BAXFENDY 1 mg/1
baxdrostat · TABLET, FILM COATED · AstraZeneca Pharmaceuticals LP
BAXFENDY is a tablet, film coated containing baxdrostat at 1 mg/1, taken oral. Manufactured by AstraZeneca Pharmaceuticals LP.
Key Facts
- Brand Name
- BAXFENDY
- Generic Name
- baxdrostat
- NDC Code (Product)
0310-6001- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Strength
- 1 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA219878
- Marketing Start
- 05/15/2026
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. For specific advice on goals and management, see published guidelines, such as those of the American College of Cardiology/American Heart Association (ACC/AHA). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled tria…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • 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.
Contraindications
4 CONTRAINDICATIONS None. None. (4)
Drug Interactions
7 DRUG INTERACTIONS • 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.
Adverse Reactions
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 a…
Frequently Asked Questions
What is BAXFENDY used for?
BAXFENDY contains baxdrostat. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is BAXFENDY a controlled substance?
BAXFENDY is not classified as a controlled substance by the DEA.
What is the generic name for BAXFENDY?
The generic name for BAXFENDY is baxdrostat. There are no other listed brand versions of baxdrostat.
What is the NDC code for BAXFENDY 1 mg/1?
The NDC (National Drug Code) for BAXFENDY 1 mg/1 is 0310-6001, listed by AstraZeneca Pharmaceuticals LP.
Other BAXFENDY Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)