Baxdrostat
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Renal Impairment Safety and effectiveness of BAXFENDY initiated in patients with eGFR < 45 mL/min/1.73 m 2 have not been established [see Clinical Studies ] . No dosage adjustment is required in patients with an eGFR ≥ 45 mL/min, unless assessed to be at risk of hyperkalemia [see Dosage and Administration and Warnings and Precautions ] .
Preparation and administration
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.
Drug interactions
Check interactions
Add the patient's other drugs. Matches come from both FDA labels: by name, drug class, and enzyme or transporter pathway.
- Baxdrostat
Label text (3 paragraphs)
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.
Contraindications
None. None. (4)
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for baxdrostat. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on the use of BAXFENDY during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcome. Hypertension during pregnancy poses a risk to the mother and fetus (see Clinical Considerations) . Although studies in animals have shown embryo-fetal toxicity at baxdrostat exposures > 29 times the human exposure at the clinical dose of 2 mg, the clinical significance of these findings is unclear (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Report any pregnancies while treated with BAXFENDY to AstraZeneca at 1-800-236-9933. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the risk for adverse maternal outcomes including pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage).
Hypertension also increases the risk of adverse fetal outcomes including intrauterine growth restriction and stillbirth. Pregnant women with hypertension should be carefully monitored and managed accordingly. Data Animal Data While baxdrostat had no effects on embryo-fetal development in rats or rabbits dosed through organogenesis at exposures up to 54‑fold (rat) and 29-fold (rabbit) the human dose of 2 mg, baxdrostat showed greatly reduced potency in rats compared to humans, which limits the interpretability of the rodent data. Higher baxdrostat doses were associated with increased incidence of adverse skeletal malformations in the rat and adverse decrease in rabbit fetal weights.
No adverse effects were noted in a pre- and postnatal study in rats dosed from gestation day 6 through lactation day 20 at exposures up to 65-fold the human exposure at 2 mg.
Breastfeeding (LactMed)
No information is available on the clinical use of baxdrostat during breastfeeding. Because baxdrostat is 74% bound to plasma proteins, the amount in milk is likely to be low. If a mother requires baxdrostat, it is not a reason to discontinue breastfeeding. Until more data become available, baxdrostat should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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