Balcoltra

2 DOSAGE AND ADMINISTRATION • Take one tablet by mouth at the same time every day. ( 2.1 ) • Take tablets in the order directed on the blister pack. ( 2.1 ) 2.1 How to Start Balcoltra Balcoltra is dispensed in a blister card [see How Supplied/Storage and Handling ( 16 )] . Balcoltra 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 Balcoltra Balcoltra (orange active tablets and blue placebo tablets) is swallowed whole once a day Table 1: Instructions for Administration of Balcoltra 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: •Balcoltra active tablets are orange (Day 1 to Day 21). •Balcoltra placebo tablets are blue (Day 22 to Day 28). Day 1 Start: •Take first orange active tablet on the first day of menses. •Take subsequent orange active tablets once daily at the same time each day for a total of 21 days. •Take one blue placebo 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 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 or spermicide) for the first seven days of the patient’s first cycle pack of Balcoltra. •Take subsequent orange tablets once daily at the same time each day for a total of 21 days. •Take one blue placebo 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 Balcoltra from another hormonal contraceptive Start on the same day that a new pack of the previous hormonal contraceptive would have started. Switching from another contraceptive method to Balcoltra Start Balcoltra: • 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 or spermicide) is needed for the first seven days of the first cycle pack. • Implant •On the day of removal Starting Balcoltra after Abortion or Miscarriage First-trimester •After a first-trimester abortion or miscarriage, Balcoltra may be started immediately. An additional method of contraception is not needed if Balcoltra is started within 5 days after termination of the pregnancy. •If Balcoltra is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of her first cycle pack of Balcoltra. Second-trimester •Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Balcoltra, 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 or spermicide) for the first seven days of the patient’s first cycle pack of Balcoltra. [See Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), and FDA-Approved Patient Labeling .] Starting Balcoltra after Childbirth •Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Balcoltra following the instructions in Table 1 for women not currently using hormonal contraception. •If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Balcoltra. [See Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 and 8.2 ), and FDA-Approved Patient Labeling ] . 2.3 Missed Tablets Table 2: Instructions for Missed Balcoltra Tablets •If one orange 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 orange 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 or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. •If two orange tablets are missed in Week 3 or three or more orange 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 or 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 ] .

See official label

1 INDICATIONS AND USAGE Balcoltra is indicated for use by females of reproductive potential to prevent pregnancy.