Norelgestromin And Ethinyl Estradiol

Every new patch should be applied on the same day of the week. " 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. No patch is worn during Week Four (the "Patch-Free Week").

Withdrawal bleeding is expected during this time. On the day after Week 4 ends, a new 4-week cycle is started by applying a new patch. Under no circumstances should there be more than a 7-day patch-free interval between dosing cycles.

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. Switching from another contraceptive method Oral combination hormonal contraception (oral CHC) • If the woman is switching from the pill to Norelgestromin and Ethinyl Estradiol Transdermal System, she should complete her current pill cycle and apply the first Norelgestromin and Ethinyl Estradiol Transdermal System patch on the day she would normally start her next pill • If she does not get her period within a week after taking the last active pill, she should check with her healthcare professional to be sure that she is not pregnant, but she may go ahead and start Norelgestromin and Ethinyl Estradiol Transdermal System for contraception.

• If the patch is applied more than a week after taking the last active pill, she should use a non-hormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) concurrently for the first 7 days of patch use.

Transdermal system • If the woman is switching from another contraceptive transdermal system to Norelgestromin and Ethinyl Estradiol Transdermal System, she should complete the current transdermal system cycle and apply the first Norelgestromin and Ethinyl Estradiol Transdermal System patch on the day the next transdermal system cycle would normally start.

• If she does not get her period within a week after removing the last transdermal system, she should check with her healthcare professional to be sure that she is not pregnant, but she may go ahead and start Norelgestromin and Ethinyl Estradiol Transdermal System for contraception.

If Norelgestromin and Ethinyl Estradiol Transdermal System is applied more than a week after removal of the last patch, nonhormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) should be used concurrently for the first 7 days of patch use.

Vaginal ring • If the woman is switching from the vaginal ring to Norelgestromin and Ethinyl Estradiol Transdermal System, she should complete her current vaginal ring cycle and apply the first Norelgestromin and Ethinyl Estradiol Transdermal System patch on the day she would normally insert her next vaginal ring.

• If she does not get her period within a week after 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 Norelgestromin and Ethinyl Estradiol Transdermal System for contraception.

• If the patch is applied more than a week after removal of the last vaginal ring, she should use a non-hormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) concurrently for the first 7 days of patch use.

Injection • If the woman is switching from an injection contraceptive to Norelgestromin and Ethinyl Estradiol Transdermal System, she should apply the first Norelgestromin and Ethinyl Estradiol Transdermal System patch on the day the next injection would normally occur.

Intrauterine system (IUS) • If the woman is switching from an intrauterine system to Norelgestromin and Ethinyl Estradiol Transdermal System, she should apply the first Norelgestromin and Ethinyl Estradiol Transdermal System patch on the day of IUS removal.

If the IUS is not removed on the first day of the menstrual cycle, nonhormonal backup contraception (such as condoms and spermicide, or diaphragm and spermicide) should be used concurrently for the first 7 days of patch use. Implant • If the woman is switching from an implant to Norelgestromin and Ethinyl Estradiol Transdermal System, she should apply the first Norelgestromin and Ethinyl Estradiol Transdermal System patch on the day of implant removal.

Progestin-only pill • If the woman is switching from a progestin-only pill to Norelgestromin and Ethinyl Estradiol Transdermal System, she should apply the first Norelgestromin and Ethinyl Estradiol Transdermal System patch on the day the next progestin-only pill cycle would normally start.

Use after Childbirth Start contraceptive therapy with norelgestromin and ethinyl estradiol transdermal system 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 norelgestromin and ethinyl estradiol transdermal system postpartum, and has not yet had a period, consider the possibility of ovulation and conception occurring prior to use of norelgestromin and ethinyl estradiol transdermal system, and instruct her to use an additional method of contraception, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days.

] Use after Abortion or Miscarriage After an abortion or miscarriage that occurs in the first trimester, norelgestromin and ethinyl estradiol transdermal system may be started immediately. An additional method of contraception is not needed if norelgestromin and ethinyl estradiol transdermal system is started immediately.

If use of norelgestromin and ethinyl estradiol transdermal system is not started within 5 days following a first trimester abortion, the woman should follow the instructions for a woman starting norelgestromin and ethinyl estradiol transdermal system 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 norelgestromin and ethinyl estradiol transdermal system no earlier than 4 weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolic disease.

3 How to Apply Norelgestromin and Ethinyl Estradiol Transdermal System CHOOSING A PLACE ON THE BODY TO PUT THE PATCH 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 • The woman should tear open the pouch at the edge.

She should gently remove the contents of the foil pouch and discard the additional piece of film above the patch. • The woman should peel away half of the clear plastic. She should avoid touching the sticky surface with her fingers. • The woman should apply the sticky side of the patch on the skin she has cleaned and dried.

She should then remove the other half of the clear plastic and attach the entire patch to her skin. • The woman should press 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 outer edges of the patch. The woman should check her patch every day to make sure all edges are sticking correctly. WHEN TO CHANGE THE NORELGESTROMIN AND ETHINYL ESTRADIOL TRANSDERMAL SYSTEM PATCH The patch works for 7 days (1 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.

) 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 norelgestromin and ethinyl estradiol transdermal system 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 1/Day 1) : SHE MAY NOT BE PROTECTED FROM PREGNANCY. She should apply the first patch of her new cycle as soon as she remembers. " 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 2/Day 8 or Week 3/Day 15) , ○ for 1 or 2 days (up to 48 hours), she should apply a new patch immediately. " No back-up contraception is needed. ○ for more than 2 days (48 hours or more), SHE MAY NOT BE PROTECTED FROM PREGNANCY.

She should stop the current contraceptive cycle and start a new 4-week cycle immediately by putting on a new patch. " The woman must use back-up contraception for 1 week. ● at the end of the patch cycle (Week 4/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 7-day patch-free interval between cycles . If there are more than 7 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 7 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 norelgestromin and ethinyl estradiol transdermal system patch on the correct day. During the patch-free week, she may select an earlier Patch Day Change by applying a new norelgestromin and ethinyl estradiol transdermal system 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 norelgestromin and ethinyl estradiol transdermal system is worn), treatment should be continued.

If unscheduled bleeding persists longer than a few cycles, consider causes other than norelgestromin and ethinyl estradiol transdermal system. 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 norelgestromin and ethinyl estradiol transdermal system 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 norelgestromin and ethinyl estradiol transdermal system 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 norelgestromin and ethinyl estradiol transdermal system 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 norelgestromin and ethinyl estradiol transdermal system use if pregnancy is confirmed. If the woman has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue norelgestromin and ethinyl estradiol transdermal system use if pregnancy is confirmed.

3 Image Image Image Image

12 (Figure 2). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). One of these studies reported no association between breast cancer risk and COC use.

33 with current or recent use. 4 with more than 8-10 years of COC use.

Figure 2:

Risk of Breast Cancer with Combined Oral Contraceptive Use RR = relative risk; OR = odds ration; HR = hazard ration. "ever COC" are females with current or past COC use; "never COC use" are fmales that never used COCs. The following adverse reactions (Table 4) have been identified during postapproval use of norelgestromin and ethinyl estradiol transdermal system.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Table 4:

Alphabetical List of Adverse Drug Reactions Identified During Postmarketing Experience with Norelgestromin and Ethinyl Estradiol Transdermal System by System Organ Class* System Organ Class Adverse Drug Reactions Cardiac disorders Myocardial infarction † Endocrine disorders Hyperglycemia, insulin resistance Eye disorders Contact lens intolerance or complication Gastrointestinal disorders Colitis General disorders and administration site conditions Application site reaction † , edema † Hepatobiliary disorders Blood cholesterol abnormal, cholelithiasis, cholestasis, hepatic lesion, jaundice cholestatic, low density lipoprotein increased Immune system disorders Allergic reaction † , urticaria Investigations Blood glucose abnormal, blood glucose decreased Metabolism and nutrition disorders Increased appetite Neoplasms benign, malignant and unspecified (Incl.

0 † Represents a bundle of similar terms figure-2

The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week. Before starting norelgestromin and ethinyl estradiol transdermal system, evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy [see Contraindications ( 4 )].

Arterial Events The use of CHCs increases the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. The risk is greater among older women (> 35 years of age), smokers, and women with hypertension, dyslipidemia, diabetes, or obesity.

Norelgestromin and ethinyl estradiol transdermal system is contraindicated in women over 35 years of age who smoke [see Contraindications ( 4 )]. Cigarette smoking increases the risk of serious cardiovascular events from CHC use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked.

Venous Events The use of CHCs increases the risk of venous thromboembolic events (VTEs), such as deep vein thrombosis and pulmonary embolism. Risk factors for VTEs include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of CHCs.

The risk of VTE may be greater with norelgestromin and ethinyl estradiol transdermal system in women with a BMI ≥ 30 kg/m 2 compared to women with a lower BMI [see Contraindications ( 4 )]. While the increased risk of VTE associated with use of CHCs is well-established, the rates of VTE are even greater during pregnancy, and especially during the postpartum period (see Figure 1).

The frequency of VTE in women using CHCs has been estimated to be 3 to 12 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of CHCs and when restarting hormonal contraception after a break of 4 weeks or longer.

This initial higher risk declines during the first year, but users of CHCs remain at an increased risk of VTE compared to non-users of CHCs. Based on results from a few studies, there is some evidence that this is true for non-oral products as well.

The risk of thromboembolic disease due to CHCs gradually disappears after CHC use is discontinued. Figure 1 shows the risk of developing a VTE for women who are not pregnant and do not use CHCs, for women who use CHCs with a range of doses and routes of administration, for pregnant women, and for women in the postpartum period.

To put the risk of developing a VTE into perspective:

If 10,000 women who are not pregnant and do not use CHCs are followed for one year, between 1 and 5 of these women will develop a VTE. 2 Ethinyl Estradiol Exposure Higher estrogen exposure may increase the risk of adverse reactions, including venous thromboembolism (VTE).

The Area Under the Curve (AUC) for ethinyl estradiol (EE) is approximately 60% higher in women using norelgestromin and ethinyl estradiol transdermal system compared to oral contraceptives containing EE 35 mcg. 3 )]. 3 Liver Disease Impaired Liver Function Do not use norelgestromin and ethinyl estradiol transdermal system in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of liver [see Contraindications ( 4 )].

Discontinue norelgestromin and ethinyl estradiol transdermal system if jaundice develops. Acute or chronic disturbances of liver function may necessitate the discontinuation of CHC use until markers of liver function return to normal and CHC causation has been excluded.

Liver Tumors Norelgestromin and ethinyl estradiol transdermal system is contraindicated in women with benign and malignant liver tumors [see Contraindications ( 4 )] . Hepatic adenomas are associated with CHC use. 3 cases/100,000 CHC users.

Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage. Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) CHC users. However, the risk of liver cancers in CHC users is less than one case per million users.

4 Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as CHCs.

Discontinue norelgestromin and ethinyl estradiol transdermal system prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications ( 4 )] . Norelgestromin and ethinyl estradiol transdermal system can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.

5 High Blood Pressure Norelgestromin and ethinyl estradiol transdermal system is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease [see Contraindications ( 4 )] . For women with well-controlled hypertension, monitor blood pressure and stop norelgestromin and ethinyl estradiol transdermal system if blood pressure rises significantly.

An increase in blood pressure has been reported in women taking hormonal contraceptives, and this increase is more likely in older women with extended duration of use. The incidence of hypertension increases with increasing concentrations of progestin.

6 Gallbladder Disease Studies suggest a small increased relative risk of developing gallbladder disease among CHC users. Use of CHCs may also worsen existing gallbladder disease. A past history of CHC-related cholestasis predicts an increased risk with subsequent CHC use.

Women with a history of pregnancy-related cholestasis may be at an increased risk for CHC-related cholestasis. 7 Carbohydrate and Lipid Metabolic Effects Carefully monitor prediabetic and diabetic women who take norelgestromin and ethinyl estradiol transdermal system.

CHCs may decrease glucose tolerance in a dose-related fashion. In a 6-cycle clinical trial with norelgestromin and ethinyl estradiol transdermal system there were no clinically significant changes in fasting blood glucose from baseline to end of treatment.

Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on hormonal contraceptives. Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using hormonal contraceptives.

8 Headache If a woman taking norelgestromin and ethinyl estradiol transdermal system develops new headaches that are recurrent, persistent or severe, evaluate the cause and discontinue norelgestromin and ethinyl estradiol transdermal system if indicated.

Consider discontinuation of norelgestromin and ethinyl estradiol transdermal system in the case of increased frequency or severity of migraine during hormonal contraceptive use (which may be prodromal of a cerebrovascular event). 9 Bleeding Irregularities Unscheduled Bleeding and Spotting Unscheduled (breakthrough) bleeding and spotting sometimes occur in women using norelgestromin and ethinyl estradiol transdermal system.

Consider non-hormonal causes and take adequate diagnostic measures to rule out malignancy, other pathology, or pregnancy in the event of unscheduled bleeding, as in the case of any abnormal vaginal bleeding. If pathology and pregnancy have been excluded, time or a change to another contraceptive product may resolve the bleeding.

In the clinical trials, most women started their scheduled (withdrawal) bleeding on the fourth day of the drug-free interval, and the median duration of withdrawal bleeding was 5 to 6 days. On average, 26% of women per cycle had 7 or more total days of bleeding and/or spotting (this includes both scheduled and unscheduled bleeding and/or spotting).

Three clinical studies of the efficacy of norelgestromin and ethinyl estradiol transdermal system in preventing pregnancy assessed scheduled and unscheduled bleeding [see Clinical Studies ( 14 )] in 3,330 women who completed 22,155 cycles of exposure.

1%) of the women discontinued norelgestromin and ethinyl estradiol transdermal system at least in part, due to bleeding or spotting. Table 2 summarizes the proportion of subjects who experienced unscheduled (breakthrough) bleeding/spotting by treatment cycle.

0 *Percentage of subjects with breakthrough bleeding/spotting events. Amenorrhea and Oligomenorrhea In the event of amenorrhea, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one patch or started the patch on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures.

If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Some women may encounter amenorrhea or oligomenorrhea after discontinuation of hormonal contraceptive use, especially when such a condition was pre-existent.

10 Hormonal Contraceptive Use Before or During Early Pregnancy Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when oral contraceptives are taken inadvertently during early pregnancy.

Discontinue norelgestromin and ethinyl estradiol transdermal system use if pregnancy is confirmed. 1 )]. 11 Depression Carefully observe women with a history of depression and discontinue norelgestromin and ethinyl estradiol transdermal system if depression recurs to a serious degree.

12 Malignant Neoplasms Breast Cancer Norelgestromin and ethinyl estradiol transdermal system are contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive [see Contraindications ( 4 )] .

Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk. Studies do not show an association between ever (current or past) use of COCs and risk of breast cancer.

2 )] . Cervical Cancer Some studies suggest that COC use has been associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.

13 Effect on Binding Globulins The estrogen component of CHCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin and cortisol-binding globulin. The dose of replacement thyroid hormone or cortisol therapy may need to be increased.

14 Monitoring A woman who is taking hormonal contraceptive should have routine visits with her healthcare provider for a blood pressure check and for other indicated healthcare. 15 Hereditary Angioedema In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.

16 Chloasma Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while using norelgestromin and ethinyl estradiol transdermal system.

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