Larin 24 Fe

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE LARIN 24 Fe is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by women to prevent pregnancy. (1) The efficacy of LARIN 24 Fe in women with a body mass index (BMI) of >35 kg/m 2 has not been evaluated. ( 1 , 8.8 ) 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/m 2 has not been evaluated. Dosage and administration 2 DOSAGE AND ADMINISTRATION Take one tablet by mouth at the same time every day for 28 days (2.1) Take tablets in the order directed on the blister pack (2.1) LARIN 24 Fe may be administered without regard to meals (12.3) 2.1 How to Start Larin 24 Fe Larin 24 Fe is dispensed in a in 28-tablet 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). The plastic compact is pre-set for a Sunday start. Day 1 Start day-label stickers are available. 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 S t arting 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 Day 1 or Sunday start, as desired. If using 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) , and Warnings and Precautions (5.1) ]. 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 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 to 4 hours after taking a pale yellow tablet, handle this as a missed tablet [see Dosage and Administration (2.3)] . 1 2 Warnings and cautions 5 WARNINGS AND PRECAUTIONS Thrombotic Disorders and Other Vascular Problems: Stop Larin 24 Fe if a thrombotic event occurs. Stop at least 4 weeks before through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. (5.1) Liver disease: Discontinue Larin 24 Fe if jaundice occurs. (5.2) High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop Larin 24 Fe if blood pressure rises significantly. (5.4) Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking Larin 24 Fe . Consider an alternative contraceptive method for women with uncontrolled dyslipidemia. (5.6) Headache: Evaluate significant change in headaches and discontinue Larin 24 Fe if indicated. (5.7) Bleeding Irregularities and Amenorrhea: Evaluate irregular bleeding or amenorrhea. (5.8) 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,