For: Prevention of Pregnancy
Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) is a progestin/estrogen combination oral contraceptive (COC) indicated for use by females of reproductive potential to prevent pregnancy. Clinical Information
Gen. Code and Des.
78077 levonorgest/eth.estradiol/iron ORAL TABLET 0.1-0.02MG
Strength
0.1 mg-0.02 mg (21)/36.5 mg (7)
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
68120000 CONTRACEPTIVES
Active Ingredients
1286 ethinyl estradiol 57636
1304 levonorgestrel 797637
9643 ferrous bis-glycinate chelate 20150349
Inactive Ingredients
10138 blue dye
10141 red dye
10143 yellow dye
2432 lactose 64044515
13405 soy
8923 FD and C no.5 (tartrazine)
Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) is a progestin/estrogen combination oral contraceptive (COC) indicated for use by females of reproductive potential to prevent pregnancy.
BOXED WARNING(WHAT IS THIS?)
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 [see Contraindications (4)].
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use BALCOLTRA� safely and effectively. See full prescribing information for BALCOLTRA�.
BALCOLTRA� (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) for oral administration
Initial U.S. Approval: 1997
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
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Balcoltra is contraindicated in women over 35 years old who smoke. (4)
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Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. (4)
INDICATIONS AND USAGE
Balcoltra is a progestin/estrogen COC indicated for use by females of reproductive potential to prevent pregnancy. (1)
DOSAGE AND ADMINISTRATION
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Take one tablet by mouth at the same time every day. ( 2.1)
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Take tablets in the order directed on the blister pack. ( 2.1)
DOSAGE FORMS AND STRENGTHS
Balcoltra consists of 28 tablets in the following order (3):
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21 orange tablets (active), each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol.
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7 blue tablets (inactive placebo) each containing ferrous bisglycinate 36.5 mg. The ferrous bisglycinate tablets do not serve any therapeutic purpose. ( 3)
CONTRAINDICATIONS
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A high risk of arterial or venous thrombotic diseases ( 4)
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Liver tumors or liver disease ( 4)
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Undiagnosed abnormal uterine bleeding ( 4)
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Pregnancy ( 4)
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Breast cancer or other estrogen- or progestin-sensitive cancer ( 4)
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Hypersensitivity of any of the components ( 4)
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Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4)
WARNINGS AND PRECAUTIONS
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Thrombotic Disorders and Other Vascular Problems: Stop Balcoltra if a thrombotic event occurs. Stop at least 4 weeks before through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding ( 5.1)
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Liver disease: Discontinue Balcoltra if jaundice occurs ( 5.2)
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High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop Balcoltra if blood pressure rises significantly. ( 5.4)
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Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking Balcoltra. Consider an alternative contraceptive method for women with uncontrolled dyslipidemia ( 5.6)
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Headache: Evaluate significant change in headaches and discontinue Balcoltra if indicated ( 5.7)
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Bleeding Irregularities and Amenorrhea: Evaluate irregular bleeding or amenorrhea ( 5.8)
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This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity ( 5.9)
ADVERSE REACTIONS
Common adverse reactions (≥2% of women): headache (14%), metrorrhagia (8%), dysmenorrhea and nausea (7% each), abdominal pain and breast pain (4% each), emotional lability and acne (3% each), and depression, amenorrhea, and vaginal moniliasis (2% each) (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Avion Pharmaceuticals, LLC at 1-888-612-8466 or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with COCs (7.1)
USE IN SPECIFIC POPULATIONS
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Nursing mothers: Advise use of another contraceptive method.
Balcoltra can decrease milk production. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 4/2018
