Mono-Linyah Dosage

How to Start Mono-Linyah

Mono-Linyah is dispensed in 28-tablet blister [see How Supplied/Storage and Handling (16)]. Mono-Linyah may be started using either a Day 1 start or a Sunday start (see Table 1). The plastic compact is pre-set for a Sunday start. Day 1 Start day-label stickers are a vailable. F or the first c ycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.

How to Take Mono-Linyah

Starting Mono-Linyah after Abortion or Miscarriage

First-trimester

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

● If Mono-Linyah 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 Mono-Linyah.

Second-trimester

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

Starting Mono-Linyah after Childbirth

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

● Mono-Linyah 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 Mono-Linyah. [See Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations(8.1 and 8.3), and FDA-Approved Patient Labeling].

Compact Blister Dispenser

If the patient starts pill-taking on Sunday, the first active pill should be taken on the first Sunday after the patient's menstrual period begins. Remove the first active pill at the top of the dispenser (Sunday) by pressing the pill through the blister foil.

If the pa tient will start pill-taking on "Day 1," place a day-label sticker on the compact which starts with the day of the week the patient will take the first pill. Remove the first active pill a t the top of the dispenser (Day 1) by pressing the pill through the blister foil.

Missed Tablets

Advice in Case of Gastrointestinal Disturbances

In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling].