Usual Adult Dose for Contraception

One tablet orally once a day for 28 days at the same time each day

Start Dates:
Not Currently Receiving Hormonal Contraceptives:

• Take first tablet on first day of menses; if not starting on the first day of menses, use a non-hormonal contraceptive (e.g., condoms and/or spermicide) as back-up until one active tablet has been taken daily for 7 days in a row

Switching from Another Contraceptive Method:

• From a combined oral contraceptive (COC): Start when the new pack of the previous COC would have started
• From a transdermal system: Start when next application would have been scheduled
• From a vaginal insert: Start when next insertion would have been scheduled
• From an injection: Start when next injection would have been scheduled
• From an intrauterine system (IUS): Start after removal of IUS
• From an implant: Start after removal of implant
• From progestin-only pill: Start after last tablet of progestin-only pill is taken

After Pregnancy (greater than 20 weeks gestation):

• Start date should be no sooner than 4 weeks after delivery
• If menstrual cycles have returned follow instructions for "Not Currently Receiving Hormonal Contraceptives"
• If menstrual cycles have not resumed, consider the possibility of ovulation/pregnancy, and use additional nonhormonal contraception for the first 7 days

After Abortion or Miscarriage: 14 weeks Gestation or Less:

• Within first 7 days of complete first trimester abortion or miscarriage: Use additional nonhormonal contraception for the next 7 days
• After the first 7 days, follow instructions for "Not Currently Receiving Hormonal Contraceptives"

After Abortion or Miscarriage: Greater than 14 weeks but less than 20 weeks gestation:

• After 4 weeks following second trimester abortion or miscarriage, consider duration of pregnancy and increased risk of thromboembolism
• If menstrual cycles have returned, follow instructions for "Not Currently Receiving Hormonal Contraceptives"
• If menstrual cycles have not resumed, consider the possibility of ovulation/pregnancy; if not pregnant, use additional nonhormonal contraception for the first 7 days

Comments:

• Verify pregnancy status prior to administering this drug.
• The pink tablets are the active tables; the white tablets are inert.
• This drug may be less effective in females with a BMI of 30 kg/m2 or greater.

Use: For use by females of reproductive potential to prevent pregnancy

Usual Pediatric Dose for Contraception

Females of reproductive potential (after menarche):
One tablet orally once a day for 28 days at the same time each day

Start Dates:
Not Currently Receiving Hormonal Contraceptives:

• Take first tablet on first day of menses; if not starting on the first day of menses, use a non-hormonal contraceptive (e.g., condoms and/or spermicide) as back-up until one active tablet has been taken daily for 7 days in a row

Switching from Another Contraceptive Method:

• From a combined oral contraceptive (COC): Start when the new pack of the previous COC would have started
• From a transdermal system: Start when next application would have been scheduled
• From a vaginal insert: Start when next insertion would have been scheduled
• From an injection: Start when next injection would have been scheduled
• From an intrauterine system (IUS): Start after removal of IUS
• From an implant: Start after removal of implant
• From progestin-only pill: Start after last tablet of progestin-only pill is taken

After Pregnancy (greater than 20 weeks gestation): Start date should be no sooner than 4 weeks after delivery:

• If menstrual cycles have returned follow instructions for "Not Currently Receiving Hormonal Contraceptives"
• If menstrual cycles have not resumed, consider the possibility of ovulation/pregnancy, and use additional nonhormonal contraception for the first 7 days

After Abortion or Miscarriage: 14 weeks Gestation or Less:

• Within first 7 days of complete first trimester abortion or miscarriage: Use additional nonhormonal contraception for the next 7 days
• After the first 7 days, follow instructions for "Not Currently Receiving Hormonal Contraceptives"

After Abortion or Miscarriage: Greater than 14 weeks but less than 20 weeks gestation:

• After 4 weeks following second trimester abortion or miscarriage, consider duration of pregnancy and increased risk of thromboembolism
• If menstrual cycles have returned, follow instructions for "Not Currently Receiving Hormonal Contraceptives"
• If menstrual cycles have not resumed, consider the possibility of ovulation/pregnancy; if not pregnant, use additional nonhormonal contraception for the first 7 days

Comments:

• Verify pregnancy status prior to administering this drug.
• The pink tablets are the active tables; the white tablets are inert.
• This drug may be less effective in females with a BMI of 30 kg/m2 or greater.
• This drug is indicated only after menarche.

Use: For use by females of reproductive potential to prevent pregnancy

Renal Dose Adjustments

Contraindicated

Liver Dose Adjustments

Contraindicated

Precautions

BOXED WARNING:
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS:

• Cigarette smoking increases the risk of serious cardiovascular events from combine hormonal contraceptive (CHC) use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs including this drug, are contraindicated in females over 35 years of age and smoke.

CONTRAINDICATIONS:
INCREASED RISK FOR, OR CURRENT ARTERIAL OR VENOUS THROMBOTIC /THROMBOEMBOLISM DISEASES:

• Smokers, if over 35 years old
• Current or history of deep vein thrombosis or pulmonary embolism
• 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 or hypertension with vascular disease
• Diabetes mellitus with hypertension or end-organ damage; or diabetes mellitus for 20 years or longer
• Migraine headaches with aura
• Current or history of a hormonally sensitive malignancy (e.g. breast cancer)
• Hepatic adenoma, hepatocellular carcinoma, acute hepatitis, or severe (decompensated) cirrhosis
• Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
• Abnormal uterine bleeding with undiagnosed etiology
• Renal Impairment
• Adrenal insufficiency
• Hepatic impairment

Safety and efficacy have not been established in patients younger than 16 years or older than 50 years.
Safety and efficacy have not been established in females with a BMI of 35 kg/m2 or higher.

Consult WARNINGS section for additional precautions.

Dialysis

Contraindicated in renal impairment

Other Comments

Administration advice:

• Take orally once a day at the same time each day; may take with or without food.
• If vomiting or acute diarrhea occur within 3 to 4 hours of taking an active tablet, take a new active tablet as soon as possible (the tablet for the next day). Take the new tablet within 12 hours of the usual time of tablet-taking, if possible. If more than two tablets are missed, follow the advice concerning missed doses, including the use of backup non-hormonal contraception.

MISSED DOSES: PINK tablets are active tablets; WHITE tablets are inert.

• If one pink tablet is missed: Take missed tablet as soon as possible and take the next tablet at the scheduled time, even if two active tablets are taken in one day; continue taking one tablet a day until pack is finished.
• If 2 or more pink tablets are missed in Week 1 or 2: Take 1 missed tablet as soon as possible and take the tablet for the current day (will be taking 2 tablets in 1 day); discard the other missed tablets; continue taking 1 tablet once a day until the pack is finished; use additional non-hormonal contraception as back-up until pink tablets have been taken for 7 consecutive days.
• If two pink tablets are missed in Week 3: Take 1 missed tablet as soon as possible and take the tablet for the current day (will be taking two tablets in 1 day); discard other missed tablets. Finish the active tablets and discard the inactive tablets in the pack. Start a new pack of tablets the next day. Use additional non-hormonal contraception as back-up until pink tablets have been taken for seven consecutive days.
• If one or more white tablets is missed: Skip the missed pill days and continue taking one tablet a day until the pack is finished.

Storage requirements:
Store at 20C to 25C (68F to 77F), excursions permitted between 15C to 30C (59F to 86F).

General:

• Smoking increases the risk of serious cardiovascular side effects; this risk increases with age and number of cigarettes smoked.
• This combination oral contraceptive may be less effective in women with a BMI 30 kg/m2 or greater; it is unknown if this drug is safe and effective in females with a BMI of 35 kg/m2 or higher.

Monitoring:

• Monitor glycemic control in patients with diabetes or prediabetes
• Monitor serum potassium during the first treatment cycle in women at increased risk for hyperkalemia; periodically monitor women at risk for hyperkalemia during therapy
• Monitor blood pressure periodically
• Monitor patients with depression or a history of depression for new onset or exacerbation of existing depression
• Monitor TSH as clinically indicated
• Monitor liver function tests if any signs or symptoms of liver disease develop

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Patients should be advised that this drug does not protect them against HIV infection or other sexually transmitted infections.
• Patients should understand what to do in the event of a missed dose or vomiting or diarrhea for greater than 48 hours.
• Patients should understand the risks, signs, and symptoms of arterial and/or venous thrombotic/thromboembolism; they should be instructed to contact a healthcare professional promptly if they develop these signs or symptoms.
• Patients should understand that this drug interacts with other drugs and dietary supplements; they should inform their healthcare provider of all prescription, nonprescription, or dietary supplements they use.