For healthcare professionals and patients

Safety and prescribing information

Approved for the treatment of anaemia associated with chronic kidney disease in adult patients on dialysis and not on dialysis.

Prescription-only medicine · Use under medical supervision.

Rx Prescription-only medicinePI Prescribing Information · Version 4.0
Kidney illustration representing safety and prescribing information
1

Before use

Contraindication

Hypersensitivity to desidustat or any excipients.

Food window

No food one hour before and two hours after the dose.

Rx

Use only as prescribed

Do not use for a condition for which it was not prescribed.

No

Do not share

Do not share the medicine with others.

2

Trial safety by population

ND
Non-dialysis · DREAM-ND

Desidustat vs darbepoetin alfa

85.2% vs 85.7%Treatment-emergent adverse events
  • 251/588 vs 252/587
  • Serious adverse events: 10.7% vs 11.1%
  • 24-week open-label active-controlled trial
View DREAM-ND safety tables
Dialysis-dependent · DREAM-D

Desidustat vs epoetin alfa

86.5% vs 88.0%Treatment-emergent adverse events
  • 339/392 vs 345/392
  • Serious adverse events: 13.8% vs 14.0%
  • 24-week open-label active-controlled trial
View DREAM-D safety tables
i

Safety data are study-specific. Do not combine populations or reporting thresholds.

2A

Related safety evidence

Observational real-world evidence

Gulati et al. (2026)

No new safety signals were reported; mild constipation and throat discomfort were described. Retrospective limitations apply.

Explore real-world tolerability
CN
Other trial evidence

China Phase III (NDD-CKD)

Placebo-controlled safety evidence should be read using its own timeframe, comparator and denominators.

View China Phase III context
3

Special populations

Preg

Pregnancy

Safety has not been established. Use only if potential benefit justifies potential risk.

Nurs

Nursing mothers

Desidustat should not be used in nursing mothers according to the PI.

WCP

Women of childbearing potential

Use appropriate contraception during treatment.

Paed

Paediatric use

Safety and efficacy have not been established.

Geri

Geriatric use

Use with caution considering comorbidity and concomitant medicines.

4

Drug interactions

CYP

CYP-mediated interactions

Available in-vitro data suggest minimal potential for clinically mediated drug–drug interactions based on CYP pathways.

OAT3

Transporter information

Desidustat is a substrate of OAT3 and may be affected by OAT3 inhibitors. Refer to the PI for the full interaction context.

Open PI
i

Do not simplify the available evidence to “no drug interactions.”

5

Driving, overdose and storage

Driving and using machines

The PI states no or negligible influence on ability to drive and use machines.

Overdose

Provide supportive care and monitor vital signs as needed.

Storage

Store below 30°C, protect from moisture and keep out of reach of children.

6

Adverse-event reporting

Toll-free number

1800 419 1141

Report suspected adverse drug reactions.

Drug-safety email

drugsafety@zyduslife.com

Zydus Lifesciences drug safety.

Reporting information

www.zyduslife.com

Contact a healthcare professional for symptoms after use.

7

Full PI and related links

Open full PI

View the complete prescribing information.

Open PI

Dosing and administration

Starting dose, schedules and adjustment rules.

View dosing
i

This page is a summary. Always refer to the full prescribing information before prescribing.