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Unpredictable periods?
We may be able to help

You’ve got a lot going on. Unpredictable periods don’t need to be a part of your life. This is how Balcoltra works.

You’ve got a lot going on. Unpredictable periods don’t need to be a part of your life. This is how Balcoltra works.

Balcoltra works hard for you

Balcoltra’s got your back with an effective combination of 2 hormones: levonorgestrel and ethinyl estradiol. These work together to prevent pregnancy by:

Levonorgestrel can also stop ovulation completely in some women, while ethinyl estradiol helps regulate the menstrual cycle.

No more surprises—
Balcoltra MAY help prevent breakthrough bleeding1,*

Balcoltra’s combination of hormones offers predictable periods that may be shorter and lighter.
  • 96% of women did not experience breakthrough bleeding.†
  • Periods lasted fewer than 5 days on average.
  • Periods were light on average.

*Outpatient multicenter, open-label trial with a single treatment group. A total of 1708 healthy women aged 17 to 49 years were enrolled in the study, providing 27,011 cycles of exposure. Study subjects participated for approximately 36 cycles, until they withdrew or were withdrawn, or until the study was terminated.1

†4% of patients had period-like bleeding outside of their scheduled periods.

The right dose, from the start

Balcoltra offers an effective, noninvasive pregnancy prevention option with low hormones.

Over the course of 1 year, only 1 woman out of 100 may become pregnant while taking Balcoltra correctly.2

Here’s how it stacks up to other forms of contraception:2

Taking your pill at the same time every day gives you the maximum level of pregnancy prevention.

A dose of hormones that’s low, but not too low

Balcoltra’s hormone dose is not too high or too low:

  • High enough to be effective for more body types
  • Low enough so side effects may not get in your way

See the Important Risk Information or ask your doctor for more information.

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Important Risk Information, including BOXED WARNING

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. Archer DF, Maheux R, DelConte A, O’Brien FB; North American Levonorgestrel Study Group. Efficacy and safety of a low-dose monophasic combination oral contraceptive containing 100 μg levonorgestrel and 20 μg ethinyl estradiol (Alesse®). Am J Obstet Gynecol. 1999;181(5)(suppl):S39-S44. doi:10.1016/S0002-9378(99)70362-5. 2. Balcoltra [package insert]. Alpharetta, GA: Avion Pharmaceuticals LLC; 2018.

© 2020 Avion Pharmaceuticals, LLC Alpharetta, GA 30005 | 1-888-612-8466 | ML-0240 0620-01

Balcoltra is a registered trademark of Avion Pharmaceuticals, LLC. All other trademarks are the property of their respective owners.

This site is intended for US customers only.

Important Risk Information, including BOXED WARNING

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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.