Beyaz (Drospirenone) is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of Beyaz (Drospirenone) for PMDD when used for more than three menstrual cycles has not been evaluated.
The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, 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 include breast tenderness, headache, joint and muscle pain, bloating and weight gain. In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders.
Beyaz (Drospirenone) has not been evaluated for the treatment of premenstrual syndrome (PMS).
Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly.
To achieve maximum contraceptive and PMDD effectiveness, Beyaz (Drospirenone) must be taken as directed. Single missed pills should be taken as soon as remembered.
Stop Beyaz (Drospirenone) if an arterial or deep venous thrombotic (VTE) event occurs. Although the 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. The risk is highest during the first year of use of a COC. 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. The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC use is discontinued.
If feasible, stop Beyaz (Drospirenone) 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 (Drospirenone) 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.
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 (Drospirenone) if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
Women who currently have or have had breast cancer should not use Beyaz (Drospirenone) because breast cancer is a hormonally-sensitive tumor.
There is substantial evidence that COCs do not increase the incidence of breast cancer. Although some past studies have suggested that COCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings.
Some studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to which these findings may be due to differences in sexual behavior and other factors.
Discontinue Beyaz (Drospirenone) 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.
For women with well-controlled hypertension, monitor blood pressure and stop Beyaz (Drospirenone) if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs.
An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women and with extended duration of use. The incidence of hypertension increases with increasing concentration of progestin.
Carefully monitor prediabetic and diabetic women who are taking Beyaz (Drospirenone) . COCs may decrease glucose tolerance in a dose-related fashion.
Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on COCs.
Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
If a woman taking Beyaz (Drospirenone) develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Beyaz (Drospirenone) if indicated.
An increase in frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of the 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 (Drospirenone) 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 (Drospirenone) was 15.1 days. The intensity of bleeding for Beyaz (Drospirenone) 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 (Drospirenone) 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.
Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb-reduction defects are concerned, when taken inadvertently during early pregnancy. Discontinue Beyaz (Drospirenone) if pregnancy is confirmed and initiate a prenatal vitamin containing folate supplementation.
The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy .
The use of COCs may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid-binding globulin increase with use of COCs. DRSP causes an increase in plasma renin activity and plasma aldosterone induced by its mild antimineralocorticoid activity.
Folates may mask vitamin B12 deficiency
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. COCs should not be used during pregnancy to treat threatened or habitual abortion.
Women who do not breastfeed may start COCs no earlier than four 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 oral contraceptive steroids and/or metabolites are present in breast milk.
After oral administration of 3 mg DRSP/0.03 mg EE tablets (Yasmin), about 0.02% of the DRSP dose was excreted into the breast milk of postpartum women within 24 hours. This results in a maximal daily dose of about 0.003 mg DRSP in an infant.
Studies to date indicate there is no adverse effect of folate on nursing infants.
Beyaz (Drospirenone) is contraindicated in patients with renal impairment .
Following administration of DRSP 3 mg daily for 14 days, serum DRSP levels in subjects with mild renal impairment (creatinine clearance CLcr, 50-80 mL/min) were comparable to those in subjects with normal renal function (CLcr, >80 mL/min). The serum DRSP levels were on average 37 % higher in subjects with moderate renal impairment (CLcr, 30 - 50 mL/min) compared to those with normal renal function. DRSP treatment did not show any clinically significant effect on serum potassium concentration. Although hyperkalemia was not observed in the study, in five of the seven subjects who continued use of potassium sparing drugs during the study, mean serum potassium levels increased by up to 0.33 mEq/L. Therefore, potential exists for hyperkalemia to occur in subjects with renal impairment whose serum potassium is in the upper reference range, and who are concomitantly using potassium sparing drugs .
Two multicenter, double-blind, randomized, placebo-controlled studies were conducted to evaluate the effectiveness of YAZ in treating the symptoms of PMDD. Women aged 18-42 who met DSM-IV criteria for PMDD, confirmed by prospective daily ratings of their symptoms, were enrolled. Both studies measured the treatment effect of YAZ using the Daily Record of Severity of Problems scale, a patient-rated instrument that assesses the symptoms that constitute the DSM-IV diagnostic criteria. The primary study was a parallel group design that included 384 evaluable reproductive-aged women with PMDD who were randomly assigned to receive YAZ or placebo treatment for 3 menstrual cycles. The supportive study, a crossover design, was terminated prematurely prior to achieving recruitment goals due to enrollment difficulties. A total of 64 women of reproductive age with PMDD were treated initially with YAZ or placebo for up to 3 cycles followed by a washout cycle and then crossed over to the alternate medication for 3 cycles.
Efficacy was assessed in both studies by the change from baseline during treatment using a scoring system based on the first 21 items of the Daily Record of Severity of Problems. Each of the 21 items was rated on a scale from 1 (not at all) to 6 (extreme); thus a maximum score of 126 was possible. In both trials, women who received YAZ had statistically significantly greater improvement in their Daily Record of Severity of Problems scores. In the primary study, the average decrease (improvement) from baseline was 37.5 points in women taking YAZ, compared to 30.0 points in women taking placebo.
In two multicenter, double blind, randomized, placebo-controlled studies, 889 subjects, ages 14 to 45 years, with moderate acne received YAZ or placebo for six 28 day cycles. The primary efficacy endpoints were the percent change in inflammatory lesions, non-inflammatory lesions, total lesions, and the percentage of subjects with a "clear" or "almost clear" rating on the Investigator's Static Global Assessment (ISGA) scale on day 15 of cycle 6, as presented in Table II:
* Evaluated at day 15 of cycle 6, last observation carried forward for the Intent to treat population
The development program for Beyaz (Drospirenone) consisted of two clinical trials.
One study was a multicenter, randomized, double-blind, active-controlled, parallel group US study. Plasma folate and red blood cell folate levels were investigated during a 24-week treatment with YAZ + 0.451 mg levomefolate calcium as compared to YAZ alone in a U.S. population with folate fortified food. A total of 379 healthy women between 18 and 40 years of age with no restrictions on folate supplementation received YAZ + levomefolate calcium (N= 285) or YAZ (N=94). The plasma and RBC folate levels at Week 24 were the co-primary endpoints. Figures 1 and 2 display the results for plasma and RBC folate, respectively, among evaluable subjects in each arm of the study.
Figure 1: US Study: Mean concentration-time curves (and SD) of plasma folates after daily oral administration of YAZ + levomefolate calcium and YAZ
Arithmetic mean values based on 4-weekly measurements are displayed with arithmetic standard deviations which are shown in only one direction to improve readability. Data are based on per protocol analysis populations. The SD bar shown represents a single SD.
Figure 2: US Study: Mean concentration-time curves (and SD) of RBC folates after daily oral administration of YAZ + levomefolate calcium and YAZ
Arithmetic mean values based on 4-weekly measurements are displayed with arithmetic standard deviations which are shown in only one direction to improve readability. Data are based on per protocol analysis populations. The SD bar shown represents a single SD.
In the second study, the pharmacodynamic effect on plasma folate, RBC folate, and the profile of circulating folate metabolites was assessed during 24 weeks of treatment with 0.451 mg levomefolate calcium or with 0.4 mg folic acid (equimolar dose to 0.451 mg levomefolate calcium), both in combination with 3 mg DRSP/0.03 mg EE (Yasmin) followed by 20 weeks of open-label treatment with Yasmin only (elimination phase). One-hundred and seventy-two healthy women between 18 to 40 years of age from a German population without folate food fortification and without concomitant intake of folate supplements were randomized to one of the two treatments. Figures 3 and 4 display the results for plasma and RBC folate, respectively, among evaluable subjects in the levomefolate arm of the study.
Figure 3: German Study: Mean trough concentration-time curve (and SD) of plasma folates after daily oral administration of Yasmin + levomefolate calcium
Arithmetic mean values based on biweekly measurements are displayed with arithmetic standard deviations. In the treatment phase, women received Yasmin + levomefolate calcium; in the elimination phase, all women received Yasmin only. Data are based on per protocol analysis populations. The SD bar shown represents a single SD.
Figure 4: German Study: Mean concentration-time curves (and SD) of RBC folates after daily oral administration of Yasmin + levomefolate calcium
Arithmetic mean values based on biweekly measurements are displayed with arithmetic standard deviations. In the treatment phase, women received Yasmin + levomefolate calcium; in the elimination phase, all women received Yasmin only. Data are based on per protocol analysis populations. The SD bar shown represents a single SD.
The potential to reduce the incidence of neural tube defects (NTDs) with folate supplementation is well established based on a body of evidence derived from randomized, controlled trials, nonrandomized intervention trials, and observational studies using folic acid. Therefore, the Centers for Disease Control and Prevention (CDC) and the U.S. Preventive Services Task Force recommend that women of childbearing age consume supplemental folic acid in a dose of at least 0.4 mg (400 mcg) daily .
Beyaz (Drospirenone) (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) are available in packages of three blister packs (NDC 50419-407-03).
The film-coated tablets are rounded with biconvex faces, one side is embossed with a regular hexagon shape with Z+ or M+.
Each blister pack (28 film-coated tablets) contains in the following order:
Guide for Using Beyaz (Drospirenone)
WARNING TO WOMEN WHO SMOKE
Do not use Beyaz (Drospirenone) if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
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 (Drospirenone) ?
Beyaz (Drospirenone) is a birth control pill. It contains two female hormones, a synthetic estrogen called ethinyl estradiol and a progestin called drospirenone. Beyaz (Drospirenone) also contains levomefolate calcium, which is a B vitamin.
The progestin drospirenone may increase potassium. Therefore, you should not take Beyaz (Drospirenone) 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 (Drospirenone) is right for you, and during the first month that you take Beyaz (Drospirenone) , you should have a blood test to check your potassium level.
Beyaz (Drospirenone) 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 (Drospirenone) 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 (Drospirenone) for treatment of PMDD if you:
Beyaz (Drospirenone) 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 (Drospirenone) only if you want to prevent pregnancy; and not for the treatment of PMS.
Beyaz (Drospirenone) may also be taken to treat moderate acne if all of the following are true:
Beyaz (Drospirenone) 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 (Drospirenone) 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 (Drospirenone) 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 (Drospirenone) .
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 list 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.
1. 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 (Drospirenone) 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 or 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.
Before You Start Taking Your Pills
1. Decide What Time of Day You Want to Take Your Pill
It is important to take Beyaz (Drospirenone) 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 (Drospirenone) can be taken without regard to meals.
2. Look at Your Pill Pack - It has 28 Pills
The Beyaz (Drospirenone) -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 or 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 (Drospirenone) 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 (Drospirenone) 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 (Drospirenone) 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 (Drospirenone) should be started when the next application would have been due. When switching from an injection, Beyaz (Drospirenone) should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Beyaz (Drospirenone) 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. Do not wait any days between packs.
What to Do if You Miss Pills
If you miss 1 pink pill in Week 1 of 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. 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.
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. 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.
If you miss 3 or more pink pills in a row during any week
1.
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. if you have sex in the 7 days after you restart your pills. You must use another birth control method (such as condoms or spermicides) as a back-up for those 7 days.
3. You may not have your period this month but this is expected.
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 (Drospirenone) ?
Your healthcare provider will not give you Beyaz (Drospirenone) 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 or any cancer that is sensitive to female hormones
• Have liver disease, including liver tumors
• 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 (Drospirenone) ?
Birth control pills do notprotect 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:
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 (Drospirenone) 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 (Drospirenone) , may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk.
If you are currently on daily, long-term treatment for a chronic condition with any of the following medications, you should consult your healthcare provider before taking Beyaz (Drospirenone) :
Tell your healthcare provider about all medicines and herbal products that you take. Some other medicines and herbal products may make birth control pills less effective, including:
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 healthcare provider may need to adjust the dose of lamotrigine.
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.
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 greater than 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 clots are blood clots in the:
A few women who take birth control pills may get:
Call your healthcare provider right away if you have:
What are the Common Side Effects of Birth Control Pills?
The most common side effects of birth control pills are:
These side effects are usually mild and usually disappear with time.
Less common side effects are:
This is not a complete list 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?
Birth control pills do not seem 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 Beyaz (Drospirenone) ?
Irregular vaginal bleeding or spotting may occur while you are taking Beyaz (Drospirenone) . 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 has you have taken the pills according to direction.
What if I Miss My Scheduled Period when Taking Beyaz (Drospirenone) ?
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 (Drospirenone) 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 (Drospirenone) , are pregnant, or plan on becoming pregnant.
General Advice about Beyaz (Drospirenone)
Your healthcare provider prescribed Beyaz (Drospirenone) for you. Please do not share Beyaz (Drospirenone) with anyone else. Keep Beyaz (Drospirenone) 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.
Manufactured for Bayer HealthCare Pharmaceuticals Inc.
Wayne, NJ 07470
Bayer HealthCare Pharmaceuticals Inc.
The following is a representative example of Beyaz (Drospirenone) labeling. See the "How Supplied" section for a complete listing of all components.
