Levonorgestrel/Ethinyl Estradiol And Ethinyl Estradiol

7.3 Concomitant Use with Hepatitis C Virus (HCV) Combination Therapy – Liver Enzyme Elevation Co-administration of Simpesse with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir is contraindicated due to potential for ALT elevations [see Warning and Precautions (5.4) ] .

7.3 Concomitant Use with Hepatitis C Virus (HCV) Combination Therapy – Liver Enzyme Elevation Co-administration of Simpesse with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir is contraindicated due to potential for ALT elevations [see Warning and Precautions (5.4) ] .

Do not co-administer due to potential for ALT elevations.

7.3 Concomitant Use with Hepatitis C Virus (HCV) Combination Therapy – Liver Enzyme Elevation Co-administration of Simpesse with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir is contraindicated due to potential for ALT elevations [see Warning and Precautions (5.4) ] .

Human immunodeficiency virus (HIV)/hepatitis C virus (HCV) protease inhibitors and nonnucleoside reverse transcriptase inhibitors: Significant decreases in systemic exposure of the estrogen and/or progestin have been noted when COCs are co-administered with some HIV protease inhibitors (e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir), some HCV protease inhibitors (e.g., boceprevir and telaprevir), and some non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine). In contrast, significant increases in systemic exposure of the estrogen and/or progestin have been noted when COCs are co-administered with certain other HIV protease inhibitors (e.g., indinavir and atazanavir/ritonavir) and with other non-nucleoside reverse transcriptase inhibitors (e.g., etravirine). 7.3 Concomitant Use with Hepatitis C Virus (HCV) Combination Therapy – Liver Enzyme Elevation Co-administration of Simpesse with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir is contraindicated due to potential for ALT elevations [see Warning and Precautions (5.4) ] .

Increase metabolism of contraceptive steroids, reducing contraceptive effectiveness and potentially resulting in unintended pregnancy or unscheduled bleeding.

Increases metabolism of contraceptive steroids, reducing contraceptive effectiveness and potentially resulting in unintended pregnancy or unscheduled bleeding.

Increases metabolism of contraceptive steroids, reducing contraceptive effectiveness and potentially resulting in unintended pregnancy or unscheduled bleeding.

Increases metabolism of contraceptive steroids, reducing contraceptive effectiveness and potentially resulting in unintended pregnancy or unscheduled bleeding.

Increases metabolism of contraceptive steroids, reducing contraceptive effectiveness and potentially resulting in unintended pregnancy or unscheduled bleeding.

COCs significantly decrease plasma concentrations of lamotrigine, which may reduce seizure control and require dosage adjustments.

Increases metabolism of contraceptive steroids, reducing contraceptive effectiveness and potentially resulting in unintended pregnancy or unscheduled bleeding.

Increases metabolism of contraceptive steroids, reducing contraceptive effectiveness and potentially resulting in unintended pregnancy or unscheduled bleeding.

Increases metabolism of contraceptive steroids, reducing contraceptive effectiveness and potentially resulting in unintended pregnancy or unscheduled bleeding.

Increases metabolism of contraceptive steroids, reducing contraceptive effectiveness and potentially resulting in unintended pregnancy or unscheduled bleeding.

Similar association with reduced efficacy and increased breakthrough bleeding, though less marked than with rifampin.

Increases metabolism of contraceptive steroids, reducing contraceptive effectiveness and potentially resulting in unintended pregnancy or unscheduled bleeding.

Increases metabolism of contraceptive steroids, reducing contraceptive effectiveness and potentially resulting in unintended pregnancy or unscheduled bleeding.

Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities associated with concomitant use.

Induces hepatic enzymes and p-glycoprotein transporter, reducing contraceptive effectiveness and potentially resulting in unscheduled bleeding.

Increases metabolism of contraceptive steroids, reducing contraceptive effectiveness and potentially resulting in unintended pregnancy or unscheduled bleeding.

CYP 3A4 inhibitor that increases plasma hormone levels and may increase risk of intrahepatic cholestasis during coadministration with combination oral contraceptives.

May increase plasma ethinyl estradiol levels.

Possible association with reduced efficacy and breakthrough bleeding, though less marked than with rifampin.

HIV protease inhibitor that may decrease plasma concentrations of estrogen and/or progestin when given with ritonavir.

Metabolic enzyme inducer that may decrease plasma concentrations of levonorgestrel and ethinyl estradiol, potentially diminishing contraceptive effectiveness or increasing breakthrough bleeding.

May increase plasma ethinyl estradiol levels.

HIV protease inhibitor that may increase plasma concentrations of estrogen and/or progestin when given with ritonavir.

Co-administration increases AUC values for ethinyl estradiol by approximately 20%.

HCV protease inhibitor that may decrease plasma concentrations of estrogen and/or progestin.

Enzyme inducer that may decrease plasma concentrations of contraceptive hormones and reduce effectiveness of hormonal contraceptives or increase breakthrough bleeding.

Significantly decreases systemic exposure of ethinyl estradiol, potentially reducing contraceptive efficacy or increasing breakthrough bleeding.

Increased plasma concentrations reported with concomitant administration of oral contraceptives containing ethinyl estradiol.

Increased plasma concentrations reported with concomitant administration of oral contraceptives containing ethinyl estradiol.

HIV protease inhibitor that may decrease plasma concentrations of estrogen and/or progestin when given with ritonavir.

Metabolic enzyme inducer that may decrease plasma concentrations of levonorgestrel and ethinyl estradiol, potentially diminishing contraceptive effectiveness or increasing breakthrough bleeding.

Non-nucleoside reverse transcriptase inhibitor that may increase plasma concentrations of estrogen and/or progestin.

CYP3A inhibitor that may increase systemic exposure of estrogen component.

HIV protease inhibitor (with ritonavir) that may decrease plasma concentrations of estrogen and/or progestin.

CYP3A inhibitor that may increase systemic exposure of estrogen component.

CYP 3A4 inhibitor that may increase plasma hormone levels.

CYP3A4 inhibitor that may increase plasma hormone levels.

CYP3A4 inhibitor that may increase plasma hormone levels.

HIV protease inhibitor that may decrease plasma concentrations of estrogen and/or progestin when given with ritonavir.

Significant changes in plasma levels of estrogen and progestin have been noted with co-administration.

HIV protease inhibitor that may decrease plasma concentrations of estrogen and/or progestin.

Non-nucleoside reverse transcriptase inhibitor that may decrease plasma concentrations of estrogen and/or progestin.

Cases of contraceptive failure and breakthrough bleeding reported with concomitant use, though clinical studies show inconsistent results.

Increased plasma concentrations reported with concomitant administration of oral contraceptives containing ethinyl estradiol.

Significant changes in plasma levels of estrogen and progestin have been noted with co-administration.

Increases systemic exposure of ethinyl estradiol by approximately 20-25 percent.

Metabolic enzyme inducer that may decrease plasma concentrations of levonorgestrel and ethinyl estradiol, potentially diminishing contraceptive effectiveness or increasing breakthrough bleeding.

HCV protease inhibitor that may decrease plasma concentrations of estrogen and/or progestin.

Oral contraceptives may increase clearance of temazepam.

Possible association with reduced efficacy and breakthrough bleeding, though less marked than with rifampin.

Increased plasma concentrations reported with concomitant administration of oral contraceptives containing ethinyl estradiol.

HIV protease inhibitor that may decrease plasma concentrations of estrogen and/or progestin when given with ritonavir.

CYP3A inhibitor that may increase systemic exposure of estrogen component.

Co-administration of Iclevia and glecaprevir/pibrentasvir is not recommended due to potential for ALT elevations.

Co-administration of Iclevia and glecaprevir/pibrentasvir is not recommended due to potential for ALT elevations.