FAYOSIM — levonorgestrel and ethinyl estradiol and ethinyl estradiol
Lupin Pharmaceuticals, Inc.
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (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. [See CONTRAINDICATIONS (4)]
Instruct patients to take Fayosim once a day by mouth at the same time every day for 91 days. To achieve maximum contraceptive effectiveness, Fayosim must be taken exactly as directed and at intervals not exceeding 24 hours. For patient instructions regarding missed pills, see FDA-approved patient labeling.
- Start the first pink tablet (0.15 mg of levonorgestrel and 0.02 mg ethinyl estradiol) on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the tablet on that day. Then take one pink tablet once a day for a total of 42 consecutive days. Use a non-hormonal back-up method of contraception (such as condoms and spermicide) for the first 7 days of treatment.
- One white tablet (0.15 mg of levonorgestrel and 0.025 mg ethinyl estradiol) once a day for 21 consecutive days.
- One light blue tablet (0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol) once a day for 21 days.
- One mustard tablet (0.01 mg of ethinyl estradiol) once a day for 7 days. Bleeding should occur during mustard tablet use.
Begin the next and all subsequent 91-day courses of Fayosim without interruption on the same day of the week (i.e., Sunday) on which the patient began her first dose. Follow the same schedule as the initial 91-day course: pink tablet once a day for 42 days, white tablet once a day for 21 days, light blue tablet once a day for 21 days, and mustard tablet once a day for 7 days. If the patient does not immediately start her next pill pack, instruct her to protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken a pink tablet daily for 7 consecutive days.
If unscheduled spotting or bleeding occurs, instruct the patient to continue on the same regimen. If the bleeding is persistent or prolonged, advise the patient to consult her healthcare provider.
For a postpartum woman who is not breastfeeding or after a second trimester abortion, start Fayosim no earlier than four weeks postpartum due to increased risk of thromboembolism. If the patient starts on Fayosim postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken a pink tablet for 7 consecutive days. Consider the possibility of ovulation and conception prior to initiation.
In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking a pink, white or light blue tablet, handle this as a missed tablet [see FDA-approved patient labeling].
Fayosim (levonorgestrel and ethinyl estradiol tablets, and ethinyl estradiol tablets) are available as round, film-coated, biconvex tablets debossed with “LU” on one side, packaged in Extended-Cycle wallet, each containing a 13-week supply of tablets in the following order:
- 42 pink tablets, each containing 0.15 mg of levonorgestrel and 0.02 mg ethinyl estradiol: debossed with “U19” on the other side
- 21 white tablets containing 0.15 mg of levonorgestrel and 0.025 mg ethinyl estradiol: debossed with “U20” on the other side
- 21 light blue tablets containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol: debossed with “V21” on the other side and
- 7 mustard tablets containing 0.01 mg of ethinyl estradiol: debossed with “V22” on the other side
• A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
- Smoke, if over age 35 [see BOXED WARNING and WARNINGS AND PRECAUTIONS (5.1)].
- Have deep vein thrombosis or pulmonary embolism, now or in the past [ 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 inherited or acquired hypercoagulopathies [see WARNINGS AND PRECAUTIONS (5.1)].
- Have uncontrolled hypertension [see WARNINGS AND PRECAUTIONS (5.3)].
- Have diabetes with vascular disease [see WARNINGS AND PRECAUTIONS (5.6].
- Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see WARNINGS AND PRECAUTIONS (5.7)].
• Undiagnosed abnormal uterine bleeding [see WARNINGS AND PRECAUTIONS (5.8)].
• Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see WARNINGS 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 [see WARNINGS AND PRECAUTIONS (5.4)].
Stop Fayosim if an arterial or deep venous thrombotic event (VTE) occurs. Stop Fayosim if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
If feasible, stop Fayosim at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE.
Start Fayosim 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. Data from a large, prospective cohort safety study of various COCs suggest that this increased risk, as compared to that in non-COC users, is greatest during the first 6 months of COC use. Data from this safety study indicate that the greatest risk of VTE is present after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued.
Use of Fayosim provides women with more hormonal exposure on a yearly basis than conventional monthly oral contraceptives containing the same strength synthetic estrogens and progestins (an additional 9 and 13 weeks of exposure to progestin and estrogen, respectively, per year). In the clinical trial, three cases of deep vein thrombosis were reported.
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 among older (>35 years of age), and hypertensive women who also smoke. COCs also increase the risk for stroke in women with other underlying risk factors.
Use COCs with caution in women with cardiovascular disease risk factors.
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