Dosage & Administration
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Balcoltra Prescribing Information
Balcoltra is contraindicated in females who are known to have or develop the following conditions:
•A high risk of arterial or venous thrombotic disease. Examples include women who are known to:
- Smoke, if over age 35
- Have deep vein thrombosis or pulmonary embolism, now or in the past
- Have inherited or acquired hypercoagulopathies
- Have cerebrovascular disease
- Have coronary artery disease
- Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)
- Have uncontrolled hypertension
- Have diabetes mellitus with vascular disease
- Have headaches with focal neurological symptoms or have migraine headaches with aura
•Women over age 35 with any migraine headaches
•Liver tumors, benign or malignant, or liver disease
•Undiagnosed abnormal uterine bleeding
•Pregnancy, because there is no reason to use COCs during pregnancy
•Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive
•Hypersensitivity to any of the components.
•Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
•A high risk of arterial or venous thrombotic diseases
•Liver tumors or liver disease
•Undiagnosed abnormal uterine bleeding
•Pregnancy
•Breast cancer
•Hypersensitivity of any of the components
•Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
Balcoltra is indicated for use by females of reproductive potential to prevent pregnancy.
• Take one tablet by mouth at the same time every day. ()2.1 How to Start BalcoltraBalcoltra is dispensed in a blister card
[see How Supplied/Storage and Handling ]. Balcoltra may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.• Take tablets in the order directed on the blister pack. ()2.1 How to Start BalcoltraBalcoltra is dispensed in a blister card
[see How Supplied/Storage and Handling ]. Balcoltra may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.
Balcoltra (levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets) is available in a 28-tablet compact blister card with:
•21 orange, round biconvex tablets (active) debossed with “A3” on one side and each containing levonorgestrel 0.10 mg and ethinyl estradiol 0.02 mg
•7 blue, round biconvex tablets (inactive placebo) debossed with “F1” on one side and each containing ferrous bisglycinate 36.5 mg
The ferrous bisglycinate tablets do not serve any therapeutic purpose.
•Nursing mothers: Advise use of another contraceptive method.
Balcoltra can decrease milk production. (
Combined hormonal contraceptives (CHCs) and/or metabolites are present in human milk and in breast-fed infants. CHCs, including Balcoltra, can reduce milk production in breast-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well-established. When possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Balcoltra and any potential adverse effects on the breast-fed child from Balcoltra or from the underlying maternal condition.
Balcoltra is contraindicated in females who are known to have or develop the following conditions:
•A high risk of arterial or venous thrombotic disease. Examples include women who are known to:
- Smoke, if over age 35
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
• Balcoltra is contraindicated in women over 35 years old who smoke.• Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use.
• Stop Balcoltra if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.• Stop Balcoltra if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.• If feasible, stop Balcoltra at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during the following prolonged immobilization.• Start Balcoltra no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.• The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued.• Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). The risk increases with age, particularly in women over 35 years of age who smoke.• Use COCs with caution in women with cardiovascular disease risk factors.
- Have deep vein thrombosis or pulmonary embolism, now or in the past
• Stop Balcoltra if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.• Stop Balcoltra if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.• If feasible, stop Balcoltra at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during the following prolonged immobilization.• Start Balcoltra no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.• The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued.• Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). The risk increases with age, particularly in women over 35 years of age who smoke.• Use COCs with caution in women with cardiovascular disease risk factors.
- Have inherited or acquired hypercoagulopathies
• Stop Balcoltra if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.• Stop Balcoltra if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.• If feasible, stop Balcoltra at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during the following prolonged immobilization.• Start Balcoltra no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.• The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued.• Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). The risk increases with age, particularly in women over 35 years of age who smoke.• Use COCs with caution in women with cardiovascular disease risk factors.
- Have cerebrovascular disease
• Stop Balcoltra if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.• Stop Balcoltra if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.• If feasible, stop Balcoltra at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during the following prolonged immobilization.• Start Balcoltra no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.• The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued.• Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). The risk increases with age, particularly in women over 35 years of age who smoke.• Use COCs with caution in women with cardiovascular disease risk factors.
- Have coronary artery disease
• Stop Balcoltra if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.• Stop Balcoltra if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.• If feasible, stop Balcoltra at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during the following prolonged immobilization.• Start Balcoltra no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.• The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued.• Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). The risk increases with age, particularly in women over 35 years of age who smoke.• Use COCs with caution in women with cardiovascular disease risk factors.
- Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)
• Stop Balcoltra if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.• Stop Balcoltra if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.• If feasible, stop Balcoltra at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during the following prolonged immobilization.• Start Balcoltra no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.• The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued.• Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). The risk increases with age, particularly in women over 35 years of age who smoke.• Use COCs with caution in women with cardiovascular disease risk factors.
- Have uncontrolled hypertension
Balcoltra is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease
An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women with extended duration of use. The incidence of hypertension increases with increasing concentrations of progestin.
- Have diabetes mellitus with vascular disease
Carefully monitor prediabetic and diabetic women who take Balcoltra. COCs may decrease glucose tolerance.
Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on COCs.
Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
- Have headaches with focal neurological symptoms or have migraine headaches with aura
If a woman taking Balcoltra develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Balcoltra if indicated.
Consider discontinuation of Balcoltra in the case of increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event).
•Women over age 35 with any migraine headaches
If a woman taking Balcoltra develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Balcoltra if indicated.
Consider discontinuation of Balcoltra in the case of increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event).
•Liver tumors, benign or malignant, or liver disease
Do not use Balcoltra in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of liver
Balcoltra is contraindicated in women with benign and malignant liver tumors
Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) COC users. However, the risk of liver cancers in COC users is less than one case per million users.
•Undiagnosed abnormal uterine bleeding
Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different contraceptive product.
In the clinical trial with levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg tablets breakthrough bleeding and spotting was reported in 4% and 12% of cycles, respectively. Breakthrough bleeding and spotting occurred together during 11% of the cycles.
Women who use Balcoltra may experience amenorrhea. In the clinical trial, 2.6% of the evaluable cycles were amenorrheic. Some women may experience amenorrhea or oligomenorrhea after discontinuation of COCs, especially when such a condition was preexistent.
If scheduled (withdrawal) bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.
•Pregnancy, because there is no reason to use COCs during pregnancy
Carefully observe women with a history of depression and discontinue Balcoltra if depression recurs to a serious degree.
Balcoltra is contraindicated in pregnancy because there is no reason to use combined hormonal contraceptives (CHCs) in pregnancy. Discontinue Balcoltra if pregnancy occurs. Based on epidemiologic studies and meta-analyses, there is little or no increased risk of birth defects in the children of females who inadvertently use COCs during early pregnancy (See Data)
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.
Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to COCs before conception or during early pregnancy.
•Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive
Balcoltra is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive [see Contraindications ].
Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk. Studies do not show an
association between ever (current or past) use of COCs and risk of breast cancer.
However, some studies report a small increase in the risk of breast cancer among current or recent users (<6 months since last use) and current users with longer duration of COC use [see Postmarketing Experience ].
Some studies suggest that COC use has been associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.
•Hypersensitivity to any of the components.
•Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as COCs. Discontinue Balcoltra prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
Balcoltra can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.