EDARBI safety and tolerability

EDARBI was well tolerated, with an overall incidence of adverse reactions similar to placebo1

  • A total of 4,814 patients were evaluated for safety when treated with EDARBI® in clinical trials
  • Diarrhea was reported in up to 2% of patients taking EDARBI 80 mg daily compared with 0.5% of patients on placebo
  • The rate of withdrawals due to adverse events in placebo-controlled monotherapy and combination therapy trials was 2.4% (19/801) for placebo, 2.2% (24/1,072) for EDARBI 40 mg, and 2.7% (29/1,074) for EDARBI 80 mg
  • Hypotension was the most common adverse event leading to discontinuation. Incidence of hypotension leading to discontinuation was 0.4% (8/2,146) in patients who were randomized to EDARBI 40 mg or 80 mg and 0% (0/801) in patients given placeboa

aOf the 8 EDARBI patients, 6 were on combination therapy.

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.

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

Fetal Toxicity: Use of drugs that act on the renin-angiotensin system during the second and third trimester of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity 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.

In patients with an activated renin-angiotensin-aldosterone (RAAS), such as volume- and/or salt-depleted patients, EDARBI or EDARBYCLOR can cause excessive hypotension. Correct volume or salt depletion prior to administration of EDARBI or EDARBYCLOR.

Monitor for worsening renal function in patients with renal impairment. In patients whose renal function may depend on the activity of the renin-angiotensin system, treatment with ACE inhibitors and ARBs has been associated with oliguria or progressive azotemia and rarely with acute renal failure and death. In patients with renal artery stenosis, EDARBI and EDARBYCLOR may cause renal failure. In patients with renal disease, chlorthalidone may precipitate azotemia; consider withholding or discontinuing EDARBYCLOR if progressive renal impairment becomes evident. Avoid use of aliskiren with EDARBI or EDARBYCLOR in patients with renal impairment (GFR <60 mL/min).

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 chlorthalidone. Coadministration of digitalis may exacerbate the adverse effects of hypokalemia. EDARBYCLOR attenuates chlorthalidone-associated hypokalemia. Monitor electrolytes periodically.

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%).

Incidence of consecutive elevations of creatinine with EDARBYCLOR (>50% from baseline and >ULN) was 2% and was typically transient, or nonprogressive and reversible, and associated with large blood pressure reductions. With EDARBI 80 mg, small reversible increases were seen.

Drug Interactions:

  • 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.
  • 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 interfere with antihypertensive effect.
  • Dual blockade of the RAAS 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. Closely monitor blood pressure, renal function and electrolytes in patients on EDARBI.

Indications and Usage

EDARBI is an angiotensin II receptor blocker (ARB) and EDARBYCLOR is an angiotensin II receptor blocker (ARB) and a thiazide-like diuretic combination product both indicated for the treatment of hypertension to lower blood pressure. 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 pharmacologically similar drug 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. EDARBI and EDARBYCLOR may be used with other antihypertensive agents.

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

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Reference: 1. Edarbi [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC.

LEARN MORE ABOUT EDARBI

See how this ARB compares with BENICAR and DIOVAN


FIND OUT MORE ABOUT EDARBYCLOR

View efficacy data from an EDARBYCLOR head-to-head study with BENICAR HCT

Edarbi or Edarbyclor is exclusively marketed in the United States by Arbor Pharmaceuticals, LLC.

Edarbi and Edarbyclor are trademarks of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Arbor Pharmaceuticals, LLC.

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