VyLibra

VYLIBRA- norgestimate and ethinyl estradiol
Afaxys Pharma, LLC

1 INDICATIONS AND USAGE

1.1 Oral Contraceptive

VyLibra 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 VyLibra

VyLibra is available in blister pack [see How Supplied/Storage and Handling (16)]. VyLibra 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 VyLibra

Table 1: Instructions for Administration of VyLibra

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: VyLibra active tablets are dark blue (Day 1 to Day 21). VyLibra 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 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: 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 pack of VyLibra. 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 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 VyLibra 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 VyLibra	Start VyLibra:
● 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
Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling.

Starting VyLibra after Abortion or Miscarriage
First-trimester

• After a first-trimester abortion or miscarriage, VyLibra may be started immediately. An additional method of contraception is not needed if VyLibra is started immediately.
• If VyLibra 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 pack of VyLibra.

Second-trimester

• Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start VyLibra, 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 pack of VyLibra. [see Contraindications (4), Warnings and Precautions (5.1), and FDA-Approved Patient Labeling.]

Starting VyLibra after Childbirth

• Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with VyLibra following the instructions in Table 1 for women not currently using hormonal contraception.
• VyLibra 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 VyLibra. [See Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.3), and FDA-Approved Patient Labeling].

How to Use the Blister Pack:

There are two ways to start taking birth control pills, Sunday Start or Day 1 Start. Your healthcare professional will tell you which to use.

1. Pick the Days of the Week Sticker that starts the first day of your period. (This is the day you begin bleeding or spotting, even if it is midnight when bleeding begins.) When you have picked the right sticker, throw away the others and place the sticker on the blister pack over the preprinted days of the week and make sure it lines up with the pills.

2. Your blister pack containing 28 individually sealed pills. Note that the pills are arranged in four numbered rows of 7 pills, with the pre-printed days of the week printed above them. There are 21 dark blue “active” pills and 7 green “reminder” pills. Refer to the sample of the blister pack below:

3. After taking the last green pill, start a new blister pack the very next day no matter when your period started. You will be taking a pill every day without interruption. Anytime you start the pills later than directed, protect yourself by using another method of birth control until you have taken a pill a day for seven consecutive days. After taking the last green pill, start taking the first dark blue pill from the blister pack the very next day.
4. Take the pills in each new package as before. Start with the dark blue pill on row #1 and take one pill each day, left to right, until the last green pill has been taken.

Three Ways to Remember in What Order to take the Pills

1. Follow the sticker with the days of the week (placed above the pills).
2. Always go from left to right. 3. Always finish all your pills.