How to Start and Take Iclevia

Iclevia is dispensed in an Extended-Cycle Wallet [see How Supplied/Storage and Handling (16)]. Iclevia should be started on a Sunday (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.

Table 1: Instructions for Administration of Iclevia

Starting Iclevia after Abortion or Miscarriage

First-trimester

• After a first-trimester abortion or miscarriage, Iclevia may be started immediately. An additional method of contraception is not needed if Iclevia is started immediately.
• If Iclevia 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 91-day course of Iclevia.

Second-trimester

• Do not start Iclevia until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Iclevia following the instructions in Table 1 for Sunday start. Use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of the patient’s first 91-day course of Iclevia [see Contraindications (4), Warnings and Precautions (5.1)].

Starting Iclevia after Childbirth

• Do not start Iclevia until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Iclevia following the instructions in Table 1 for women not currently using hormonal contraception.
• Iclevia 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 Iclevia [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.2)].

Dosing Iclevia

Instruct patients to take one tablet by mouth at the same time every day. The dosing of Iclevia is one white pill containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one green pill (inactive pills without hormone) for 7 days. To achieve maximum contraceptive effectiveness, Iclevia must be taken exactly as directed, in the order directed on the Wallet, and at intervals not exceeding 24 hours. Start taking the first white pill from a new Wallet the very next day after taking the last green inactive pill in the Wallet. The failure rate may increase when pills are missed or taken incorrectly.

Missed Doses

Table 2: Instructions for Missed Iclevia Tablets

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 a white tablet, handle this as a missed tablet.