Beyaz (drospirenone 3 mg ethinyl estradiol 0.02 mg levomefolate calcium 0.451 mg) Dailymed

Beyaz is indicated for use by females of reproductive potential to prevent pregnancy.

Beyaz® is indicated for use by females of reproductive potential to prevent pregnancy.

Beyaz is indicated in females of reproductive potential who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.

Beyaz is indicated in females of reproductive potential who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.

During the first cycle of Beyaz use, instruct the patient to take one pink Beyaz daily, beginning on the first Sunday after the onset of her menstrual period. She should take one pink Beyaz daily for 24 consecutive days, followed by one light orange tablet daily on Days 25 through 28. Beyaz should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Beyaz can be taken without regard to meals. Beyaz should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. The patient should begin her next and all subsequent 28-day regimens of Beyaz on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her pink tablets on the next day after ingestion of the last light orange folate tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Beyaz is started later than the day following administration of the last light orange tablet, the patient should use another method of contraception until she has taken a pink Beyaz daily for seven consecutive days. When switching from a different birth control pill When switching from another birth control pill, Beyaz should be started on the same day that a new pack of the previous oral contraceptive would have been started. When switching from a method other than a birth control pill When switching from a transdermal patch or vaginal ring, Beyaz should be started when the next application would have been due. When switching from an injection, Beyaz should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Beyaz should be started on the day of removal. Withdrawal bleeding usually occurs within 3 days following the last pink tablet. If spotting or breakthrough bleeding occurs while taking Beyaz, instruct the patient to continue taking Beyaz by the regimen described above. Counsel her that this type of bleeding is usually transient and without significance; however, advise her that if the bleeding is persistent or prolonged, she should consult her healthcare provider. Although the occurrence of pregnancy is low if Beyaz is taken according to directions, if withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue Beyaz if pregnancy is confirmed. The risk of pregnancy increases with each active pink tablet missed. If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. If the patient misses one or more light orange tablets, she should still be protected against pregnancy provided she begins taking a new cycle of pink tablets on the proper day. For postpartum women who do not breastfeed or after a second trimester abortion, start Beyaz no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Beyaz postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Beyaz for 7 consecutive days.

Table 1: Instructions for Beyaz Missed Doses If one pink active tablet is missed Take it as soon as possible. Take the next tablet at the regular time. This means two tablets may be taken in one day. A back-up birth control method is not required if the patient has sex. If two pink active tablets in a row are missed in Week 1 or Week 2 Take two tablets as soon as possible and two tablets the next day. Then take one tablet a day until the pack is finished. Additional nonhormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. If two pink active tablets in a row are missed in Week 3 or Week 4 Day 1 Start: Throw out the rest of the pack and start a new pack that same day. Sunday Start: Keep taking one tablet every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that same day. Additional nonhormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. The patient may not have their period this month but this is expected. However, if they miss their period two months in a row, they should call their healthcare provider because they might be pregnant. If three or more pink active tablets in a row are missed during any week Day 1 Start: Throw out the rest of the pack and start a new pack that same day. Sunday Start: Keep taking one tablet every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that same day. Additional nonhormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. The patient may not have their period this month but this is expected. However, if they miss their period two months in a row, they should call their healthcare provider because they might be pregnant. If any of the four light orange inactive tablets are missed in Week 4: Throw away the tablets that were missed. Keep taking one tablet each day until the pack is empty. They do not need a back-up method. Finally, if they are still not sure what to do about the tablets they have missed: Use nonhormonal contraception (such as condoms and spermicides) anytime they have sex. Contact their healthcare provider and continue taking one active pink tablet each day until otherwise directed.

The U.S. Preventive Services Task Force recommends that women of childbearing age consume supplemental folic acid in a dose of at least 0.4 mg (400 mcg) daily. Consider other folate supplementation that a woman may be taking before prescribing Beyaz. Ensure that folate supplementation is maintained if a woman discontinues Beyaz due to pregnancy.

The U.S. Preventive Services Task Force recommends that women of childbearing age consume supplemental folic acid in a dose of at least 0.4 mg (400 mcg) daily.1 Consider other folate supplementation that a woman may be taking before prescribing Beyaz. Ensure that folate supplementation is maintained if a woman discontinues Beyaz due to pregnancy.

Stop Beyaz if an arterial or venous thrombotic (VTE) event occurs. Based on presently available information on DRSP-containing COCs with 0.03 mg ethinyl estradiol (that is, Yasmin), DRSP-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins. Epidemiologic studies that compared the risk of VTE reported that the risk ranged from no increase to a three-fold increase. Before initiating use of Beyaz in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE. Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs [see Contraindications (4)]. A number of studies have compared the risk of VTE for users of Yasmin (which contains 0.03 mg of EE and 3 mg of DRSP) to the risk for users of other COCs, including COCs containing levonorgestrel. Those that were required or sponsored by regulatory agencies are summarized in Table 2. Table 2: Estimates (Hazard Ratios) of Venous Thromboembolism Risk in Current Users of Yasmin Compared to Users of Oral Contraceptives that Contain Other Progestins Epidemiologic Study (Author, Year of Publication) Population Studied Comparator Product (all are low-dose COCs; with ≤ 0.04 mg of EE) Hazard Ratio (HR) (95% CI) i3 Ingenix (Seeger 2007) Initiators, including new users"New users" - no use of combination hormonal contraception for at least the prior 6 months All COCs available in the USduring the conduct of the studyIncludes low-dose COCs containing the following progestins: norgestimate, norethindrone, levonorgestrel, desogestrel, norgestrel, medroxyprogesterone, or ethynodiol diacetate HR: 0.9(0.5-1.6) EURAS(Dinger 2007)Initiators, including new users All COCs available in Europeduring the conduct of the studyIncludes low-dose COCs containing the following progestins: levonorgestrel, desogestrel, dienogest, chlormadinone acetate, gestodene, cyproterone acetate, norgestimate, or norethindrone HR: 0.9 (0.6-1.4) Levonorgestrel/EE HR: 1.0(0.6-1.8) FDA-funded study” (2011) New users Other COCs available during the course of the studyIncludes low-dose COCs containing the following progestins: norgestimate, norethindrone, or levonorgestrel HR: 1.8(1.3-2.4) Levonorgestrel/0.03 mg EE HR: 1.6(1.1-2.2) All users(i.e., initiation and continuing use of study combination hormonal contraception) Other COCs available during the course of the study HR: 1.7(1.4-2.1) Levonorgestrel/0.03 mg EE HR: 1.5(1.2-1.8) In addition to these “regulatory studies,” other studies of various designs have been conducted. Overall, there are two prospective cohort studies (see Table 2): the US post-approval safety study Ingenix [Seeger 2007], the European post-approval safety study EURAS (European Active Surveillance Study) [Dinger 2007]. An extension of the EURAS study, the Long-Term Active Surveillance Study (LASS), did not enroll additional subjects, but continued to assess VTE risk. There are three retrospective cohort studies: one study in the US funded by the FDA (see Table 2), and two from Denmark [Lidegaard 2009, Lidegaard 2011]. There are two case-control studies: the Dutch MEGA study analysis [van Hylckama Vlieg 2009] and the German case-control study [Dinger 2010]. There are two nested case-control studies that evaluated the risk of non-fatal idiopathic VTE: the PharMetrics study [Jick 2011] and the GPRD study [Parkin 2011]. The results of all of these studies are presented in Figure 1. Figure 1: VTE Risk with Yasmin Relative to LNG-Containing COCs (adjusted risk#) Risk ratios displayed on logarithmic scale; risk ratio < 1 indicates a lower risk of VTE for DRSP, > 1 indicates an increased risk of VTE for DRSP. *Comparator “Other COCs”, including LNG- containing COCs † LASS is an extension of the EURAS study #Some adjustment factors are indicated by superscript letters: a) Current heavy smoking, b) hypertension, c) obesity, d) family history, e) age, f) BMI, g) duration of use, h) VTE history, i) period of inclusion, j) calendar year, k) education, l) length of use, m) parity, n) chronic disease, o) concomitant medication, p) smoking, q) duration of exposure, r) site (References: Ingenix [Seeger 2007]2, EURAS (European Active Surveillance Study) [Dinger 2007]3, LASS (Long-Term Active Surveillance Study) [Dinger, unpublished document on file], FDA-funded study [Sidney 2011]4, Danish [Lidegaard 2009]5, Danish re-analysis [ Lidegaard 2011]6, MEGA study [van Hylckama Vlieg 2009]7, German Case-Control study [Dinger 2010]8, PharMetrics [Jick 2011]9, GPRD study [Parkin 2011]10) Although the absolute VTE rates are increased for users of hormonal contraceptives compared to non-users, the rates during pregnancy are even greater, especially during the post-partum period (see Figure 2). The risk of VTE in women using COCs has been estimated to be 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use. Data from a large, prospective cohort safety study of various COCs suggest that this increased risk, as compared to that in non-COC users, is greatest during the first 6 months of COC use. Data from this safety study indicate that the greatest risk of VTE is present after initially starting a COC or restarting (following a 4 week or greater pill-free interval) the same or a different COC. The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC use is discontinued. Figure 2 shows the risk of developing a VTE for women who are not pregnant and do not use oral contraceptives, for women who use oral contraceptives, for pregnant women, and for women in the postpartum period. To put the risk of developing a VTE into perspective: If 10,000 women who are not pregnant and do not use oral contraceptives are followed for one year, between 1 and 5 of these women will develop a VTE. Figure 2: Likelihood of Developing a VTE If feasible, stop Beyaz at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism. Start Beyaz 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. 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. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with other underlying risk factors. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors. Stop Beyaz if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately. [See Adverse Reactions ( 6 ).]

Discontinue Beyaz if jaundice develops. Steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. 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 or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, 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.

Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, 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. Data for Beyaz show the average number of episodes of bleeding per reference period (90 days) was 3.2 in Cycles 4-6. The average number of bleeding and/or spotting days with Beyaz was 15.1 days. The intensity of bleeding for Beyaz based on the ratio of spotting-only days versus total bleeding and/or spotting days was 5.2/15.1 days. Based on patient diaries from two contraceptive clinical trials of YAZ, 8 to 25% of women experienced unscheduled bleeding per 28-day cycle. A total of 12 subjects out of 1,056 (1.1%) discontinued YAZ due to menstrual disorders including intermenstrual bleeding, menorrhagia, and metrorrhagia. Women who use Beyaz may experience absence of withdrawal bleeding, even if they are not pregnant. Based on subject diaries from YAZ contraception trials for up to 13 cycles, 6 to 10% of women experienced cycles with no withdrawal bleeding. Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was pre-existent. If withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.

Substances diminishing the efficacy of COCs: Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John’s wort. Interactions between oral contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with COCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability. Substances increasing the plasma concentrations of COCs: Co-administration of atorvastatin and certain COCs containing EE increase AUC values for EE by approximately 20%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. Concomitant administration of moderate or strong CYP3A4 inhibitors such as azole antifungals (e.g., ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (e.g., clarithromycin, erythromycin), diltiazem, and grapefruit juice can increase the plasma concentrations of the estrogen or the progestin or both. In a clinical drug-drug interaction study conducted in premenopausal women, once daily co-administration of DRSP 3 mg/EE 0.02 mg containing tablets with strong CYP3A4 inhibitor, ketoconazole 200 mg twice daily for 10 days resulted in a moderate increase of DRSP systemic exposure. The exposure of EE was increased mildly [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)]. Human immunodeficiency virus (HIV)/Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma concentrations of estrogen and progestin have been noted in some cases of co-administration with HIV/HCV protease inhibitors or with non-nucleoside reverse transcriptase 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.



There is no use for contraception in pregnancy; therefore, Beyaz should be discontinued during 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 CHCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.

A retrospective database study of women in Norway, that included 44,734 pregnancies of which 368 were women who inadvertently took drospirenone/ethinyl estradiol during the first trimester of a pregnancy, found there were no adverse effects on pre-term birth, small for gestational age, or birth weight Z-scores.

A retrospective database study of women in Norway, that included 44,734 pregnancies of which 368 were women who inadvertently took drospirenone/ethinyl estradiol during the first trimester of a pregnancy, found there were no adverse effects on pre-term birth, small for gestational age, or birth weight Z-scores. Post-marketing adverse event data on the use of Beyaz in pregnant women suggest that frequencies of miscarriage and congenital anomalies were not higher than the estimated background risk in the general population.

COCs lower the risk of becoming pregnant primarily by suppressing ovulation.

Substances diminishing the efficacy of COCs: Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Substances increasing the plasma concentrations of COCs: Co-administration of atorvastatin and certain COCs containing EE increase AUC values for EE by approximately 20%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. In a clinical drug-drug interaction study conducted in 20 premenopausal women, co-administration of a DRSP (3 mg)/EE (0.02 mg) COC with the strong CYP3A4 inhibitor ketoconazole (200 mg twice daily) for 10 days increased the AUC(0-24h) of DRSP and EE by 2.68-fold (90% CI: 2.44, 2.95) and 1.40-fold (90% CI: 1.31, 1.49), respectively. The increases in Cmax were 1.97-fold (90% CI: 1.79, 2.17) and 1.39-fold (90% CI: 1.28, 1.52) for DRSP and EE, respectively. Although no clinically relevant effects on safety or laboratory parameters including serum potassium were observed, this study only assessed subjects for 10 days. The clinical impact for a patient taking a DRSP-containing COC concomitantly with chronic use of a CYP3A4/5 inhibitor is unknown [see Warnings and Precautions (5.2)]. HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma concentrations of estrogen and progestin have been noted in some cases of co-administration with HIV/HCV protease inhibitors or with non-nucleoside reverse transcriptase 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.

In the primary contraceptive efficacy study of YAZ (3 mg DRSP/0.02 mg EE) of up to 1 year duration, 1,027 subjects were enrolled and completed 11,480 28-day cycles of use. The age range was 17 to 36 years. The racial demographic was: 87.8% Caucasian, 4.6% Hispanic, 4.3% Black, 1.2% Asian, and 2.1% other. Women with a BMI greater than 35 were excluded from the trial. The pregnancy rate (Pearl Index) was 1.41 (95% CI [0.73 – 2.47]) per 100 woman-years of use based on 12 pregnancies that occurred after the onset of treatment and within 14 days after the last dose of YAZ in women 35 years of age or younger during cycles in which no other form of contraception was used.

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

Birth control pills help to lower the chances of becoming pregnant when taken as directed. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases. What Is Beyaz? Beyaz is a birth control pill. It contains two female hormones, a synthetic estrogen called ethinyl estradiol and a progestin called drospirenone. Beyaz also contains levomefolate calcium, which is a B vitamin. The progestin drospirenone may increase potassium. Therefore, you should not take Beyaz if you have kidney, liver or adrenal disease because this could cause serious heart and health problems. Other drugs may also increase potassium. If you are currently on daily, long-term treatment for a chronic condition with any of the medications below, you should consult your healthcare provider about whether Beyaz is right for you, and during the first month that you take Beyaz, you should have a blood test to check your potassium level. •NSAIDs (ibuprofen [Motrin, Advil], naproxen [Aleve and others] when taken long-term and daily for treatment of arthritis or other problems) •Potassium-sparing diuretics (spironolactone and others) •Potassium supplementation •ACE inhibitors (Capoten, Vasotec, Zestril and others) •Angiotensin-II receptor antagonists (Cozaar, Diovan, Avapro and others) •Heparin •Aldosterone antagonists Beyaz may also be taken to treat premenstrual dysphoric disorder (PMDD) if you choose to use the Pill for birth control. Unless you have already decided to use the Pill for birth control, you should not start Beyaz to treat your PMDD because there are other medical therapies for PMDD that do not have the same risks as the Pill. PMDD is a mood disorder related to the menstrual cycle. PMDD significantly interferes with work or school, or with usual social activities and relationships with others. Symptoms include markedly depressed mood, anxiety or tension, mood swings, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD may include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly before menstruation starts and go away within a few days following the start of the period. Diagnosis of PMDD should be made by healthcare providers. You should only use Beyaz for treatment of PMDD if you: •Have already decided to use oral contraceptives for birth control, and •Have been diagnosed with PMDD by your healthcare provider. Beyaz has not been shown to be effective for the treatment of premenstrual syndrome (PMS), a less serious set of symptoms occurring before menstruation. If you or your healthcare provider believe you have PMS, you should take Beyaz only if you want to prevent pregnancy; and not for the treatment of PMS. Beyaz may also be taken to treat moderate acne if all of the following are true: •Your healthcare provider says it is safe for you to use Beyaz. •You are at least 14 years old. •You have started having menstrual periods. •You want to use a birth control pill to prevent pregnancy. Beyaz may also be taken to provide folate supplementation in women who elect to use an oral contraceptive. It is recommended that women of reproductive age supplement their diet with 0.4 mg (400 mcg) of folic acid daily to lower their risk of having a pregnancy with a rare type of birth defect (known as a neural tube defect). The amount of folate contained in Beyaz supplements folate in the diet to lower this risk should you become pregnant while taking the drug or shortly after stopping it. How Well Does Beyaz Work? Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant. Based on the results of one clinical study, 1 to 2 women out of 100 women, may get pregnant during the first year they use Beyaz. 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.  How Do I Take Beyaz? 1. Be sure to read these directions before you start taking your pills or anytime you are not sure what to do. 2. The right way to take the pill is to take one pill every day at the same time in the order directed on the package. Preferably, take the pill after the evening meal or at bedtime, with some liquid, as needed. Beyaz can be taken without regard to meals. 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. See "WHAT TO DO IF YOU MISS PILLS” below. 3. Many women have spotting or light bleeding at unexpected times, or may feel sick to their stomach during the first 1-3 packs of pills. If you do have spotting or light bleeding or feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it does not go away, check with your healthcare provider. 4. Missing pills can also cause spotting or light bleeding, even when you make up these missed pills. On the days you take two pills, to make up for missed pills, you could also feel a little sick to your stomach. 5. If you have vomiting (within 3 to 4 hours after you take your pill), you should follow the instructions for "WHAT TO DO IF YOU MISS PILLS." If you have diarrhea or if you take certain medicines, including some antibiotics and some herbal products such as St. John's Wort, your pills may not work as well. Use a back-up method (such as condoms and spermicides) until you check with your healthcare provider. 6. If you have trouble remembering to take the pill, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control. 7. If you have any questions or are unsure about the information in this leaflet, call your healthcare provider. Before You Start Taking Your Pills 1. Decide What Time of Day You Want to Take Your Pill It is important to take Beyaz in the order directed on the package at the same time every day, preferably after the evening meal or at bedtime, with some liquid, as needed. Beyaz can be taken without regard to meals. 2. Look at Your Pill Pack—It has 28 Pills The Beyaz-pill pack has 24 pink pills (with hormones and folate) to be taken for 24 days, followed by 4 light orange pills (without hormones, containing folate) to be taken for the next four days. It is important to take the light orange pills because they contain folate. 3. Also look for: a) Where on the pack to start taking pills, b) In what order to take the pills (follow the arrows) 4. Be sure you have ready at all times (a) another kind of birth control (such as condoms and spermicides) to use as a back-up in case you miss pills, and (b) an extra, full pill pack. When To Start the First Pack of Pills You have a choice for which day to start taking your first pack of pills. Decide with your healthcare provider which is the best day for you. Pick a time of day which will be easy to remember. Day 1 Start: 1. Take the first pink pill of the pack during the first 24 hours of your period. 2. You will not need to use a back-up method of birth control, since you are starting the Pill at the beginning of your period. However, if you start Beyaz later than the first day of your period, you should use another method of birth control (such as a condom and spermicide) as a back-up method until you have taken 7 pink pills. Sunday Start: 1. Take the first pink pill of the pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack that same day. 2. Use another method of birth control (such as a condom and spermicide) as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days). This also applies if you start Beyaz after having been pregnant, and you have not had a period since your pregnancy. When You Switch From a Different Birth Control Pill When switching from another birth control pill, Beyaz should be started on the same day that a new pack of the previous birth control pill would have been started. When You Switch From Another Type of Birth Control Method When switching from a transdermal patch or vaginal ring, Beyaz should be started when the next application would have been due. When switching from an injection, Beyaz should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Beyaz should be started on the day of removal. What to Do During the Month 1. Take one pill at the same time every day until the pack is empty. Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea). Do not skip pills even if you do not have sex very often. 2. When you finish a pack of pills, start the next pack on the day after your last light orange pill. It is important to take the light orange pills because they contain folate. Do not wait any days between packs. What to Do if You Miss Pills If you miss 1 pink pill in your pack: 1. Take it as soon as you remember. Take the next pill at your regular time. This means you may take two pills in one day. 2. You do not need to use a back-up birth control method if you have sex. If you miss 2 pink pills in a row in Week 1 or Week 2 of your pack: 1. Take two pills on the day you remember and two pills the next day. 2. Then take one pill a day until you finish the pack. 3. You could become pregnant if you have sex in the 7 days after you restart your pills. You must use another birth control method (such as a condom and spermicide) as a back-up for those 7 days. If you miss 2 pink pills in a row in Week 3 or Week 4 of your pack: 1. If you are a Day 1 Starter: Throw out the rest of the pill pack and start a new pack that same day. If you are a Sunday Starter: Keep taking one pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day. 2. You could become pregnant if you have sex in the 7 days after you restart your pills. You must use another birth control method (such as a condom and spermicide) as a back-up for those 7 days. 3. You may not have your period this month but this is expected. However, if you miss your period two months in a row, call your healthcare provider because you might be pregnant. If you miss 3 or more pink pills in a row during any week: 1. If you are a Day 1 Starter: Throw out the rest of the pill pack and start a new pack that same day. If you are a Sunday Starter: Keep taking 1 pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day. 2. You could become pregnant if you have sex in the 7 days after you restart your pills. You must use another birth control method (such as condoms and spermicides) as a back-up for those 7 days. 3. You may not have your period this month but this is expected. However, if you miss your period two months in a row, call your healthcare provider because you might be pregnant. If you miss any of the 4 light orange pills in Week 4: Throw away the pills you missed. Keep taking one pill each day until the pack is empty. You do not need a back-up method. Finally, if you are still not sure what to do about the pills you have missed: Use a back-up method (such as condoms and spermicides) anytime you have sex. Contact your healthcare provider and continue taking one active pink pill each day until otherwise directed. WHO SHOULD NOT TAKE Beyaz? Your healthcare provider will not give you Beyaz if you: •Ever had blood clots in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis) •Ever had a stroke •Ever had a heart attack •Have certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart •Have an inherited problem with your blood that makes it clot more than normal •Have high blood pressure that medicine can't control •Have diabetes with kidney, eye, nerve, or blood vessel damage •Ever had certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision •Ever had breast cancer which may be sensitive to female hormones •Have liver disease, including liver tumors •Take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood. •Have kidney disease •Have adrenal disease Also, do not take birth control pills if you: •Smoke and are over 35 years old •Are or suspect you 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 (also called cholestasis of pregnancy). Tell your healthcare provider if you have ever had any of the above conditions (your healthcare provider can recommend another method of birth control). Tell your healthcare provider if you are already taking daily folate supplements. What Else Should I Know about Taking Beyaz? 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. If you miss a period, you could be pregnant. However, some women miss periods or have light periods on birth control pills, even when they are not pregnant. Contact your healthcare provider for advice if you: •Think you are pregnant •Miss one period and have not taken your birth control pills every day •Miss two periods in a row 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. You should stop Beyaz at least four weeks before you have major surgery and not restart it until at least two weeks after the surgery due to an increased risk of blood clots. If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like Beyaz, may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk. Folates may make certain drugs, including some used for epilepsy, less effective, so talk to your healthcare provider about any medicines you take. If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like condoms and a spermicide, until you check with your healthcare provider. If you are scheduled for any laboratory tests, tell your doctor you are taking birth-control pills. Certain blood tests may be affected by birth-control pills. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Beyaz may affect the way other medicines work, and other medicines may affect how well Beyaz works. Know the medicines you take. Keep a ul of them to show your healthcare provider and pharmacist when you get a new medicine. What are the Most Serious Risks of Taking Birth Control Pills? Like pregnancy, birth control pills increase the risk of serious blood clots (see following graph), especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start taking birth control pills and when you restart the same or different birth control pills after not using them for a month or more. Women who use birth control pills with drospirenone (like Beyaz) may have a higher risk of getting a blood clot. Some studies reported that the risk of blood clots was higher for women who use birth control pills that contain drospirenone than for women who use birth control pills that do not contain drospirenone. Talk with your healthcare provider about your risk of getting a blood clot before deciding which birth control pill is right for you. It is possible to die or be permanently disabled from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious clots are blood clots in the: •Legs (deep vein thrombosis or DVT) •Lungs (pulmonary embolus or PE) •Eyes (loss of eyesight) •Heart (heart attack) •Brain (stroke) To put the risk of developing a blood clot into perspective: If 10,000 women who are not pregnant and do not use birth control pills are followed for one year, between 1 and 5 of these women will develop a blood clot. The figure below shows the likelihood of developing a serious blood clot for women who are not pregnant and do not use birth control pills, for women who use birth control pills, for pregnant women, and for women in the first 12 weeks after delivering a baby. Likelihood of Developing a Serious Blood Clot 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 healthcare 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 the 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 (cholesterol; triglyceride) levels in the blood •Depression, especially if you have had depression in the past. Call your healthcare 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 healthcare provider if you develop any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088. No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children. Do Birth Control Pills Cause Cancer? It is not known if hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use. If you have breast cancer now, or have had it in the past, do not use hormonal birth control 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 Beyaz? Irregular vaginal bleeding or spotting may occur while you are taking Beyaz. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding, which is a flow much like a regular period. Irregular bleeding occurs most often during the first few months of oral contraceptive use, but may also occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue taking your pills on schedule. If the bleeding occurs in more than one cycle, is unusually heavy, or lasts for more than a few days, call your healthcare provider. Some women may not have a menstrual period but this should not be cause for alarm as long as you have taken the pills according to direction. What if I Miss My Scheduled Period when Taking Beyaz? It is not uncommon to miss your period. However, if you miss two periods in a row or miss one period when you have not taken your birth control pills according to directions, call your healthcare provider. 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 checks you to find out if you are pregnant. Stop taking Beyaz if you are pregnant. What If I Want to Become Pregnant? You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill. See your health care provider about appropriate folate supplementation if you stop taking Beyaz, are pregnant, or plan on becoming pregnant. General Advice about Beyaz Your healthcare provider prescribed Beyaz for you. Please do not share Beyaz with anyone else. Keep Beyaz out of the reach of children. If you have concerns or questions, ask your healthcare provider. You may also ask your healthcare provider for a more detailed label written for medical professionals. Revised: 5/2023 Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981 Manufactured in Germany ©2010 Bayer HealthCare Pharmaceuticals Inc. All Rights Reserved Bayer HealthCare Pharmaceuticals Inc.