A POWERFUL ARb

Abbreviation: ARB, angiotensin II receptor blocker
Actor Portrayal
EDARBI® (azilsartan medoxomil) Efficacy

Systolic blood pressure (SBP) control you can count on for your appropriate patients*

EDARBI delivered statistically superior SBP control compared to Diovan® (valsartan) and Benicar® (olmesartan medoxomil).1,2

*Based on clinical trial data vs Diovan and Benicar.1,2

EDARBI Head-to-Head Clinical Trial Results

Primary endpoint in the study was a change in 24-hour mean ambulatory SBP
after 6 weeks of treatment.1

Mean ambulatory SBP reduction at 6 weeks1

As measured by ambulatory blood pressure monitoring: In this study, EDARBI 80 mg lowered SBP by 14.3 mm
Hg vs placebo (P<0.001) compared with 11.7 mg Hg with Benicar 40 mg vs placebo (P<0.001) and 10.0 mm Hg with Diovan 320 mg vs placebo (P<0.001).1

See Study Design
Mean ambulatory SBP reduction measured hourly at 6 weeks1

EDARBI 80 mg reduced ambulatory SBP at each hour to a larger extent than Diovan 320 mg and Benicar 40 mg
for most of the 24-hour period after 6 weeks of therapy.1

See Study Design
EDARBI SAFETY AND TOLERABILITY
Demonstrated safety profile2

Safety and tolerability were evaluated in more than 4800 patients.

Diarrhea was the most common adverse event (AE) and was reported in up to 2% of patients treated with EDARBI 80 mg daily vs 0.5% of patients on placebo.
Hypotension was the most common AE leading to discontinuation.
*Combined data from both placebo-controlled monotherapy and combination trials.
Simple daily oral administration

EDARBI is a once-daily oral medication taken
as initial or add-on therapy.2

  • May be administered with or without food.
  • No dose titration is required.
  • May be administered with other antihypertensive agents.
  • Correct volume or salt depletion in patients prior to use.
80 mg Once Daily
Recommended starting dose
40 mg Once Daily
Recommended dose for use with high doses of diuretics
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Powerful Products Meet Powerful Savings for Patients

Your patients may get the prescription treatment they need at a more affordable cost with our comprehensive suite of savings programs. Help your patients reach their goals by finding the savings program that works for them.
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EDARBYCLOR® (azilsartan medoxomil/
chlorthalidone)
When your patients need a powerful combo

EDARBYCLOR is the only ARB fixed-dose combination with chlorthalidone for hypertension that is not controlled with monotherapy. EDARBYCLOR has been proven effective in head-to-head clinical trials with Benicar HCT®.3
Learn about EDARBYCLOR
edarbyclor logo

1. White WB, Weber MA, Sica D, et al. Effects of the angiotensin receptor blocker azilsartan medoxomil versus olmesartan and valsartan on ambulatory and clinic blood pressure in patients with stages 1 and 2 hypertension. Hypertension. 2011;57(3):413-420. doi:10.1161/HYPERTENSIONAHA.110.163402
2. Edarbi [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc; 2024.
3. Edarbyclor [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc; 2022.

INDICATIONS

EDARBI is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension in adults, to lower blood pressure and EDARBYCLOR is an angiotensin II receptor blocker (ARB) and a thiazide-like diuretic combination product indicated for the treatment of hypertension to lower blood pressure. EDARBI may be used either alone or in combination with other antihypertensive agents. EDARBYCLOR may be used if a patient is not adequately controlled on monotherapy or as initial therapy if multiple drugs are needed to help achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. There are no controlled trials demonstrating risk reduction with EDARBI or EDARBYCLOR, but trials with chlorthalidone and at least one antihypertensive agent pharmacologically similar to azilsartan medoxomil have demonstrated such benefits. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on hypertension goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). EDARBI and EDARBYCLOR may be used with other antihypertensive agents.

IMPORTANT SAFETY INFORMATION

WARNING: FETAL TOXICITY

See full Prescribing Information for complete boxed warnings.

  • When pregnancy is detected, discontinue EDARBI or EDARBYCLOR as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

WARNINGS AND PRECAUTIONS

EDARBYCLOR is contraindicated in patients with anuria.

Do not coadminister aliskiren-containing products with EDARBI or EDARBYCLOR in patients with diabetes.

Fetal Toxicity: EDARBI or EDARBYCLOR can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue EDARBI or EDARBYCLOR as soon as possible. Thiazides cross the placental barrier and appear in cord blood and may be associated with adverse reactions, including fetal or neonatal jaundice and thrombocytopenia.

Hypotension in Volume - or Salt-Depleted Patients: In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with EDARBI or EDARBYCLOR. Such patients are probably not good candidates to start therapy with more than one drug; therefore, correct volume prior to administration of EDARBYCLOR. Correct volume or salt depletion prior to administering EDARBI, or start treatment at 40 mg. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

Impaired Renal Function: Monitor for worsening renal function in patients with renal impairment. Consider withholding or discontinuing EDARBYCLOR if progressive renal impairment becomes evident. As a consequence of inhibiting the renin-angiotensin system, changes in renal function may be anticipated in susceptible individuals treated with EDARBI or EDARBYCLOR. In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g., patients with severe congestive heart failure, renal artery stenosis, or volume depletion), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers has been associated with oliguria or progressive azotemia and rarely with acute renal failure and death. Similar results may be anticipated in patients treated with EDARBI or EDARBYCLOR. In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen have been reported. There has been no long-term use of azilsartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar results are expected. In patients with renal disease, chlorthalidone may precipitate azotemia. If progressive renal impairment becomes evident, as indicated by increased blood urea nitrogen, consider withholding or discontinuing diuretic therapy.

Serum Electrolyte Imbalances: Thiazide diuretics can cause hyponatremia and hypokalemia. Drugs that inhibit the renin angiotensin system can cause hyperkalemia. Hypokalemia is a dose-dependent adverse reaction that may develop with chlorthalidone. Co-administration of digitalis may exacerbate the adverse effects of hypokalemia. Monitor serum electrolytes periodically. EDARBYCLOR attenuates chlorthalidone-associated hypokalemia. In patients with normal potassium levels at baseline, 1.7% of EDARBYCLOR-treated patients, 0.9% of azilsartan medoxomil-treated patients, and 13.4% of chlorthalidone-treated patients shifted to low potassium values (less than 3.4 mmol/L).

Hyperuricemia: Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving chlorthalidone or other thiazide diuretics.

ADVERSE REACTIONS (AEs):

- The most common AE that occurred more frequently with EDARBI than placebo in adults was
diarrhea (2% vs 0.5%).

- AEs occurred at an incidence of ≥2% of EDARBYCLOR-treated patients and greater than
azilsartan medoxomil or chlorthalidone were dizziness (8.9%) and fatigue (2.0%).

The incidence of consecutive increases of creatinine (≥50% from baseline and >ULN) was 2.0% in patients treated with the recommended doses of Edarbyclor compared with 0.4% and 0.3% with azilsartan medoxomil and chlorthalidone, respectively.

DRUG INTERACTIONS:

- Monitor renal function periodically in patients receiving EDARBI or EDARBYCLOR and NSAIDs who are also elderly, volume-depleted (including those on diuretics), or who have compromised renal function, as deterioration of renal function, including possible acute renal failure, may result. These effects are usually reversible. NSAIDs may reduce the antihypertensive effect of EDARBI or EDARBYCLOR.
- Dual blockade of the renin-angiotensin system (RAS) with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on EDARBI or EDARBYCLOR and other agents that affect the RAS. Do not coadminister aliskiren with EDARBI or EDARBYCLOR in patients with diabetes or renal impairment (GFR ❮ 60 mL/min).
- Renal clearance of lithium is reduced by diuretics, such as chlorthalidone, increasing the risk of lithium toxicity. Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor agonists. Monitor serum lithium levels during concomitant use.

The Important Safety Information does not include all the information needed to use EDARBI and EDARBYCLOR safely and effectively.

For further information, please see accompanying complete Prescribing Information for EDARBI and EDARBYLCOR.

To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

PP-EDB-US-0664

EDARBI and EDARBYCLOR are exclusively marketed in the United States by Azurity Pharmaceuticals, Inc.

EDARBI and EDARBYCLOR are a trademark of Takeda Pharmaceutical Company Limited, registered with the US Patent and Trademark Office and used under license by Azurity Pharmaceuticals, Inc.

© {current_year} Azurity Pharmaceuticals, Inc. All Rights Reserved. All Trademarks referred to are the property of the irrespective owners. Product packaging and imagery are for representation purposes only and shall constitute the property of Azurity and all applicable affiliates. PP-EDB-US-0664.

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IMPORTANT SAFETY INFORMATION

WARNING: FETAL TOXICITY
See full Prescribing Information for complete boxed warnings.

  • When pregnancy is detected, discontinue EDARBI or EDARBYCLOR as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

EDARBYCLOR is contraindicated in patients with anuria.

INDICATIONS

EDARBI is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension in adults, to lower blood pressure and EDARBYCLOR is an angiotensin II receptor blocker (ARB) and a thiazide-like diuretic combination product indicated for the treatment of hypertension to lower blood pressure. EDARBI may be used either alone or in combination with other antihypertensive agents. EDARBYCLOR may be used if a patient is not adequately controlled on monotherapy or as initial therapy if multiple drugs are needed to help achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. There are no controlled trials demonstrating risk reduction with EDARBI or EDARBYCLOR, but trials with chlorthalidone and at least one antihypertensive agent pharmacologically similar to azilsartan medoxomil have demonstrated such benefits. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on hypertension goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). EDARBI and EDARBYCLOR may be used with other antihypertensive agents.

IMPORTANT SAFETY INFORMATION

WARNING: FETAL TOXICITY

See full Prescribing Information for complete boxed warnings.

  • When pregnancy is detected, discontinue EDARBI or EDARBYCLOR as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

WARNINGS AND PRECAUTIONS

EDARBYCLOR is contraindicated in patients with anuria.

Do not coadminister aliskiren-containing products with EDARBI or EDARBYCLOR in patients with diabetes.

Fetal Toxicity: EDARBI or EDARBYCLOR can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue EDARBI or EDARBYCLOR as soon as possible. Thiazides cross the placental barrier and appear in cord blood and may be associated with adverse reactions, including fetal or neonatal jaundice and thrombocytopenia.

Hypotension in Volume - or Salt-Depleted Patients: In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with EDARBI or EDARBYCLOR. Such patients are probably not good candidates to start therapy with more than one drug; therefore, correct volume prior to administration of EDARBYCLOR. Correct volume or salt depletion prior to administering EDARBI, or start treatment at 40 mg. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

Impaired Renal Function: Monitor for worsening renal function in patients with renal impairment. Consider withholding or discontinuing EDARBYCLOR if progressive renal impairment becomes evident. As a consequence of inhibiting the renin-angiotensin system, changes in renal function may be anticipated in susceptible individuals treated with EDARBI or EDARBYCLOR. In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g., patients with severe congestive heart failure, renal artery stenosis, or volume depletion), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers has been associated with oliguria or progressive azotemia and rarely with acute renal failure and death. Similar results may be anticipated in patients treated with EDARBI or EDARBYCLOR. In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen have been reported. There has been no long-term use of azilsartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar results are expected. In patients with renal disease, chlorthalidone may precipitate azotemia. If progressive renal impairment becomes evident, as indicated by increased blood urea nitrogen, consider withholding or discontinuing diuretic therapy.

Serum Electrolyte Imbalances: Thiazide diuretics can cause hyponatremia and hypokalemia. Drugs that inhibit the renin angiotensin system can cause hyperkalemia. Hypokalemia is a dose-dependent adverse reaction that may develop with chlorthalidone. Co-administration of digitalis may exacerbate the adverse effects of hypokalemia. Monitor serum electrolytes periodically. EDARBYCLOR attenuates chlorthalidone-associated hypokalemia. In patients with normal potassium levels at baseline, 1.7% of EDARBYCLOR-treated patients, 0.9% of azilsartan medoxomil-treated patients, and 13.4% of chlorthalidone-treated patients shifted to low potassium values (less than 3.4 mmol/L).

Hyperuricemia: Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving chlorthalidone or other thiazide diuretics.

ADVERSE REACTIONS (AEs):

- The most common AE that occurred more frequently with EDARBI than placebo in adults was
diarrhea (2% vs 0.5%).

- AEs occurred at an incidence of ≥2% of EDARBYCLOR-treated patients and greater than
azilsartan medoxomil or chlorthalidone were dizziness (8.9%) and fatigue (2.0%).

The incidence of consecutive increases of creatinine (≥50% from baseline and >ULN) was 2.0% in patients treated with the recommended doses of Edarbyclor compared with 0.4% and 0.3% with azilsartan medoxomil and chlorthalidone, respectively.

DRUG INTERACTIONS:

- Monitor renal function periodically in patients receiving EDARBI or EDARBYCLOR and NSAIDs who are also elderly, volume-depleted (including those on diuretics), or who have compromised renal function, as deterioration of renal function, including possible acute renal failure, may result. These effects are usually reversible. NSAIDs may reduce the antihypertensive effect of EDARBI or EDARBYCLOR.
- Dual blockade of the renin-angiotensin system (RAS) with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on EDARBI or EDARBYCLOR and other agents that affect the RAS. Do not coadminister aliskiren with EDARBI or EDARBYCLOR in patients with diabetes or renal impairment (GFR ❮ 60 mL/min).
- Renal clearance of lithium is reduced by diuretics, such as chlorthalidone, increasing the risk of lithium toxicity. Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor agonists. Monitor serum lithium levels during concomitant use.

The Important Safety Information does not include all the information needed to use EDARBI and EDARBYCLOR safely and effectively.

For further information, please see accompanying complete Prescribing Information for EDARBI and EDARBYLCOR.

To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

PP-EDB-US-0664

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