How to Start Introvale

Introvale is dispensed in an Extended-Cycle Blister Card [see How Supplied/Storage and Handling (16)]. Introvale 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.

Instruct patients to take Introvale once a day by mouth at the same time every day for 91 days. To achieve maximum contraceptive effectiveness, Introvale should be taken exactly as directed and at intervals not exceeding 24 hours. For patient instructions regarding missed pills, see FDA-approved patient labeling.

How to Take Introvale

Table 1 Instructions for Administration of Introvale

Starting Introvale after Abortion or Miscarriage

First-trimester

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

Second-trimester

• Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Introvale 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 Introvale [see Contraindications (4), Warnings and Precautions (5.1), and FDA-approved Patient Labeling].

Starting Introvale after Childbirth

• Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Introvale following the instructions in Table 1 for women not currently using hormonal contraception.
• Introvale is not recommended for use in lactating women [see Use in Specific Populations (8.3) and FDA-Approved Patient Labeling].
• If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Introvale [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.3), and FDA-approved Patient Labeling].

Tablet Dispenser Instructions:

• The Tablet Dispenser consists of a Tri-Fold Blister Card that holds 91 individually sealed pills (a 13-week, or 91-day, cycle). The 91 pills consist of 84 peach pills (active pills with hormones) and 7 white pills (inactive pills without hormone) arranged in 12 rows of 7 tablets each, labeled weeks “START” through “Week 12” (active pills with hormones) followed by 1 row of 7 white pills, labeled “Week 13” (inactive pills without hormone).

• Advise the patient to remove the first pill in the upper left corner by pushing down on the pill. The pill will come out through a hole in the back of the Tablet Dispenser.
• Advise the patient to wait 24 hours to take the next pill, and continue to take one pill each day until all the pills have been taken.
• Advise the patient, after taking the last white pill, to start taking the first peach pill from a new Tablet Dispenser the very next day, regardless of when their period started.

Missed Tablets

Table 2 Instructions for Missed Introvale 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 peach tablet, handle this as a missed tablet [see FDA-approved patient labeling].