How to Start and Take MARLISSA® (levonorgestrel and ethinyl estradiol tablets)

MARLISSA® (levonorgestrel and ethinyl estradiol tablets) is dispensed in a compact dispenser containing 28 tablets (see HOW SUPPLIED). MARLISSA® (levonorgestrel and ethinyl estradiol tablets) may be started using either a Day 1 start or a Sunday start (see Table 3). 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 3: Instructions for Administration of MARLISSA® (levonorgestrel and ethinyl estradiol tablets)

Starting MARLISSA® (levonorgestrel and ethinyl estradiol tablets) after Abortion or Miscarriage

First-trimester

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After a first-trimester abortion or miscarriage, MARLISSA® (levonorgestrel and ethinyl estradiol tablets) may be started immediately. An additional method of contraception is not needed if MARLISSA® (levonorgestrel and ethinyl estradiol tablets) is started immediately.

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If MARLISSA® (levonorgestrel and ethinyl estradiol tablets) 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 cycle of MARLISSA® (levonorgestrel and ethinyl estradiol tablets).

Second-trimester

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Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start MARLISSA® (levonorgestrel and ethinyl estradiol tablets) following the instructions in Table 3 for Day 1 or Sunday start. Use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of the patient’s first cycle of MARLISSA® (levonorgestrel and ethinyl estradiol tablets) (see CONTRAINDICATIONS, WARNINGS (1), PRECAUTIONS (10) and FDA-APPROVED PATIENT LABELING).

Starting MARLISSA® (levonorgestrel and ethinyl estradiol tablets) after Childbirth

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Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with MARLISSA® (levonorgestrel and ethinyl estradiol tablets) following the instructions in Table 3 for women not currently using hormonal contraception.

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MARLISSA® (levonorgestrel and ethinyl estradiol tablets) is not recommended for use in lactating women (see PRECAUTIONS (7) and FDA-APPROVED PATIENT LABELING).

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If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of MARLISSA® (levonorgestrel and ethinyl estradiol tablets) (see CONTRAINDICATIONS, WARNINGS (9), PRECAUTIONS (6) and FDA‑ APPROVED PATIENT LABELING).

Dosing MARLISSA® (levonorgestrel and ethinyl estradiol tablets)

Instruct patients to take one tablet by mouth at the same time every day. To achieve maximum contraceptive effectiveness, patients must take MARLISSA® (levonorgestrel and ethinyl estradiol tablets) as directed, in the order directed on the blister pack. The failure rate may increase when pills are missed or taken incorrectly.

Missed doses

Instruct patients about the handling of missed doses (e.g., to take single missed pills as soon as possible) and to follow the dosing instructions provided in the FDA-approved patient labeling.

Table 4: Instructions for Missed MARLISSA® (levonorgestrel and ethinyl estradiol tablets) Tablets

Advice in Case of Gastrointestinal Disturbances

If vomiting occurs within 3 to 4 hours after taking MARLISSA® (levonorgestrel and ethinyl estradiol tablets), the patient should proceed as if she missed a tablet. In case of prolonged vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken.