Important Risk Information, including BOXED WARNING & Indication
WARNING TO WOMEN WHO SMOKE
Do not use Balcoltra 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.
Who should not take Balcoltra?
Do not use Balcoltra 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 which may be
sensitive to female hormones, liver disease or liver tumors, unexplained bleeding from the
vagina, hypersensitivity to any of the components, 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 Balcoltra?
Treatment with Balcoltra 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 Balcoltra any earlier than
4 weeks after having a baby. If you are breastfeeding, talk to your doctor before taking
Balcoltra. If you experience yellowing of the skin or eyes due to problems with your liver, you
should stop taking Balcoltra. If you are prediabetic or diabetic, your doctor should monitor
you while using Balcoltra. Your doctor should evaluate you if you have any significant change
in headaches or irregular menstrual bleeding. Balcoltra contains FD&C Yellow No. 5 and may
cause an allergic reaction, including in those with an allergy to aspirin.
What are the most serious risks of taking Balcoltra?
Balcoltra increases the risk of serious conditions, including blood clots, stroke, and heart
attack. These can be life-threatening and require immediate medical care.
What are the possible side effects of Balcoltra?
The most common side effects of Balcoltra are headache, spotting or bleeding between
periods or no menstrual bleeding, nausea, breast tenderness or pain, stomach pain, pain
during periods, depression, acne, and vaginal infections.
Birth control pills do not protect you against any sexually
transmitted disease, including HIV, the virus that causes
AIDS.
What is Balcoltra?
Balcoltra is a prescription birth control pill used for the prevention of pregnancy.
You may report side effects to Avion Pharmaceuticals, LLC at
1-888-612-8466 or to the FDA at 1-800-FDA-1088.
Please see full
Prescribing Information, including BOXED WARNING, and Patient Information.