Strong CYP3A4 inducer. Should not use Estradiol Valerate/Dienogest while taking or for 28 days after discontinuation due to risk of decreased contraceptive efficacy.
Source: NLP:estradiol valerate and estradiol valerate/dienogest
Estradiol Valerate And Estradiol Valerate/Dienogest Interactions
Brand names: Estradiol Valerate And Estradiol Valerate/Dienogest
FDA Black Box Warning
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (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 ).] WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. • Women over 35 years old who smoke should not use Estradiol Valerate and Estradiol Valerate/Dienogest . ( 4 ) • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 )
Contraindications
4 CONTRAINDICATIONS Do not prescribe Estradiol Valerate and Estradiol Valerate/Dienogest to women who are known to have the following: • 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 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 inherited or acquired hypercoagulopathies [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 or without aura if over age 35 [see Warnings and Precautions ( 5.7 )] • Undiagnosed abnormal uterine bleeding [see Warnings and Precautions ( 5.8 )] • Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see Warnings and Precautions ( 5.2 )] • Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 )] . • Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions ( 5.9 ) and Use in Specific Populations ( 8.1 )] . • A high risk of arterial or venous thrombotic diseases ( 4 ) • Undiagnosed abnormal uterine bleeding ( 4 ) • Breast cancer or other estrogen- or progestin-sensitive cancer ( 4 ) • Liver tumors or liver disease ( 4 ) • Pregnancy ( 4 )
Pregnancy & Breastfeeding
8.1 Pregnancy There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy. COCs should not be used during pregnancy to treat threatened or habitual abortion. Women who do not breastfeed may start COCs no earlier than four weeks postpartum.
21 interactions on record
Strong CYP3A4 inducer. Should not use Estradiol Valerate/Dienogest while taking or for 28 days after discontinuation due to risk of decreased contraceptive efficacy.
Source: NLP:estradiol valerate and estradiol valerate/dienogest
Strong CYP3A4 inducer causing 83% decrease in dienogest AUC and 44% decrease in estradiol AUC. Should not use Estradiol Valerate/Dienogest while taking or for 28 days after discontinuation.
Source: NLP:estradiol valerate and estradiol valerate/dienogest
Strong CYP3A4 inducer. Should not use Estradiol Valerate/Dienogest while taking or for 28 days after discontinuation due to risk of decreased contraceptive efficacy.
Source: NLP:estradiol valerate and estradiol valerate/dienogest
CYP3A4 enzyme inducer that may decrease the effectiveness of the contraceptive or increase breakthrough bleeding.
Source: NLP:estradiol valerate and estradiol valerate/dienogest
CYP3A4 enzyme inducer that may decrease the effectiveness of the contraceptive or increase breakthrough bleeding.
Source: NLP:estradiol valerate and estradiol valerate/dienogest
[See Clinical Pharmacology (12.3).] Substances Increasing the Systemic Exposure of COCs (enzyme inhibitors): Concomitant administration of moderate or strong CYP3A4 inhibitors like azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit increase the serum concentrations of both estradiol and dienogest.
Source: FDA drug label - estradiol valerate and estradiol valerate/dienogest
CYP3A4 inhibitor that increases serum concentrations of estradiol and dienogest.
Source: NLP:estradiol valerate and estradiol valerate/dienogest
[See Clinical Pharmacology (12.3).] Substances Increasing the Systemic Exposure of COCs (enzyme inhibitors): Concomitant administration of moderate or strong CYP3A4 inhibitors like azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit increase the serum concentrations of both estradiol and dienogest. In a multiple dose study investigating the effect of CYP3A4 inhibitors (ketoconazole and erythromycin) on Natazia, steady state estradiol and dienogest exposures were increased when co-administered with ketoconazole or erythromycin [see Clinical Pharmacology ( 12.3 )] .
Source: FDA drug label - estradiol valerate and estradiol valerate/dienogest
CYP3A4 enzyme inducer that may decrease the effectiveness of the contraceptive or increase breakthrough bleeding.
Source: NLP:estradiol valerate and estradiol valerate/dienogest
[See Clinical Pharmacology (12.3).] Substances Increasing the Systemic Exposure of COCs (enzyme inhibitors): Concomitant administration of moderate or strong CYP3A4 inhibitors like azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit increase the serum concentrations of both estradiol and dienogest.
Source: FDA drug label - estradiol valerate and estradiol valerate/dienogest
CYP3A4 inhibitor that increases serum concentrations of estradiol and dienogest.
Source: NLP:estradiol valerate and estradiol valerate/dienogest
CYP3A4 enzyme inducer that may decrease the effectiveness of the contraceptive or increase breakthrough bleeding.
Source: NLP:estradiol valerate and estradiol valerate/dienogest
[See Clinical Pharmacology (12.3).] Substances Increasing the Systemic Exposure of COCs (enzyme inhibitors): Concomitant administration of moderate or strong CYP3A4 inhibitors like azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit increase the serum concentrations of both estradiol and dienogest.
Source: FDA drug label - estradiol valerate and estradiol valerate/dienogest
[See Clinical Pharmacology (12.3).] Substances Increasing the Systemic Exposure of COCs (enzyme inhibitors): Concomitant administration of moderate or strong CYP3A4 inhibitors like azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit increase the serum concentrations of both estradiol and dienogest. In a multiple dose study investigating the effect of CYP3A4 inhibitors (ketoconazole and erythromycin) on Natazia, steady state estradiol and dienogest exposures were increased when co-administered with ketoconazole or erythromycin [see Clinical Pharmacology ( 12.3 )] .
Source: FDA drug label - estradiol valerate and estradiol valerate/dienogest
CYP3A4 enzyme inducer that may decrease the effectiveness of the contraceptive or increase breakthrough bleeding.
Source: NLP:estradiol valerate and estradiol valerate/dienogest
CYP3A4 enzyme inducer that may decrease the effectiveness of the contraceptive or increase breakthrough bleeding.
Source: NLP:estradiol valerate and estradiol valerate/dienogest
CYP3A4 inhibitor that increases serum concentrations of estradiol and dienogest.
Source: NLP:estradiol valerate and estradiol valerate/dienogest
[See Clinical Pharmacology (12.3).] Substances Increasing the Systemic Exposure of COCs (enzyme inhibitors): Concomitant administration of moderate or strong CYP3A4 inhibitors like azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit increase the serum concentrations of both estradiol and dienogest.
Source: FDA drug label - estradiol valerate and estradiol valerate/dienogest
May cause significant changes (increase or decrease) in plasma concentrations of estrogen and progestin.
Source: NLP:estradiol valerate and estradiol valerate/dienogest
May cause significant changes (increase or decrease) in plasma concentrations of estrogen and progestin.
Source: NLP:estradiol valerate and estradiol valerate/dienogest