Ashlyna

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

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

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, including Ashlyna, are contraindicated in women who are over 35 years of age and smoke. [See Contraindications (4), and Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

Ashlyna is indicated for use by females of reproductive potential to prevent pregnancy.

2 DOSAGE AND ADMINISTRATION

2.1 How to Start and Take Ashlyna

Begin Ashlyna on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the first light blue to blue tablet that day.

For each 91-day course, take in the following order:

3.
Start the first light blue to blue tablet on the first Sunday after onset of menstruation. Then take one light blue to blue tablet daily for 84 consecutive days. Use a non-hormonal back-up method of contraception (such as condoms and spermicide) until a light blue to blue tablet has been taken daily for 7 consecutive days.
4.
Then take one yellow tablet for 7 consecutive days. Bleeding 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 light blue to blue tablet followed by 7 days taking a light yellow to yellow tablet. 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 light blue to blue tablet daily for 7 consecutive days.

Switching to Ashlyna from another oral hormonal contraceptive or from another contraceptive method (transdermal patch, vaginal ring, injection, intrauterine contraceptive, implant)

Start on the Sunday after the patient’s next period starts. Use additional non-hormonal contraceptive (such as condoms and spermicide) until the patient has taken a light blue to blue tablet for 7 consecutive days.

Starting Ashlyna after Abortion or Miscarriage

First-trimester

Ashlyna may be started on the Sunday after an abortion or miscarriage. The patient must use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken a light blue to blue tablet for 7 consecutive days.

Second-trimester

Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Ashlyna following the instructions for women not currently using hormonal contraception. Use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken a light blue to blue tablet for 7 consecutive days [see Contraindications (4) and Warnings and Precautions (5.1)].

Starting Ashlyna after Childbirth

Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Ashlyna following the instructions for women not currently using hormonal contraception. Use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken a light blue to blue tablet for 7 consecutive days [see Contraindications (4) and Warnings and Precautions (5.1)].

If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Ashlyna [see Warnings and Precautions (5.1), Use in Specific Populations (8.1)].

2.2 Dosing Ashlyna

Take one tablet by mouth at the same time every day. The dosage of Ashlyna is one light blue to blue tablet daily for 84 consecutive days, followed by one yellow tablet daily for 7 days. To achieve maximum contraceptive effectiveness, Ashlyna must be taken exactly as directed, in the order directed, and at intervals not exceeding 24 hours. The failure rate may increase when pills are missed or taken incorrectly.

2.3 Missed Doses

Table 1. Instructions for Missed Ashlyna Tablets

If one light blue to blue tablet tablet is missed

Take the missed tablet as soon as possible. Take the next tablet at the regular time. Continue taking one tablet a day until the pack is finished. A back-up birth control method is not required if the patient has sex.

If two light blue to blue tablet in a row are missed

Take the two missed tablets as soon as possible, and the next two tablets the next day. Continue taking one tablet a day until the pack is finished. Use additional nonhormonal contraception (such as condoms and spermicide) until tablets have been taken for 7 days after missing tablets.

If three or more light blue to blue pills in a row are missed

Throw away the missed pills. Continue taking one tablet every day as indicated on the pack until the pack is finished. Bleeding may occur during the week following the missed tablets. Use additional nonhormonal contraception (such as condoms and spermicide) until tablets have been taken for 7 days after missing tablets.

If any of the seven light yellow to yellow tablets are missed

Throw away the missed tablets. Continue taking the remaining tablets until the pack is finished. A backup birth control method is not needed.

2.4 Advice in Case of Gastrointestinal Disturbances

In case of prolonged vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken.

3 DOSAGE FORMS AND STRENGTHS

Ashlyna® (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 light blue to blue tablets, each containing 0.15 mg of levonorgestrel, USP and 0.03 mg ethinyl estradiol, USP and 7 light yellow to yellow tablets, each containing 0.01 mg of ethinyl estradiol, USP. The light blue to blue tablets are round, film-coated, biconvex, unscored tablets debossed with “E1” on one side. The light yellow to yellow tablets are round, biconvex, film-coated, unscored tablets debossed with “D8” on one side.

4 CONTRAINDICATIONS

Ashlyna 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 females who are known to:
o
Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)].
o
Have current or history of deep vein thrombosis or pulmonary embolism [see Warnings and Precautions (5.1)].
o
Have cerebrovascular disease [see Warnings and Precautions (5.1)].
o
Have coronary artery disease [see Warnings and Precautions (5.1)].
o
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)].
o
Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)].
o
Have uncontrolled hypertension or hypertension with vascular disease [see Warnings and Precautions (5.3)].
o
Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or with vascular disease or other end-organ damage, or diabetes mellitus of > 20 years duration [see Warnings and Precautions (5.7)].
o
Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches [see Warnings and Precautions (5.8)].
Current diagnosis of, or history of, breast cancer, which may be hormone sensitive [see Warnings and Precautions (5.11)].
Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6)].
Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.9)].
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)].

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