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Gwyn Lo (norelogestromin and ethinyl estradiol transdermal system) 220/20 mcg per day

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IMPORTANT SAFETY INFORMATION
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BOXED WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 kg/m2.
Gwyn Lo is contraindicated in:

  • Women over 35 years old who smoke. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptives (CHC) use.
  • Women with a BMI ≥ 30 kg/m2. Women with a BMI ≥ 30 kg/m2 who use transdermal combined hormonal contraceptives may have a higher risk of venous thromboembolic events compared with women with a lower BMI.

CONTRAINDICATIONS
Gwyn Lo is contraindicated in females who are known to have or develop the following conditions:

  • High risk of arterial or venous thromboembolic events. Examples include women who smoke (if over age 35) or have: deep vein thrombosis or pulmonary embolism, now or in the past; inherited or acquired hypercoagulopathies; cerebrovascular disease; coronary artery disease; thrombogenic valvular or thrombogenic rhythm diseases of the heart; uncontrolled hypertension; diabetes mellitus with vascular disease; headaches with focal neurological symptoms or migraine headaches with aura or women over age 35 with any migraine headaches.
  • BMI ≥ 30 kg/m2.
  • Liver tumors, benign or malignant, or liver disease.
  • Undiagnosed abnormal uterine bleeding.
  • Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive.
  • Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin, due to the potential for alanine aminotransferase elevations.

WARNINGS AND PRECAUTIONS:
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. Discontinue Gwyn Lo during prolonged immobilization and, if feasible, stop Gwyn Lo at least 4 weeks before and through 2 weeks after major surgery. Start Gwyn Lo no earlier than 4 weeks after delivery in women who are not breastfeeding. 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.

Arterial Events: CHCs increase the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke, particularly among older women (>35 years of age), smokers, and women with hypertension, dyslipidemia, diabetes, or obesity.

Venous Events: The use of CHCs increase the risk of VTEs. Risk factors include, smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of CHCs.

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. 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.

Liver Disease:
Elevated Liver Enzymes: 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: Hepatic adenomas are associated with CHC use. 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.

Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment: Discontinue Gwyn Lo prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin. Gwyn Lo can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.

Hypertension: For all women, 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.

Gallbladder Disease: Studies suggest a small increased relative risk of developing gallbladder disease among CHC users. Use of CHCs may also worsen existing gallbladder disease.

Adverse Carbohydrate and Lipid Metabolic Effects: Carefully monitor prediabetic and diabetic women taking Gwyn Lo. CHCs may decrease glucose tolerance in a dose-related fashion. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using hormonal contraceptives.

Headache: 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).

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.
Amenorrhea and Oligomenorrhea: In the event of amenorrhea, consider the possibility of pregnancy.

Depression: Monitor females with a history of depression and discontinue Gwyn Lo if depression recurs.

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.
Cervical Cancer: Some studies suggest that combined oral contraceptive use has been associated with an increase in the risk of cervical cancer or intraepithelial neoplasia.

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.

Hereditary angioedema: In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.

Chloasma may occur with Gwyn Lo, especially in women with a history of chloasma gravidarum.

ADVERSE REACTIONS:

Venous Thromboembolism (VTE): During study 1, one thromboembolic event (pulmonary embolism), syncope, and seizure were reported in one female.

Other Serious Adverse Reactions: Serious adverse reactions occurred in < 1% of women who received Gwyn Lo: suicidal ideation in three women with psychiatric histories, one of whom also experienced exacerbation of depression.

The most common adverse reactions (≥ 2%) in clinical trials for Gwyn Lo were application-site irritation, application-site erythema, application-site pruritus, intercycle bleeding, heavy withdrawal bleeding, and nausea.

DRUG INTERACTIONS: Enzyme inducers (eg, CYP3A4) may decrease the effectiveness of Gwyn Lo or increase the risk of breakthrough bleeding. Counsel women to use a backup or alternative methods of contraception when enzyme inducers are used with Gwyn Lo.

USE IN SPECIFIC POPULATIONS: Discontinue if pregnancy occurs.
Lactation: Contraceptive hormones and/or metabolites are present in human milk. CHCs can reduce milk production in breastfeeding women. When possible, advise the nursing woman to use other methods of contraception until she discontinues breastfeeding.

Advise women that Gwyn Lo does not protect against HIV infection and other sexually transmitted infections.

INDICATIONS

Gwyn Lo is a progestin/estrogen combination hormonal contraceptive (CHC) indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.

Please see Full Prescribing Information, including Boxed WARNING.

Gwyn Lo is available by prescription only.


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Gwyn Lo and the Gwyn Lo Logo are trademarks of Mylan
Pharmaceuticals Inc., a Viatris Company.
VIATRIS and the Viatris Logo are trademarks of Mylan Inc., a Viatris
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