Kaitlib Fe

KAITLIB 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 should not be used by women who are over 35 years of age and smoke. [see CONTRAINDICATIONS (4) and WARNINGS and PRECAUTIONS (5.1).]

1 INDICATIONS AND USAGE

Kaitlib™ Fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) is indicated for use by women to prevent pregnancy.

The efficacy of Kaitlib 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 Kaitlib Fe

To achieve maximum contraceptive effectiveness, Kaitlib 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. Kaitlib Fe may be administered without regard to meals [see CLINICAL PHARMACOLOGY (12.3)].

2.2 How to Start Kaitlib Fe

Instruct the patient to begin taking Kaitlib 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. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Kaitlib Fe other than on the first day of her menstrual cycle.

For postpartum women who do not breastfeed or after a second trimester abortion, Kaitlib 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:

o Another pill

o Vaginal ring

o 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 Kaitlib 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:

o Progestin-only pill

o Implant

o Intrauterine system

o 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 Missed Doses

Table 1. Instructions for Missed Kaitlib Fe Tablets
If one light green tablet is missed Take the missed tablet as soon as possible. Take the next tablet at the regular time. Continue taking one tablet a day until the pack is finished. Additional nonhormonal contraception (such as condoms) is not needed.
If two light green tablets in a row are missed in Week 1 or Week 2 of the tablet pack Take the two missed tablets as soon as possible, and the next two tablets the next day. Continue taking one tablet a day until the pack is finished. Use additional nonhormonal contraception (such as condoms) until hormonal tablets have been taken for 7 days after missing tablets.
If two light green tablets in a row are missed in Week 3 or Week 4 of the tablet pack Throw away the remainder of the tablet pack. Start a new tablet pack the same day. Use additional nonhormonal contraception (such as condoms) until hormonal tablets have been taken for 7 days after missing tablets.
If three or more light green tablets in a row are missed Throw away the missed tablets. Continue taking one tablet every day as indicated on the pack until the pack is finished. Bleeding may occur during the week following the missed tablets.
Use additional nonhormonal contraception (such as condoms) until hormonal tablets have been taken for 7 days after missing tablets.
If any of the four brown tablets are missed Throw away the missed tablets. Continue taking the remaining tablets until the pack is finished. Additional nonhormonal contraception (such as condoms) is not needed.

2.4 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 to 4 hours after taking a light green tablet, this can be regarded as a missed tablet. [see DOSAGE and ADMINISTRATION (2.3).]

3 DOSAGE FORMS AND STRENGTHS

Kaitlib Fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) is available in blister.

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

  • 24 light green, round flat face beveled edged tablets (active) debossed with “I61” on one side and “LU” on the other side each containing 0.8 mg norethindrone and 0.025 mg ethinyl estradiol.
  • 4 brown mottled, round, flat face beveled edge tablets (non-hormonal placebo) debossed with “LU” on one side and “I62” on the other side and each containing 75 mg ferrous fumarate. The ferrous fumarate chewable tablets do not serve any therapeutic purpose.

4 CONTRAINDICATIONS

Kaitlib Fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) is contraindicated in females who are known to have or develop the following conditions:

  • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:

o Smoke, if over age 35 [see BOXED WARNING , and WARNINGS AND PRECAUTIONS (5.1.)]

o Have deep vein thrombosis or pulmonary embolism, now or in the past [see WARNINGS AND PRECAUTIONS (5.1)]

o Have cerebrovascular disease [see WARNINGS AND PRECAUTIONS (5.1)]

o Have coronary artery disease [see WARNINGS AND PRECAUTIONS (5.1)]

o 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)]

o Have inherited or acquired hypercoagulopathies [see WARNINGS AND PRECAUTIONS (5.1)]

o Have uncontrolled hypertension [see WARNINGS AND PRECAUTIONS (5.5)]

o Have diabetes with vascular disease [see WARNINGS AND PRECAUTIONS (5.7)]

o Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see WARNINGS AND PRECAUTIONS (5.8)]

  • Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [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 (5.9)]
  • 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 (5.4)]

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