Generic Name: ETHINYL ESTRADIOL 0.02mg, NORETHINDRONE ACETATE 1mg;
Dosage Form: tablets
Drug Class: Contraceptives
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.
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.
- 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].
Missed 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. |
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)].
