Source: FDA, National Drug Code (US) Revision Year: 2023
To achieve maximum contraceptive effectiveness, Finzala must be taken exactly as directed. Instruct patients to take one tablet by mouth at the same time every day. The tablet may be chewed and swallowed or swallowed whole. The patient should drink a full glass (8 ounces) of water immediately after the white tablets are chewed or swallowed whole. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed tablets. Finzala may be administered without regard to meals [see Clinical Pharmacology (12.3)].
Instruct the patient to begin taking Finzala either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).
During the first cycle of Finzala use, instruct the patient to take one white Finzala tablet daily, beginning on Day one (1) of her menstrual cycle (the first day of menstruation is Day one). She should take one white Finzala tablet daily for 24 consecutive days, followed by one brown tablet daily on days 25 through 28. Finzala should be taken in the order directed on the package at the same time each day. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Finzala on a day other than the first day of her menstrual cycle. The possibility of ovulation and conception prior to initiation of medication should be considered.
During the first cycle of Finzala use, instruct the patient to take one white Finzala tablet daily, beginning on the first Sunday after the onset of her menstrual period. She should take one white Finzala tablet daily for 24 consecutive days, followed by one brown tablet daily on days 25 through 28. Finzala should be taken in the order directed on the package at the same time each day. Finzala should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.
The patient should begin her next and all subsequent 28-day regimens of Finzala on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her white Finzala tablets on the next day after ingestion of the last brown tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Finzala is started later than the day following administration of the last brown tablet, the patient should use another method of contraception until she has taken a white Finzala tablet daily for 7 consecutive days.
For postpartum women who do not breastfeed or after a second trimester abortion, start Finzala no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Finzala postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Finzala for 7 consecutive days.
Finzala may be initiated immediately after a first-trimester abortion or miscarriage; if the patient starts Finzala immediately, additional contraceptive measures are not needed.
If the patient is switching from a combination hormonal method such as:
If the patient is switching from a progestin-only method such as a:
Table 1. Instructions for Missed Finzala Tablets:
| If one white tablet is missed | Take the missed tablet as soon as possible. Take the next tablet at the regular time. Continue taking one tablet a day until the pack is finished. Additional nonhormonal contraception (such as condoms) is not needed. |
| If two white tablets in a row are missed in Week 1 or Week 2 of the tablet pack | Take the two missed tablets as soon as possible, and the next two tablets the next day. Continue taking one tablet a day until the pack is finished. Use additional nonhormonal contraception (such as condoms) until hormonal tablets have been taken for 7 days after missing tablets. |
| If two white tablets are missed in Week 3 or Week 4 of the tablet pack | Day 1 Starter: Throw out the rest of the tablet pack and start a new pack that same day.Sunday Starter:Keep taking one tablet every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of tablets that same day.Use additional nonhormonal contraception (such as condoms) until hormonal tablets have been taken for 7 days after missing tablets. |
| If three or more white tablets in a row are missed | Day 1 Starter: Throw out the rest of the tablet pack and start a new pack that same day.Sunday Starter: Keep taking one tablet every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of tablets that same day.Bleeding may occur during the week following the missed tablets.Use additional nonhormonal contraception (such as condoms) until hormonal tablets have been taken for 7 days after missing tablets. |
| If any of the four brown tablets are missed | Throw away the missed tablets. Continue taking the remaining tablets until the pack is finished. Additional nonhormonal contraception (such as condoms) is not needed. |
If the patient vomits or has diarrhea (within 3 to 4 hours after she takes a white Finzala tablet), she should follow the instructions in the “What to Do if You Miss Tablets” section [see 2.3 Missed Doses].
There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Keep this and all medications out of the reach of children.
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