General MedicationsOralBlack Box

Blisovi 24 Fe

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Standard Dose

2 DOSAGE AND ADMINISTRATION Take one tablet by mouth at the same time every day for 28 days ( 2.1 ) Take tablets in the order directed on the blister pack ( 2.1 ) Blisovi 24 Fe may be administered without regard to meals ( 12.3 ) 2.1 How to Start Blisovi 24 Fe Blisovi 24 Fe is dispensed in a blister card [see HOW SUPPLIED/STORAGE AND HANDLING ( 16 )] . Blisovi 24 Fe 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 must be used until after the first 7 consecutive days of administration. 2.2 How to Take Blisovi 24 Fe Table 1: Instructions for Administration of Blisovi 24 Fe Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start) Day 1 Start: ● Take first white active tablet without regard to meals on the first day of menses. Important: Consider the possibility of ovulation and conception prior to initiation of this product. ● Take subsequent active tablets once daily at the same time each day for a total of 24 days. Tablet Color: ● Blisovi 24 Fe active tablets are white (Day 1 to Day 24). ● Take one brown inactive tablet daily for 4 days and at the same time of day that active tablets were taken. ● Blisovi 24 Fe inactive tablets are brown (Day 25 to Day 28). ● 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: For each 28-day course, take in the following order: ● Take the white 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 7 days of the patient's first cycle pack of Blisovi 24 Fe. ● Take subsequent active tablets once daily at the same time each day for a total of 24 days. ● Take one brown tablet (ferrous fumarate) daily for the following 4 days and at the same time of day that active tablets were taken. A scheduled period should occur during the 4 days that the brown tablets are 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 Blisovi 24 Fe from another oral contraceptive Start on the same day that a new pack of the previous oral contraceptive would have started. S w itching from another contraceptive method to Blisovi 24 Fe Start Blisovi 24 Fe: ● 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 Starting Blisovi 24 Fe after Abortion or Miscarriage First-trimester: After a first-trimester abortion or miscarriage, Blisovi 24 Fe may be started immediately. An additional method of contraception is not needed if Blisovi 24 Fe is started immediately. If Blisovi 24 Fe is not started within 5 days after termination of the pregnancy, the patient must use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of her first 28-day course of Blisovi 24 Fe. Second-trimester: Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Blisovi 24 Fe following the instructions in Table 1 for Sunday start. Use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of the patient's first 28-day course of Blisovi 24 Fe [see CONTRAINDICATIONS ( 4 ) and WARNINGS AND PRECAUTIONS ( 5.1 ). Starting Blisovi 24 Fe after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Blisovi 24 Fe 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 Blisovi 24 Fe [see CONTRAINDICATIONS ( 4 ), WARNINGS AND PRECAUTIONS ( 5.1 ), USE IN SPECIFIC POPULATIONS ( 8.1 and 8.2 ]. 2.3 Missed Tablets Table 2: Instructions for Missed Blisovi 24 Fe Tablets ● If one active tablet is missed in Weeks 1, 2 or 3 Take the tablet as soon as possible. Take the next pill at the regular time and continue taking one tablet a day until the pack is finished. Back-up contraception is not needed ● If two consecutive 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) must be used as back-up if the patient has sex within 7 days after missing tablets . ● If two consecutive active tablets are missed in Week 3 or Week 4 or three or more consecutive active tablets are missed at any time 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) must be used as back-up if the patient has sex within 7 days after missing 3 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 must be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking a white tablet, handle this as a missed tablet [see DOSAGE AND ADMINISTRATION ( 2.3 )] .

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE Blisovi ™ 24 Fe is indicated for use by women to prevent pregnancy [see CLINICAL STUDIES ( 14 )].

Summary

Indications and usage 1 INDICATIONS AND USAGE Blisovi ™ 24 Fe is indicated for use by women to prevent pregnancy [see CLINICAL STUDIES ( 14 )].

The efficacy of Blisovi 24 Fe in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated.

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Blisovi ™ 24 Fe is indicated for use by women to prevent pregnancy [see CLINICAL STUDIES ( 14 )]. The efficacy of Blisovi 24 Fe in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated. Blisovi 24 Fe is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by women to prevent pregnancy. (1) The efficacy of Blisovi 24 Fe in women with a body mass index (BMI) of >35 kg/m 2 has not been evaluated. ( 1 , 8.8 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Take one tablet by mouth at the same time every day for 28 days ( 2.1 ) Take tablets in the order directed on the blister pack ( 2.1 ) Blisovi 24 Fe may be administered without regard to meals ( 12.3 ) 2.1 How to Start Blisovi 24 Fe Blisovi 24 Fe is dispensed in a blister card [see HOW SUPPLIED/STORAGE AND HANDLING ( 16 )] . Blisovi 24 Fe 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 must be used until after the first 7 consecutive days of administration. 2.2 How to Take Blisovi 24 Fe Table 1: Instructions for Administration of Blisovi 24 Fe Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start) Day 1 Start: ● Take first white active tablet without regard to meals on the first day of menses. Important: Consider the possibility of ovulation and conception prior to initiation of this product. ● Take subsequent active tablets once daily at the same time each day for a total of 24 days. Tablet Color: ● Blisovi 24 Fe active tablets are white (Day 1 to Day 24). ● Take one brown inactive tablet daily for 4 days and at the same time of day that active tablets were taken. ● Blisovi 24 Fe inactive tablets are brown (Day 25 to Day 28). ● 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: For each 28-day course, take in the following order: ● Take the white 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 7 days of the patient's first cycle pack of Blisovi 24 Fe. ● Take subsequent active tablets once daily at the same time each day for a total of 24 days. ● Take one brown tablet (ferrous fumarate) daily for the following 4 days and at the same time of day that active tablets were taken. A scheduled period should occur during the 4 days that the brown tablets are 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 Blisovi 24 Fe from another oral contraceptive Start on the same day that a new pack of the previous oral contraceptive would have started. S w itching from another contraceptive method to Blisovi 24 Fe Start Blisovi 24 Fe: ● 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 Starting Blisovi 24 Fe after Abortion or Miscarriage First-trimester: After a first-trimester abortion or miscarriage, Blisovi 24 Fe may be started immediately. An additional method of contraception is not needed if Blisovi 24 Fe is started immediately. If Blisovi 24 Fe is not started within 5 days after termination of the pregnancy, the patient must use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of her first 28-day course of Blisovi 24 Fe. Second-trimester: Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Blisovi 24 Fe following the instructions in Table 1 for Sunday start. Use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of the patient's first 28-day course of Blisovi 24 Fe [see CONTRAINDICATIONS ( 4 ) and WARNINGS AND PRECAUTIONS ( 5.1 ). Starting Blisovi 24 Fe after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Blisovi 24 Fe 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 Blisovi 2

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 should not be used by 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. ● Blisovi 24 Fe 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 Thrombotic Disorders and Other Vascular Problems: Stop Blisovi 24 Fe if a thrombotic event occurs.
• Stop at least 4 weeks before 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 Blisovi 24 Fe if jaundice occurs.

Interaction Notes

• 7 DRUG INTERACTIONS Consult the labeling of concurrently used drugs to obtain further information about interactions with oral contraceptives or the potential for enzyme alterations.
• Drugs or herbal products that induce certain enzymes (for example CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding.
• Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with COCs.
• ( 7.1 ) 7.1 Effects of Other Drugs on Combined Oral Contraceptives Substances Decreasing the Plasma Concentrations of COCs and Potentially Diminishing the Efficacy of COCs Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of COCs or increase breakthrough bleeding.