Beyaz

The active ingredients in Beyaz are drospirenone, ethinyl estradiol, and levomefolate calcium.

Drospirenone is a progestin, and ethinyl estradiol is an estrogen. Together, they prevent pregnancy mainly by stopping ovulation. They also thicken cervical mucus so sperm cannot reach an egg easily, and they change the lining of the uterus so a fertilised egg is less likely to implant. The levomefolate calcium helps maintain folate levels while you are taking the pill and shortly after stopping.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Beyaz. However, the following is a synopsis of the general guidelines for the use of Beyaz:

• Take one tablet by mouth at the same time every day.
• Take the tablets in the order shown in the blister pack.
• Each 28-day pack includes 24 pink active tablets and 4 light orange tablets with levomefolate only.
• Start a new pack the day after finishing your current pack, even if you are still bleeding.
• A common way to start is on the first day of your menstrual period (first-day start). Some people start on the first Sunday after bleeding begins (Sunday start). Your healthcare provider will tell you which start method to follow.
• If you start Beyaz later than the first day of your period, use back-up birth control (such as condoms or spermicide) for the first 7 days.
• If you miss pills, follow the instructions in the Medication Guide. Missing pills increases the risk of pregnancy and may cause bleeding.
• If you vomit or have severe diarrhea soon after taking a pill, absorption may be reduced. Use back-up birth control and follow missed pill instructions.
• Beyaz is meant for continuous daily use. Do not take breaks between packs unless your healthcare provider tells you to.

Some mild or common side effects of Beyaz seen in clinical trials as compared to placebo include:

• Breast tenderness.
• Breakthrough bleeding or spotting (uterine bleeding).
• Changes in menstrual cycles, including lighter periods or missed periods.
• Mood changes, including irritability or low mood.
• Bloating or stomach discomfort.
• Weight gain or fluid retention.
• Decreased sex drive.
• Fatigue.
• Skin darkening (chloasma), especially with sun exposure.

Some individuals may experience serious side effects while using Beyaz. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of blood clots, such as leg pain or swelling, sudden chest pain, trouble breathing, or coughing blood.
• Signs of stroke, such as sudden severe headache, weakness on one side, slurred speech, or vision changes.
• Signs of a heart attack include chest pressure, pain spreading to the arm or jaw, sweating, or nausea.
• Severe migraine headaches, especially if you are over 35 or if the pattern changes.
• Liver problems, such as yellowing of skin or eyes, dark urine, pale stools, or strong stomach pain.
• Severe allergic reactions, including angioedema, with swelling of the face, lips, tongue, or throat, or trouble breathing.

These are not all of the possible side effects of Beyaz. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Beyaz, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• A history of blood clots, thrombosis, pulmonary embolism, or stroke.
• High blood pressure or problems controlling blood pressure.
• Heart disease, including coronary artery disease or a past heart attack.
• High cholesterol or triglycerides.
• Migraine headaches, especially migraines with aura.
• Liver disease, liver tumours, or past jaundice linked to pregnancy or birth control pills.
• Kidney disease.
• An adrenal gland disorder.
• Gallbladder disease.
• A history of breast cancer or other hormone-sensitive cancers.
• A history of hereditary angioedema.
• If you smoke, especially if you are over 35 years of age.

Other Precautions:

• Beyaz may raise potassium levels because drospirenone acts a bit like spironolactone.
• If you need major surgery or will be on bed rest, your provider may tell you to stop Beyaz ahead of time to lower the risk.
• Beyaz can worsen some conditions, like high blood pressure, gallbladder problems, or depression. Let your provider know if symptoms change.
• Beyaz does not prevent sexually transmitted diseases. Use condoms if STI protection is needed.

Boxed Warning

Beyaz has a boxed warning about cigarette smoking and serious cardiovascular events. Women over 35 years of age who smoke should not use Beyaz because smoking greatly increases the risk of blood clots, stroke, and heart attack.

• A high risk of blood clots due to certain heart problems or hereditary conditions.
• History of stroke or heart attack.
• Uncontrolled high blood pressure.
• Severe migraine headaches with aura, or migraines in women over 35.
• Liver disease, liver tumours, or liver cancer.
• Kidney disease or adrenal gland problems.
• Hormone-related cancers, such as breast cancer or cancers of the uterus or cervix.
• Use with certain hepatitis C drug combinations that contain ombitasvir, paritaprevir, and ritonavir.

If you start Beyaz on the first day of your period, it starts working right away. If you start at another time, you need back-up birth control for the first 7 days. Beyaz helps prevent pregnancy as long as you take one pill every day and do not miss doses.

For PMDD or moderate acne, improvement may take a few cycles. Many people see changes after about 2 to 3 months of steady use.

When Beyaz is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Strong CYP3A4 inducers such as carbamazepine. These can lower hormone levels and make Beyaz less effective.
• Herbal products such as St. John’s wort. These can reduce effectiveness and raise the risk of breakthrough bleeding.
• Some HIV or hepatitis C medicines that affect liver enzymes, including ritonavir-containing regimens. These may change hormone levels or increase liver risks.
• Lamotrigine. Beyaz may lower lamotrigine levels, which can reduce seizure control.
• Medicines that raise potassium, such as spironolactone, ACE inhibitors, ARBs, potassium-sparing diuretics, NSAIDs, or potassium supplements. Using them with Beyaz may increase the risk of high potassium.

Beyaz is available as a 28-day blister pack with fixed-dose tablets:

Each of the 24 active pink tablets contains drospirenone 3 mg, ethinyl estradiol 0.02 mg, and levomefolate calcium 0.451 mg (equivalent to 0.4 mg levomefolate).

Each of the 4 light orange tablets contains levomefolate calcium 0.451 mg only.

Store at room temperature and keep out of reach of children.

Beyaz is manufactured by Bayer.

Beyaz is a brand-name product. Generic versions of drospirenone and ethinyl estradiol exist, but tablets that combine drospirenone, ethinyl estradiol, and levomefolate calcium may not be available as a direct generic in all countries.

You can stop Beyaz at any time, but talk to your healthcare provider first if you are stopping because of side effects. When you stop, your menstrual cycles may take a few weeks to return to their usual pattern. If you are stopping because you want to become pregnant, some people ovulate right away, so consider another method if pregnancy is not desired.

Beyaz should not be used during pregnancy. If you think you may be pregnant, stop taking Beyaz and contact your healthcare provider. There is no evidence that Beyaz causes birth defects if taken accidentally early in pregnancy, but it should be discontinued once pregnancy is confirmed.

Talk to your doctor if you are breastfeeding or planning to breastfeed. Combination birth control pills can lower milk supply, and small amounts of hormones may pass into breast milk. Your healthcare provider may suggest waiting until breastfeeding is established or using a different method.