Usual Adult Dose for Contraception

Apply 1 new patch each week for 3 weeks (21 days total) topically followed by 1 week that is patch-free

Comments:

• Withdrawal bleeding will usually occur during the 1 week patch-free time period.
• Every new patch should be applied on the same day of the week known as the "patch change day."
• May be less effective in preventing pregnancy in women weighing 90 kg or more.
• May be placed on the upper outer arm, abdomen, buttock, or back in a place where it won't be rubbed by tight clothing.
• Not to be placed on the breasts, on cut or irritated skin, or on the same location as the previous patch.

Usual Pediatric Dose for Contraception

Apply 1 new patch each week for 3 weeks (21 days total) topically followed by 1 week that is patch-free

Comments:

• Withdrawal bleeding will usually occur during the 1 week patch-free time period.
• Every new patch should be applied on the same day of the week known as the "patch change day."
• May be less effective in preventing pregnancy in women weighing 90 kg or more.
• May be placed on the upper outer arm, abdomen, buttock, or back in a place where it won't be rubbed by tight clothing.
• Not to be placed on the breasts, on cut or irritated skin, or on the same location as the previous patch.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Contraindicated

Dose Adjustments

Elderly patients: Not indicated in postmenopausal women.

Changing from an oral contraceptive pill or vaginal contraceptive ring:

• Complete current pill cycle or vaginal contraceptive ring cycle and apply first norelgestromin and ethinyl estradiol transdermal system on the day the patient would normally start the next pill or insert the next vaginal ring.
• If the patient does not get her period within a week after taking the last active pill or removing the last vaginal ring, pregnancy should be ruled out, but the norelgestromin and ethinyl estradiol transdermal system may still be started.
• If the norelgestromin and ethinyl estradiol transdermal system is applied more than a week after taking the last active pill or removal of last vaginal ring, a nonhormonal backup contraceptive method should be used for the first 7 days of patch use

• May be started immediately; an additional method of contraception is not required if started immediately.
• If not started within 5 days after termination of pregnancy, follow instructions for a woman starting this drug for the first time; an additional nonhormonal method of contraception is required.

• To be started no earlier than 4 weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolic disease.

• Start no sooner than 4 weeks after childbirth in women who choose not to breastfeed due to increased risk of thromboembolism.
• If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use; an additional method of contraception (e.g., condom and spermicide or diaphragm and spermicide) for the first 7 days of norelgestromin and ethinyl estradiol transdermal system use.

• If the patient wishes to change her "patch change day," she should complete her current cycle, removing the third patch on the correct day.
• During the patch-free week, the patient may select an earlier "patch change day" by applying a new patch on the desired day; however, in no case should there be more than 7 consecutive transdermal patch-free days.

Precautions

US BOXED WARNINGS:

• CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR ADVERSE EFFECTS: Cigarette smoking increases the risk of serious cardiovascular side effects from combination hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs are contraindicated in women who are over 35 years of age and smoke.
• RISK OF VENOUS THROMBOEMBOLISM: The risk of venous thromboembolism (VTE) among women aged 15 to 44 who used norelgestromin and ethinyl estradiol transdermal system compared to women who used several different oral contraceptives was assessed in five US 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 this drug.
• PHARMACOKINETIC (PK) PROFILE OF ETHINYL ESTRADIOL (EE): The PK profile for the norelgestromin and ethinyl estradiol transdermal system 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 about 60% higher in women using the norelgestromin and ethinyl estradiol transdermal system compared with women using an oral contraceptive containing 35 mcg of EE. In contrast, the peak concentration (Cmax) for EE is about 25% lower in women using the norelgestromin and ethinyl estradiol transdermal system. 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 the norelgestromin and ethinyl estradiol transdermal system compared with women using oral contraceptives containing 30 to 35 mcg of EE. Increased estrogen exposure may increase the risk of adverse events, including VTE.

Dialysis

Data not available

Other Comments

Administration Advice:

• To be used exactly as directed to achieve maximum contraceptive effectiveness.
• Apply to clean, dry skin.
• Lotions, creams, oils, powders, or makeup should not be used at the patch site.
• The transdermal system uses a 28 day (4 week cycle) in which a new patch is applied each week for 3 weeks (21 days total) and Week 4 is patch-free.
• Every new patch is to be applied on the same day each week.
• Do not cut, damage, or alter the patch in any way; if the patch is cut, damaged, or altered in size, contraceptive efficacy may be impaired.
• On the day after week 4 ends, a new 4 week cycle begins by applying a new patch.
• There should be no more than a 7-day patch-free interval between dosing cycles.
• Patch may be placed on the upper outer arm, abdomen, buttock, or back in a place where it will not be rubbed by tight clothing.
• Do not place patch on the breasts, cut or irritated skin, or on the same location as the previous patch.
• If skin irritation occurs, a new transdermal patch may be applied to a new location until the next change day; only 1 patch is to be worn at a time.
• The patient may decide between a day 1 start or a Sunday start method.
• The manufacturer product information should be consulted for further application instructions.

• Apply the first patch on the first Sunday after the menstrual period begins.
• A non-hormonal backup method of birth control (e.g., condom and spermicide or diaphragm and spermicide) is needed for the first 7 days of the first cycle only.
• If the period starts on a Sunday, the first patch should be applied that day, and no backup contraception is needed.

• If the patch has been off or partially off for less than 1 day, the patch should be reapplied; if it does not completely adhere, apply a new patch immediately; no backup contraception is needed and the patch change day will stay the same.
• If the patch has been off or partially off for more than 1 day or an unknown amount of time, a new patch should be applied and a new 4 week cycle begun; she will now have a new patch change day and must use a nonhormonal backup contraceptive method for the next 7 days.

• If the patient forgets to change her patch at the start of any patch cycle (Week 1/Day 1): She may not be protected from pregnancy and 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 start" and a nonhormonal backup contraceptive method must be used for the next 7 days.
• If the patient forgets to change her patch 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 and the next patch should be applied on the usual "patch change day" and no back-up contraception is needed. For more than 2 days (48 hours or more), she may not be protected from pregnancy and should stop the current contraceptive cycle and start a new 4-week cycle immediately by putting on a new patch, resulting in a new "patch change day" and a new "day 1 start;" must use back-up contraception for 1 week.
• If the patient forgets to change her patch 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 and 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.

• Store in protective pouches.
• Apply immediately upon removal from protective pouch.
• Do not store in refrigerator or freezer.
• Used patches: The sticky sides of the patch should be folded together and the folded patch placed in a sturdy container, preferably with a child-resistant cap, and the container thrown in the trash; used patches should not be flushed down the toilet.

• Cardiovascular: Regularly monitor blood pressure throughout therapy
• General: Women using this drug should have a yearly visit with a healthcare provider for a blood pressure check and other indicated healthcare.
• Pregnancy: Consider the possibility of pregnancy at the time of the first missed period if the patient has been nonadherent or if absence of withdrawal bleeding occurs in 2 consecutive cycles

• Each patch works for 1 week (7 days) and therefore a new patch is to be applied on the same day each week for 3 weeks in a row; be sure to remove old patch before applying the new one.
• During week 4, no patch is worn; be sure to remove old patch for the patch-free week when withdrawal bleeding should occur.
• The patch must stick securely to the skin to work properly; do not try to reapply the patch if it is no longer sticky, has become stuck to itself or another surface, or if it has other material stuck to it.
• Consult the Patient Information and Instructions for Use for further information.