GENERESS Fe

GENERESS FE- norethindrone and ethinyl estradiol and ferrous fumarate
Watson Pharma, Inc.

BOXED WARNING

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 INDICATIONS AND USAGE

GENERESS Fe is indicated for use by women to prevent pregnancy.

The efficacy of GENERESS 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 GENERESS Fe

To achieve maximum contraceptive effectiveness, GENERESS Fe must be taken exactly as directed. Chew and swallow one tablet without water 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. For patient instructions for missed pills, see FDA-Approved Patient Labeling. GENERESS Fe may be administered without regard to meals [see Clinical Pharmacology (12.3)].

2.2 How to Start GENERESS Fe

Instruct the patient to begin taking GENERESS Fe on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding). One light green tablet should be taken daily for 24 consecutive days followed by one brown tablet daily for 4 consecutive days [see FDA-Approved Patient Labeling]. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking GENERESS Fe other than on the first day of her menstrual cycle.

For postpartum women who do not breastfeed or after a second trimester abortion, GENERESS 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 combined oral contraceptives (COCs) are used during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. The possibility of ovulation and conception before starting COCs should also be considered.

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

  • Instruct her to take the first light green pill on the day she would have started a new cycle of her previous birth control pack (Day 1).
  • If she previously used a vaginal ring or transdermal patch, she should start using GENERESS Fe on the day she would have restarted the ring or patch.
  • Instruct the patient to use a non-hormonal back-up method such as a condom and spermicide for the first 7 days.

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

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

  • Instruct her to take the first light green pill on the day she would have taken her next progestin-only pill or on the day of removal of her implant or intrauterine system or on the day when she would have had her next injection.
  • Instruct the patient to use a non-hormonal back-up method such as a condom and spermicide for the first 7 days.

2.3 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 3-4 hours after taking a light green tablet, this can be regarded as a missed tablet [see FDA-Approved Patient Labeling].

3 DOSAGE FORMS AND STRENGTHS

GENERESS Fe is available in blister packs.

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

  • 24 light green, round tablets (active) imprinted with “WC” on one side and “483” on the other and each containing 0.8 mg norethindrone and 0.025 mg ethinyl estradiol.
  • 4 brown, round tablets (non-hormonal placebo) imprinted with “WC” on one side and “624” on the other and each containing 75 mg ferrous fumarate. The ferrous fumarate chewable tablets do not serve any therapeutic purpose.

4 CONTRAINDICATIONS

Do not prescribe GENERESS Fe to women who are known to have the following:

  • 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 with vascular disease [see Warnings and Precautions (5.6)]
    - Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions (5.7)]
  • Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.2) ]
  • Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions ( 5.3), Use in Specific Populations ( 8.7), and Clinical Pharmacology ( 12.3)]
  • 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)]

5 WARNINGS AND PRECAUTIONS

5.1 Thrombotic and Other Vascular Events

Stop GENERESS Fe if an arterial or deep venous thrombotic (VTE) event occurs. Although the use of COCs increases the risk of venous thromboembolism, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of venous thromboembolism in women using COCs is 3 to 9 per 10,000 woman-years. The excess risk is highest during the first year of use of a COC. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC use is discontinued.

If feasible, stop GENERESS Fe at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.

Start GENERESS Fe no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.

COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (> 35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with other underlying risk factors.

Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.

Stop GENERESS Fe if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.