WYMZYA Fe

WYMZYA FE — norethindrone and ethinyl estradiol
Lupin Pharmaceuticals, Inc.

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see CONTRAINDICATIONS (4)].

1 INDICATIONS AND USAGE

WYMZYA TM Fe is indicated for use by females of reproductive potential to prevent pregnancy.

2 DOSAGE AND ADMINISTRATION

2.1 How to Start WYMZYA Fe

WYMZYA Fe is dispensed in a blister [see HOW SUPPLIED/STORAGE AND HANDLING (16)]. WYMZYA 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 should be used until after the first 7 consecutive days of administration.

2.2 How to Take WYMZYA Fe

WYMZYA Fe (white active tablets and brown placebo tablets) may be swallowed whole or chewed and swallowed. If the tablet is chewed, the patient should drink a full glass (8 ounces) of liquid immediately after swallowing.

Table 1 : Instructions for Administration of WYMZYA Fe
Starting CHCs in women not currently using hormonal contraception ( Day 1 Start or Sunday Start ) Important : Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color : ● WYMZYA Fe active tablets are white (Day 1 to Day 21).● WYMZYA Fe placebo tablets are brown (Day 22 to Day 28). Day 1 Start : ● Take first white active tablet on the first day of menses.● Take subsequent white active tablets once daily at the same time each day for a total of 21 days.● Take one brown placebo tablet daily for 7 days and at the same time of day that active tablets were taken.● 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 : ● Take first active tablet 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 seven days of the patient’s first cycle pack of WYMZYA Fe.● Take subsequent white active tablets once daily at the same time each day for a total of 21 days.● Take one brown placebo tablet daily for the following 7 days and at the same time of day that active tablets were 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 WYMZYA Fe from another hormonal contraceptive Start on the same day that a new pack of the previous hormonal contraceptive would have started.
Switching from another contraceptive method to WYMZYA Fe Start WYMZYA 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
Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA Approved Patient Labeling .

Starting WYMZYA Fe after Abortion or Miscarriage

First-trimester:

  • After a first-trimester abortion or miscarriage, WYMZYA Fe may be started immediately. An additional method of contraception is not needed if WYMZYA Fe is started within 5 days after termination of the pregnancy.
  • If WYMZYA Fe is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of WYMZYA Fe.

Second-trimester:

  • Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start WYMZYA Fe, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non- hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of WYMZYA Fe. [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.1), and FDA-APPROVED PATIENT LABELING.]

Starting WYMZYA Fe after Childbirth

  • Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with WYMZYA 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 WYMZYA Fe. [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.1), USE IN SPECIFIC POPULATIONS (8.1 and 8.3), and FDA-APPROVED PATIENT LABELING].

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