Usual Adult Dose for Contraception

Oral tablets: 1 tablet orally once a day at the same time each day in the order directed on the blister pack

Transdermal System:
Four week cycle: Apply 1 patch once a week for 3 consecutive weeks; no patch is to be worn during week 4, cycle is then repeated

Comments:

• To achieve maximal contraceptive efficacy, tablets should be taken at intervals not exceeding 24 hours.
• Tablets may be started on the first Sunday after the onset of menstruation (Sunday Start) or on Day 1 of menstruation (Day 1 Start).
• The first transdermal system should be applied during the first 24 hours of menstruation.

• Transdermal use is for women with a body mass index (BMI) of less than 30 kg/m2 as those with a BMI of 30 kg/m2 or greater may have reduced efficacy and may be at higher risk for venous thromboembolism events; consider reduced effectiveness in women with a BMI of 25 to less than 30 kg/m2

Usual Pediatric Dose for Contraception

For postmenarchal females:
Oral tablets: 1 tablet orally once a day at the same time each day in the order directed on the blister pack

Transdermal System:
Four week cycle: Apply 1 patch once a week for 3 consecutive weeks; no patch is to be worn during week 4, cycle is then repeated

Comments:

• To achieve maximal contraceptive efficacy, tablets should be taken at intervals not exceeding 24 hours.
• Tablets may be started on the first Sunday after the onset of menstruation (Sunday Start) or on Day 1 of menstruation (Day 1 Start).
• The first transdermal system should be applied during the first 24 hours of menstruation.

• Transdermal use is for women with a body mass index (BMI) of less than 30 kg/m2 as those with a BMI of 30 kg/m2 or greater may have reduced efficacy and may be at higher risk for venous thromboembolism events; consider reduced effectiveness in women with a BMI of 25 to less than 30 kg/m2

Renal Dose Adjustments

Use with caution; monitor blood pressure closely.

Liver Dose Adjustments

Contraindicated

Dose Adjustments

Elderly patients: Not indicated in postmenopausal women.

Changing from another oral contraceptive:
Tablets: Start on the same day that a new pack of the previous oral contraceptive would have started.
Patch: Apply first patch on day the next pill cycle would start

Changing from another transdermal patch:
Tablets: Start on the day when the next application would have been scheduled.
Patch: Apply on the day the next patch cycle would normally start.

Changing from a vaginal ring:
Tablet: Start on the day when the next insertion would have been scheduled.
Patch: Apply on the day the next vaginal ring would have been scheduled.

Changing from an injectable formulation:
Tablet: Start on the day when the next injection would have been scheduled
Patch: Apply on day when next injection would have been scheduled

Changing from an intrauterine system (IUS) contraceptive:
Tablet: Start on the day of the removal of the IUS; if the IUS is not removed on the first day of the menstrual cycle, additional nonhormonal contraceptives (e.g., condoms and spermicide) is needed for the first 7 days of the first cycle pack.
Patch: Apply on the day of the IUS removal

Changing from an implant:
Tablet: Start on the day when the implant is removed.
Patch: Apply on the day of implant removal

Following a first trimester abortion or miscarriage:
Tablet: 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, an additional nonhormonal method of contraception (e.g., condoms and spermicide) is to be used for the first 7 days of the first cycle pack.

• If not started within 5 days after first trimester abortion or miscarriage, an additional nonhormonal method of contraception (e.g., condoms and spermicide) is to be used.

• Tablets or patch: Do not start until 4 weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolic disease.
• Follow the instructions for Sunday start, as desired and use additional non-hormonal contraception (e.g., condoms and spermicide) for the first 7 days of the patient's first cycle pack.

• Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease.
• Follow the instructions for women not currently using hormonal contraception.
• Not recommended for use in lactating women
• If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use.

Precautions

US BOXED WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR ADVERSE EFFECTS:

• Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.

• The transdermal system is contraindicated in women with a BMI of 30 kg/m2 or greater as women with a BMI of 30 kg/m2 or greater had reduced effectiveness and may have a higher risk for venous thromboembolism events.

• Women over 35 years who smoke
• Deep vein thrombosis or pulmonary embolism, now or in the past
• Cerebrovascular disease
• Coronary artery disease
• Thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)
• Inherited or acquired hypercoagulopathies
• Uncontrolled hypertension
• Diabetes mellitus with vascular disease
• Headaches with focal neurological symptoms or migraine headaches with or without aura if over age 35
• Breast cancer or other estrogen or progestin-sensitive cancer, now or in the past
• Liver tumors, benign or malignant, or liver disease
• Undiagnosed abnormal uterine bleeding
• Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
• Hypersensitivity to the active components or to any of the ingredients
• BMI of 30 mg/m2 or greater (transdermal use)

Dialysis

Data not available

Other Comments

Administration Advice:
Tablets:

• For maximum effectiveness, tablets must be taken exactly as directed and at intervals not exceeding 24 hours.
• Withdrawal bleeding will usually occur during the last week of pills, or 3 days after taking the last active tablet, depending on the formulation used; consult the manufacturer product information.
• If severe vomiting or diarrhea occurs, absorption may not be complete and additional contraceptive measures should be taken; if vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet.
• Unscheduled breakthrough bleeding/spotting may occur; if prolonged, the patient should contact their healthcare provider.
• Some manufacturers do not advise a "day 1 start" and instead a Sunday start after menstruation begins; consult specific manufacturer product information.
• If the next pack is not immediately started, patients should use backup nonhormonal birth control (e.g., condoms) for the first 7 days of using the new pack.
• The manufacturer product information should be consulted for information regarding specific preparations.

• Take the first active pill on the Sunday after the onset of menstruation, even if the patient is still bleeding; if menstruation begins on a Sunday, start the pack the same day.
• A backup form of birth control (e.g., condoms) should be used from the Sunday the pills are started to the next Sunday (7 days) for the first cycle.
• Take all subsequent pills once a day at the same time each day and begin all subsequent packs on the same day of the week (i.e., Sunday).

• Take the first active pill during the first 24 hours of starting the period.
• Take all subsequent pills once a day at the same time each day.
• A backup method of birth control will not be necessary with the Day 1 start.

• If 1 active pill is missed, take it as soon as it is remembered and the next pill at the regular time (2 pills in 1 day); a backup birth control method is not necessary
• If 2 active pills are missed in a row on week 1 or week 2 of the pack, take 2 pills on the day they are remembered and 2 pills the next day, then 1 pill each day until the pack is finished; a form of back-up birth control is necessary for the next 7 days
• If 2 active pills are missed in a row on Week 3, or 3 or more pills are missed in a row, the rest of the pill pack should be thrown out and a new pack started the same day for Day 1 starters; for Sunday starters, keep taking 1 pill every day until Sunday, then on Sunday, throw out the rest of the pack and start a new pack of pills the same day; back-up birth control is necessary for the next 7 days

• Do not cut, damage, or change patch in any way as it may render the patch ineffective
• Apply patch to clean/dry skin on abdomen, buttock, or upper torso (excluding breasts); avoid waistline or near clothing or undergarment seams; do not apply on cut or irritated skin or on the same location as the old patch
• Avoid make up, creams, lotions, oils, powders, or any other product on the skin area where the patch will be placed
• Patients should be instructed to follow FDA-approved patient labeling (Instructions for Use) for proper administration

• Tablets: Protect from light.
• Transdermal system: Store in original unopened pouch until ready to use

• Postpartum women who are not breastfeeding should start this medication no earlier than 4 to 6 weeks postpartum.
• The transdermal system is contraindicated for use in women with a BMI of 30 kg/m2 or greater due to decreased efficacy and increase risk for venous thromboembolism events; efficacy may be reduced in women with a BMIs of 25 to 30 kg/m2.

• Cardiovascular: Regularly monitor blood pressure throughout therapy.
• General: A complete medical history and physical examination should occur prior to initiation or reinstitution of this drug.
• Women using this drug should have a yearly visit with a healthcare provider for a blood pressure check and other indicated healthcare.

• Patients should be instructed to read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• This drug does not protect against HIV infection, AIDS, and other sexually transmitted diseases.
• Additional (back-up) contraception may be necessary when doses are missed or because of potential drug interactions; patients should inform their healthcare provided of all medications, including over the counter and herbal products, they are taking.