Ashlyna

ASHLYNA- levonorgestrel and ethinyl estradiol and ethinyl estradiol
A-S Medication Solutions

1 INDICATIONS AND USAGE

Ashlynais indicated for use by women to prevent pregnancy.

2 DOSAGE AND ADMINISTRATION

Take one tablet by mouth at the same time every day. The dosage of Ashlyna is one blue tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one yellow ethinyl estradiol tablet for 7 days. To achieve maximum contraceptive effectiveness, Ashlyna must be taken exactly as directed and at intervals not exceeding 24 hours.

Instruct the patient to begin taking Ashlyna on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first blue tablet is taken that day. One blue tablet should be taken daily for 84 consecutive days, followed by one yellow tablet for 7 consecutive days. A non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until a blue tablet has been taken daily for 7 consecutive days. A scheduled period should occur during the 7 days that the yellow tablets are taken.

Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of Ashlyna, following the same schedule: 84 days taking a blue tablet followed by 7 days taking a yellow tablet. If the patient does not immediately start her next pill pack, she should protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken a blue 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 patient instructions regarding missed pills, see FDA-Approved Patient Labeling.

For postpartum women who are not breastfeeding, start Ashlyna no earlier than four to six weeks postpartum due to increased risk of thromboembolism. If the patient starts on Ashlyna 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 blue tablet for 7 consecutive days.

3 DOSAGE FORMS AND STRENGTHS

Ashlyna^TM (Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets USP, 0.01 mg) are available in Extended-Cycle Tablet Dispensers, each containing a 13-week supply of tablets: 84 blue tablets, each containing 0.15 mg of levonorgestrel, USP and 0.03 mg ethinyl estradiol, USP and 7 yellow tablets each containing 0.01 mg of ethinyl estradiol, USP. The blue tablets are round, film-coated, biconvex, unscored tablets debossed with “D7” on one side. The yellow tablets are round, biconvex, film-coated, unscored tablets debossed with “D8” on one side.

4 CONTRAINDICATIONS

Do not prescribe Ashlyna to women who are known to have the following:

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A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:

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Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)].

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Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)].

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Have cerebrovascular disease [see Warnings and Precautions (5.1)]

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Have coronary artery disease [see Warnings and Precautions (5.1)].

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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)].

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Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)].

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Have uncontrolled hypertension [see Warnings and Precautions (5.5)].

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Have diabetes with vascular disease [see Warnings and Precautions (5.7)].

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Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions (5.8)].

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Undiagnosed abnormal genital bleeding [see Warnings and Precautions (5.9)].

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Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.2)].

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Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6)].

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Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.10) and Use in Specific Populations (8.1)].

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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) ].

5 WARNINGS AND PRECAUTIONS

5.1 Thrombotic and Other Vascular Events

Stop Ashlyna if an arterial or deep venous thrombotic event occurs. Although the use of COCs increases the risk of venous thromboembolism, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of venous thromboembolism in women using COCs is 3 to 9 per 10,000 woman-years. The excess risk is highest during the first year of use of a COC. 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. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued.

Use of Ashlyna 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).

If feasible, stop Ashlyna at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.

Start Ashlyna no earlier than 4 to 6 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.

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.

Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.

Stop Ashlyna if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.