Tri-vylibra

Contraindications, Pregnancy (

Tri-VyLibra is combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (

Tri-VyLibra 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-VyLibra should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (

• Take one tablet daily by mouth at the same time every day. (
  2.1 Recommended Dosage and Administration

  Take one tablet by mouth at the same time each day with or without food. Table 1 provides the recommended dosage and administration instructions for Tri-VyLibra.

  
  
  

  Table 1: Instructions for Administration of Tri-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: Tri-VyLibra active tablets are white (Day 1 to Day 7), light blue (Day 8 to Day 14) and dark blue (Day 15 to Day 21). Tri-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 Tri-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 Tri-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 Tri-VyLibra	Start Tri-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 Tri-VyLibra after Abortion or Miscarriage

  
  
  

  First-trimester

  • After a first-trimester abortion or miscarriage, Tri-VyLibra may be started immediately. An additional method of contraception is not needed if Tri-VyLibra is started immediately.
  • If Tri-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 Tri-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 Tri-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 Tri-VyLibra
    [see
    Contraindications (4)
    and
    Warnings and Precautions (5.1)
    ].

  Starting Tri-VyLibra after Childbirth

  • Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Tri-VyLibra following the instructions in Table 1 for women not currently using hormonal contraception.
  • Tri-VyLibra is not recommended for use in lactating women
    [see Use in Specific Populations (8.2)].
  • If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Tri-VyLibra
    [see
    Contraindications (4)
    ,
    Warnings and Precautions (5.1)
    ,
    and
    Use in Specific Populations (8.1
    , and
    8.2)
    ].
  )
• Take tablets in the order directed on the blister pack. (
  2.1 Recommended Dosage and Administration

  Take one tablet by mouth at the same time each day with or without food. Table 1 provides the recommended dosage and administration instructions for Tri-VyLibra.

  
  
  

  Table 1: Instructions for Administration of Tri-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: Tri-VyLibra active tablets are white (Day 1 to Day 7), light blue (Day 8 to Day 14) and dark blue (Day 15 to Day 21). Tri-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 Tri-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 Tri-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 Tri-VyLibra	Start Tri-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 Tri-VyLibra after Abortion or Miscarriage

  
  
  

  First-trimester

  • After a first-trimester abortion or miscarriage, Tri-VyLibra may be started immediately. An additional method of contraception is not needed if Tri-VyLibra is started immediately.
  • If Tri-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 Tri-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 Tri-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 Tri-VyLibra
    [see
    Contraindications (4)
    and
    Warnings and Precautions (5.1)
    ].

  Starting Tri-VyLibra after Childbirth

  • Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Tri-VyLibra following the instructions in Table 1 for women not currently using hormonal contraception.
  • Tri-VyLibra is not recommended for use in lactating women
    [see Use in Specific Populations (8.2)].
  • If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Tri-VyLibra
    [see
    Contraindications (4)
    ,
    Warnings and Precautions (5.1)
    ,
    and
    Use in Specific Populations (8.1
    , and
    8.2)
    ].
  )
• Do not skip or delay tablet intake. (
  2.1 Recommended Dosage and Administration

  Take one tablet by mouth at the same time each day with or without food. Table 1 provides the recommended dosage and administration instructions for Tri-VyLibra.

  
  
  

  Table 1: Instructions for Administration of Tri-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: Tri-VyLibra active tablets are white (Day 1 to Day 7), light blue (Day 8 to Day 14) and dark blue (Day 15 to Day 21). Tri-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 Tri-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 Tri-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 Tri-VyLibra	Start Tri-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 Tri-VyLibra after Abortion or Miscarriage

  
  
  

  First-trimester

  • After a first-trimester abortion or miscarriage, Tri-VyLibra may be started immediately. An additional method of contraception is not needed if Tri-VyLibra is started immediately.
  • If Tri-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 Tri-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 Tri-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 Tri-VyLibra
    [see
    Contraindications (4)
    and
    Warnings and Precautions (5.1)
    ].

  Starting Tri-VyLibra after Childbirth

  • Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Tri-VyLibra following the instructions in Table 1 for women not currently using hormonal contraception.
  • Tri-VyLibra is not recommended for use in lactating women
    [see Use in Specific Populations (8.2)].
  • If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Tri-VyLibra
    [see
    Contraindications (4)
    ,
    Warnings and Precautions (5.1)
    ,
    and
    Use in Specific Populations (8.1
    , and
    8.2)
    ].
  )

Tri-VyLibra tablets are available in blister packs. Each blister pack contains 28 tablets in the following order:

• 7 white, round, biconvex, coated tablets, debossed with “S” on one side and “19” on other side of the tablet contains 0.180 mg norgestimate and 0.035 mg ethinyl estradiol
• 7 light blue, round, biconvex, coated tablets, debossed with “S” on one side and “21” on other side of the tablet contains 0.215 mg norgestimate and 0.035 mg ethinyl estradiol
• 7 dark blue, round, biconvex, coated tablets, debossed with “S” on one side and “22” on other side of the tablet contains 0.250 mg norgestimate and 0.035 mg ethinyl estradiol
• 7 green, round, mottled biconvex, uncoated tablets (non-hormonal placebo) debossed with “S” on one side and “24” on other side of the tablet contains inert ingredients

Lactating women: Not recommended; can decrease milk production. (