Important Risk Information
WARNING TO WOMEN WHO SMOKE
Do not use TYBLUME™ if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heartand 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.
What is Tyblume?
Tyblume is a birth control pill (oral contraceptive) used by women who can become pregnant to prevent pregnancy.
Who should not take Tyblume?
Do not use Tyblume if you have or have had blood clots, history of heart attack or stroke, high blood pressure that medicine cannot control, breast cancer or any cancer that is sensitive to female hormones, liver disease or liver tumors, unexplained bleeding from the vagina, if you are or may be pregnant, or if you take Hepatitis C drugs containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, as this may increase levels of liver enzymes in the blood.
What else should I know about taking Tyblume?
Treatment with Tyblume should be stopped if you have a blood clot, and at least 4 weeks before and through 2 weeks after major surgery. You should not take Tyblume any earlier than 4 weeks after having a baby, or if you are breastfeeding. Ifyou experience yellowing of the skin or eyes due to problems with your liver, you should stop taking Tyblume. See your healthcare provider to check your blood pressure regularly. If you are pre-diabetic or diabetic, your doctor should monitor your sugar and cholesterol levels while using Tyblume. Your doctor should evaluate you if you have any significant change in headaches or irregular menstrual bleeding.
What are most serious risks of taking Tyblume?
Tyblume increases the risk of serious conditions including blood clots, stroke, and heart attack. These can be life-threatening or lead to permanent disability.
What are the most common side effects of Tyblume?
The most common side effects of Tyblume are nausea, headache, abdominal pain, spotting or bleeding between menstrual periods, acne, vaginal yeast infection and infection or swelling of the vagina that can cause discharge, itching, and pain.
Birth control pills do not protect you against any sexually transmitted disease, including HIV, the virus that causes AIDS.
Discontinue Tyblume if pregnancy occurs.
These are not all the possible side effects and risks of Tyblume. For more information, ask your healthcare provider or pharmacist. You may report side effects to the FDA by visiting www.fda.gov/medwatch, or calling 1-800-FDA-1088. You may also report side effects to Exeltis by calling 1-877-324-9349.
Please see the full Prescribing Information, including Patient Information for complete safety and risk information regarding Tyblume.