Baxdrostat

BAXFENDY, in combination with other antihypertensive drugs, is indicated 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating risk reduction of these events with BAXFENDY. 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.

Baxdrostat is an inhibitor of human aldosterone synthase. Aldosterone contributes to hypertension by promoting the retention of sodium and water by the kidneys, which increases blood volume and, consequently, raises blood pressure. Aldosterone can cause vascular dysfunction, inflammation, and fibrosis. Inhibition of aldosterone synthase by baxdrostat decreases plasma aldosterone concentrations, thereby reducing blood pressure. Baxdrostat has a higher potency and selectivity for aldosterone synthase compared to the closely related enzyme 11β-hydroxylase (final enzyme in cortisol synthesis). In nonclinical and clinical studies, baxdrostat significantly lowered aldosterone concentrations without affecting cortisol responses over a wide dose range. Baxdrostat does not inhibit synthesis of sex hormones such as testosterone and estrone.

• Consider the patient’s risk of hyperkalemia and hyponatremia before initiating BAXFENDY. • Recommended dosage is 2 mg orally once daily. • For patients at increased risk of hyperkalemia or hyponatremia, the recommended dosage is 1 mg once daily. • Take with or without food.

None. None.

• Hyperkalemia: Assess serum potassium before initiation and periodically thereafter. Assess more frequently in patients at increased risk of hyperkalemia. • Hyponatremia: Assess serum sodium before initiation and periodically thereafter. Assess more frequently in patients at increased risk of hyponatremia.

The following clinically significant adverse reactions are also discussed elsewhere in the labeling: • Hyperkalemia • Hyponatremia The most common adverse reaction (more frequent than placebo and ≥ 5% in BAXFENDY-treated patients) was hyperkalemia.

• Drugs That Increase Serum Potassium: Monitor serum potassium more frequently during concomitant use with BAXFENDY. • Strong and moderate CYP3A inducers: Monitor the therapeutic effect of BAXFENDY more frequently during concomitant use.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store and dispense in original container with desiccant to protect from moisture.