Gemmily

GEMMILY- norethindrone acetate and ethinyl estradiol, and ferrous fumarate
Xiromed, LLC

gemmily-cartongemmily-blister-figure

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 women who are over 35 years of age and smoke [see Contraindications (4) ] .

1 INDICATION S AND USAGE

Gemmily is indicated for use by females of reproductive age to prevent pregnancy [ see Clinical Studies (14)].

The efficacy of Gemmily in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.

2 DOSAGE AND ADMINISTRATION

2.1 How to Take NA/EE and Fe

To achieve maximum contraceptive effectiveness, Gemmily must be taken exactly as directed. Instruct patients to take one capsule by mouth at the same time every day. Capsules must be taken in the order directed on the blister pack. Capsules should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed pills, see FDA-approved patient labeling. Gemmily may be administered without regard to meals [see Clinical Pharmacology (12.3)].

2.2 How to Start Gemmily

Instruct the patient to begin taking Gemmily either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).

Day 1 Start

During the first cycle of Gemmily use, instruct the patient to take one pink capsule daily, beginning on Day one (1) of her menstrual cycle (the first day of menstruation is Day one). She should take one pink capsule daily for 24 consecutive days, followed by one maroon capsule daily on days 25 through 28. Gemmily should be taken in the order directed on the package at the same time each day. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Gemmily on a day other than the first day of her menstrual cycle. The possibility of ovulation and conception prior to initiation of medication should be considered.

Sunday Start

During the first cycle of Gemmily use, instruct the patient to take one pink capsule daily, beginning on the first Sunday after the onset of her menstrual period. She should take one pink capsules capsule daily for 24 consecutive days, followed by one maroon capsule daily on days 25 through 28. Gemmily should be taken in the order directed on the package at the same time each day. Gemmily should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient should begin her next and all subsequent 28-day regimens of Gemmily on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her pink capsules on the next day after ingestion of the last maroon capsule, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Gemmily is started later than the day following administration of the last maroon capsule, the patient should use another method of contraception until she has taken a pink capsule daily for 7 consecutive days.

For postpartum women who do not breastfeed or after a second trimester abortion, start Gemmily no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts Gemmily postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Gemmily for 7 consecutive days.

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

2.3 Switching from another Hormonal Method of Contraception

If the patient is switching from a combination hormonal method such as:
● Another pill
● Vaginal ring
● Patch

  • Instruct her to take the first pink capsule on the day she would have taken her next COC pill. She should not continue taking the tablet 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 Gemmily.
  • If she previously used a vaginal ring or transdermal patch, she should start using Gemmily 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

  • She may switch any day from a progestin-only pill; instruct her to take the first pink capsule on the day she would have taken her next progestin-only pill. She should use a non-hormonal method of contraception for 7 consecutive days.
  • If switching from an implant or injection, start the first pink capsule on the day her next injection would have been due 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 Advice in Case of Gastrointestinal Disturbances

If the patient vomits or has diarrhea (within 3 to 4 hours after she takes a pink capsule), she should follow the instructions in the “What to Do if You Miss Capsules” section [see FDA-approved patient labeling].

3 DOSAGE FORM S AND STRENGTH S

Gemmily is available in blister packs.

Each blister pack contains 28 soft gelatin capsules in the following order:

  • 24 oval, opaque, pale pink (active) soft gelatin capsule with “XI” printed on the outer shell in white and each containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.
  • 4 oval, opaque, maroon, (non-hormonal placebo) capsules imprinted with “LF” on one side and each containing 75 mg ferrous fumarate. The ferrous fumarate capsules do not serve any therapeutic purpose.

4 CONTRAINDICATIONS

Do not prescribe Gemmily to women who are known to have the following conditions:

  • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
    ● Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]
    ● Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]
    ● Have cerebrovascular disease [see Warnings and Precautions (5.1)]
    ● Have coronary artery disease [see Warnings and Precautions (5.1)]
    ● Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]
    ● Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]
    ● Have uncontrolled hypertension [see Warnings and Precautions (5.4)]
    ● Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6)]
    ● Have headaches with focal neurological symptoms or have migraine headaches with aura
    ● Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7)]
  • Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2)]
  • Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8)]
  • Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1)]
  • Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.11)]
  • Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.3)]

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