RECENT MAJOR CHANGES

INDICATIONS AND USAGE

Edarbi is an angiotensin II receptor blocker indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Edarbi may be used, either alone or in combination with other antihypertensive agents. (1)

DOSAGE AND ADMINISTRATION

The recommended dose in adults is 80 mg taken once daily. Consider a starting dose of 40 mg for patients who are treated with high doses of diuretics. (2.1)

Edarbi may be administered with or without food. (2.1)

Edarbi may be administered with other antihypertensive agents. (2.1)

DOSAGE FORMS AND STRENGTHS

Tablets: 40 mg and 80 mg. (3)

CONTRAINDICATIONS

None

WARNINGS AND PRECAUTIONS

• Avoid fetal or neonatal exposure. (5.1)
• Correct volume or salt depletion prior to administration of Edarbi. (5.2)
• Monitor for worsening renal function in patients with renal impairment. (5.3)

ADVERSE REACTIONS

The most common adverse reaction in adults was diarrhea (2%). (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-825-3327 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

• Nursing Mothers: Discontinue nursing or drug. (8.3)
• Geriatric Patients: Abnormally high serum creatinine values were more likely to be reported for patients age 75 or older. No overall difference in efficacy versus younger patients, but greater sensitivity of some older individuals cannot be ruled out. (8.5)
• In patients with an activated renin-angiotensin system, as by volume- or salt-depletion, renin-angiotensin-aldosterone system (RAAS) blockers such as azilsartan medoxomil can cause excessive hypotension. In susceptible patients, e.g., with renal artery stenosis, RAAS blockers can cause renal failure (5.2, 5.3).
• Pediatrics: Safety and efficacy in children have not been established.