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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Vascular Risks: Stop GWYN LO if a thrombotic or thromboembolic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. Consider cardiovascular risk factors before initiating in all women, particularly those over 35 years. ( 5.1 ) • Liver Disease: Discontinue GWYN LO if jaundice occurs. ( 5.2 ) • Risk of Liver Enzyme Elevations with Concomitant Hepatitis C . ( 5.3 ) • Hypertension: If used in women with well-controlled hypertension, monitor blood pressure and stop use if blood pressure rises significantly. ( 5.4 ) • Gallbladder Disease: May cause or worsen gallbladder disease. ( 5.5 ) • Adverse Carbohydrate and Lipid Metabolic Effects: Monitor glucose in prediabetic and diabetic women taking GWYN LO. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. ( 5.6 ) • Headache: Evaluate significant change in headaches and discontinue GWYN LO if indicated. ( 5.7 ) • Uterine Bleeding: May cause irregular bleeding or amenorrhea. Evaluate for other causes if symptoms persist. ( 5.8 ) 5.1 Thromboembolic Disorders and Other Vascular Conditions • Stop GWYN LO if an arterial or venous thromboembolic event (VTE) occurs. • Stop GWYN LO if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately. • If feasible, stop GWYN LO at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE. Discontinue use of GWYN LO during prolonged immobilization and resume treatment based on clinical judgment. • Start GWYN LO 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. • Before starting GWYN LO, evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy [see Contraindications (4) ] . Arterial Events The use of CHCs increases the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. The risk is greater among older women (> 35 years of age), smokers, and women with hypertension, dyslipidemia, diabetes, or obesity. GWYN LO is contraindicated in women over 35 years of age who smoke [see Contraindications (4) ] . Cigarette smoking increases the risk of serious cardiovascular events from CHC use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. Venous Events GWYN LO is contraindicated in women with a BMI ≥ 30 kg/m 2 . The use of CHCs increases the risk of venous thromboembolic events (VTEs), such as deep vein thrombosis and pulmonary embolism. Risk factors for VTEs include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of CHCs. The risk of VTE may be greater with transdermal CHCs in women with a BMI ≥ 30 kg/m 2 compared to women with a lower BMI [see Contraindications (4) ]. While the increased risk of VTE associated with use of CHCs is well-established, the rates of VTE are even greater during pregnancy, and especially during the postpartum period (see Figure 1). The frequency of VTE in women using CHCs has been estimated to be 3 to 12 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of CHCs and when restarting hormonal contraception after a break of 4 weeks or longer. This initial higher risk declines during the first year, but users of CHCs remain at an increased risk of VTE compared to non-users of CHCs. Based on results from a few studies, there is some evidence that this is true for non-oral products as well. The risk of thromboembolic disease due to CHCs gradually disappears after CHC use is discontinued. Figure 1 shows the risk of developing a VTE for women who are not pregnant and do not use CHCs, for women who use CHCs with a range of doses and routes of administration, for pregnant women, and for women in the postpartum period. To put the risk of developing a VTE into perspective: If 10,000 women who are not pregnant and do not use CHCs are followed for one year, between 1 and 5 of these women will develop a VTE. Figure 1: Likelihood of Developing a VTE within One Year Among Pregnant and Non-Pregnant Women Figure 1: Likelihood of Developing a VTE within One Year Among Pregnant and Non-Pregnant Women 5.2 Liver Disease Elevated Liver Enzymes GWYN LO is contraindicated in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of liver [see Contraindications (4) ] . Discontinue GWYN LO if jaundice develops. Acute or chronic disturbances of liver function may necessitate the discontinuation of CHC use until markers of liver function return to normal and CHC causation has been excluded. Liver Tumors GWYN LO is contraindicated in women with benign and malignant liver tumors [see Contraindications (4) ] . Hepatic adenomas are associated with CHC use. An estimate of the attributable risk is 3.3 cases/100,000 CHC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage. Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) CHC users. However, the risk of liver cancers in CHC users is less than one case per million users. 5.3 Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment During clinical trials with the Hepatitis C (HCV) combination drug regimen that contains ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as CHCs. Additionally, similar ALT elevations were observed in women using ethinyl estradiol-containing medications such as CHCs when co-administered with Directly Acting Antivirals (DAA) that contains combination drug regimen with glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir. Discontinue GWYN LO prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin [see Contraindications (4) ] . GWYN LO can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen. 5.4 Hypertension GWYN LO is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease [see Contraindications (4) ] . For all women, including those with well-controlled hypertension, monitor blood pressure at routine visits and stop GWYN LO if blood pressure rises significantly. An increase in blood pressure has been reported in women using CHCs, and this increase is more likely in older women with extended duration of use. The effect of CHCs on blood pressure may vary according to the progestin in the CHC. 5.5 Gallbladder Disease Consider discontinuing GWYN LO in women with symptomatic gallbladder disease or cholestatic disease. Studies suggest a small increased relative risk of developing gallbladder disease among CHC users. Use of CHCs may also worsen existing gallbladder disease. A past history of CHC-related cholestasis predicts an increased risk with subsequent CHC use. Women with a history of pregnancy-related cholestasis may be at an increased risk for CHC-related cholestasis. 5.6 Adverse Carbohydrate and Lipid Metabolic Effects Hyperglycemia GWYN LO is contraindicated in women with diabetes and vascular disease [see Contraindications (4) ]. Carefully monitor prediabetic and diabetic women who take GWYN LO. CHCs may decrease glucose tolerance in a dose-related fashion. Dyslipidemia Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on hormonal contraceptives. Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using hormonal contraceptives. 5.7 Headache GWYN LO is contraindicated in women who have headaches with focal neurological symptoms or have migraine headaches with aura, and in women over age 35 years who have migraine headaches with or without aura [see Contraindications (4) ]. If a woman using GWYN LO develops new headaches that are recurrent, persistent or severe, evaluate the cause and discontinue GWYN LO, if indicated. Consider discontinuation of GWYN LO in the case of increased frequency or severity of migraine during hormonal contraceptive use (which may be prodromal of a cerebrovascular event). 5.8 Bleeding Irregularities and Amenorrhea Unscheduled Bleeding and Spotting Unscheduled (breakthrough) bleeding and spotting sometimes occur in women using GWYN LO. Consider non-hormonal causes and take adequate diagnostic measures to rule out malignancy, other pathology, or pregnancy in the event of unscheduled bleeding, as in the case of any abnormal vaginal bleeding. If pathology and pregnancy have been excluded, time or a change to another contraceptive product may resolve the bleeding. Based on women’s electronic diaries from a clinical trial evaluating the safety and efficacy of GWYN LO, the proportion of subjects reporting unscheduled bleeding per 28-day cycle decreased over time. At cycle 1, 34.5% women reported unscheduled bleeding and/or spotting which gradually reduced to 20.0% at cycle 13. Women reported a mean number of unscheduled bleeding and/or spotting days per month that generally decreased over the 13 cycles from 3.2 days in cycle 1 to 2.4 days in cycle 13. A total of 20 women (1.6%) discontinued the study prematurely due to menstrual disorders including intercycle and heavy withdrawal bleeding, menometrorrhagia, abnormal uterine bleeding, dysmenorrhea and vaginal hemorrhage [see Adverse Reactions (6.1) and Clinical Studies (14) ] . Amenorrhea and Oligomenorrhea In the event of amenorrhea, consider the possibility of pregnancy. If the woman has not adhered to the prescribed dosing schedule (missed one TDS or started the TDS on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the woman has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Some women may encounter amenorrhea or oligomenorrhea after discontinuation of hormonal contraceptive use, especially when such a condition was pre-existent. 5.9 Depression Monitor females with a history of depression and discontinue GWYN LO if depression recurs. Data on the association of CHCs with onset of depression or exacerbation of existing depression are limited. 5.10 Malignant Neoplasms Breast Cancer GWYN LO is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive [see Contraindications (4) ] . Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk. Studies do not show an association between ever (current or past) use of COCs and risk of breast cancer. However, some studies report a small increase in the risk of breast cancer among current or recent users (< 6 months since last use) and current users with longer duration of COC use. Cervical Cancer Some studies suggest that COC use has been associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. 5.11 Effect on Binding Globulins The estrogen component of CHCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin and cortisol-binding globulin. The dose of replacement thyroid hormone or cortisol therapy may need to be increased. 5.12 Hereditary Angioedema In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. 5.13 Chloasma Chloasma may occur with GWYN LO use, especially in women with a history of chloasma gravidarum. Advise women with history of chloasma to avoid exposure to the sun or ultraviolet radiation while using GWYN LO.