Acne:
Indications for: BEYAZ
Moderate acne vulgaris in women ≥14 years old who choose an oral contraceptive for contraception.
Adult Dosage:
1 tablet daily for 28 days; repeat. Take at the same time daily. Use Day 1 or Sunday start for 1st cycle; use backup method for first 7 days. Allow at least 4 weeks postpartum, if not breastfeeding, to begin cycle.
Children Dosage:
Pre-menarche: not applicable.
BEYAZ Contraindications:
Renal impairment. Adrenal insufficiency. High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or thromboembolism, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, diabetes with vascular disease, headaches with focal neurologic symptoms). Breast or other estrogen or progestin-sensitive neoplasms. Hepatic disease or tumors. Undiagnosed abnormal uterine bleeding. Pregnancy. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Boxed Warning:
Cigarette smoking increases risk of serious cardiovascular events.
BEYAZ Warnings/Precautions:
Increased risk of cardiovascular events esp. in cigarette smokers >35yrs of age. Discontinue if thrombotic event, unexplained visual changes, jaundice, or severe migraine occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Hyperkalemia or risk thereof. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Pregnancy-related cholestasis. History of depression; monitor and discontinue if serious depression recurs. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Do regular complete physical exams. Monitor BP; discontinue if significant rise occurs. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Nursing mothers: not recommended.
BEYAZ Classification:
Progestin + estrogen + folate.
BEYAZ Interactions:
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Beyaz prior to starting HCV regimen and restart 2wks after completion. Monitor serum K+ during 1st cycle with drugs that increase potassium (eg, ACE inhibitors, ARBs, NSAIDs, K+-sparing diuretics, K+ supplements, heparin, aldosterone antagonists); consider monitoring in high-risk patients taking concomitant long-term strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, voriconazole, indinavir, boceprevir, clarithromycin). May be antagonized by CYP3A4 or other enzyme inducers (eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, topiramate) (use backup contraception). May be affected by protease inhibitors, NNRTIs, acetaminophen, ascorbic acid, itraconazole, ketoconazole. May antagonize lamotrigine. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hormones. May mask vitamin B12 deficiency (folate).
Adverse Reactions:
Headache/migraine, menstrual irregularities, nausea, vomiting, breast pain/tenderness, headache, fatigue, irritability, decreased libido, increased weight, affect lability; hypertension, chloasma, serious thromboembolic events, liver disease.
How Supplied:
Packs—3
Contraception:
Indications for: BEYAZ
Oral contraception. To raise folate levels in women who choose to use an oral contraceptive for contraception.
Adult Dosage:
1 tablet daily for 28 days; repeat. Take at the same time daily. Use Day 1 or Sunday start for 1st cycle; use backup method for first 7 days. Allow at least 4 weeks postpartum, if not breastfeeding, to begin cycle.
Children Dosage:
Pre-menarche: not applicable.
BEYAZ Contraindications:
Renal impairment. Adrenal insufficiency. High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or thromboembolism, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, diabetes with vascular disease, headaches with focal neurologic symptoms). Breast or other estrogen or progestin-sensitive neoplasms. Hepatic disease or tumors. Undiagnosed abnormal uterine bleeding. Pregnancy. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Boxed Warning:
Cigarette smoking increases risk of serious cardiovascular events.
BEYAZ Warnings/Precautions:
Increased risk of cardiovascular events esp. in cigarette smokers >35yrs of age. Discontinue if thrombotic event, unexplained visual changes, jaundice, or severe migraine occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Hyperkalemia or risk thereof. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Pregnancy-related cholestasis. History of depression; monitor and discontinue if serious depression recurs. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Do regular complete physical exams. Monitor BP; discontinue if significant rise occurs. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Nursing mothers: not recommended.
BEYAZ Classification:
Progestin + estrogen + folate.
BEYAZ Interactions:
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Beyaz prior to starting HCV regimen and restart 2wks after completion. Monitor serum K+ during 1st cycle with drugs that increase potassium (eg, ACE inhibitors, ARBs, NSAIDs, K+-sparing diuretics, K+ supplements, heparin, aldosterone antagonists); consider monitoring in high-risk patients taking concomitant long-term strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, voriconazole, indinavir, boceprevir, clarithromycin). May be antagonized by CYP3A4 or other enzyme inducers (eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, topiramate) (use backup contraception). May be affected by protease inhibitors, NNRTIs, acetaminophen, ascorbic acid, itraconazole, ketoconazole. May antagonize lamotrigine. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hormones. May mask vitamin B12 deficiency (folate).
Adverse Reactions:
Headache/migraine, menstrual irregularities, nausea, vomiting, breast pain/tenderness, headache, fatigue, irritability, decreased libido, increased weight, affect lability; hypertension, chloasma, serious thromboembolic events, liver disease.
How Supplied:
Packs—3
Mood disorders:
Indications for: BEYAZ
Premenstrual dysphoric disorder (PMDD) in women who choose an oral contraceptive for contraception.
Adult Dosage:
1 tablet daily for 28 days; repeat. Take at the same time daily. Use Day 1 or Sunday start for 1st cycle; use backup method for first 7 days. Allow at least 4 weeks postpartum, if not breastfeeding, to begin cycle.
Children Dosage:
Pre-menarche: not applicable.
BEYAZ Contraindications:
Renal impairment. Adrenal insufficiency. High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or thromboembolism, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, diabetes with vascular disease, headaches with focal neurologic symptoms). Breast or other estrogen or progestin-sensitive neoplasms. Hepatic disease or tumors. Undiagnosed abnormal uterine bleeding. Pregnancy. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Boxed Warning:
Cigarette smoking increases risk of serious cardiovascular events.
BEYAZ Warnings/Precautions:
Increased risk of cardiovascular events esp. in cigarette smokers >35yrs of age. Discontinue if thrombotic event, unexplained visual changes, jaundice, or severe migraine occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Hyperkalemia or risk thereof. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Pregnancy-related cholestasis. History of depression; monitor and discontinue if serious depression recurs. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Do regular complete physical exams. Monitor BP; discontinue if significant rise occurs. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Nursing mothers: not recommended.
BEYAZ Classification:
Progestin + estrogen + folate.
BEYAZ Interactions:
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Beyaz prior to starting HCV regimen and restart 2wks after completion. Monitor serum K+ during 1st cycle with drugs that increase potassium (eg, ACE inhibitors, ARBs, NSAIDs, K+-sparing diuretics, K+ supplements, heparin, aldosterone antagonists); consider monitoring in high-risk patients taking concomitant long-term strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, voriconazole, indinavir, boceprevir, clarithromycin). May be antagonized by CYP3A4 or other enzyme inducers (eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, topiramate) (use backup contraception). May be affected by protease inhibitors, NNRTIs, acetaminophen, ascorbic acid, itraconazole, ketoconazole. May antagonize lamotrigine. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hormones. May mask vitamin B12 deficiency (folate).
Adverse Reactions:
Headache/migraine, menstrual irregularities, nausea, vomiting, breast pain/tenderness, headache, fatigue, irritability, decreased libido, increased weight, affect lability; hypertension, chloasma, serious thromboembolic events, liver disease.
How Supplied:
Packs—3
