Safety Profile for WELIREG™ (belzutifan)
The median duration of exposure to WELIREG was 68 weeks (range: 8.4 to 104.7 weeks).
Dosage interruptions due to ARs occurred in 39% of patients; dose reductions due to ARs occurred in 13% of patients.
Patients on WELIREG experienced a low rate of permanent discontinuation (3.3%) due to ARs. ARs that resulted in permanent discontinuation of WELIREG were dizziness and opioid overdose (1.6% each).
Serious ARs occurred in 15% of patients who received WELIREG, including anemia, hypoxia, anaphylaxis reaction, retinal detachment, and central retinal vein occlusion (1 patient each).
Monitoring for anemia and hypoxia
Monitor for anemia and oxygen saturation before initiation of, and periodically throughout, treatment with WELIREG.
- Decreased hemoglobin occurred in 93% of patients and 7% had Grade 3 events.
- Median time to onset of anemia was 31 days (range: 1 day to 8.4 months).
- Hypoxia occurred in 1.6% of patients.
Graded per NCI CTCAE v4.0.
Includes other related terms.
Includes visual impairment, vision blurred, central retinal vein occlusion and retinal detachment.
The denominator used to calculate the rate is based on all patients in the safety analysis population.
AR = adverse reaction; ALT = alanine aminotransferase; AST = aspartate aminotransferase; NCI CTCAE = National Cancer Institute Common Terminology Criteria for Adverse Events.
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