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IMPORTANT SAFETY INFORMATION for BAXFENDY® (baxdrostat)
Warnings and Precautions
Hyperkalemia
BAXFENDY can cause hyperkalemia. Assess serum potassium prior to initiation of BAXFENDY and monitor periodically during treatment. Correct serum potassium abnormalities prior to initiation. More frequent monitoring is recommended for patients at increased risk of hyperkalemia (eg, patients ≥65 years of age, those with diabetes mellitus or chronic kidney disease, and those receiving concomitant medications that increase serum potassium). If hyperkalemia occurs, treat hyperkalemia and consider interrupting or discontinuing BAXFENDY. Consider more frequent monitoring in patients who restart BAXFENDY after experiencing hyperkalemia. Permanently discontinue if clinically significant hyperkalemia recurs.
Hyponatremia
BAXFENDY can cause hyponatremia. Assess serum sodium prior to initiation and monitor periodically during treatment. Correct serum sodium abnormalities prior to initiation. More frequent monitoring is recommended for patients with low baseline serum sodium concentrations and those at risk for hyponatremia. If clinically significant hyponatremia occurs, treat the hyponatremia and consider interrupting or discontinuing BAXFENDY. Consider more frequent monitoring of serum sodium in patients who restart BAXFENDY after experiencing hyponatremia. Permanently discontinue if clinically significant hyponatremia recurs.
Adverse Reactions
Most frequently reported adverse reactions (≥2% with BAXFENDY and greater (≥1%) than placebo in pooled, placebo-controlled trials) reported for BAXFENDY 1 mg and 2 mg, respectively, were hyperkalemia (6.6%, 10.2%), hypotension (2.1%, 3.6%), hyponatremia (2.1%, 3.2%), dizziness (3.0%, 2.9%), and muscle spasms (1.8%, 2.9%).
Drug Interactions
Drugs That Increase Serum Potassium: Monitor serum potassium more frequently when BAXFENDY is used concomitantly with drugs that impair potassium secretion or increase serum potassium. Concomitant use may increase the risk of hyperkalemia.
Strong and moderate CYP3A inducers: Monitor the therapeutic effect of BAXFENDY more frequently during concomitant use. BAXFENDY is a CYP3A substrate.
INDICATION for BAXFENDY
BAXFENDY is an aldosterone synthase inhibitor indicated, in combination with other antihypertensive drugs, for the treatment of hypertension to lower blood pressure in adults who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
DOSING
The recommended dosage of BAXFENDY is 2 mg orally once daily. For patients at increased risk of hyperkalemia or hyponatremia, the recommended dosage is 1 mg orally once daily.
Please see accompanying US Full Prescribing Information for BAXFENDY.
You may report side effects related to AstraZeneca products.
