Baxfendy

Baxfendy (baxdrostat) is a prescription medicine used to treat high blood pressure, also called hypertension, in adults whose blood pressure is not adequately controlled with other medicines. It should be used in combination with other antihypertensive drugs. By lowering blood pressure, Baxfendy may reduce the risk of serious cardiovascular events, including strokes and heart attacks.

Baxfendy contains baxdrostat, a medicine called an aldosterone synthase inhibitor (ASI). Baxfendy works by reducing the production of aldosterone, a hormone that can increase blood pressure by causing the body to retain sodium and water.

The most common Baxfendy side effect is high potassium, also called hyperkalemia, and this medicine can also cause low sodium levels.

Controlling high blood pressure is only one part of reducing cardiovascular risk. Your treatment plan may also include cholesterol control, diabetes management, smoking cessation, exercise, limiting sodium, and taking other medicines as prescribed.

Baxfendy is used to treat hypertension in adults when blood pressure is not well controlled by other blood pressure medicines. It is used in combination with other antihypertensive drugs. It is not FDA-approved for use in patients under 18 years of age.

Baxfendy works by inhibiting aldosterone synthase, the enzyme involved in producing aldosterone. Aldosterone contributes to high blood pressure by promoting sodium and water retention in the kidneys, which increases blood volume and raises blood pressure. Aldosterone may also contribute to vascular dysfunction, inflammation, and fibrosis.

By inhibiting aldosterone synthase, Baxfendy lowers plasma aldosterone concentrations and reduces blood pressure.

Take this medicine exactly as prescribed by your healthcare provider.

Baxfendy tablet is taken once daily and may be taken with or without food. Swallow the tablet whole. Do not cut, crush, or chew tablets.

Your healthcare provider should check your potassium and sodium levels before treatment and periodically during treatment. Do not stop taking these tablets unless your healthcare provider tells you to.

Baxfendy can cause high potassium levels in your blood, called hyperkalemia. Your healthcare provider should check your potassium level before you start Baxfendy and monitor it periodically during treatment. More frequent monitoring is recommended if you are at increased risk, including if you are 65 years of age or older, have type 2 diabetes, have chronic kidney disease, or take medicines that increase potassium.

This medicine can also cause low sodium levels in your blood, called hyponatremia. Your healthcare provider should check your sodium level before starting these tablets and periodically during treatment. More frequent monitoring may be needed if you already have low sodium or take medicines that can cause hyponatremia.

Your healthcare provider should correct abnormal potassium or sodium levels before you start this medicine.

Do not take potassium supplements or salt substitutes that contain potassium during treatment with Baxfendy unless your healthcare provider tells you to.

Before taking Baxfendy, tell your healthcare provider if you:

• have high potassium levels;
• have kidney problems;
• have diabetes;
• are pregnant or plan to become pregnant, as it is not known if these tablets can harm your unborn baby;
• are breastfeeding or plan to breastfeed, as it is not known if this medicine passes into your breast milk. Talk to your healthcare providers about the best way to feed your baby during treatment with this medicine.

Tell your healthcare provider if you have kidney problems. The safety and effectiveness of starting this medicine in patients with eGFR less than 45 mL/min/1.73 m² have not been established. No dosage adjustment is required in patients with eGFR 45 mL/min or higher, unless the patient is at increased risk of hyperkalemia.

Baxfendy can cause serious side effects, including:

• high potassium levels, also called hyperkalemia;
• low sodium levels, also called hyponatremia.

Symptoms of low sodium may include unusual tiredness, dizziness, headache, shortness of breath, or confusion. Tell your healthcare provider right away if you develop these symptoms during treatment.

The most common Baxfendy side effect is hyperkalemia. In clinical trials, adverse reactions reported in at least 2% of Baxfendy-treated patients and more often than placebo included hyperkalemia, hypotension, hyponatremia, dizziness, and muscle spasms.

Common Baxfendy side effects may include:

• high potassium;
• low blood pressure;
• low sodium;
• dizziness;
• muscle spasms.

In clinical trials, hyperkalemia occurred in 10.2% of patients taking Baxfendy 2 mg, 6.6% taking Baxfendy 1 mg, and 2.5% taking placebo. Hypotension occurred in 3.6%, 2.1%, and 0.5%, respectively. Hyponatremia occurred in 3.2%, 2.1%, and 0.9%, respectively.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

This is not a complete list of side effects, and others may occur.

The recommended Baxfendy dosage is 2 mg by mouth once daily.

For patients at increased risk of high potassium levels (hyperkalemia) or low sodium levels (hyponatremia) the recommended dosage is 1 mg by mouth once daily.

Baxfendy is available as 1mg and 2 mg tablets.

If you miss a dose of this medicine, take your next dose at your regular scheduled time. Do not take 2 doses on the same day to make up for a missed dose.

If you take too much Baxfendy, call your healthcare provider, call the Poison Help line at 1-800-222-1222, or go to the nearest emergency room right away. Removal of baxdrostat by hemodialysis has not been studied.

Some medicines may interact with Baxfendy. Tell your healthcare provider about all medicines you take.

Baxfendy may interact with medicines that increase potassium or impair potassium excretion. Your healthcare provider may monitor your potassium more frequently if Baxfendy is used with these medicines.

Strong or moderate CYP3A inducers may reduce the therapeutic effect of Baxfendy. Your healthcare provider may monitor the effect of Baxfendy more closely if you take these medicines.

Other drugs may interact with this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if this medicine can harm your unborn baby.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if this medicine passes into breast milk.

It is not known if this medicine is safe and effective in children under 18 years of age. It is only FDA-approved for use in adults

The FDA approval of Baxfendy was supported by the Phase 3 BaxHTN (NCT06034743) trial in adults with hypertension who were taking at least 2 antihypertensive medications, including a diuretic. Patients had systolic blood pressure of at least 140 mmHg and less than 170 mmHg before randomization.

At Week 12, Baxfendy 2 mg reduced seated systolic blood pressure by a mean of 15.7 mmHg from baseline, compared with 5.8 mmHg for placebo. The placebo-adjusted reduction was 9.8 mmHg. Baxfendy 1 mg reduced systolic blood pressure by 14.5 mmHg from baseline, with a placebo-adjusted reduction of 8.7 mmHg.

Store Baxfendy at room temperature between 68°F and 77°F (20°C to 25°C). Keep Baxfendy tablets in the original bottle. The bottle contains a desiccant packet to help keep the tablets dry; do not throw it away.

Keep Baxfendy and all medicines out of the reach of children.