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Check Drug InteractionsVylibra Prescribing Information
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
]
.VyLibra is contraindicated in females who are known to have or develop the following conditions:
- A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
- Smoke, if over age 35[see Boxed Warningand Warnings and Precautions (5.1)]
- Have deep vein thrombosis or pulmonary embolism, now or in the past[see Warnings and Precautions (5.1)]
- Have inherited or acquired hyper coagulopathies[see Warnings and Precautions (5.1)]
- Have cerebrovascular disease[see Warnings and Precautions (5.1)]
- Have coronary artery disease[see Warnings and Precautions (5.1)]
- Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)[see Warnings and Precautions (5.1)]
- Have uncontrolled hypertension[see Warnings and Precautions (5.4)]
- Have diabetes mellitus with vascular disease[see Warnings and Precautions (5.6)]
- Have headaches with focal neurological symptoms or migraine headaches with aura[see Warnings and Precautions (5.7)]
- Women over age 35 with any migraine headaches[see Warnings and Precautions (5.7)]
- Women over age 35 with any migraine headaches
- Smoke, if over age 35
- Liver tumors, benign or malignant, or liver disease[see Warnings and Precautions (5.2)]
- Undiagnosed abnormal uterine bleeding[see Warnings and Precautions (5.8)]
- Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive[see Warnings and Precautions (5.10)]
- Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations[see Warnings and Precautions (5.3)]
- A high risk of arterial or venous thrombotic diseases
- Liver tumors or liver disease
- Undiagnosed abnormal uterine bleeding
- Breast cancer
- Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
VyLibra is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (
VyLibra tablets are indicated for use by females of reproductive potential to prevent pregnancy
[see Clinical Studies (14)]
.- Take one tablet daily by mouth at the same time every day. ()
2.1 Recommended Dosage and AdministrationTake one tablet by mouth at the same time each day with or without food. Table 1 provides the recommended dosage and administration instructions for VyLibra.
Table 1: Instructions for Administration ofVyLibraStarting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start)Important:
Consider the possibility of ovulation and conception prior to initiation of this product.Tablet Color:- VyLibra active tablets are dark blue (Day 1 to Day 21).
- VyLibra has green inactive tablets (Day 22 to Day 28).
Day 1 Start:- Take first active tablet without regard to meals on the first day of menses.
- Take subsequent active tablets once daily at the same time each day for a total of 21 days.
- Take onegreeninactive tablet daily for 7 days and at the same time of day that active tablets were taken.
- Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet)
Sunday Start:- Take first active tablet without regard to meals on the first Sunday after the onset of menses.Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack ofVyLibra.
- Take subsequent active tablets once daily at the same time each day for a total of 21 days.
- Take onegreeninactive tablet daily for the following 7 days and at the same time of day that active tablets were taken.
- Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed.
Switching to VyLibrafrom another oral contraceptiveStart on the same day that a new pack of the previous oral contraceptive would have started. Switching from another contraceptive method toVyLibraStartVyLibra:• Transdermal patch- On the day when next application would have been scheduled
• Vaginal ring- On the day when next insertion would have been scheduled
• Injection- On the day when next injection would have been scheduled
• Intrauterine contraceptive- On the day of removal
- If the IUD is not removed on first day of the patient’s menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack.
• Implant- On the day of removal
Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling.StartingVyLibraafter Abortion or MiscarriageFirst-trimester- After a first-trimester abortion or miscarriage, VyLibra may be started immediately. An additional method of contraception is not needed if VyLibra is started immediately.
- If VyLibra is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of VyLibra.
Second-trimester- Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start VyLibra, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of VyLibra.[see Contraindications (4)and Warnings and Precautions (5.1)].
StartingVyLibraafter Childbirth- Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with VyLibra following the instructions in Table 1 for women not currently using hormonal contraception.
- VyLibra is not recommended for use in lactating women[see Use in Specific Populations (8.2)].
- If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of VyLibra.[see Contraindications (4), Warnings and Precautions (5.1),andUse in Specific Populations (8.1, and 8.2)].
- Take tablets in the order directed on the blister pack. ()
2.1 Recommended Dosage and AdministrationTake one tablet by mouth at the same time each day with or without food. Table 1 provides the recommended dosage and administration instructions for VyLibra.
Table 1: Instructions for Administration ofVyLibraStarting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start)Important:
Consider the possibility of ovulation and conception prior to initiation of this product.Tablet Color:- VyLibra active tablets are dark blue (Day 1 to Day 21).
- VyLibra has green inactive tablets (Day 22 to Day 28).
Day 1 Start:- Take first active tablet without regard to meals on the first day of menses.
- Take subsequent active tablets once daily at the same time each day for a total of 21 days.
- Take onegreeninactive tablet daily for 7 days and at the same time of day that active tablets were taken.
- Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet)
Sunday Start:- Take first active tablet without regard to meals on the first Sunday after the onset of menses.Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack ofVyLibra.
- Take subsequent active tablets once daily at the same time each day for a total of 21 days.
- Take onegreeninactive tablet daily for the following 7 days and at the same time of day that active tablets were taken.
- Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed.
Switching to VyLibrafrom another oral contraceptiveStart on the same day that a new pack of the previous oral contraceptive would have started. Switching from another contraceptive method toVyLibraStartVyLibra:• Transdermal patch- On the day when next application would have been scheduled
• Vaginal ring- On the day when next insertion would have been scheduled
• Injection- On the day when next injection would have been scheduled
• Intrauterine contraceptive- On the day of removal
- If the IUD is not removed on first day of the patient’s menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack.
• Implant- On the day of removal
Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling.StartingVyLibraafter Abortion or MiscarriageFirst-trimester- After a first-trimester abortion or miscarriage, VyLibra may be started immediately. An additional method of contraception is not needed if VyLibra is started immediately.
- If VyLibra is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of VyLibra.
Second-trimester- Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start VyLibra, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of VyLibra.[see Contraindications (4)and Warnings and Precautions (5.1)].
StartingVyLibraafter Childbirth- Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with VyLibra following the instructions in Table 1 for women not currently using hormonal contraception.
- VyLibra is not recommended for use in lactating women[see Use in Specific Populations (8.2)].
- If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of VyLibra.[see Contraindications (4), Warnings and Precautions (5.1),andUse in Specific Populations (8.1, and 8.2)].
- Do not skip or delay tablet intake. ()
2.1 Recommended Dosage and AdministrationTake one tablet by mouth at the same time each day with or without food. Table 1 provides the recommended dosage and administration instructions for VyLibra.
Table 1: Instructions for Administration ofVyLibraStarting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start)Important:
Consider the possibility of ovulation and conception prior to initiation of this product.Tablet Color:- VyLibra active tablets are dark blue (Day 1 to Day 21).
- VyLibra has green inactive tablets (Day 22 to Day 28).
Day 1 Start:- Take first active tablet without regard to meals on the first day of menses.
- Take subsequent active tablets once daily at the same time each day for a total of 21 days.
- Take onegreeninactive tablet daily for 7 days and at the same time of day that active tablets were taken.
- Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet)
Sunday Start:- Take first active tablet without regard to meals on the first Sunday after the onset of menses.Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack ofVyLibra.
- Take subsequent active tablets once daily at the same time each day for a total of 21 days.
- Take onegreeninactive tablet daily for the following 7 days and at the same time of day that active tablets were taken.
- Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed.
Switching to VyLibrafrom another oral contraceptiveStart on the same day that a new pack of the previous oral contraceptive would have started. Switching from another contraceptive method toVyLibraStartVyLibra:• Transdermal patch- On the day when next application would have been scheduled
• Vaginal ring- On the day when next insertion would have been scheduled
• Injection- On the day when next injection would have been scheduled
• Intrauterine contraceptive- On the day of removal
- If the IUD is not removed on first day of the patient’s menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack.
• Implant- On the day of removal
Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling.StartingVyLibraafter Abortion or MiscarriageFirst-trimester- After a first-trimester abortion or miscarriage, VyLibra may be started immediately. An additional method of contraception is not needed if VyLibra is started immediately.
- If VyLibra is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of VyLibra.
Second-trimester- Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start VyLibra, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of VyLibra.[see Contraindications (4)and Warnings and Precautions (5.1)].
StartingVyLibraafter Childbirth- Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with VyLibra following the instructions in Table 1 for women not currently using hormonal contraception.
- VyLibra is not recommended for use in lactating women[see Use in Specific Populations (8.2)].
- If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of VyLibra.[see Contraindications (4), Warnings and Precautions (5.1),andUse in Specific Populations (8.1, and 8.2)].
VyLibra tablets are available in blister packs. Each blister pack contains 28 tablets in the following order:
- 21 dark blue, round, biconvex, coated tablet debossed with “S” on one side and “22” on other side of the tablet contains 0.250 mg norgestimate and 0.035 mg ethinyl estradiol
- 7 green round, mottled biconvex, uncoated tablets (non-hormonal placebo) debossed with “S” on one side and “24” on other side of the tablet contains inert ingredients
Lactating women: Not recommended; can decrease milk production. (
Risk Summary
Contraceptive hormones and/or metabolites are present in human milk. CHCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well-established. When possible, advise the nursing female to use other forms of contraception until she discontinues breast-feeding. The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for VyLibra and any potential adverse effects on the breast-fed child from VyLibra or from the underlying maternal condition.
VyLibra is contraindicated in females who are known to have or develop the following conditions:
- A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
- Smoke, if over age 35 [seeand
WARNING: CIGARETTE SMOKING and SERIOUS CARDIOVASCULAR EVENTSCigarette 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)].WARNING: CIGARETTE SMOKING and SERIOUS CARDIOVASCULAR EVENTS
See full prescribing information for complete boxed warning.- VyLibra is contraindicated in women over 35 years old who smoke. (4)
- Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. (4)
]5.1 Thromboembolic Disorders and Other Vascular Problems- Stop VyLibra if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
- Stop VyLibra if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately[see Adverse Reactions (6.2)].
- If feasible, stop VyLibra 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 and following prolonged immobilization.
- Start VyLibra 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 cases 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). This 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 [see]
5.1 Thromboembolic Disorders and Other Vascular Problems- Stop VyLibra if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
- Stop VyLibra if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately[see Adverse Reactions (6.2)].
- If feasible, stop VyLibra 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 and following prolonged immobilization.
- Start VyLibra 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 cases 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). This 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 hyper coagulopathies [see]
5.1 Thromboembolic Disorders and Other Vascular Problems- Stop VyLibra if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
- Stop VyLibra if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately[see Adverse Reactions (6.2)].
- If feasible, stop VyLibra 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 and following prolonged immobilization.
- Start VyLibra 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 cases 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). This 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 [see]
5.1 Thromboembolic Disorders and Other Vascular Problems- Stop VyLibra if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
- Stop VyLibra if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately[see Adverse Reactions (6.2)].
- If feasible, stop VyLibra 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 and following prolonged immobilization.
- Start VyLibra 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 cases 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). This 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 [see]
5.1 Thromboembolic Disorders and Other Vascular Problems- Stop VyLibra if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
- Stop VyLibra if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately[see Adverse Reactions (6.2)].
- If feasible, stop VyLibra 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 and following prolonged immobilization.
- Start VyLibra 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 cases 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). This 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) [see]
5.1 Thromboembolic Disorders and Other Vascular Problems- Stop VyLibra if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
- Stop VyLibra if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately[see Adverse Reactions (6.2)].
- If feasible, stop VyLibra 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 and following prolonged immobilization.
- Start VyLibra 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 cases 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). This 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 [see]
5.4 High Blood PressureVyLibra is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease
[see Contraindications (4)]. For women with well-controlled hypertension, monitor blood pressure and stop VyLibra if blood pressure rises significantly.
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 [see]
5.6 Carbohydrate and Lipid Metabolic EffectsCarefully monitor prediabetic and diabetic women who take VyLibra. 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 migraine headaches with aura [see]
5.7 HeadacheIf a woman taking VyLibra develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue VyLibra if indicated.
Consider discontinuation of VyLibra 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 [see]
5.7 HeadacheIf a woman taking VyLibra develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue VyLibra if indicated.
Consider discontinuation of VyLibra 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
- Smoke, if over age 35
- Liver tumors, benign or malignant, or liver disease [see]
5.2 Liver DiseaseImpaired Liver FunctionVyLibra is contraindicated in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of liver[see Contraindications (4)]. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. Discontinue VyLibra if jaundice develops.Liver Tumors
VyLibra is contraindicated in women with benign and malignant liver tumors[see Contraindications (4)]. Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases/100,000 COC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.
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 [see]
5.8 Bleeding Irregularities and AmenorrheaUnscheduled Bleeding and SpottingUnscheduled (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 clinical trials of VyLibra, the frequency and duration of breakthrough bleeding and/or spotting was assessed in 1,647 patients (21,275 evaluable cycles). A total of 100 (7.5%) women discontinued VyLibra, at least in part, due to bleeding or spotting. Based on data from the clinical trials, 14 to 34% of women using VyLibra experienced unscheduled bleeding per cycle in the first year. The percent of women who experienced breakthrough/unscheduled bleeding tended to decrease over time.Amenorrhea and Oligomenorrhea
Women who use VyLibra may experience amenorrhea. Some women may experience amenorrhea or oligomenorrhea after discontinuation of COCs, especially when such a condition was pre-existent.
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. - Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive[see]
5.10 Malignant NeoplasmsBreast Cancer
VyLibra is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive[see Contraindications (4)].
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[seePostmarketing Experience (6.2)].Cervical Cancer
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. - Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see]
5.3 Risk of Liver Enzyme Elevations with Concomitant Hepatitis C TreatmentDuring 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 VyLibra prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
[see Contraindications (4)]. VyLibra can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available