Frequently Asked Questions
What is Balcoltra®?
Balcoltra is a birth control pill (oral contraceptive) used by women to prevent pregnancy. Balcoltra does not protect against HIV infections (AIDS) and other sexually transmitted infections.1
Who should not take
Balcoltra?
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.1
How effective is
Balcoltra?
Based on the results of a clinical study, about 1 out of 100 women may get pregnant within the first year they use Balcoltra. The better you follow the dosing instructions, the less chance you have of getting pregnant.1
The following chart shows the chance of getting pregnant for women who use different methods of birth control.1
How do I take
Balcoltra?
Take your pill at the same time each day. For the first 21 days, take 1 orange pill per day in the order of your pill pack. For the fourth week, take 1 blue placebo pill per day. When you’ve finished the pill pack, start a new pack whether or not you’re having your period.1
See also: Dosing
How do I start taking
Balcoltra?
You can either start on the first Sunday after your period starts (Sunday Start) or start on the first day of your period (Day 1 Start). If you start on a day other than Sunday, use the stickers provided to label your pill pack appropriately for your cycle.1
Ask your healthcare provider when to start taking your birth control pill.
See also: Starting Balcoltra
What should I do if I forget to take my active orange
pills?
If you miss 1:
Take it as soon as you remember. Continue taking 1 pill every day until you finish the pack.
If you miss 2 in a row in Weeks 1 or 2:
Take the 2 missed pills ASAP. Take the next 2 pills the next day. Continue taking 1 pill every day until you finish the pack. Use a nonhormonal backup birth control method for the next 7 days.1
If you miss 2 in a row in Week 3, or if you miss 3+ pills in a row:
If you started your pill pack on a Sunday, take 1 pill per day until Sunday. Then throw out the rest of the pill pack and start a new pack. Otherwise, throw out the rest of your pill pack and start a new pack that same day. Use a nonhormonal backup birth control method for the next 7 days.1
See also: What If I Miss a Pill?
Can I take Balcoltra with my other
medications?
Balcoltra may affect the way other medicines work, and other medicines may affect how well Balcoltra works. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.1
What are the common side effects of birth control
pills?
Common side effects include headache/migraine, irregular vaginal bleeding (including absence of period), nausea, breast tenderness, pain and discomfort, stomach (abdominal) pain, pain with your periods, mood changes (including depression), acne, and vaginal infections.1
See also: Side Effects
Are there any serious risks of taking birth control
pills?
Balcoltra may cause serious side effects, including blood clots in your lungs, heart attack, or a stroke that may lead to death.1
How will Balcoltra affect my
period?
Some women may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking Balcoltra, especially during the first few months of use. This usually is not a serious problem. If the irregular vaginal bleeding or spotting continues or happens again after you have had regular menstrual cycles, call your healthcare provider. It is important to continue taking your pills on a regular schedule to prevent a pregnancy.1
See also: Your Period on Balcoltra
What if I miss my scheduled period when taking
Balcoltra?
Some women miss periods on hormonal birth control, even when they are not pregnant. However, if you go 2 or more months in a row without a period, or you miss your period after a month in which you did not use all of your Balcoltra correctly, call your healthcare provider because you may be pregnant. Also call your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. Stop taking Balcoltra if you are pregnant.1
What if I want to become
pregnant?
You may stop taking Balcoltra whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the Pill.1
Does Balcoltra cause
cancer?
Based on the scientific research, birth control pills do not seem to cause breast cancer. However, some breast cancers are sensitive to hormones. If you have breast cancer now, or have had it in the past, do not use birth control pills. Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this is thought to be due to other factors.1
What is Balcoltra?
Balcoltra is a prescription birth control pill used for the prevention of pregnancy.
IMPORTANT RISK INFORMATION for Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets)
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 that is 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.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‐800‐FDA‐1088.
Please see the full Prescribing Information, including BOXED WARNING, and Patient Information.
References: 1. Balcoltra [package insert]. Alpharetta, GA: Avion Pharmaceuticals LLC; 2018.