FOR US HEALTHCARE PROFESSIONALS ONLY |
Full Prescribing Information, including BOXED WARNING

Balcoltra Savings Club

A New Choice
for Balanced
Birth Control

Balcoltra—the only branded monthly combination oral contraceptive (COC) with levonorgestrel—offers a balance of high efficacy and low dose.1,2

Request Samples for Your Practice

Eligible patients pay only $21 per fill for Balcoltra with our co-pay savings card.*

Not an actual patient.

Effective Pregnancy Prevention

Approximately 1 pregnancy per 100 woman-years2

Not actual patients.

Cycle Control for Your Patients With Familiar 21/7 Monophasic Dosing

In a clinical study of a COC containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol:

The mean intensity of withdrawal bleeding was light3,†

The mean duration of withdrawal bleeding was 4.7 days3,†

4% of patients had period-like bleeding outside of their scheduled periods2

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 Study subjects participated for approximately 36 cycles, until they withdrew or were withdrawn, or until the study was terminated.3

Familiar Levonorgestrel and Ethinyl Estradiol

Levonorgestrel/ethinyl estradiol combinations have been widely studied.4

Elimination half-life following a single dose2
Levonorgestrel: ≈34 ± 14 hours Ethinyl estradiol: 17 ± 5.7 hours

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

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.

Contraindications

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).

Warnings and Precautions

Adverse Reactions

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%).

Drug Interactions

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.

Please see the full Prescribing Information, including BOXED WARNING, for Balcoltra.

*Most eligible patients will pay no more than $21 per co-pay. Patients should present this coupon with their prescription to their participating pharmacy. For each Balcoltra prescription, patients pay the first $21 of their out-of-pocket expense and Avion will cover up to $100 of their remaining expense. They could have additional responsibility depending on their insurance plan or remaining expense. This offer is good for 21 uses. Cardholders with questions, please call 1-877-838-3846 (8:30 AM-5:30 PM ET, Monday-Friday).

References: 1. Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations [database online]. Silver Spring, MD: US Food and Drug Administration; 2018. http://www.fda.gov/cder/ob/default.htm/. Updated February 2018. Accessed March 8, 2018. 2. Balcoltra [package insert]. Alpharetta, GA: Avion Pharmaceuticals LLC; 2018. 3. 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. 4. ClinicalTrials.gov, US National Library of Medicine (NLM). Bethesda, MD: National Institutes of Health; 2018. https://clinicaltrials.gov/ct2/results?cond=&term=%22levonorgestrel%22+%2B+%22ethinyl+estradiol%22&cntry=&state=&city=&dist=. Accessed February 23, 2018.

IMPORTANT SAFETY INFORMATION

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.

Contraindications

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).

Warnings and Precautions

Adverse Reactions

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%).

Drug Interactions

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.

Please see the full Prescribing Information, including BOXED WARNING, for Balcoltra.