRA. It is not known whether there are changes in the risk of serious adverse events based on the differences in PK profiles of EE in women using ORTHO EVRA compared with women using oral contraceptives containing 30–35 mcg of EE. Increased estrogen exposure may increase the risk of adverse events, including VTE

Overview

Norelgestromin and ethinyl estradiol transdermal system is a hormonal contraceptive that is FDA approved for the prophylaxis of prevention of pregnancy. There is a Black Box Warning for this drug as shown here. Common adverse reactions include breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • ORTHO EVRA is indicated for the prevention of pregnancy in women who elect to use a transdermal patch as a method of contraception.

Limitation of Use:

  • ORTHO EVRA may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more.

Dosing

  • To achieve maximum contraceptive effectiveness, ORTHO EVRA must be used exactly as directed.
  • Complete instructions to facilitate patient counseling on proper system usage may be found in the FDA-Approved Patient Labeling.

How to Use ORTHO EVRA

  • The ORTHO EVRA transdermal system uses a 28-day (four-week) cycle. A new patch is applied each week for three weeks (21 total days). Week Four is patch-free. Withdrawal bleeding is expected during this time.
  • Every new patch should be applied on the same day of the week. This day is known as the "Patch Change Day." For example, if the first patch is applied on a Monday, all subsequent patches should be applied on a Monday. Only one patch should be worn at a time.
  • Do not cut, damage or alter the ORTHO EVRA patch in any way. If the ORTHO EVRA patch is cut, damaged or altered in size, contraceptive efficacy may be impaired.
  • On the day after Week Four ends, a new four-week cycle is started by applying a new patch. Under no circumstances should there be more than a seven-day patch-free interval between dosing cycles.

How to Start Using ORTHO EVRA

The woman has two options for starting the patch and she should choose the option that is right for her:

  • First Day Start—The woman should apply her first patch during the first 24 hours of her menstrual period.
  • Sunday Start—The woman should apply her first patch on the first Sunday after her menstrual period begins. With this option, a non-hormonal backup method of birth control, such as a condom and spermicide or diaphragm and spermicide, is needed for the first 7 days of the first cycle only. If her period starts on a Sunday, the first patch should be applied that day, and no backup contraception is needed.
  • When Switching From the Pill or Vaginal Contraceptive Ring to the Patch—If the woman is switching from the pill or vaginal contraceptive ring to ORTHO EVRA, she should complete her current pill cycle or vaginal ring cycle and apply the first ORTHO EVRA patch on the day she would normally start her next pill or insert her next vaginal ring. If she does not get her period within a week after taking the last active pill or removing the last vaginal ring, she should check with her healthcare professional to be sure that she is not pregnant, but she may go ahead and start ORTHO EVRA for contraception. If the patch is applied more than a week after taking the last active pill or removal of the last vaginal ring, she should use a non-hormonal contraceptive concurrently for the first 7 days of patch use.

Use after Childbirth

  • Start contraceptive therapy with ORTHO EVRA in women who elect not to breastfeed no sooner than 4 weeks after childbirth due to increased risk of thromboembolism. If a woman begins using ORTHO EVRA postpartum, and has not yet had a period, consider the possibility of ovulation and conception occurring prior to use of ORTHO EVRA, and instruct her to use an additional method of contraception, such as a condom and spermicide or diaphragm and spermicide, for the first seven days.

Use after Abortion or Miscarriage

  • After an abortion or miscarriage that occurs in the first trimester, ORTHO EVRA may be started immediately. An additional method of contraception is not needed if ORTHO EVRA is started immediately. If use of ORTHO EVRA is not started within 5 days following a first trimester abortion, the woman should follow the instructions for a woman starting ORTHO EVRA for the first time. In the meantime she should be advised to use a non-hormonal contraceptive method. Ovulation may occur within 10 days of an abortion or miscarriage.
  • Start ORTHO EVRA no earlier than 4 weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolic disease.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Norelgestromin and ethinyl estradiol transdermal system in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Norelgestromin and ethinyl estradiol transdermal system in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Norelgestromin and ethinyl estradiol transdermal system in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Norelgestromin and ethinyl estradiol transdermal system in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Norelgestromin and ethinyl estradiol transdermal system in pediatric patients.

Contraindications

  • Condition1

Warnings

WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING, RISK OF VENOUS THROMBOEMBOLISM, AND PHARMACOKINETIC PROFILE OF ETHINYL ESTRADIOL
See full prescribing information for complete Boxed Warning.
* Cigarette Smoking and Serious Cardiovascular Risks
  • Cigarette smoking increases the risk of serious cardiovascular events from 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, hormonal contraceptives, including ORTHO EVRA, should not be used by women who are over 35 years of age and smoke.
  • Risk of Venous Thromboembolism
  • The risk of venous thromboembolism (VTE) among women aged 15–44 who used the ORTHO EVRA patch compared to women who used several different oral contraceptives was assessed in five U.S. epidemiologic studies using electronic healthcare claims data. The relative risk estimates ranged from 1.2 to 2.2; one of the studies found a statistically significant increased relative risk of VTE for current users of ORTHO EVRA.
  • Pharmacokinetic (PK) Profile of Ethinyl Estradiol (EE)
  • The PK profile for the ORTHO EVRA patch is different from the PK profile for oral contraceptives in that it has a higher steady state concentrations and a lower peak concentration. Area under the time-concentration curve (AUC) and average concentration at steady state (Css) for EE are approximately 60% higher in women using ORTHO EVRA compared with women using an oral contraceptive containing 35 mcg of EE. In contrast, the peak concentration (Cmax) for EE is approximately 25% lower in women using ORTHO EVRA. It is not known whether there are changes in the risk of serious adverse events based on the differences in PK profiles of EE in women using ORTHO EVRA compared with women using oral contraceptives containing 30–35 mcg of EE. Increased estrogen exposure may increase the risk of adverse events, including VTE

There is limited information regarding Norelgestromin and ethinyl estradiol transdermal system Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Norelgestromin and ethinyl estradiol transdermal system in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Norelgestromin and ethinyl estradiol transdermal system in the drug label.

Body as a Whole
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

There is limited information regarding Norelgestromin and ethinyl estradiol transdermal system Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Norelgestromin and ethinyl estradiol transdermal system in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Norelgestromin and ethinyl estradiol transdermal system during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Norelgestromin and ethinyl estradiol transdermal system with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Norelgestromin and ethinyl estradiol transdermal system with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Norelgestromin and ethinyl estradiol transdermal system with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Norelgestromin and ethinyl estradiol transdermal system with respect to specific gender populations.

Race

There is no FDA guidance on the use of Norelgestromin and ethinyl estradiol transdermal system with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Norelgestromin and ethinyl estradiol transdermal system in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Norelgestromin and ethinyl estradiol transdermal system in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Norelgestromin and ethinyl estradiol transdermal system in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Norelgestromin and ethinyl estradiol transdermal system in patients who are immunocompromised.

Administration and Monitoring

Administration

How to Apply ORTHO EVRA

CHOOSING A PLACE ON THE BODY TO PUT THE PATCH

This image is provided by the National Library of Medicine.
  • The patch may be placed on the upper outer arm, abdomen, buttock or back in a place where it won't be rubbed by tight clothing. For example, it should not be placed under the waistband of clothing.
  • The patch should not be placed on the breasts, on cut or irritated skin, or on the same location as the previous patch.

Before applying the patch:

  • The woman should make sure the skin is clean and dry.
  • She should not use lotions, creams, oils, powders, or make-up at the patch site. It may cause the patch to fail to stick properly or to become loose.

HOW TO APPLY THE PATCH

This image is provided by the National Library of Medicine.
  • The woman should check her patch every day to make sure all edges are sticking correctly.

WHEN TO CHANGE THE ORTHO EVRA PATCH

  • The patch works for seven days (one week). The woman should apply a new patch on the same day each week (her Patch Change Day) for 3 weeks in a row. She must make sure she has removed her old patch prior to applying the new patch.
  • During Week 4, she DOES NOT wear a patch. She must make sure she removes her old patch. (Her period should begin during this week.)
  • Following Week 4, she repeats the cycle of three weekly applications followed by a patch-free week.

WHAT IF THE PATCH BECOMES LOOSE OR FALLS OFF?

  • The patch must stick securely to the skin to work properly. If the ORTHO EVRA patch becomes partially or completely detached and remains detached, insufficient drug delivery occurs. The woman should not try to reapply a patch if it is no longer sticky, if it has become stuck to itself or another surface, or if it has other material stuck to it.

If a patch edge lifts up:

  • The woman should press down firmly on the patch with the palm of her hand for 10 seconds, making sure that the whole patch adheres to her skin. She should run her fingers over the entire surface area to smooth out any "wrinkles" around the edges of the patch.
  • If her patch does not stick completely, she should remove it and apply a replacement patch.
  • She should not tape or wrap the patch to her skin or reapply a patch that is partially adhered to clothing.

If the patch has been off or partially off:

  • For less than 1 Day, she should try to reapply it. If the patch does not adhere completely, she should apply a new patch immediately. (No backup contraception is needed and her Patch Change Day will stay the same).
  • For more than 1 Day or if she is not sure for how long, she may not be protected from pregnancy. To reduce this risk, she should apply a new patch and start a new 4-week cycle. She will now have a new Patch Change Day and MUST USE NON-HORMONAL BACKUP CONTRACEPTION (such as a condom and spermicide or diaphragm and spermicide) for the first week of her new cycle.

IF THE WOMAN FORGETS TO CHANGE HER PATCH

  • At the start of any patch cycle (Week One/Day 1): SHE MAY NOT BE PROTECTED FROM PREGNANCY. She should apply the first patch of her new cycle as soon as she remembers. There is now a new "Patch Change Day" and a new "Day 1." The woman must use back-up contraception, such as a condom and spermicide or diaphragm and spermicide, for the first week of the new cycle.
  • In the middle of the patch cycle (Week Two/Day 8 or Week Three/Day 15),
  • For one or two days (up to 48 hours), she should apply a new patch immediately. The next patch should be applied on the usual "Patch Change Day." No back-up contraception is needed.
  • For more than two days (48 hours or more), SHE MAY NOT BE PROTECTED FROM PREGNANCY. She should stop the current contraceptive cycle and start a new four-week cycle immediately by putting on a new patch. There is now a new "Patch Change Day" and a new "Day 1." The woman must use back-up contraception for one week.
  • At the end of the patch cycle (Week Four/Day 22),
  • If the woman forgets to remove her patch, she should take it off as soon as she remembers. The next cycle should be started on the usual "Patch Change Day," which is the day after Day 28. No back-up contraception is needed.

Under no circumstances should there be more than a seven-day patch-free interval between cycles. If there are more than seven patch-free days, THE WOMAN MAY NOT BE PROTECTED FROM PREGNANCY and back-up contraception, such as a condom and spermicide or diaphragm and spermicide, must be used for seven days. As with combined oral contraceptives, the risk of ovulation increases with each day beyond the recommended drug-free period. If she has had intercourse during such an extended patch-free interval, consider the possibility of pregnancy.

Change Day Adjustment

  • If the woman wishes to change her Patch Change Day, she should complete her current cycle, removing the third ORTHO EVRA patch on the correct day. During the patch-free week, she may select an earlier Patch Day Change by applying a new ORTHO EVRA patch on the desired day. In no case should there be more than 7 consecutive patch-free days.

Breakthrough Bleeding or Spotting

  • In the event of unscheduled or breakthrough bleeding or spotting (bleeding that occurs on the days that ORTHO EVRA is worn), treatment should be continued. If unscheduled bleeding persists longer than a few cycles, consider causes other than ORTHO EVRA.
  • If the woman does not have scheduled or withdrawal bleeding (bleeding that should occur during the patch-free week), she should resume treatment on the next scheduled Change Day. If ORTHO EVRA has been used correctly, the absence of withdrawal bleeding is not necessarily an indication of pregnancy. Nevertheless, consider the possibility of pregnancy, especially if absence of withdrawal bleeding occurs in 2 consecutive cycles. Discontinue ORTHO EVRA if pregnancy is confirmed.

In Case of Skin Irritation

  • If patch use results in uncomfortable irritation, the patch may be removed and a new patch may be applied to a different location until the next Change Day. Only one patch should be worn at a time.

Additional Instructions for Dosing

  • Unscheduled bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing hormonal contraceptives. In case of breakthrough bleeding, as in all cases of irregular bleeding from the vagina, consider nonfunctional causes. In case of undiagnosed persistent or recurrent abnormal bleeding from the vagina, take adequate diagnostic measures to rule out pregnancy or malignancy. If pathology has been excluded, time or a change to another method of contraception may solve the problem.

Use of Hormonal Contraceptives in the Event of a Missed Menstrual Period

  • If the woman has not adhered to the prescribed schedule, consider the possibility of pregnancy at the time of the first missed period. Discontinue use of ORTHO EVRA if pregnancy is confirmed.
  • If the woman has adhered to the prescribed regimen and misses one period, she should continue using her contraceptive patches. However, if she has adhered to the prescribed regimen, misses one period and has symptoms associated with pregnancy, rule out pregnancy. Discontinue ORTHO EVRA use if pregnancy is confirmed.

If the woman has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue ORTHO EVRA use if pregnancy is confirmed.

Monitoring

There is limited information regarding Monitoring of Norelgestromin and ethinyl estradiol transdermal system in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Norelgestromin and ethinyl estradiol transdermal system in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Norelgestromin and ethinyl estradiol transdermal system in the drug label.

Pharmacology

There is limited information regarding Norelgestromin and ethinyl estradiol transdermal system Pharmacology in the drug label.

Mechanism of Action

Structure

File:Norelgestromin and ethinyl estradiol transdermal system01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Norelgestromin and ethinyl estradiol transdermal system in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Norelgestromin and ethinyl estradiol transdermal system in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Norelgestromin and ethinyl estradiol transdermal system in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Norelgestromin and ethinyl estradiol transdermal system in the drug label.

How Supplied

Storage

There is limited information regarding Norelgestromin and ethinyl estradiol transdermal system Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Norelgestromin and ethinyl estradiol transdermal system in the drug label.

Precautions with Alcohol

  • Alcohol-Norelgestromin and ethinyl estradiol transdermal system interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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