Vadadustat is used in adults with anemia of chronic kidney disease who have been on dialysis for at least 3 months, and use in special populations requires careful assessment of risks and benefits.

1. Use in Pregnancy and Lactation

1. Use in Pregnancy

Available data are insufficient to establish the safety of vadadustat for the fetus.

In animal studies, rats and rabbits showed decreased fetal weight at maternally toxic doses, but no teratogenicity was observed.

Chronic kidney disease itself may increase the risks of maternal hypertension, preeclampsia, miscarriage, and preterm birth.

Use during pregnancy only if the benefits outweigh the potential risks.

A pregnancy exposure registry is available, and healthcare providers and patients are encouraged to report pregnancies.

2. Use in Lactation

There are no data on the presence of vadadustat in human milk, and its effects on the breastfed infant or milk production are unknown.

Vadadustat is detectable in rat milk, suggesting that it may pass into human milk.

Given serious adverse reactions such as thrombotic vascular events observed in adults, breastfeeding is not recommended during treatment and for 2 days after the final dose.

2. Use in Pediatric and Geriatric Patients

1. Pediatric Patients

The safety and effectiveness of vadadustat in pediatric patients have not been established.

It is currently not recommended for use in children.

2. Geriatric Patients

Clinical trials included a large number of patients aged 65 years and older, including those over 75 and over 85 years of age.

No overall differences in safety or effectiveness were observed between geriatric patients and younger adults.

No special dose adjustment is required solely based on age in geriatric patients, but individualized assessment should still be performed.

3. Use in Patients with Hepatic or Renal Impairment

1. Patients with Hepatic Impairment

Vadadustat is not recommended for patients with cirrhosis or active, acute liver disease.

The drug may cause hepatotoxicity, and ALT, AST, and bilirubin should be monitored before and during early treatment.

If persistent transaminase elevation or elevation accompanied by increased bilirubin occurs, the drug should be discontinued.

Moderate hepatic impairment has no significant effect on pharmacokinetics, while the effect of severe impairment is unknown.

2. Patients with Renal Impairment

Vadadustat is indicated for adults with anemia of chronic kidney disease who have been on dialysis for at least 3 months.

It is not recommended for patients with anemia of chronic kidney disease who are not on dialysis.

Drug exposure is higher in dialysis-dependent patients than in healthy adults, but pharmacokinetics do not differ significantly when administered before or after dialysis.

Administration does not need to consider dialysis timing or dialysis type.