General MedicationsOralBlack Box

Tri-Linyah

NORGESTIMATE AND ETHINYL ESTRADIOL

Standard Dose

2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. ( 2.2 ) Take tablets in the order directed on the blister pack. ( 2.2 ) Do not skip or delay tablet intake. ( 2.2 ) 2.1 How to Start Tri-Linyah Tri-Linyah is dispensed in 28-tablet blister [see How Supplied/Storage and Handling (16) ] . Tri-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 available. 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 Tri-Linyah Table 1: Instructions for Administration of Tri-Linyah 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: Tri-Linyah active tablets are green (Day 1 to Day 7), light blue (Day 8 to Day 14) and blue (Day 15 to Day 21). Tri-Linyah has white 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 white 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 Tri-Linyah. Take subsequent active tablets once daily at the same time each day for a total of 21 days. Take one white 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 Tri-Linyah 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 Tri-Linyah Start Tri-Linyah: 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 Tri-Linyah after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, Tri-Linyah may be started immediately. An additional method of contraception is not needed if Tri-Linyah is started immediately. If Tri-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 Tri-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 Tri-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 Tri-Linyah. [see Contraindications (4) , Warnings and Precautions (5.1) , and FDA-Approved Patient Labeling .] Starting Tri-Linyah after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Tri-Linyah following the instructions in Table 1 for women not currently using hormonal contraception. Tri-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 Tri-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 patient 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 at the top of the dispenser (Day 1) by pressing the pill through the blister foil. 2.3 Missed Tablets Table 2: Instructions for Missed Tri-Linyah Tablets If one active tablet is missed in Weeks 1, 2, or 3 Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished. If two 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) should be used as back-up if the patient has sex within 7 days after missing tablets. If two active tablets are missed in the third week or three or more active tablets are missed in a row in Weeks 1, 2, or 3 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) should be used as back-up if the patient has sex within 7 days after missing tablets. 2.4 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 ] . 2.5 Tri-Linyah Use for Acne The timing of initiation of dosing with Tri-Linyah for acne should follow the guidelines for use of Tri-Linyah as an oral contraceptive. Consult the DOSAGE AND ADMINISTRATION section (2.1) for instructions.

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE Tri-Linyah is an estrogen/progestin COC, indicated for use by women to prevent pregnancy.

Summary

Tri-Linyah should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. ( 1.2 ) 1.1 Oral Contraceptive Tri-Linyah Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14) ] . 1.2 Acne Tri-Linyah is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche.

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Tri-Linyah is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) Tri-Linyah is also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Linyah should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. ( 1.2 ) 1.1 Oral Contraceptive Tri-Linyah Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14) ] . 1.2 Acne Tri-Linyah is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Linyah should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see Clinical Studies (14) ] . Dosage and administration 2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. ( 2.2 ) Take tablets in the order directed on the blister pack. ( 2.2 ) Do not skip or delay tablet intake. ( 2.2 ) 2.1 How to Start Tri-Linyah Tri-Linyah is dispensed in 28-tablet blister [see How Supplied/Storage and Handling (16) ] . Tri-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 available. 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 Tri-Linyah Table 1: Instructions for Administration of Tri-Linyah 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: Tri-Linyah active tablets are green (Day 1 to Day 7), light blue (Day 8 to Day 14) and blue (Day 15 to Day 21). Tri-Linyah has white 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 white 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 Tri-Linyah. Take subsequent active tablets once daily at the same time each day for a total of 21 days. Take one white 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 Tri-Linyah 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 Tri-Linyah Start Tri-Linyah: 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 Tri-Linyah after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, Tri-Linyah may be started immediately. An additional method of contraception is not needed if Tri-Linyah is started immediately. If Tri-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 Tri-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 Tri-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

Boxed Warning

WARNING: CIGARETTE SMOKING and SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (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 are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4) ] . WARNING: CIGARETTE SMOKING and SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Tri-Linyah is contraindicated in women over 35 years old who smoke. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. ( 4 )

Monitoring

• 5 WARNINGS AND PRECAUTIONS Thromboembolic Disorders and Other Vascular Problems: Stop Tri-Linyha if a thrombotic 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.
• ( 5.1 ) Liver disease: Discontinue Tri-Linyah if jaundice occurs.

Interaction Notes

• 7 DRUG INTERACTIONS Consult the labeling of concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
• No drug-drug interaction studies were conducted with Tri-Linyah.
• Drugs or herbal products that induce certain enzymes including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding.
• Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs.