INDICATION

What is TYBLUME®? TYBLUME (levonorgestrel and ethinyl estradiol) is a birth control pill (oral contraceptive) used by women to prevent pregnancy.
TYBLUME does not protect against HIV infections (AIDS) and other sexually transmitted infections.

IMPORTANT RISK INFORMATION

What is the most important information I should know about TYBLUME?

Do not use TYBLUME 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, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

Do not take TYBLUME if you:

• smoke and are over 35 years of age.
• have or have had blood clots in your arms, legs, lungs, or eyes.
• have a problem with your blood that makes it clot more than normal.
• have certain heart valve problems or an irregular heartbeat that increases your risk of having blood clots.
• had a stroke.
• had a heart attack.
• have high blood pressure that cannot be controlled by medicine or have high blood pressure with blood vessel problems.
• have diabetes and are over 35 years of age.
• have diabetes with high blood pressure, blood vessel problems, or kidney, eye, nerve, or blood vessel damage; or have had diabetes for more than 20 years.
• have certain kinds of severe migraine headaches with aura, numbness, weakness, or changes in vision, or any migraine headaches if you are over 35 years of age.
• have liver problems, including liver tumors.
• have any unexplained vaginal bleeding.
• have or have had breast cancer or any cancer that is sensitive to female hormones.
• 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.

If any of these conditions happen while you are taking TYBLUME, stop taking TYBLUME right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking TYBLUME.

Before you take TYBLUME, tell your healthcare provider about all of your medical conditions, including if you:

• are scheduled for surgery. TYBLUME may increase your risk of blood clots after surgery. You should stop taking TYBLUME at least 4 weeks before you have surgery and not restart TYBLUME until at least 2 weeks after your surgery.
• are pregnant or think you may be pregnant.
• are depressed now or have been depressed in the past.
• had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy).
• are breastfeeding or plan to breastfeed. TYBLUME may decrease the amount of breast milk you make. A small amount of the hormones in TYBLUME may pass into your breast milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TYBLUME may affect the way other medicines work, and other medicines may affect how well TYBLUME works. Women on thyroid replacement therapy or steroid therapy may need increased doses of thyroid hormone or steroid medicines. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of TYBLUME?

TYBLUME may cause serious side effects, including:

• blood clots in your lungs, heart attack, or a stroke that may lead to death. Some other examples of serious blood clots include blood clots in the legs or eyes. Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. Serious blood clots are more likely to happen when you:
  • first start taking birth control pills.
  • restart the same or different birth control pills after not using them for a month or more.

Call your healthcare provider or go to the nearest emergency room right away if you have:

• leg pain that will not go away.
• sudden severe shortness of breath.
• sudden change in vision or blindness.
• chest pain.
• a sudden, severe headache unlike your usual headaches.
• weakness or numbness in your arm or leg.
• trouble speaking.

Other serious side effects include:

• liver problems, including:
  • jaundice. Call your healthcare provider if you have yellowing of your skin or eyes.
  • rare liver tumors.
• high blood pressure. You should see your healthcare provider to check your blood pressure regularly.
• gallbladder problems (cholestasis), especially if you previously had cholestasis of pregnancy.
• changes in the sugar and fat (cholesterol and triglycerides) levels in your blood.
• new or worsening headaches including migraine headaches.
• irregular or unusual vaginal bleeding and spotting between your menstrual periods, especially during the first 3 months of taking TYBLUME or the absence of menstrual periods (amenorrhea).
• depression.
• possible cancer in your cervix.
• swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare provider right away if you have a swollen face, lips, mouth, tongue or throat, which may lead to difficulty swallowing or breathing. Your chance of having angioedema is higher if you have a history of angioedema.
• dark patches of skin around your forehead, nose, cheeks and around your mouth, especially during pregnancy (chloasma). Women who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sun lamps while taking TYBLUME. Use sunscreen if you have to be in the sunlight.

The most common side effects of TYBLUME include:

• headache
• stomach (abdominal) pain
• nausea
• vaginal bleeding in between your periods
• vaginal yeast infection and pain
• acne
• infection or swelling of the vagina that can cause discharge, itching, and pain

These are not all the possible side effects of TYBLUME. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information including BOXED WARNING for detailed information [here].