Control and consistency
RIGHT FROM
THE START
Control and consistency
Balcoltra is a low-dose combination oral contraceptive that brings together long half-life, effective period control, and pregnancy prevention for a total-package birth control she can count on.1,2
Balcoltra is a low-dose combination oral contraceptive that brings together long half-life, effective period control, and pregnancy prevention for a total-package birth control she can count on.1,2
A low dose
A half-life for her life
Elimination half-life of:
• Levonorgestrel: 34 ± 14 hours1
• Ethinyl estradiol: 17 ± 5.7 hours1
Predictable periods
In clinical trials, women experienced:
• Low breakthrough bleeding (4%)1
• Light monthly periods2
Effective pregnancy prevention
Contraceptive efficacy you can both count on
• 1/100 unintended pregnancies
per woman-years1
A low dose
A half-life for her life
Predictable periods
Effective pregnancy prevention
Contraceptive efficacy you can both count on
• 1/100 unintended pregnancies per woman-years1
Fill out our form to receive complimentary
samples for your practice.
Eligible patients pay no more than
$21 per fill* for Balcoltra.
*Terms and conditions apply.
Fill out our form to receive complimentary samples for your practice.
Eligible patients pay no more
than $21 per fill* for Balcoltra.
*Terms and conditions apply.
A brief explanation of ovulation, fertilization, and menstruation
Important Safety Information, including BOXED WARNING
Indications and Usage
Balcoltra is a progestin/estrogen combination oral contraceptive (COC) indicated for use by females of reproductive potential to prevent pregnancy.
IMPORTANT SAFETY INFORMATION for Balcoltra® (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets)
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke.
Balcoltra is contraindicated in women with a high risk of arterial or venous thrombotic diseases, liver tumors (benign or malignant) or liver disease, undiagnosed abnormal uterine bleeding, during pregnancy, with breast cancer or other estrogen- or progestin-sensitive cancer (now or in the past), hypersensitivity to any of the components, or in women who are currently taking Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir (with or without dasabuvir).
In a clinical trial with levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg, the most common adverse reactions (incidence ≥ 2%) were headache (14%), metrorrhagia (8%), dysmenorrhea (7%), nausea (7%), abdominal pain (4%), breast pain (4%), emotional lability (3%), acne (3%), depression (2%), amenorrhea (2%), and vaginal moniliasis (2%).
Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the effectiveness of COCs or increase breakthrough bleeding.
Patients should be counseled that COCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
You are encouraged to report negative side effects of prescription drugs to the FDA. To report suspected adverse reactions, visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information, including BOXED WARNING, and Patient Information.
References: 1. Balcoltra [package insert]. Alpharetta, GA: Avion Pharmaceuticals, LLC; 2018. 2. 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(suppl):S39-S44.
© 2020 Avion Pharmaceuticals, LLC
Alpharetta, GA 30005 | 1-888-612-8466 | ML-0335 0920-01
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 healthcare professionals only.
© 2020 Avion Pharmaceuticals, LLC
Alpharetta, GA 30005 | 1-888-612-8466
ML-0335 0920-01
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 healthcare professionals only.
In 1960, the FDA approved the first oral contraceptive in the US, empowering women to control their reproductive futures. See how Avion is supporting women’s access to Balcoltra through our co-pay program.
Important Safety Information, including BOXED WARNING
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke.
Balcoltra is contraindicated in women with a high risk of arterial or venous thrombotic diseases, liver tumors (benign or malignant) or liver disease, undiagnosed abnormal uterine bleeding, during pregnancy, with breast cancer or other estrogen- or progestin-sensitive cancer (now or in the past), hypersensitivity to any of the components, or in women who are currently taking Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir (with or without dasabuvir).
In a clinical trial with levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg, the most common adverse reactions (incidence ≥ 2%) were headache (14%), metrorrhagia (8%), dysmenorrhea (7%), nausea (7%), abdominal pain (4%), breast pain (4%), emotional lability (3%), acne (3%), depression (2%), amenorrhea (2%), and vaginal moniliasis (2%).
Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the effectiveness of COCs or increase breakthrough bleeding.
Patients should be counseled that COCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
You are encouraged to report negative side effects of prescription drugs to the FDA. To report suspected adverse reactions, visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information, including BOXED WARNING, and Patient Information.