Dosage & Administration
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Taytulla Prescribing Information
TAYTULLA 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[seeBoxed WarningandWarnings and Precautions (5.1)]
• Have deep vein thrombosis or pulmonary embolism, now or in the past[seeWarnings and Precautions (5.1)]
• Have cerebrovascular disease[seeWarnings and Precautions (5.1)]
• Have coronary artery disease[seeWarnings 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)[seeWarnings and Precautions (5.1)]
• Have inherited or acquired hypercoagulopathies[seeWarnings and Precautions (5.1)]
• Have uncontrolled hypertension[seeWarnings and Precautions (5.4)]
• Have diabetes mellitus with vascular disease[seeWarnings and Precautions (5.6)]
• Have headaches with focal neurological symptoms or have migraine headaches with aura
• Women over age 35 with any migraine headaches[seeWarnings and Precautions (5.7)] - Liver tumors, benign or malignant, or liver disease[seeWarnings and Precautions (5.2)]
- Undiagnosed abnormal uterine bleeding[seeWarnings and Precautions (5.8)]
- Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive[seeWarnings and Precautions (5.11)]
- Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations[seeWarnings 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
Stop TAYTULLA if an arterial or deep venous thrombotic event (VTE) occurs. Stop TAYTULLA if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
If feasible, stop TAYTULLA at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE.
Start TAYTULLA 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 a COC. The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC 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), although, in general, the risk is greatest in older (> 35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with underlying risk factors.
Use COCs with caution in women with cardiovascular disease risk factors.
TAYTULLA is indicated for use by females of reproductive age to prevent pregnancy
The data presented in Section 14 are from a clinical trial conducted with a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 0.020 mg tablets. TAYTULLA capsules are bioequivalent to these norethindrone acetate/ethinyl estradiol tablets.
In a clinical study, 743 women 18 to 45 years of age were studied to assess the efficacy of norethindrone acetate/ethinyl estradiol tablets, for up to six 28-day cycles providing a total of 3,823 treatment-cycles of exposure. The racial demographic of all enrolled women was: 70% Caucasian, 16% African-American, 10% Hispanic, 2% Asian and 2% Other. Women with body mass index (BMI) greater than 35 mg/m2were excluded from the study. The weight range for those women treated was 90 to 260 pounds, with a mean weight of 147 pounds. Among the women in the study, about 40% had not used hormonal contraception immediately prior to enrolling in this study.
A total of 583 women completed 6 cycles of treatment. There were a total of 5 on-treatment pregnancies in 3,565 treatment cycles during which no backup contraception was used. The Pearl Index for norethindrone acetate/ethinyl estradiol tablets was 1.82 (95% confidence interval 0.59 - 4.25).
The efficacy of TAYTULLA in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.
- Take one capsule by mouth at the same time every day ()2.1How to TakeTAYTULLA
To achieve maximum contraceptive effectiveness, TAYTULLA must be taken exactly as directed. Instruct patients to take one capsule by mouth at the same time every day. Capsules must be taken in the order directed on the blister pack. Capsules should not be skipped or taken at intervals exceeding 24 hours. TAYTULLA may be administered without regard to meals
[seeClinical Pharmacology (12.3)]. - Take capsules in the order directed on the blister pack ()2.1How to TakeTAYTULLA
To achieve maximum contraceptive effectiveness, TAYTULLA must be taken exactly as directed. Instruct patients to take one capsule by mouth at the same time every day. Capsules must be taken in the order directed on the blister pack. Capsules should not be skipped or taken at intervals exceeding 24 hours. TAYTULLA may be administered without regard to meals
[seeClinical Pharmacology (12.3)]. - Capsules may be administered without regard to meals ()2.1How to TakeTAYTULLA
To achieve maximum contraceptive effectiveness, TAYTULLA must be taken exactly as directed. Instruct patients to take one capsule by mouth at the same time every day. Capsules must be taken in the order directed on the blister pack. Capsules should not be skipped or taken at intervals exceeding 24 hours. TAYTULLA may be administered without regard to meals
[seeClinical Pharmacology (12.3)].
TAYTULLA is available in blister packs.
Each blister pack contains 28 soft gelatin capsules in the following order:
- 24 oval, opaque, pale pink (active) soft gelatin capsule with “WC” printed on the outer shell in white and each containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.
- 4 oval, opaque, maroon, (non-hormonal placebo) capsules imprinted with “WC” on one side and each containing 75 mg ferrous fumarate. The ferrous fumarate capsules do not serve any therapeutic purpose.
- Lactation: Not recommended; TAYTULLA can decrease milk production ()8.2LactationRisk Summary
Contraceptive hormones and/or metabolites are present in human milk. COCs 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 [
seeDosage and Administration (2.2)]. The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for TAYTULLA and any potential adverse effects on the breast-fed child from TAYTULLA or from the underlying maternal condition.
TAYTULLA 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[seeWARNING: 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 should not be used by women who are over 35 years of age and smoke[seeContraindications (4)andWarnings & Precautions (5.1)].WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTSSee Full Prescribing Information for complete boxed warning.- Women over 35 years old who smoke should not use TAYTULLA. (4)
- Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. (4)
and5.1ThromboembolicDisordersand Other VascularProblemsStop TAYTULLA if an arterial or deep venous thrombotic event (VTE) occurs. Stop TAYTULLA if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
If feasible, stop TAYTULLA at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE.
Start TAYTULLA 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 a COC. The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC 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), although, in general, the risk is greatest in older (> 35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with underlying risk factors.
Use COCs with caution in women with cardiovascular disease risk factors.
]
• Have deep vein thrombosis or pulmonary embolism, now or in the past[see5.1ThromboembolicDisordersand Other VascularProblemsStop TAYTULLA if an arterial or deep venous thrombotic event (VTE) occurs. Stop TAYTULLA if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
If feasible, stop TAYTULLA at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE.
Start TAYTULLA 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 a COC. The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC 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), although, in general, the risk is greatest in older (> 35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with underlying risk factors.
Use COCs with caution in women with cardiovascular disease risk factors.
]
• Have cerebrovascular disease[see5.1ThromboembolicDisordersand Other VascularProblemsStop TAYTULLA if an arterial or deep venous thrombotic event (VTE) occurs. Stop TAYTULLA if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
If feasible, stop TAYTULLA at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE.
Start TAYTULLA 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 a COC. The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC 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), although, in general, the risk is greatest in older (> 35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with underlying risk factors.
Use COCs with caution in women with cardiovascular disease risk factors.
]
• Have coronary artery disease[see5.1ThromboembolicDisordersand Other VascularProblemsStop TAYTULLA if an arterial or deep venous thrombotic event (VTE) occurs. Stop TAYTULLA if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
If feasible, stop TAYTULLA at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE.
Start TAYTULLA 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 a COC. The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC 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), although, in general, the risk is greatest in older (> 35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with underlying risk factors.
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)[see5.1ThromboembolicDisordersand Other VascularProblemsStop TAYTULLA if an arterial or deep venous thrombotic event (VTE) occurs. Stop TAYTULLA if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
If feasible, stop TAYTULLA at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE.
Start TAYTULLA 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 a COC. The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC 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), although, in general, the risk is greatest in older (> 35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with underlying risk factors.
Use COCs with caution in women with cardiovascular disease risk factors.
]
• Have inherited or acquired hypercoagulopathies[see5.1ThromboembolicDisordersand Other VascularProblemsStop TAYTULLA if an arterial or deep venous thrombotic event (VTE) occurs. Stop TAYTULLA if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
If feasible, stop TAYTULLA at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE.
Start TAYTULLA 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 a COC. The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC 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), although, in general, the risk is greatest in older (> 35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with underlying risk factors.
Use COCs with caution in women with cardiovascular disease risk factors.
]
• Have uncontrolled hypertension[see5.4High Blood PressureTAYTULLA is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease
[seeContraindications (4)]. For women with well-controlled hypertension, monitor blood pressure and stop TAYTULLA 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[see5.000000000000000e+006Carbohydrate and Lipid Metabolic EffectsCarefully monitor prediabetic and diabetic women who are taking TAYTULLA. COCs may decrease glucose tolerance in a dose-related fashion.
Consider alternative contraception for women with uncontrolled dyslipidemias. 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
• Women over age 35 with any migraine headaches[see5.000000000000000e+007HeadacheIf a woman taking TAYTULLA develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue TAYTULLA if indicated.
Consider discontinuation of TAYTULLA in the case of increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event)
[seeContraindications (4)].] - Liver tumors, benign or malignant, or liver disease [see5.2Liver DiseaseImpaired Liver Function
Do not use TAYTULLA in women with acute viral hepatitis or severe (decompensated) cirrhosis of liver
[seeContraindications (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 TAYTULLA if jaundice develops.Liver TumorsTAYTULLA is contraindicated in women with benign and malignant liver tumors
[seeContraindications (4)].Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases per 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 attributable risk of liver cancers in COC users is less than one case per million users.
] - Undiagnosed abnormal uterine bleeding [see5.000000000000000e+008Bleeding Irregularities and AmenorrheaUnscheduledBleeding and Spotting
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 COC.
Based on patient diaries from a clinical trial evaluating the safety and efficacy of a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 0.020 mg tablets, 24-35% of women experienced unscheduled bleeding per cycle. A total of 10 subjects out of 743 (1.3%) discontinued due to bleeding or spotting.
Amenorrhea and OligomenorrheaWomen who are not pregnant and use TAYTULLA may experience amenorrhea. In the clinical trial with a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 0.020 mg tablets, 22 to 36% of the women using norethindrone acetate 1 mg/ethinyl estradiol 0.020 mg tablets experienced amenorrhea in at least one of 6 cycles of use. Some women may experience post-pill amenorrhea or oligomenorrhea, 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 capsules 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 [see5.11Malignant NeoplasmsBreast Cancer
TAYTULLA is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive
[seeContraindications (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
[seeAdverse Reactions (6.2)].Cervical CancerSome studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to which these 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 [see5.3RiskofLiverEnzymeElevationswithConcomitant HepatitisC Treatment
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 TAYTULLA prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
[seeContraindications (4)].TAYTULLA can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.]