Larin 24 Fe

LARIN 24 FE — norethindrone acetate/ethinyl estradiol and ferrous fumarate
Northstar Rx LLC

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

LARIN 24 Fe is indicated for use by women to prevent pregnancy [see Clinical Studies (14)].

The efficacy of LARIN 24 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 Start LARIN 24 Fe

LARIN 24 Fe is dispensed in a blister card [see How Supplied/Storage and Handling (16)]. LARIN 24 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 must be used until after the first 7 consecutive days of administration.

2.2 How to Take LARIN 24 Fe

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Starting LARIN 24 Fe after Abortion or Miscarriage

First-trimester

  • After a first-trimester abortion or miscarriage, LARIN 24 Fe may be started immediately. An additional method of contraception is not needed if LARIN 24 Fe is started immediately.
  • If LARIN 24 Fe is not started within 5 days after termination of the pregnancy, the patient must use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of her first 28-day course of LARIN 24 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 LARIN 24 Fe following the instructions in Table 1 for Sunday start. Use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of the patient’s first 28-day course of LARIN 24 Fe [see Contraindications (4), Warnings and Precautions (5.1), and FDA-approved Patient Labeling].

Starting LARIN 24 Fe after Childbirth

  • Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with LARIN 24 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 LARIN 24 Fe [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.3)].

2.3 Missed Tablets

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2.4 Advice in Case of Gastrointestinal Disturbances

In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures must be taken. If vomiting or diarrhea occurs within 3-4 hours after taking a pale yellow tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling].

3 DOSAGE FORMS AND STRENGTHS

LARIN 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) is available in blister packs.

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

  • 24 pale yellow, round (active) tablets debossed with “L2″ on one side and each containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.
  • 4 brown, round (non-hormonal placebo) tablets debossed with “F” on one side and “N ” on the other side and each containing 75 mg ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.

4 CONTRAINDICATIONS

Do not prescribe LARIN 24 Fe 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 inherited or acquired hypercoagulopathies[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 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[see Warnings and Precautions (5.7)]
  • 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)]

5 WARNINGS AND PRECAUTIONS

5.1 Thrombotic Disorders and Other Vascular Problems

  • Stop LARIN 24 Fe if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
  • Stop LARIN 24 Fe if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately[see Adverse Reactions (6.2)].
  • If feasible, stop LARIN 24 Fe at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during the following prolonged immobilization.
  • Start LARIN 24 Fe no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.
  • The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of a COCs and when restarting oral contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued.
  • 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. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). This risk increases with age, particularly in women over 35 years of age who smoke.
  • Use COCs with caution in women with cardiovascular disease risk factors.

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