General MedicationsOralBlack Box

Ashlyna

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

Standard Dose

2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day for 91 days in the order directed on the blister pack. ( 2 ) 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: 1. 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. 2. 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.

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE Ashlynais indicated for use by females of reproductive potential to prevent pregnancy.

Summary

Indications and usage 1 INDICATIONS AND USAGE Ashlynais indicated for use by females of reproductive potential to prevent pregnancy.

Ashlyna is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day for 91 days in the order directed on the blister pack. ( 2 ) 2.1 How to Start and Take Ashlyna Begin Ashlyna on the first Sunday after the onset of menstruation.

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Ashlynais indicated for use by females of reproductive potential to prevent pregnancy. Ashlyna is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day for 91 days in the order directed on the blister pack. ( 2 ) 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: 1. 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. 2. 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 a

Boxed Warning

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 )]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning • Ashlyna is contraindicated in women over 35 years old who smoke. • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.

Monitoring

• 5 WARNINGS AND PRECAUTIONS • Vascular risks: Stop if a thrombotic or thromboembolic event occurs.
• Stop at least 4 weeks before and through 2 weeks after major surgery.
• Start no earlier than 4 weeks after delivery, in women who are not breastfeeding.
• Consider cardiovascular risk factors before initiating in all females, particularly those over 35 years.

Interaction Notes

• 7 DRUG INTERACTIONS The sections below provide information on substances for which data on drug interactions with COCs are available.
• There is little information available about the clinical effect of most drug interactions that may affect COCs.
• However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested.
• Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with COCs or the potential for metabolic enzyme or transporter system alterations.