Lo Loestrin Fe

LO LOESTRIN FE- norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate
Allergan, 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 should not be used by w omen who are over 35 years of age and smoke [ see Contraindications (4) ] .

1 INDICATIONS AND USAGE

Lo Loestrin® Fe is indicated for use by women to prevent pregnancy [ see Clinical Studies (14)].

The efficacy of Lo Loestrin Fe in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated.

2 DOSAGE AND ADMINISTRATION

2.1 How to Take Lo Loestrin Fe

To achieve maximum contraceptive effectiveness, Lo Loestrin Fe must be taken exactly as directed. Take one tablet by mouth at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. Lo Loestrin Fe tablets may be administered without regard to meals [see Clinical Pharmacology (12.3)].

2.2 How to Start Lo Loestrin Fe

Instruct the patient to begin taking Lo Loestrin Fe on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding). One blue tablet should be taken daily for 24 consecutive days, followed by one white tablet daily for 2 consecutive days, followed by one brown tablet daily for 2 consecutive days. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Lo Loestrin Fe other than on the first day of her menstrual cycle.

For postpartum women who do not breastfeed or after a second trimester abortion, Lo Loestrin Fe may be started no earlier than 4 weeks postpartum. Recommend use of a non-hormonal back-up method for the first 7 days. When COCs are used during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered [see Warnings and Precautions (5.1)]. The possibility of ovulation and conception before starting COCs should also be considered.

Lo Loestrin Fe may be initiated immediately after a first-trimester abortion or miscarriage; if the patient starts Lo Loestrin Fe immediately, additional contraceptive measures are not needed.

2.3 Switching from another H ormonal M ethod of C ontraception

If the patient is switching from a combination hormonal method such as:

○ Another pill
○ Vaginal ring
○ Patch

  • Instruct her to take the first blue tablet on the day she would have taken her next COC pill. She should not continue taking the tablets from her previous birth control pack and should not skip any days between packs. If she does not have a withdrawal bleed, rule out pregnancy before starting Lo Loestrin Fe.
  • If she previously used a vaginal ring or transdermal patch, she should start using Lo Loestrin Fe on the day she would have resumed the previous product.

If the patient is switching from a progestin-only method such as a:

○ Progestin-only pill
○ Implant
○ Intrauterine system
○ Injection

  • Instruct her to take the first blue tablet on the day she would have taken her next progestin-only pill, or had her next injection or on the day of removal of her implant.
  • If switching from an IUD, depending on the timing of removal, back-up contraception may be needed.

2.4 Missed Doses

Table 1: Instructions for Missed Lo Loestrin Fe Tablets in a Monthly Dosing Regimen

  • If one blue tablet is missed
Take the tablet as soon as possible, even if two tablets are taken in one day. Continue taking one tablet a day until the pack is finished.
  • If two consecutive blue tablets are missed in Week 1 or Week 2
Take the two missed tablets as soon as possible, and the next two tablets the next day. Continue taking the remaining tablets, one tablet a day until the pack is finished. Use ad ditional non-hormonal contraception (such as condoms and spermicide) for 7 consecutive days after missing tablets.
  • If two consecutive tablets (blue or white) are missed in Week 3 or Week 4
Throw out the rest of the pack and start a new pack the same day. A withdrawal bleed may not occur.Use ad ditional non-hormonal contraception (such as condoms and spermicide) for 7 consecutive days after missing tablets.
  • If three or more consecutive tablets (blue or white) are missed at any time
Throw out the rest of the pack and start a new pack that same day. A withdrawal bleeding may not occur.Use a dditional non-hormonal contraception (such as condoms and spermicide) for 7 consecutive days after missing tablets.
  • If either of the brown tablets in Week 4 are missed
Throw out the tablet you missed. Start a new pack on the same day a new pack is usually started.

2.5 Advice in Case of Gastrointestinal Disturbances

If the patient vomits or has diarrhea (within 3 to 4 hours after she takes a blue or white pill), she should follow the instructions in Missed Doses [see Dosage and Administration (2.4)].

3 DOSAGE FORM S AND STRENGTH S

Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets) is available in blister packs.

Each blister pack (28 tablets) contains in the following order:

  • 24 blue, round (active) tablets imprinted with “WC” on one side and “421” on the other and each containing 1 mg norethindrone acetate and 10 mcg ethinyl estradiol.
  • 2 white, hexagonal (active) tablets imprinted with “WC” on one side and “422” on the other and each containing 10 mcg ethinyl estradiol.
  • 2 brown, round (non-hormonal placebo) tablets imprinted with “WC” on one side and “624” on the other and each containing 75 mg ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.

4 CONTRAINDICATIONS

Lo Loestrin Fe is contraindicated in females who are known to have or develop the following conditions:

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