LoSeasonique (levonorgestrel 0.1 mg ethinyl estradiol 0.02 mg) Dailymed

Stop COCs if an arterial or deep venous thrombotic event occurs. Although use of COCs increases the risk of venous thromboembolism, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of venous thromboembolism in women using COCs is 3 to 9 per 10,000 woman-years. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events.

Stop COCs if an arterial or deep venous thrombotic event occurs. Although use of COCs increases the risk of venous thromboembolism, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of venous thromboembolism in women using COCs is 3 to 9 per 10,000 woman-years. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. Use of LoSeasonique provides women with more hormonal exposure on a yearly basis than conventional monthly oral contraceptives containing the same strength synthetic estrogens and progestins (an additional 9 and 13 weeks of exposure to progestin and estrogen, respectively, per year.) If feasible, stop COCs at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism. Start COCs no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week. Stop COCs if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.

Discontinue COCs if jaundice develops. Steroid hormones may be poorly metabolized in patients with impaired liver function. Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases/100,000 COC 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) COC users. However, the attributable risk of liver cancers in COC users is less than one case per million users. Oral contraceptive-related cholestasis may occur in women with a history of pregnancy-related cholestasis. Women with a history of COC-related cholestasis may have the condition recur with subsequent COC use.

Unscheduled (breakthrough) bleeding and spotting sometimes occur in patients on COCs, especially during the first 3 months of use. If bleeding persists, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different COC product.

Unscheduled (breakthrough) bleeding and spotting sometimes occur in patients on COCs, especially during the first 3 months of use. If bleeding persists, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different COC product. When prescribing LoSeasonique, the convenience of fewer planned menses (4 per year instead of 13 per year) should be weighed against the inconvenience of increased unscheduled bleeding and/or spotting. The clinical trial that evaluated the efficacy of LoSeasonique also assessed unscheduled bleeding. The participants in this 12-month clinical trial (N=2,185) completed the equivalent of over 20,000 28-day cycles of exposure and were composed primarily of women who had used OCs previously (89%), as opposed to new users (11%). A total of 209 subjects (9.6%) discontinued LoSeasonique, at least in part, due to bleeding and/or spotting. Scheduled (withdrawal) bleeding and/or spotting remained fairly constant over time, with an average of 2-3 days of bleeding and/or spotting per each 91-day cycle. Unscheduled bleeding and unscheduled spotting decreased over successive 91-day cycles. Table 1 below presents the number of days with unscheduled bleeding in treatment cycles 1 and 4. Table 2 presents the number of days with unscheduled spotting in treatment cycles 1 and 4. Table 1: Total Number of Days with Unscheduled Bleeding 91-Day Treatment Cycle Days per 84-Day Interval Days per 28-Day Interval Q1 Median Q3 Mean Mean 1st 0 5 11 7.5 2.5 4th 0 0 5 3.5 1.2  Q1=Quartile 1: 25% of women had this number of days of unscheduled bleeding Median: 50% of women had ≤ this number of days of unscheduled bleeding Q3=Quartile 3: 75% of women had ≤ this number of days of unscheduled bleeding Table 2: Total Number of Days with Unscheduled Spotting 91-Day Treatment Cycle Days per 84-Day Interval Days per 28-Day Interval Q1 Median Q3 Mean Mean 1st 3 10 19 14.0 4.7 4th 0 3 10 6.5 2.2  Q1=Quartile 1: 25% of women had ≤ this number of days of unscheduled spotting Median: 50% of women had ≤ this number of days of unscheduled spotting Q3=Quartile 3: 75% of women had ≤ this number of days of unscheduled spotting Figure 1 shows the percentage of LoSeasonique subjects participating in the primary clinical trial with ≥ 7 days or ≥ 20 days of unscheduled bleeding and/or spotting, or just unscheduled bleeding, during each 91-day treatment cycle. Figure 1. Percent of Women Taking LoSeasonique who Reported Unscheduled Bleeding and/or Spotting (Based on Daily Diaries) Amenorrhea sometimes occurs in women who are using COCs. Pregnancy should be ruled out in the event of amenorrhea. Some women may encounter amenorrhea or oligomenorrhea after stopping COCs, especially when such a condition was pre-existent.

If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception. Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of contraceptive hormones, and may decrease the effectiveness of hormonal contraceptives or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John’s wort topiramate HIV protease inhibitors: Significant changes (increase or decrease) in the plasma levels of the estrogen and progestin have been noted in some cases of co-administration of HIV protease inhibitors. Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids. Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy.

There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy. Combination OCs should not be used during pregnancy to treat threatened or habitual abortion. Women who do not breastfeed may start COCs no earlier than four to six weeks postpartum.

When possible, advise the nursing mother to use other forms of contraception until she has weaned her child. Estrogen-containing OCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well established; however, it can occur at any time in some women. Small amounts of estrogen and progestin from low dose COCs are present in breast milk, but these doses have not produced adverse effects in breastfeeding infants.

Combination OCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

Birth control pills help to lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Birth control pills help to lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases. WHAT IS LoSeasonique? LoSeasonique is a birth control pill. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called levonorgestrel. HOW WELL DOES LoSeasonique WORK? Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The more carefully you follow the directions, the less chance you have of getting pregnant. Based on the results of a single clinical study lasting 12 months, 2 to 4 women, out of 100 women, may get pregnant during the first year they use LoSeasonique. The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a ul of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant. Fewer than 1 pregnancy per 100 women in one year Fewer Pregnancies Implants Injections Intrauterine devices Sterilization Birth control pills Skin patch Vaginal ring with hormones 10-20 pregnancies per 100 women in one year Condoms Diaphragm No sex during the most fertile days of the monthly cycle Spermicide Withdrawal 85 or more pregnancies per 100 women in one year More Pregnancies No birth control HOW DO I TAKE LoSeasonique? Take one pill every day at the same time. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant. Many women have spotting or light bleeding, or may feel sick to their stomach during the first few months of taking LoSeasonique. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your healthcare provider. Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach. If you have trouble remembering to take LoSeasonique, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control. Before  you start taking LoSeasonique Decide what time of day you want to take your pill. It is important to take it at about the same time every day. Look at your Extended-Cycle Tablet Dispenser. Your Tablet Dispenser consists of 3 trays with cards that hold 91 individually sealed pills (a 13-week or 91-day cycle). The 91 pills consist of 84 orange and 7 yellow pills. Trays 1 and 2 each contain 28 orange pills (4 rows of 7 pills). Tray 3 contains 35 pills consisting of 28 orange pills (4 rows of 7 pills) and 7 yellow pills (1 row of 7 pills).   Also find: Where on the first tray in the pack to start taking pills (upper left corner at the start arrow) and In what order to take the pills (follow the weeks and arrow). Be sure you have ready at all times another kind of birth control (such as condoms or spermicides), to use as a back-up in case you miss pills. When to Start LoSeasonique Take the first orange pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first orange pill that same day. Use another method of birth control (such as condoms or spermicides) as a back-up method if you have sex anytime from the Sunday you start your first orange pill until the next Sunday (first 7 days). If you have been using a different hormonal method of birth control (such as a different pill, the “patch,” or the “vaginal ring”), you need to use another method of birth control (such as condoms or spermicides) each time you have sex after stopping your old method of birth control until you have taken LoSeasonique for 7 days. How to Take LoSeasonique Take one pill at the same time every day until you have taken the last pill in the tablet dispenser. Do not skip pills even if you are experiencing spotting or bleeding  or feel sick to your stomach (nausea). Do not skip pills even if you do not have sex very often. When you finish a tablet dispenser After taking the last yellow pill, start taking the first orange pill from a new Extended-Cycle Tablet Dispenser the very next day (this should be on a Sunday) regardless of when your period started. If you miss your scheduled period when you are taking the yellow pills, contact your healthcare provider because you may be pregnant. If you are pregnant, you should stop taking LoSeasonique. WHAT TO DO IF YOU MISS PILLS If you MISS 1 orange pill: Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day. You do not need to use a back-up birth control method if you have sex. If you MISS 2 orange pills in a row: Take 2 pills on the day you remember, and 2 pills the next day. Then take 1 pill a day until you finish the pack. You could become pregnant if you have sex in the 7 days after you miss two pills. You MUST use another birth control method (such as condoms or spermicide) as a back up for the 7 days after you restart your pills. If you MISS 3 OR MORE orange pills in a row: Do not take the missed pills. Keep taking 1 pill every day as indicated on the pack until you have completed all of the remaining pills in the pack. For example: If you resume taking the pill on Thursday, take the pill under “Thursday” and do not take the missed pills. You may experience bleeding during the week following the missed pills. You could become pregnant if you have sex during the days of missed pills or during the first 7 days after restarting your pills. You MUST use a non-hormonal birth control method (such as condoms or spermicide) as a back-up when you miss pills and for the first 7 days after you restart your pills. If you do not have your period when you are taking the yellow pills, call your healthcare provider because you may be pregnant. If you MISS ANY of the 7 yellow pills: Throw away the missed pills. Keep taking the scheduled pills until the pack is finished. You do not need a back-up method of birth control. Finally, if you are still not sure what to do about the pills you have missed Use a back-up method anytime you have sex. Keep taking one pill each day until you contact your healthcare provider. WHO SHOULD NOT TAKE LoSeasonique? Your healthcare provider will not give you LoSeasonique if you have: Ever had breast cancer or any cancer that is sensitive to female hormones Liver disease, including liver tumors Ever had blood clots in your arms, legs, or lungs Ever had a stroke Ever had a heart attack Certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart An inherited problem with your blood that makes it clot more than normal High blood pressure that medicine can't control Diabetes with kidney, eye, or blood vessel damage Certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision Also, do not take birth control pills if you: Smoke and are over 35 years old Are pregnant Birth control pills may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy. WHAT ELSE SHOULD I KNOW ABOUT TAKING LoSeasonique? Birth control pills do not protect you against any sexually transmitted disease, including HIV, the virus that causes AIDS. Do not skip any pills, even if you do not have sex often. Birth control pills should not be taken during pregnancy. However, birth control pills taken by accident during pregnancy are not known to cause birth defects. If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like LoSeasonique, may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk, but this has not caused harmful effects in breastfeeding infants. Tell your health care provider about all medicines and herbal products that you take. Some medicines and herbal products may make birth control pills less effective, including: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John’s wort topiramate Consider using another birth control method when you take medicines that may make birth control pills less effective. Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your physician may need to adjust the dose of lamotrigine. If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like condoms or a spermicide, until you check with your health care provider. WHAT ARE THE MOST SERIOUS RISKS OF TAKING BIRTH CONTROL PILLS? Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age > 35. It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the: Legs (thrombophlebitis) Lungs (pulmonary embolus) Eyes (loss of eyesight) Heart (heart attack) Brain (stroke) A few women who take birth control pills may get: High blood pressure Gallbladder problems Rare cancerous or noncancerous liver tumors All of these events are uncommon in healthy women. Call your health care provider right away if you have: Persistent leg pain Sudden shortness of breath Sudden blindness, partial or complete Severe pain in your chest Sudden, severe headache unlike your usual headaches Weakness or numbness in an arm or leg, or trouble speaking Yellowing of the skin or eyeballs WHAT ARE COMMON SIDE EFFECTS OF BIRTH CONTROL PILLS? The most common side effects of birth control pills are: Spotting or bleeding between menstrual periods Nausea Breast tenderness Headache These side effects are usually mild and usually disappear with time. Less common side effects are: Acne Less sexual desire Bloating or fluid retention Blotchy darkening of the skin, especially on the face High blood sugar, especially in women who already have diabetes High fat levels in the blood. Depression, especially if you have had depression in the past. Call your health care provider immediately if you have any thoughts of harming yourself. Problems tolerating contact lenses Weight changes This is not a complete ul of possible side effects. Talk to your health care provider if you develop any side effects that concern you. No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children. DO BIRTH CONTROL PILLS CAUSE CANCER? Birth control pills do not appear to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use birth control pills because some breast cancers are sensitive to hormones. Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners. WHAT SHOULD I KNOW ABOUT MY PERIOD WHEN TAKING LoSeasonique? When you take LoSeasonique, which has a 91-day extended dosing cycle, you should expect to have 4 scheduled periods per year (bleeding when you are taking the 7 yellow pills). Each period is likely to last about 2 to 3 days. However, you will probably have more bleeding or spotting between your scheduled periods than if you were using a birth control pill with a 28-day dosing cycle. This bleeding or spotting tends to decrease with time. Do not stop taking LoSeasonique because of this bleeding or spotting. If the spotting continues for more than 7 consecutive days or if the bleeding is heavy, call your healthcare provider. WHAT IF I MISS MY SCHEDULED PERIOD WHEN TAKING LoSeasonique? You should consider the possibility that you are pregnant if you miss your scheduled period (no bleeding on the days that you are taking yellow tablets). Since scheduled periods are less frequent when you are taking LoSeasonique, notify your healthcare provider that you have missed your period and that you are taking LoSeasonique. Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your healthcare provider evaluates you to determine if you are pregnant. Stop taking LoSeasonique if it is determined that you are pregnant. WHAT IF I WANT TO BECOME PREGNANT? You may stop taking the pill whenever you wish. Consider a visit with your health care provider for a pre-pregnancy checkup before you stop taking the pill. Rx only TEVA WOMEN’S HEALTH, INC. Subsidiary of TEVA PHARMACEUTICALS USA, INC. Sellersville, PA  18960 Iss. 6/2011 799-33-100090