baxfendy

Consider the patient’s risk of hyperkalemia and hyponatremia before initiating BAXFENDY. (2.1) • Recommended dosage is 2 mg orally once daily. (2.2) • For patients at increased risk of hyperkalemia or hyponatremia, the recommended dosage is 1 mg once daily. (2.2) • Take with or without food. (2.3) 2.1 Testing Prior to and After Initiation of BAXFENDY Consider the patient’s risk of hyperkalemia and hyponatremia before initiating BAXFENDY. Assess serum potassium and sodium before initiation of BAXFENDY and periodically thereafter. Correct serum potassium and sodium abnormalities prior to initiation of BAXFENDY [see Warnings and Precautions (5.1 , 5.2 )] . 2.2 Recommended Dosage 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 [see Warnings and Precautions (5.1 , 5.2) ] . 2.3 Administration Instructions Swallow tablets whole. Do not cut, crush, or chew tablets. BAXFENDY may be taken with or without food. If a dose is missed, take the next dose at the usual time. Do not take a double dose on the same day.

The following clinically significant adverse reactions are also discussed elsewhere in the labeling: • Hyperkalemia [see Warnings and Precautions (5.1) ] • Hyponatremia [see Warnings and Precautions (5.2) ] The most common adverse reaction (more frequent than placebo and ≥ 5% in BAXFENDY-treated patients) was hyperkalemia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of BAXFENDY was evaluated over 12 weeks using the randomized, double-blind, placebo-controlled periods from three clinical trials in patients with hypertension not adequately controlled on other antihypertensive medications. Three of these trials [BaxHTN (NCT06034743), BrigHTN (NCT04519658), Bax24 (NCT06168409)] evaluated BAXFENDY 2 mg as add-on treatment and two trials [BaxHTN, BrigHTN] evaluated BAXFENDY 1 mg as add-on treatment. These data reflect exposure of 441 patients to BAXFENDY 2 mg and 333 patients to BAXFENDY 1 mg, with a mean treatment duration of 80 days for both BAXFENDY 2 mg and 1 mg. Analyses in this section are…

None. None. (4)

BAXFENDY did not show any toxicity in healthy subjects at single oral doses up to 360 mg. In the event of an overdose, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. It is also reasonable to employ supportive measures as dictated by the patient’s clinical status. The removal of baxdrostat by hemodialysis has not been studied.

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

Drugs That Increase Serum Potassium: Monitor serum potassium more frequently during concomitant use with BAXFENDY. (7.1) • Strong and moderate CYP3A inducers: Monitor the therapeutic effect of BAXFENDY more frequently during concomitant use. (7.2) 7.1 Drugs That Increase Serum Potassium Monitor serum potassium more frequently when BAXFENDY is used concomitantly with drugs that impair potassium excretion or increase serum potassium. Concomitant use may increase the risk of hyperkalemia [see Warnings and Precautions (5.1) ] . 7.2 Effect of Other Drugs on BAXFENDY Strong and Moderate CYP3A Inducers Monitor the therapeutic effect of BAXFENDY more frequently when concomitantly used with strong or moderate CYP3A inducers. Baxdrostat is a CYP3A substrate. Strong or moderate CYP3A inducers may decrease baxdrostat plasma concentration, which may reduce the efficacy of BAXFENDY.