Estarylla

ESTARYLLA- norgestimate and ethinyl estradiol
Xiromed, LLC.

Estarylla Blister ImageEstarylla Carton ImageFigure 2Pregnancy Risk Chart

1 INDICATIONS AND USAGE

1.1 Oral Contraceptive

Estarylla™ (norgestimate and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14)].

2 DOSAGE AND ADMINISTRATION

2.1 How to Start Estarylla?

Estarylla™ (norgestimate and ethinyl estradiol tablets), dispensed in a blister pack [see HOW SUPPLIED/STORAGE AND HANDLING (16)]. Estarylla™ 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 should be used until after the first 7 consecutive days of administration.

2.2 How to Take Estarylla?

Table 1: Instructions for Administration of Estarylla™

Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling.
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: • Estarylla™ active tablets are blue (Day 1 to Day 21). • Estarylla™ has green inactive tablets (Day 22 to Day 28)	Day 1 Start: • Take first 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 21 days. • Take one green inactive tablet daily for 7 days and at the same time of day that active tablets were taken. • Begin each subsequent blister pack on the same day of Estarylla™ the week as the first cycle blister pack (i.e., on the day after taking the last inactive tablet)
	Sunday Start: • Take first 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 seven days of the patient’s first cycle blister pack of Estarylla ™. • Take subsequent active tablets once daily at the same time each day for a total of 21 days. • Take one green inactive tablet daily for the following 7 days and at the same time of day that active tablets were taken. • Begin each subsequent blister pack on the same day of the week as the first cycle blister pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed.
Switching to Estarylla ™ from another oral contraceptive	Start on the same day that a new blister pack of the previous oral contraceptive would have started.
Switching from another contraceptive method to Estarylla ™	Start Estarylla ™:
• 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 blister pack.
• Implant	• On the day of removal

Starting Estarylla ™ after Abortion or Miscarriage

First-trimester

•

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

•

If Estarylla™ is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle blister pack of Estarylla™.

Second-trimester

•

Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Estarylla™, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle blister pack of Estarylla^TM [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.1), and FDA-APPROVED PATIENT LABELING].

Starting Estarylla ™ after Childbirth

•

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

•

Estarylla™ is not recommended for use in lactating women [see USE IN SPECIFIC POPULATIONS (8.3)].

•

If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Estarylla™. [See CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.1), USE IN SPECIFIC POPULATIONS (8.1 and 8.3), and FDA-Approved Patient Labeling].

BEFORE YOU START TAKING YOUR PILLS

•

DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL. It is important to take it at about the same time every day.

•

LOOK AT YOUR PILL PACK

The pill blister pack has 21 active pills (with hormones) to take for 3 weeks. This is followed by 1 week of reminder green pills (without hormones).

There are 21 blue active pills, and 7 green reminder pills.

3. ALSO FIND:

1.

where on the blister pack to start taking pills,

2.

in what order to take the pills (follow the arrows)

3.

The week numbers as shown in the diagram below.

4

BE SURE YOU HAVE READY AT ALL TIMES:

Another kind of birth control (such as a condom or spermicide) to use as a back-up method in case you miss pills.

An extra, full pill blister pack.