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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Hyperkalemia : Assess serum potassium before initiation and periodically thereafter. Assess more frequently in patients at increased risk of hyperkalemia. ( 5.1 ) • Hyponatremia : Assess serum sodium before initiation and periodically thereafter. Assess more frequently in patients at increased risk of hyponatremia. ( 5.2 ) 5.1 Hyperkalemia BAXFENDY can cause hyperkalemia [see Adverse Reactions (6.1) ] . Assess serum potassium prior to initiation of BAXFENDY and monitor periodically during treatment. Correct serum potassium abnormalities prior to initiation of BAXFENDY [see Dosage and Administration (2.1 , 2.2) ] . More frequent monitoring is recommended for patients at increased risk of hyperkalemia (e.g., patients ≥ 65 years of age, those with diabetes mellitus or chronic kidney disease, and those receiving concomitant medications that increase serum potassium) [see Drug Interactions (7.1) and Geriatric Use (8.5) ] . If hyperkalemia occurs, treat hyperkalemia and consider interrupting or discontinuing BAXFENDY. Consider more frequent monitoring of serum potassium in patients who restart BAXFENDY after experiencing hyperkalemia. Permanently discontinue BAXFENDY if clinically significant hyperkalemia recurs. 5.2 Hyponatremia BAXFENDY can cause hyponatremia [see Adverse Reactions (6.1) ] . Assess serum sodium prior to initiation of BAXFENDY and monitor periodically during treatment. Correct serum sodium abnormalities prior to initiation of BAXFENDY [see Dosage and Administration (2.1 , 2.2 )] . More frequent monitoring is recommended for patients with low baseline serum sodium concentrations and those at risk of hyponatremia, such as those receiving concomitant medications that may cause 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 BAXFENDY if clinically significant hyponatremia recurs.
6 ADVERSE REACTIONS 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 based on the 12‑week periods in these three trials. Uncontrolled, long-term safety data from 192 patients exposed to BAXFENDY 1 mg or 2 mg for a mean of 293 days and 172 patients exposed to BAXFENDY 2 mg for a mean of 327 days, were consistent with the safety profile observed during the 12-week, randomized, double-blind, placebo-controlled periods. Hyperkalemia was the most frequently reported adverse reaction to BAXFENDY in the three clinical trials [see Warnings and Precautions (5.1) ] . Hyperkalemia led to permanent discontinuation of treatment in 8 (1.8%) patients in the BAXFENDY 2 mg group, 2 (0.6%) patients in the BAXFENDY 1 mg group, and none in the placebo group. Table 1 shows the most frequently reported adverse reactions to BAXFENDY during the 12-week period in the three clinical trials. Table 1: Adverse Reactions Reported in ≥ 2% of Patients Treated with BAXFENDY and Greater (≥ 1%) than Placebo During the 12-Week, Randomized, Double-Blind Periods from Three Clinical Trials in Patients with Hypertension Adverse Reaction BAXFENDY 2 mg Frequencies derived from the pool of three hypertension studies (BaxHTN, BrigHTN, Bax24) with BAXFENDY 2 mg as add-on treatment. N=441 % BAXFENDY 1 mg Frequencies derived from the pool of two hypertension studies (BaxHTN, BrigHTN) with BAXFENDY 1 mg as add-on treatment. N=333 % Placebo Frequencies derived from the pool of three hypertension studies (BaxHTN, BrigHTN, Bax24) with BAXFENDY 1 mg and/or 2 mg as add‑on treatment. N=442 % Hyperkalemia 10.2 6.6 2.5 Hypotension 3.6 2.1 0.5 Hyponatremia 3.2 2.1 0.9 Dizziness 2.9 3.0 0.9 Muscle spasms 2.9 1.8 0.7 Laboratory Tests Serum Potassium During the 12-week, randomized, double-blind periods from BAXFENDY clinical trials in patients with hypertension, increases in serum potassium (> 5.5 mEq/L) were reported for 12.2% of patients administered BAXFENDY 2 mg, 6.3% of patients administered BAXFENDY 1 mg, and 0.9% of placebo-treated patients. Serum Sodium During the 12-week, randomized, double-blind periods from BAXFENDY clinical trials in patients with hypertension, decreases in serum sodium (< 130 mEq/L) were reported for 3.7% of patients administered BAXFENDY 2 mg, 3.3% of patients administered BAXFENDY 1 mg, and 0.9% of placebo-treated patients. Estimated Glomerular Filtration Rate (eGFR) A decrease in mean eGFR was observed in BAXFENDY clinical trials in patients with hypertension. At Week 12, the mean placebo-corrected decrease in eGFR was 8.0 mL/min/1.73 m 2 in the BAXFENDY 2 mg group and 7.1 mL/min/1.73 m 2 in the BAXFENDY 1 mg group. In BAXFENDY-treated patients, the mean reduction in eGFR appeared to plateau by Week 12 and the mean eGFR increased after BAXFENDY discontinuation, suggesting a hemodynamic effect on renal function.
adverse reactions table
<table width="100%"><caption>Table 1: Adverse Reactions Reported in ≥ 2% of Patients Treated with BAXFENDY and Greater (≥ 1%) than Placebo During the 12-Week, Randomized, Double-Blind Periods from Three Clinical Trials in Patients with Hypertension</caption><col width="34%"/><col width="23%"/><col width="23%"/><col width="20%"/><thead><tr><th align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">Adverse Reaction</content></th><th align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">BAXFENDY 2 mg</content><footnote ID="_Ref228359669">Frequencies derived from the pool of three hypertension studies (BaxHTN, BrigHTN, Bax24) with BAXFENDY 2 mg as add-on treatment.</footnote><content styleCode="bold"> N=441</content> <content styleCode="bold">%</content></th><th align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">BAXFENDY 1 mg</content><footnote ID="_Ref228359938">Frequencies derived from the pool of two hypertension studies (BaxHTN, BrigHTN) with BAXFENDY 1 mg as add-on treatment.</footnote><content styleCode="bold"> N=333</content> <content styleCode="bold">%</content></th><th align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">Placebo</content><footnote ID="_Ref229130377">Frequencies derived from the pool of three hypertension studies (BaxHTN, BrigHTN, Bax24) with BAXFENDY 1 mg and/or 2 mg as add‑on treatment.</footnote><content styleCode="bold"> N=442</content> <content styleCode="bold">%</content></th></tr></thead><tbody><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Hyperkalemia</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>10.2</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>6.6</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>2.5</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Hypotension</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>3.6</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>2.1</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>0.5</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Hyponatremia</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>3.2</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>2.1</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>0.9</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Dizziness</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>2.9</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>3.0</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>0.9</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>Muscle spasms</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>2.9</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>1.8</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>0.7</paragraph></td></tr></tbody></table>