Hailey 24 Fe

HAILEY 24 FE- norethindrone acetate and ethinyl estradiol, and ferrous fumarate
Glenmark Pharmaceuticals Inc., USA

1 INDICATIONS AND USAGE

Hailey 24 Fe is indicated for use by women to prevent pregnancy [see Clinical Studies (14)].

The efficacy of Hailey 24 Fe in women with a body mass index (BMI) of > 35 kg/m² has not been evaluated.

2 DOSAGE AND ADMINISTRATION

2.1 How to Start Hailey 24 Fe

Hailey 24 Fe is dispensed in a blister [see How Supplied/Storage and Handling (16)]. Hailey 24 Fe may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception must be used until after the first 7 consecutive days of administration.

2.2 How to Take Hailey 24 Fe

Table 1: Instructions for Administration of Hailey 24 Fe

Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: • Hailey 24 Fe active tablets are white to off-white (Day 1 to Day 24). • Hailey 24 Fe inactive tablets are brown to dark brown (Day 25 to Day 28).	Day 1 Start: • Take first white to off-white active tablet without regard to meals on the first day of menses. • Take subsequent active tablets once daily at the same time each day for a total of 24 days. • Take one brown to dark brown inactive tablet daily for 4 days and at the same time of day that active tablets were taken. • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet).
	Sunday Start: For each 28-day course, take in the following order: • Take the white to off-white active tablet without regard to meals on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of the patient’s first cycle pack of Hailey 24 Fe. • Take subsequent active tablets once daily at the same time each day for a total of 24 days. • Take one brown to dark brown tablet (ferrous fumarate) daily for the following 4 days and at the same time of day that active tablets were taken. A scheduled period should occur during the 4 days that the brown to dark brown tablets are taken. • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed.
Switching to Hailey 24 Fe from another oral contraceptive	Start on the same day that a new pack of the previous oral contraceptive would have started.
Switching from another contraceptive method to Hailey 24 Fe	Start Hailey 24 Fe:
• Transdermal patch	• On the day when next application would have been scheduled.
• Vaginal ring	• On the day when next insertion would have been scheduled
• Injection	• On the day when next injection would have been scheduled
• Intrauterine contraceptive	• On the day of removal • If the IUD is not removed on first day of the patient’s menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack.
• Implant	• On the day of removal

Starting Hailey 24 Fe after Abortion or Miscarriage

First-trimester

•

After a first-trimester abortion or miscarriage, Hailey 24 Fe may be started immediately. An additional method of contraception is not needed if Hailey 24 Fe is started immediately.

•

If Hailey 24 Fe is not started within 5 days after termination of the pregnancy, the patient must use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of her first 28-day course of Hailey 24 Fe.

Second-trimester

•

Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Hailey 24 Fe following the instructions in Table 1 for Sunday start. Use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of the patient’s first 28-day course of Hailey 24 Fe [see Contraindications (4) and Warnings and Precautions (5.1)].

Starting Hailey 24 Fe after Childbirth

•

Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Hailey 24 Fe following the instructions in Table 1 for women not currently using hormonal contraception.

•

If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Hailey 24 Fe [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.2)].

2.3 Missed Tablets

Table 2: Instructions for Missed Hailey 24 Fe Tablets

• If one active tablet is missed in Weeks 1, 2 or 3	Take the tablet as soon as possible. Take the next pill at the regular time and continue taking one tablet a day until the pack is finished. Back-up contraception is not needed
• If two consecutive active tablets are missed in Week 1 or Week 2	Take the two missed tablets as soon as possible and the next two active tablets the next day. Continue taking one tablet a day until the pack is finished. Additional non-hormonal contraception (such as condoms and spermicide) must be used as back-up if the patient has sex within 7 days after missing tablets.
• If two consecutive active tablets are missed in Week 3 or Week 4 or three or more consecutive active tablets are missed at any time	Day 1 Start: Throw out the rest of the pack and start a new pack that same day. Sunday Start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Additional non-hormonal contraception (such as condoms and spermicide) must be used as back-up if the patient has sex within 7 days after missing 3 tablets.