estetrol/drospirenone (Rx)

Brand and Other Names:Nextstellis
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

estetrol/drospirenone

tablet

  • 14.2mg/3mg

Contraception

Indicated for use by females of reproductive potential to prevent pregnancy

Days 1-24: 1 active tablet (3 mg drospirenone [DRSP]/14.2 mg estetrol [E4]) PO qDay, THEN

Days 25-28: 1 inert tablet PO qDay

Dosage Modifications

Renal impairment

  • All severities of renal impairment: Contraindicated
  • CrCl 30-49 mL/min: Serum DRSP concentrations were ~37 higher than control group
  • Females with renal impairment whose serum potassium is in upper reference range and are concomitantly using potassium-sparing drugs may potentially develop hyperkalemia

Hepatic impairment

  • All severities of hepatic impairment: Contraindicated
  • Moderate: Mean exposure to DRSP was ~3x higher than females with normal liver function
  • Severe: Not studied

Dosing Considerations

Initiating with no current use of hormonal contraception

  • Females with irregular menstrual cycles: Consider pregnancy testing before initiation
  • Days 1-24: Take 1 pink active tablet once daily starting on first day of menses
  • Days 25-28: Take 1 white inert tablet daily
  • Each subsequent 28-day pack: Begin on same day of week as first cycle pack (eg, on day after taking the last tablet)
  • If not starting on first day of menses, use nonhormonal contraceptive (eg, condoms and/or spermicide) as backup until 1 active tablet has been taken daily for 7 days in a row

Switching from another contraceptive method

  • Combined oral contraceptive (COC): Start when new pack of previous COC would have started
  • Transdermal system, vaginal insert, or injection: Start when next administration would have been scheduled
  • Intrauterine system (IUS) or implant: Start after removal
  • Progestin-only pill: Start after last tablet was taken

Initiating after delivery (>20 weeks gestation)

  • Do not start <4 weeks after delivery
  • Menstrual cycles have resumed: Follow instructions for “starting estetrol/drospirenone in females with no current use of hormonal contraception”
  • Menstrual cycles have not resumed: Consider possibility of ovulation and pregnancy; if not pregnant, use additional nonhormonal contraception for first 7 days of use

Starting DRSP/E4 after delivery (>20 weeks gestation)

  • ≤14 weeks gestation
    • Starting ≤7 days of complete first trimester abortion or miscarriage: Use additional contraception for next 7 days
    • Starting >7 days: Follow instructions for “starting DRSP/E4 in females with no current use of hormonal contraception”
  • >14 weeks to ≤20 weeks gestation
    • Start after 4 weeks following second trimester abortion or miscarriage; consider duration of pregnancy and increased risk of thromboembolism
    • Menstrual cycles have resumed: Follow instructions for “starting DRSP/E4 in females with no current use of hormonal contraception”
    • Menstrual cycles have not resumed: Consider possibility of ovulation and pregnancy; if not pregnant, use additional nonhormonal contraception for first 7 days of use

Limitation of use

  • May be less effective in females with a body mass index (BMI) ≥30 kg/m2; decreased effectiveness may be associated with increased BMI

Dosage Forms & Strengths

estetrol/drospirenone

tablet

  • 14.2mg/3mg

Contraception

Indicated for use by females of reproductive potential to prevent pregnancy

Study was done on females of reproductive potential aged 16-50 years

Days 1-24: 1 active tablet (3 mg drospirenone [DRSP]/14.2 mg estetrol [E4]) PO qDay, THEN

Days 25-28: 1 inert tablet PO qDay

Dosage Modifications

Renal impairment

  • All severities of renal impairment: Contraindicated
  • CrCl 30-49 mL/min: Serum DRSP concentrations were ~37 higher than control group
  • Females with renal impairment whose serum potassium is in upper reference range and are concomitantly using potassium-sparing drugs may potentially develop hyperkalemia

Hepatic impairment

  • All severities of hepatic impairment: Contraindicated
  • Moderate: Mean exposure to DRSP was ~3x higher than females with normal liver function
  • Severe: Not studied

Dosing Considerations

Initiating with no current use of hormonal contraception

  • Females with irregular menstrual cycles: Consider pregnancy testing before initiation
  • Days 1-24: Take 1 pink active tablet once daily starting on first day of menses
  • Days 25-28: Take 1 white inert tablet daily
  • Each subsequent 28-day pack: Begin on same day of week as first cycle pack (eg, on day after taking the last tablet)
  • If not starting on first day of menses, use nonhormonal contraceptive (eg, condoms and/or spermicide) as backup until 1 active tablet has been taken daily for 7 days in a row

Switching from another contraceptive method

  • Combined oral contraceptive (COC): Start when new pack of previous COC would have started
  • Transdermal system, vaginal insert, or injection: Start when next administration would have been scheduled
  • Intrauterine system (IUS) or implant: Start after removal
  • Progestin-only pill: Start after last tablet was taken

Initiating after delivery (>20 weeks gestation)

  • Do not start <4 weeks after delivery
  • Menstrual cycles have resumed: Follow instructions for “starting estetrol/drospirenone in females with no current use of hormonal contraception”
  • Menstrual cycles have not resumed: Consider possibility of ovulation and pregnancy; if not pregnant, use additional nonhormonal contraception for first 7 days of use

Starting DRSP/E4 after delivery (>20 weeks gestation)

  • ≤14 weeks gestation
    • Starting ≤7 days of complete first trimester abortion or miscarriage: Use additional contraception for next 7 days
    • Starting >7 days: Follow instructions for “starting DRSP/E4 in females with no current use of hormonal contraception”
  • >14 weeks to ≤20 weeks gestation
    • Start after 4 weeks following second trimester abortion or miscarriage; consider duration of pregnancy and increased risk of thromboembolism
    • Menstrual cycles have resumed: Follow instructions for “starting DRSP/E4 in females with no current use of hormonal contraception”
    • Menstrual cycles have not resumed: Consider possibility of ovulation and pregnancy; if not pregnant, use additional nonhormonal contraception for first 7 days of use

Limitation of use

  • May be less effective in females with a body mass index (BMI) ≥30 kg/m2; decreased effectiveness may be associated with increased BMI
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Interactions

Interaction Checker

and estetrol/drospirenone

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              Serious - Use Alternative (14)

              • amiloride

                amiloride and drospirenone both increase serum potassium. Avoid or Use Alternate Drug.

                amiloride, drospirenone. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Hyperkalemia.

              • belzutifan

                belzutifan will decrease the level or effect of drospirenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of belzutifan with hormonal contraceptives may lead to contraceptive failure or increased breakthrough bleeding. Advise females of reproductive potential to use effective nonhormonal contraception. Based on animal studies, belzutifan can cause fetal harm.

              • calaspargase pegol

                calaspargase pegol, drospirenone. unknown mechanism. Avoid or Use Alternate Drug. Due to the potential for an indirect interaction between calaspargase pegol and oral contraceptives, concomitant use of these drugs is not recommended. Use another non-oral contraceptive method for females of childbearing potential.

              • eplerenone

                drospirenone, eplerenone. Mechanism: pharmacodynamic synergism. Contraindicated. Hyperkalemia.

              • fedratinib

                drospirenone will increase the level or effect of fedratinib by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of fedratinib (a CYP3A4 and CYP2C19 substrate) with dual CYP3A4 and CYP2C19 inhibitor. Effect of coadministration of a dual CYP3A4 and CYP2C19 inhibitor with fedratinib has not been studied.

              • isavuconazonium sulfate

                isavuconazonium sulfate will increase the level or effect of drospirenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • lonafarnib

                drospirenone will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarnib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to, or continue lonafarnib at starting dose. Closely monitor for arrhythmias and events (eg, syncope, heart palpitations) since lonafarnib effect on QT interval is unknown.

              • mobocertinib

                mobocertinib will decrease the level or effect of drospirenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of mobocertinib with hormonal contraceptives may lead to contraceptive failure or increased breakthrough bleeding. Advise females of reproductive potential to use effective non-hormonal contraception.

              • potassium acid phosphate

                drospirenone and potassium acid phosphate both increase serum potassium. Avoid or Use Alternate Drug.

              • potassium chloride

                drospirenone and potassium chloride both increase serum potassium. Avoid or Use Alternate Drug.

              • potassium citrate

                drospirenone and potassium citrate both increase serum potassium. Avoid or Use Alternate Drug.

              • potassium phosphates, IV

                drospirenone and potassium phosphates, IV both increase serum potassium. Avoid or Use Alternate Drug.

              • spironolactone

                drospirenone and spironolactone both increase serum potassium. Avoid or Use Alternate Drug.

                drospirenone, spironolactone. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Hyperkalemia.

              • triamterene

                drospirenone and triamterene both increase serum potassium. Avoid or Use Alternate Drug.

                drospirenone, triamterene. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Hyperkalemia.

              Monitor Closely (137)

              • acebutolol

                acebutolol and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • aceclofenac

                drospirenone and aceclofenac both increase serum potassium. Modify Therapy/Monitor Closely.

              • acemetacin

                drospirenone and acemetacin both increase serum potassium. Modify Therapy/Monitor Closely.

              • albiglutide

                drospirenone decreases effects of albiglutide by passive renal tubular reabsorption due to increased pH. Use Caution/Monitor. Oral contraceptives may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. Monitor for glycemic control in diabetic patients.

              • albuterol

                drospirenone increases and albuterol decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • aldesleukin

                aldesleukin increases effects of drospirenone by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • arformoterol

                drospirenone increases and arformoterol decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • aspirin

                drospirenone and aspirin both increase serum potassium. Modify Therapy/Monitor Closely.

              • aspirin rectal

                drospirenone and aspirin rectal both increase serum potassium. Modify Therapy/Monitor Closely.

              • aspirin/citric acid/sodium bicarbonate

                drospirenone and aspirin/citric acid/sodium bicarbonate both increase serum potassium. Modify Therapy/Monitor Closely.

              • atazanavir

                atazanavir, drospirenone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Atazanavir may increase or decrease levels of drospirenone. Use alternatives if available.

              • atenolol

                atenolol and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • atogepant

                drospirenone will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • avapritinib

                drospirenone will increase the level or effect of avapritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • axitinib

                drospirenone increases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • benazepril

                benazepril and drospirenone both increase serum potassium. Use Caution/Monitor.

              • bendroflumethiazide

                drospirenone increases and bendroflumethiazide decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • betaxolol

                betaxolol and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • bisoprolol

                bisoprolol and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • bumetanide

                drospirenone increases and bumetanide decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • canagliflozin

                drospirenone and canagliflozin both increase serum potassium. Use Caution/Monitor.

              • candesartan

                candesartan and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • captopril

                captopril, drospirenone. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Risk of hyperkalemia.

              • carbenoxolone

                drospirenone increases and carbenoxolone decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • carvedilol

                carvedilol and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • celecoxib

                drospirenone and celecoxib both increase serum potassium. Modify Therapy/Monitor Closely.

              • celiprolol

                celiprolol and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • chlorothiazide

                drospirenone increases and chlorothiazide decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • chlorthalidone

                drospirenone increases and chlorthalidone decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • choline magnesium trisalicylate

                drospirenone and choline magnesium trisalicylate both increase serum potassium. Modify Therapy/Monitor Closely.

              • clobazam

                clobazam will decrease the level or effect of drospirenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Clobazam is a weak CYP3A4 inducer; effectiveness of hormonal contraceptives may be diminished when given concurrently with clobazam. Additional non-hormonal forms of contraception are recommended.

              • cyclopenthiazide

                drospirenone increases and cyclopenthiazide decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • cyclosporine

                drospirenone, cyclosporine. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Monitor serum cyclosporine concentrations, and for signs and symptoms of renal and hepatic toxicity.

              • darunavir

                darunavir will increase the level or effect of drospirenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Significant changes (increase or decrease) can occur in estrogen plasma levels. Efficacy of hormonal contraceptives may be reduced. Use of a nonhormonal contraceptive is recommended.

              • diclofenac

                drospirenone and diclofenac both increase serum potassium. Modify Therapy/Monitor Closely.

              • diflunisal

                drospirenone and diflunisal both increase serum potassium. Modify Therapy/Monitor Closely.

              • digoxin

                drospirenone and digoxin both increase serum potassium. Modify Therapy/Monitor Closely.

              • disopyramide

                drospirenone increases effects of disopyramide by pharmacodynamic synergism. Use Caution/Monitor. Additive cardiovascular depression.

              • dobutamine

                drospirenone increases and dobutamine decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • dopexamine

                drospirenone increases and dopexamine decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • enalapril

                enalapril, drospirenone. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Risk of hyperkalemia.

              • ephedrine

                drospirenone increases and ephedrine decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • epinephrine

                drospirenone increases and epinephrine decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • epinephrine racemic

                drospirenone increases and epinephrine racemic decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • eprosartan

                eprosartan and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • esmolol

                esmolol and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • ethacrynic acid

                drospirenone increases and ethacrynic acid decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • etodolac

                drospirenone and etodolac both increase serum potassium. Modify Therapy/Monitor Closely.

              • exenatide injectable solution

                drospirenone, exenatide injectable solution. Other (see comment). Use Caution/Monitor. Comment: Oral contraceptives may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. The effect of exenatide to slow gastric emptying may reduce the extent and rate of oral medications that require rapid GI absorption. Advise patients to take oral contraceptives at least 1 hr before exenatide. .

              • exenatide injectable suspension

                drospirenone, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Oral contraceptives may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. The effect of exenatide to slow gastric emptying may reduce the extent and rate of oral medications that require rapid GI absorption. Advise patients to take oral contraceptives at least 1 hr before exenatide.

              • fenbufen

                drospirenone and fenbufen both increase serum potassium. Modify Therapy/Monitor Closely.

              • fenoprofen

                drospirenone and fenoprofen both increase serum potassium. Modify Therapy/Monitor Closely.

              • finerenone

                drospirenone will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.

                drospirenone and finerenone both increase serum potassium. Modify Therapy/Monitor Closely. Finerenone dose adjustment based on current serum potassium concentration. Monitor serum potassium and adjust finerenone dose as described in the prescribing information as necessary.

              • flibanserin

                drospirenone will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors.

              • flurbiprofen

                drospirenone and flurbiprofen both increase serum potassium. Modify Therapy/Monitor Closely.

              • formoterol

                drospirenone increases and formoterol decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • fosinopril

                fosinopril, drospirenone. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Risk of hyperkalemia.

              • furosemide

                drospirenone increases and furosemide decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • gentamicin

                drospirenone increases and gentamicin decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • hydrochlorothiazide

                drospirenone increases and hydrochlorothiazide decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • ibuprofen

                drospirenone and ibuprofen both increase serum potassium. Modify Therapy/Monitor Closely.

              • ibuprofen IV

                drospirenone and ibuprofen IV both increase serum potassium. Modify Therapy/Monitor Closely.

              • imidapril

                imidapril, drospirenone. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Risk of hyperkalemia.

              • indapamide

                drospirenone increases and indapamide decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • indomethacin

                drospirenone and indomethacin both increase serum potassium. Modify Therapy/Monitor Closely.

              • irbesartan

                irbesartan and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • isoproterenol

                drospirenone increases and isoproterenol decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • ivacaftor

                drospirenone increases levels of ivacaftor by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor when coadministered with weak CYP3A4 inhibitors .

              • juniper

                juniper, drospirenone. Other (see comment). Use Caution/Monitor. Comment: Juniper may potentiate or interfere with diuretic therapy. Juniper has diuretic effects, but may cause kidney damage at large doses.

              • ketoprofen

                drospirenone and ketoprofen both increase serum potassium. Modify Therapy/Monitor Closely.

              • ketorolac

                drospirenone and ketorolac both increase serum potassium. Modify Therapy/Monitor Closely.

              • ketorolac intranasal

                drospirenone and ketorolac intranasal both increase serum potassium. Modify Therapy/Monitor Closely.

              • labetalol

                labetalol and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • lamotrigine

                drospirenone will decrease the level or effect of lamotrigine by increasing hepatic clearance. Use Caution/Monitor. Combination oral contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation.

              • lemborexant

                drospirenone will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.

              • levalbuterol

                drospirenone increases and levalbuterol decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • liraglutide

                drospirenone decreases effects of liraglutide by passive renal tubular reabsorption due to increased pH. Use Caution/Monitor. Oral contraceptives may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. Monitor for glycemic control in diabetic patients.

              • lisinopril

                lisinopril, drospirenone. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Risk of hyperkalemia.

              • lomitapide

                drospirenone increases levels of lomitapide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lomitapide dose should not exceed 30 mg/day.

              • lornoxicam

                drospirenone and lornoxicam both increase serum potassium. Modify Therapy/Monitor Closely.

              • losartan

                losartan and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • maraviroc

                drospirenone increases levels of maraviroc by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity.

              • meclofenamate

                drospirenone and meclofenamate both increase serum potassium. Modify Therapy/Monitor Closely.

              • mefenamic acid

                drospirenone and mefenamic acid both increase serum potassium. Modify Therapy/Monitor Closely.

              • meloxicam

                drospirenone and meloxicam both increase serum potassium. Modify Therapy/Monitor Closely.

              • metaproterenol

                drospirenone increases and metaproterenol decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • metformin

                drospirenone decreases effects of metformin by pharmacodynamic antagonism. Use Caution/Monitor.

              • methyclothiazide

                drospirenone increases and methyclothiazide decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely. .

              • metolazone

                drospirenone increases and metolazone decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • metoprolol

                metoprolol and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • midazolam intranasal

                drospirenone will increase the level or effect of midazolam intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of mild CYP3A4 inhibitors with midazolam intranasal may cause higher midazolam systemic exposure, which may prolong sedation.

              • mifepristone

                mifepristone decreases effects of drospirenone by pharmacodynamic antagonism. Use Caution/Monitor. Backup contraceptive method recommended.

              • moexipril

                moexipril, drospirenone. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Risk of hyperkalemia.

              • nabumetone

                drospirenone and nabumetone both increase serum potassium. Modify Therapy/Monitor Closely.

              • nadolol

                nadolol and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • naproxen

                drospirenone and naproxen both increase serum potassium. Modify Therapy/Monitor Closely.

              • nebivolol

                nebivolol and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • noni juice

                drospirenone and noni juice both increase serum potassium. Use Caution/Monitor.

              • norepinephrine

                drospirenone increases and norepinephrine decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • olmesartan

                olmesartan and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • oxaprozin

                drospirenone and oxaprozin both increase serum potassium. Modify Therapy/Monitor Closely.

              • parecoxib

                drospirenone and parecoxib both increase serum potassium. Modify Therapy/Monitor Closely.

              • penbutolol

                penbutolol and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • perindopril

                perindopril, drospirenone. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Risk of hyperkalemia.

              • pindolol

                pindolol and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • pirbuterol

                drospirenone increases and pirbuterol decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • piroxicam

                drospirenone and piroxicam both increase serum potassium. Modify Therapy/Monitor Closely.

              • pivmecillinam

                pivmecillinam increases effects of drospirenone by unspecified interaction mechanism. Use Caution/Monitor. Hyperkalemia.

              • potassium citrate/citric acid

                drospirenone and potassium citrate/citric acid both increase serum potassium. Use Caution/Monitor.

              • potassium iodide

                potassium iodide and drospirenone both increase serum potassium. Use Caution/Monitor.

              • propranolol

                propranolol and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • quinapril

                quinapril, drospirenone. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Risk of hyperkalemia.

              • ramipril

                ramipril, drospirenone. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Risk of hyperkalemia.

              • sacubitril/valsartan

                sacubitril/valsartan and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • salicylates (non-asa)

                drospirenone and salicylates (non-asa) both increase serum potassium. Modify Therapy/Monitor Closely.

              • salmeterol

                drospirenone increases and salmeterol decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • salsalate

                drospirenone and salsalate both increase serum potassium. Modify Therapy/Monitor Closely.

              • siltuximab

                siltuximab, drospirenone. Other (see comment). Use Caution/Monitor. Comment: CYP450 activity in the liver is down regulated by infection and inflammation stimuli including cytokines (eg, IL-6); inhibition of IL-6 by siltuximab may restore CYP450 enzymatic activity; caution if coadministered with CYP substrates that have a narrow therapeutic index.

              • sotalol

                sotalol and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • succinylcholine

                drospirenone and succinylcholine both increase serum potassium. Modify Therapy/Monitor Closely.

              • sulfasalazine

                drospirenone and sulfasalazine both increase serum potassium. Modify Therapy/Monitor Closely.

              • sulindac

                drospirenone and sulindac both increase serum potassium. Modify Therapy/Monitor Closely.

              • tazemetostat

                drospirenone will increase the level or effect of tazemetostat by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • telmisartan

                telmisartan and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • temocillin

                temocillin increases effects of drospirenone by unspecified interaction mechanism. Use Caution/Monitor. Hyperkalemia.

              • terbutaline

                drospirenone increases and terbutaline decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • ticarcillin

                ticarcillin increases effects of drospirenone by unspecified interaction mechanism. Use Caution/Monitor. Hyperkalemia.

              • timolol

                timolol and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • tinidazole

                drospirenone will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • tolfenamic acid

                drospirenone and tolfenamic acid both increase serum potassium. Modify Therapy/Monitor Closely.

              • tolmetin

                drospirenone and tolmetin both increase serum potassium. Modify Therapy/Monitor Closely.

              • tolvaptan

                drospirenone and tolvaptan both increase serum potassium. Modify Therapy/Monitor Closely.

              • torsemide

                drospirenone increases and torsemide decreases serum potassium. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

              • trandolapril

                trandolapril, drospirenone. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Risk of hyperkalemia.

              • valsartan

                valsartan and drospirenone both increase serum potassium. Modify Therapy/Monitor Closely.

              • voclosporin

                voclosporin and drospirenone both increase serum potassium. Use Caution/Monitor.

              • xipamide

                xipamide increases effects of drospirenone by pharmacodynamic synergism. Use Caution/Monitor.

              Minor (33)

              • agrimony

                agrimony increases effects of drospirenone by pharmacodynamic synergism. Minor/Significance Unknown.

              • birch

                birch increases effects of drospirenone by pharmacodynamic synergism. Minor/Significance Unknown.

              • brimonidine

                brimonidine increases effects of drospirenone by pharmacodynamic synergism. Minor/Significance Unknown.

              • cadexomer iodine

                cadexomer iodine, drospirenone. Mechanism: decreasing renal clearance. Minor/Significance Unknown. Hyperkalemia.

              • calcium acetate

                drospirenone decreases levels of calcium acetate by increasing renal clearance. Minor/Significance Unknown.

              • calcium carbonate

                drospirenone decreases levels of calcium carbonate by increasing renal clearance. Minor/Significance Unknown.

              • calcium chloride

                drospirenone decreases levels of calcium chloride by increasing renal clearance. Minor/Significance Unknown.

              • calcium citrate

                drospirenone decreases levels of calcium citrate by increasing renal clearance. Minor/Significance Unknown.

              • calcium gluconate

                drospirenone decreases levels of calcium gluconate by increasing renal clearance. Minor/Significance Unknown.

              • cornsilk

                cornsilk increases effects of drospirenone by pharmacodynamic synergism. Minor/Significance Unknown.

              • enasidenib

                enasidenib, drospirenone. unknown mechanism. Minor/Significance Unknown. Coadministration of enasidenib may increase or decrease the concentrations of combined hormonal contraceptives. Clinical significance of this interaction is unknown.

              • epoprostenol

                epoprostenol increases effects of drospirenone by pharmacodynamic synergism. Minor/Significance Unknown. Additive hypotensive effects.

              • forskolin

                forskolin increases effects of drospirenone by pharmacodynamic synergism. Minor/Significance Unknown.

              • goldenrod

                goldenrod increases effects of drospirenone by pharmacodynamic synergism. Minor/Significance Unknown.

              • iodinated glycerol

                iodinated glycerol, drospirenone. Mechanism: decreasing renal clearance. Minor/Significance Unknown. Hyperkalemia.

              • iodine

                iodine, drospirenone. Mechanism: decreasing renal clearance. Minor/Significance Unknown. Hyperkalemia.

              • magnesium chloride

                drospirenone increases levels of magnesium chloride by decreasing renal clearance. Minor/Significance Unknown.

              • magnesium citrate

                drospirenone increases levels of magnesium citrate by decreasing renal clearance. Minor/Significance Unknown.

              • magnesium hydroxide

                drospirenone increases levels of magnesium hydroxide by decreasing renal clearance. Minor/Significance Unknown.

              • magnesium oxide

                drospirenone increases levels of magnesium oxide by decreasing renal clearance. Minor/Significance Unknown.

              • magnesium sulfate

                drospirenone increases levels of magnesium sulfate by decreasing renal clearance. Minor/Significance Unknown.

              • maitake

                maitake increases effects of drospirenone by pharmacodynamic synergism. Minor/Significance Unknown.

              • minoxidil

                drospirenone increases effects of minoxidil by pharmacodynamic synergism. Minor/Significance Unknown.

              • octacosanol

                octacosanol increases effects of drospirenone by pharmacodynamic synergism. Minor/Significance Unknown.

              • reishi

                reishi increases effects of drospirenone by pharmacodynamic synergism. Minor/Significance Unknown.

              • ruxolitinib

                drospirenone will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • shepherd's purse

                shepherd's purse, drospirenone. Other (see comment). Minor/Significance Unknown. Comment: Theoretically, shepherd's purse may interfere with BP control.

              • sulfadiazine

                drospirenone increases levels of sulfadiazine by unspecified interaction mechanism. Minor/Significance Unknown.

              • sulfamethoxazole

                drospirenone, sulfamethoxazole. Mechanism: unspecified interaction mechanism. Minor/Significance Unknown. Hyperkalemia.

                drospirenone increases levels of sulfamethoxazole by unspecified interaction mechanism. Minor/Significance Unknown.

              • sulfisoxazole

                drospirenone increases levels of sulfisoxazole by unspecified interaction mechanism. Minor/Significance Unknown.

              • tizanidine

                tizanidine increases effects of drospirenone by pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypotension.

              • treprostinil

                treprostinil increases effects of drospirenone by pharmacodynamic synergism. Minor/Significance Unknown.

              • trimethoprim

                drospirenone, trimethoprim. Mechanism: unspecified interaction mechanism. Minor/Significance Unknown. Hyperkalemia.

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              Adverse Effects

              >10%

              Bleeding irregularities (9.7-10.8%)

              Mood disturbance (9.1-10.9%)

              1-10%

              Headache (4.8-6.3%)

              Breast symptoms (5.3-5.4%)

              Dysmenorrhea (3.7-4.1%)

              Weight increased (3-3.3%)

              Acne (3.2-3.7%)

              Libido decreased/lost (1.3-2%)

              Depression (1.7%)

              Frequency Not Defined

              Thromboembolic event reported in a female who had been taking therapy for 75 days and had normal BMI < 25 kg/m2

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              Warnings

              Black Box Warnings

              Cigarette smoking and serious cardiovascular events

              • Cigarette smoking increases risk of serious cardiovascular adverse effects from CHC use
              • This risk increases with age, particularly in females aged >35 years, and number of cigarettes smoked
              • CHCs, including DRSP/E4, are contraindicated in females aged ≥35 years and smoke

              Contraindications

              History of, increased risk for, or current arterial or venous thrombotic/thromboembolic diseases

              • Examples include females with the following conditions
                • Smoking, if aged ≥35 years
                • Current or history of deep vein thrombosis or pulmonary embolism
                • Cerebrovascular disease
                • Coronary artery disease
                • Thrombogenic valvular or thrombogenic rhythm diseases of the heart (eg, subacute bacterial endocarditis with valvular disease, atrial fibrillation)
                • Inherited or acquired hypercoagulopathies
                • Uncontrolled hypertension or hypertension with vascular disease
                • Diabetes mellitus with hypertension or end-organ damage; or diabetes mellitus of >20 years duration
                • Migraine headaches with aura

              Current or history of a hormonally-sensitive malignancy (eg, breast cancer)

              Hepatic adenoma, hepatocellular carcinoma, acute hepatitis, or severe (decompensated) cirrhosis

              Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir

              Abnormal uterine bleeding with undiagnosed etiology

              Renal impairment

              Adrenal insufficiency

              Cautions

              Increased blood pressure (BP) reported in females using COCs; increase is more likely in older females with extended duration of use; monitor BP periodically and discontinue if BP rises significantly

              Migraine headaches with aura increase the risk for stroke; stroke risk is further increased in females who have migraine headaches with aura with use of CHCs; discontinue if new migraine headaches develop that are recurrent, persistent, or severe or increased frequency or severity of migraine headaches (which may be prodromal of a cerebrovascular event)

              May promote growth of any hormone receptor–positive tumor, both within and external to female reproductive tract (eg, hormone receptor–positive include melanoma, adenocarcinoma of the lung, meningioma); discontinue if a hormonally sensitive malignancy is diagnosed

              May cause elevated liver enzymes; withhold or permanently discontinue for persistent or significant elevation of liver enzymes

              CHCs increase the risk of hepatic tumors, particularly hepatic adenomas; rupture of hepatic adenomas may cause death from abdominal hemorrhage

              May decrease glucose tolerance; carefully monitor females with prediabetes and diabetes during therapy

              Females with hypertriglyceridemia or with family history may have increase serum triglyceride concentrations during use, which may increase risk of pancreatitis; consider alternative contraception

              Studies suggest an increased risk of developing gallbladder disease among CHC users; use of CHCs may also worsen existing gallbladder disease; females with a history of pregnancy-related cholestasis may be at an increased risk for CHC-related cholestasis; consider discontinuing treatment in females with symptomatic gallbladder disease or cholestatic disease

              Limited data are available on association of COCs with onset of depression or exacerbation of existing depression; monitor females with a history of depression and discontinue if depression recurs to a serious degree

              Causal relationship between use of CHCs and development of cervical cancer and intraepithelial neoplasia has not been clearly established

              Exogenous estrogens may induce or exacerbate symptoms of hereditary angioedema; avoid in females with hereditary angioedema

              Chloasma may occur with use, especially in females with history of chloasma gravidarum; avoid in females with a history of chloasma gravidarum or increased sensitivity to sun and/or ultraviolet radiation exposure

              Bleeding irregularities and amenorrhea

              • May experience unscheduled (breakthrough or intracyclic) bleeding and spotting, especially during first 4 months of use
              • Bleeding irregularities may resolve over time or by changing to a different contraceptive product; if bleeding persists or occurs after previously regular cycles, evaluate for causes (eg, pregnancy, malignancy)
              • Females may also experience absence of scheduled (withdrawal) bleeding, even if they are not pregnant; if scheduled bleeding does not occur, consider possibility of pregnancy
              • If patient has not adhered to prescribed dosing schedule (missed 1 or 2 active tablets or started taking them on a day later than prescribed), consider possibility of pregnancy at time of the first missed period and perform appropriate diagnostic measures
              • After discontinuation, amenorrhea or oligomenorrhea may occur, especially if these conditions were preexistent

              Thromboembolic disorders

              • Before starting, evaluate any medical history or family history of thrombotic or thromboembolic disorders; consider whether history suggests an inherited or acquired hypercoagulopathy
              • Use of CHCs increases the risk of cardiovascular events and cerebrovascular events, (eg, myocardial infarction, stroke); risk is greater among females aged >40, smokers, and females with hypertension, dyslipidemia, diabetes, or obesity; risk increases with age, particularly in females aged ≥35 years, and with number of cigarettes smoked or use of other nicotine-containing products
              • Use of CHCs also increases the risk of venous thromboembolic events (VTEs) (eg, deep vein thrombosis, pulmonary embolism); risk of VTE is highest during first year of CHC use and when restarting hormonal contraception after a break ≥4 weeks; risk of VTE returns to baseline ~3 months after CHC discontinued
              • Postpartum VTE
                • VTE is increased during first 6 weeks postpartum compared with risk in nonpregnant, nonpostpartum females
                • Risk highest in first 3 weeks postpartum; remains higher than baseline until at least 6 weeks postpartum
                • Multiple risk factors for VTE may further increase the risk
                • Obstetric complications may extend elevated risk up to 12 weeks postpartum
              • Discontinue for the following
                • Thrombotic event occurs
                • Unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis immediately
                • During prolonged immobilization

              Hyperkalemia

              • Contraindicated in females with conditions that predispose to hyperkalemia (eg, renal impairment, hepatic impairment, adrenal insufficiency)
              • Females receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium concentration should have their serum potassium concentration checked during first treatment cycle and monitored
              • Product contains drospirenone, a progestin, which has anti-mineralocorticoid activity, including potential for hyperkalemia in high-risk females, comparable to a 25-mg dose of spironolactone

              Drug interaction overview

              • DRSP: CYP3A4 substrate
              • CYP3A4 inducers
                • Strong CYP3A4 inducers: Avoid coadministration; if unavoidable, use alternant contraceptive method (eg, IUS) or backup nonhormonal contraceptive during coadministration and up to 28 days after discontinuing strong CYP3A4 inducer
                • Moderate and weak CYP3A4 inducers: Use alternant or backup contraceptive method during coadministration and up to 28 days after discontinuing CYP3A inducer, unless prescribing information of specific moderate or weak CYP3A inducer indicates there is no clinically significant interaction
                • Strong CYP3A inducers or certain moderate or weak CYP3A inducers may decrease DRSP exposure, which may lead to contraceptive failure
              • Strong CYP3A4 inhibitors
                • May increase drospirenone/estetrol systemic exposure
                • Consider monitoring serum potassium concentration in patients who take a strong CYP3A4 inhibitor long-term and concomitantly with DRSP/E4
              • Drugs that may reduce absorption
                • Separate administration times of DRSP/E4 and concomitant drug; refer to concomitant drug's prescribing information for additional information
                • Drugs such as bile acid sequestrants may decrease the E4 and DRSP exposure, which may lead to contraceptive failure and/or an increased breakthrough bleeding
              • Antidiabetic drugs
                • Increase frequency of glucose monitoring and increase antidiabetic drug dosage, as needed, based on glucose levels
                • DRSP/E4 may reduce blood glucose–lowering effects of antidiabetic drugs
                Drugs that may increase serum potassium concentration
                • Monitor serum potassium concentration in females at increased risk for hyperkalemia
                • DRSP/E4 may increase serum potassium concentration in females concurrently taking other drugs that may increase serum potassium
              • Lamotrigine
                • Adjust lamotrigine dosage as recommended by prescribing information
                • DRSP/E4 may decrease exposure and efficacy of lamotrigine
              • Systemic corticosteroids
                • Follow recommendations in accordance with prescribing information of corticosteroids consider more frequent monitoring for corticosteroid adverse reactions
                • DRSP/E4 may increase exposure and toxicities of systemic corticosteroids (owing to increased corticosteroid-binding globulin) and mineralocorticoids (owing to increased aldosterone)
              • Hepatitis C treatment
                • CHCs are contraindicated for use with hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir (with or without dasabuvir)
                • Discontinue DRSP/E4 before starting therapy with combination drug regimen ombitasvir/paritaprevir/ritonavir (with or without dasabuvir)
                • May restart ~2 weeks following completion of treatment with this hepatitis C combination drug regimen
                • During clinical trials with these hepatitis C combination drug regimens, ALT elevations >5x ULN, including some cases >20x ULN, were significantly more frequent in females using ethinyl estradiol (EE) containing drugs, such as CHCs
              • Thyroid hormone replacement therapy
                • Increase thyroid hormone replacement dose as needed
                • Estrogen component may increase the serum concentrations of thyroxine-binding globulin
              • Sex hormones
                • Coadministration may decrease androstenedione, progesterone, and free testosterone owing to increased sex hormone-binding globulin
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              Pregnancy & Lactation

              Pregnancy

              Discontinue if pregnancy occurs

              Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (eg, cardiac anomalies, limb-reduction defects) following COC exposure before conception or during early pregnancy

              Animal studies

              • Reproductive toxic studies performed with E4 alone have shown expected pharmacologic effects in animals, which are consistent with estrogen exposure

              Lactation

              Contraceptive hormones and/or metabolites are present in human milk

              COCs can reduce milk production in breastfeeding females; reduction may occur at any time, but less likely to occur once breastfeeding is well established

              When possible, advise nursing females to use other methods of contraception until breastfeeding is discontinued

              After oral administration of DRSP 3 mg/ethinyl estradiol 30 mcg, about 0.02% of the DRSP dose was excreted into the breast milk of postpartum females within 24 hr; results in a potential maximal daily dose <1 mcg DRSP in an infant

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Estetrol (E4): Synthetic analogue of a native estrogen present during pregnancy, that is selective for nuclear estrogen receptor-alpha (ER-alpha) and ER-beta; treatment results in decrease of follicle-stimulating hormone and luteinizing hormone, ultimately leading to ovulation suppression

              Drospirenone: Progestin; spironolactone analogue with anti-mineralocorticoid and anti-androgenic activity that provides contraception primarily by suppressing ovulation

              Absorption

              Peak plasma concentration

              • E4: 17.9 ng/mL
              • DRSP: 48.7 ng/mL

              Peak plasma time

              • E4: 0.5 hr
              • DRSP: 1 hr

              AUC

              • E4: 59.1 ng·hr/mL
              • DRSP: 519 ng·hr/mL

              Time to steady-state

              • E4: 4 days
              • DRSP: 10 days

              Effects of high-fat meal (relative to fasting)

              • Geometric mean peak plasma concentration ratio: 0.5 (E4); 0.75 (DRSP)
              • Geometric mean AUC ratio: 1.01 (E4); 1.08 (DRSP)

              Distribution

              Protein bound

              • E4: 46-50%
              • DRSP: 95-97%

              Metabolism

              E4

              • Phase 2 metabolism to form glucuronide and sulphate conjugates which have negligible in-vitro estrogenic activity
              • In vitro studies show that UGT2B7 is dominant UGT isoform that catalyzes the formation of E4-16-glucuronide

              DRSP

              • Metabolized by CYP3A4
              • Two main metabolites (not active): acid form of DRSP generated by opening of lactone ring and 4,5 dihydrodrospirenone formed by reduction followed by sulfation

              Elimination

              Half-life

              • E4: 27 hr (bound to albumin)
              • DRSP: 34 hr

              Excretion

              • E4: Urine (69%); feces (22%; 100% unchanged)
              • DRSP: Urine (38%); feces (44%)
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              Administration

              Oral Administration

              Take at the same time every day and in the order directed by blister pack

              May take with or without food

              Swallow both pink pills and white pills whole

              Missed dose

              • Missed 1 pink active tablet
                • Take missed dose as soon as possible and take next tablet at scheduled time, even if 2 active tablets are taken in 1 day
                • Continue taking 1 tablet a day until pack is finished
              • Missed ≥2 pink active tablets in Week 1 or 2
                • Take missed dose as soon as possible and take next tablet at scheduled time, even if 2 active tablets are taken in 1 day and discard other missed tablets
                • Continue taking 1 tablet a day until pack is finished
                • Use additional nonhormonal contraception as backup until pink tablets have been taken for 7 consecutive days
              • Missed ≥2 pink active tablets in Week 3
                • Take missed dose as soon as possible and take next tablet at scheduled time, even if 2 active tablets are taken in 1 day and discard other missed tablets
                • Finish active tablets and discard inactive tablets in pack; start a new pack of tablets the next day
                • Use additional nonhormonal contraception as backup until pink tablets have been taken for 7 consecutive days
              • Missed ≥1 white inert tablets
                • Skip missed doses and continue taking 1 tablet a day until pack is finished
              • After vomiting or acute diarrhea
                • Vomiting or acute diarrhea occurs within 3-4 hr after taking active tablet: Take new active tablet (scheduled for next day) as soon as possible; if possible, take new tablet [wrap]within 12 hr of next scheduled dose
                • Missed >2 tablets: Follow advice above concerning missed tablets

              Storage

              Store at 20-25°C; excursion permitted to 15-30°C (50-86°F)

              Dispose unused medication via a take-back option if available

              Otherwise, follow FDA instructions for disposing medication in household trash, www.fda.gov/drugdisposal; do NOT flush down the toilet

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              Patient Handout

              A Patient Handout is not currently available for this monograph.
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              Formulary

              FormularyPatient Discounts

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              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
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              QL Quantity Limits
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.