Approved indication
Treatment of anaemia in adult patients with:
- Chronic kidney disease (CKD) not on dialysis
- Chronic kidney disease (CKD) on dialysis
The essential safety
information in one place
OXEMIA® (Desidustat) is indicated for the treatment of
anaemia in adult patients with chronic kidney disease (CKD)
not on dialysis and on dialysis.
Prescribers are advised to read the full prescribing
information and follow approved dosing guidelines.
Prescribing information (PI) version: March 2025v2.0
BEFORE YOU USE OXEMIA
Contraindication
Do not use in patients with
hypersensitivity to desidustat
or any of the excipients
used in the formulation.
Food timing
Do not consume any food
for at least 2 hours before
or 2 hours after taking
Desidustat.
Use as prescribed
Do not use Oxemia® by a
non-doctor as it is not
intended for sale.
Do not share
Do not share your
medication with others,
even if they have similar
symptoms.
Missed dose
Do not take additional
doses to make up for
a missed dose.
SAFETY IN CLINICAL STUDIES
PHASE III · NON-DIALYSIS CKD
DREAM-ND Phase III Trial
Desidustat vs Darbepoetin alfa
583 patients 24 weeks
| Safety outcomes | Desidustat (n=290) | Darbepoetin alfa (n=293) |
|---|---|---|
| Treatment-emergent adverse events (TEAEs) | 201 (69.3%) | 209 (71.3%) |
| Serious adverse events (SAEs) | 31 (10.7%) | 31 (10.6%) |
| Discontinuation due to TEAEs | 3 (1.0%) | 3 (1.0%) |
PHASE III · DIALYSIS-DEPENDENT CKD
DREAM-D Phase III Trial
Desidustat vs Epoetin alfa
390 patients 24 weeks
| Safety outcomes | Desidustat (n=194) | Epoetin alfa (n=196) |
|---|---|---|
| Treatment-emergent adverse events (TEAEs) | 126 (64.9%) | 126 (64.3%) |
| Serious adverse events (SAEs) | 25 (12.9%) | 26 (13.3%) |
| Discontinuation due to TEAEs | 3 (1.5%) | 2 (1.0%) |
REAL-WORLD EVIDENCE (OBSERVATIONAL)
Real-world multicenter study
Gulati S, et al. (2026)
517 patients Up to 6 months
- Mild events such as constipation and
throat discomfort were reported - No discontinuations due to drug-related
toxicity were documented - No new safety signals were reported
during the observation period
Clinical trial results cannot predict all possible side effects. Individual responses may vary. Please refer to the full PI for complete safety information.
SPECIAL POPULATIONS
Pregnancy
The safety of desidustat in
pregnant women has not
been established. Use only
if the potential benefit
justifies the potential
risk to the fetus.
Nursing mothers
Desidustat should not
be used in nursing
mothers according
to the PI.
Women of childbearing
potential
Appropriate contraception
should be used during
treatment with
desidustat.
Paediatric use
Safety and efficacy of
desidustat in paediatric
patients have not been
established.
Geriatric use
Use with caution in
elderly patients considering
comorbidity and
concomitant medicines.
DRUG INTERACTIONS
Compared with interaction profiles reported for available HIF-PHIs, desidustat has minimal potential for CYP-mediated drug–drug interactions.
Potential interaction for CYP-mediated metabolism
In vitro assay has shown minimal inhibition of major CYP enzymes
Transporter interactions
No significant interaction
with OATP1B1, OATP1B3, OAT1, OCT2
Clinical relevance
Based on available data, desidustat has minimal potential
to cause CYP-mediated clinical drug–drug interactions at
therapeutically relevant concentrations in humans.
OTHER IMPORTANT INFORMATION
Driving and using machines
Desidustat has no or nil influence on the ability to drive or use machines.
Overdose
In case of overdose, initiate symptomatic and supportive care.
Monitor the patient and give appropriate treatment as needed.
Storage
Store below 30°C in a dry place. Protect from light.
Keep out of reach of children.
REPORTING ADVERSE EVENTS
Report any suspected adverse reactions to improve patient safety.
Toll-free number1800-419-1141
Emaildrugsafety@zyduslife.com
Online reportingwww.zyduslife.com →
Safety Reporting
Safety Reporting
If you experience any symptoms or side effects after taking Oxemia, contact your doctor or healthcare professional immediately.