Prevention of pregnancy - ALYACEN 1/35 (monophasic 28-day regimen)
Women of reproductive age
1 active tablet QD x21 days, then 1 light-green reminder tablet QD x7 days (Sunday Start or Day 1 Start)
1 tablet QD continuously; start next 28-tablet pack the day after finishing
1 tablet QD
Prevention of pregnancy - ALYACEN 7/7/7 (triphasic 28-day regimen)
Women of reproductive age
1 active tablet QD x21 days (three 7-day phases), then 1 light-green reminder tablet QD x7 days (Sunday Start or Day 1 Start)
1 tablet QD continuously; start next 28-tablet pack the day after finishing
1 tablet QD
Renal Undefined
Hepatic Discontinue if jaundice develops; steroid hormones may be poorly metabolized in impaired liver function (contraindicated in acute/chronic hepatocellular disease with abnormal liver function)
Interval between tablets must not exceed 24 hours
Instructions
Take at intervals not exceeding 24 hours; efficacy depends on strict schedule adherence
Sunday Start, first cycle: use backup contraception (condom/spermicide) through the first 7 consecutive days
Missed 1 active tablet (week 1, 2 or 3): take it as soon as remembered
Missed 2 active tablets in week 1 or 2: take 2 tablets that day and 2 the next day, then 1 QD to end of pack; backup contraception x7 days
Missed 2 active tablets in week 3, or >=3 active tablets in a row: Sunday Start - continue 1 tablet daily until Sunday, then discard pack and start a new pack that day; Day 1 Start - discard pack and start a new pack that day; backup contraception x7 days
May be started 4 weeks postpartum in women who elect not to breastfeed (postpartum thromboembolic risk)
Postpubertal adolescents: safety and efficacy expected to be the same as in adults; not indicated before menarche
Rule out pregnancy after two consecutive missed periods (or after the first missed period if tablets were not taken on schedule)
Available strengths
tab 1/0.02, 1.5/0.03 mg
Contraindications
Thrombophlebitis or thromboembolic disorders, current or past (incl. deep vein thrombophlebitis); known thrombophilic conditions
Cerebral vascular or coronary artery disease (current or history)
Valvular heart disease with complications
Persistent BP >=160 mmHg systolic or >=100 mmHg diastolic
Diabetes with vascular involvement
Headaches with focal neurological symptoms
Major surgery with prolonged immobilization
Known or suspected carcinoma of the breast
Endometrial carcinoma or other known/suspected estrogen-dependent neoplasia
Undiagnosed abnormal genital bleeding
Cholestatic jaundice of pregnancy or jaundice with prior pill use
Acute or chronic hepatocellular disease with abnormal liver function; hepatic adenomas or carcinomas
Known or suspected pregnancy
Hepatitis C regimens containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (ALT elevations)
Women over 35 years who smoke (WARNINGS: combination oral contraceptives should not be used)
Cautions
Cigarette smoking increases risk of serious cardiovascular events from COC use, rising with age (esp. >35 y) and cigarettes/day - do not use in women >35 who smoke
Increased risk of MI, thromboembolism (VTE risk highest in first year of use and on restarting after a break >=4 weeks), stroke, hepatic neoplasia and gallbladder disease
Discontinue >=4 weeks before and 2 weeks after elective surgery with thromboembolic risk and during prolonged immobilization; start no earlier than 4 weeks postpartum
Do not start hormonal contraception in women with significant hypertension; discontinue if persistent BP >=160/100 mmHg cannot be controlled; monitor BP throughout therapy
Discontinue for unexplained partial/complete vision loss, proptosis, diplopia, papilledema or retinal vascular lesions (retinal thrombosis)
Discontinue for new-onset or worsening migraine, or new recurrent/persistent/severe headache
Discontinue and evaluate for jaundice; ALT elevations with concomitant HCV ombitasvir/paritaprevir/ritonavir regimens
Decreased glucose tolerance and hypertriglyceridemia - monitor prediabetic/diabetic patients and those treated for hyperlipidemia
Breakthrough bleeding/spotting, especially in the first 3 months - rule out malignancy or pregnancy
Ectopic as well as intrauterine pregnancy may occur in contraceptive failures
Fluid retention; observe women with a history of depression and discontinue if depression recurs seriously
Does not protect against HIV or other sexually transmitted diseases
Diminution in lactation when given immediately postpartum
Pregnancy Pregnancy Category X - contraindicated in known or suspected pregnancy; discontinue if pregnancy is confirmed. Epidemiologic studies show no increased risk of birth defects from use before or inadvertently during early pregnancy
Lactation Small amounts of contraceptive steroids appear in milk; jaundice and breast enlargement reported in infants. Combined OCs in the postpartum period may reduce quantity and quality of breast milk - if possible use another method until completely weaned