If several Velcade doses in consecutive
cycles are withheld due to toxicity
Velcade dose should be
reduced by one dose level (from 1.3 mg/m2to 1 mg/m2, or from 1 mg/m2to 0.7 mg/m2)
Serious (Grade 3) or higher non-hematological
Velcade therapy should
be withheld until symptoms of the toxicity have resolved to Grade 1 or
baseline. Then, Velcade may be restarted with one dose level reduction (from
1.3 mg/m2to 1 mg/m2, or
from 1 mg/m2to 0.7 mg/m2).
neuropathic pain and/or peripheral neuropathy, hold or modify Velcade as
Recommended Dose Modifications for Velcade-related Neuropathic Pain and/or Peripheral Sensory or Motor Neuropathy
Severity of Peripheral Neuropathy Signs and Symptoms
Modification of Dose and Regimen
[sensations of numbness, tingling,
or prickling], weakness, and/or loss of reflexes) without
pain or loss of function
1 with pain or Grade 2 (interfering with function but not with activities of
Velcade dose to 1.0 mg/m2
2 with pain or Grade 3 (interfering with activities of daily living)
Velcade therapy until toxicity resolves. When toxicity resolves, reinitiate
with a reduced dose of Velcade at 0.7 mg/m2 and change treatment
schedule to once per week.
4 (permanent sensory loss that interferes with function, sensory neuropathy
which is disabling, or motor neuropathy that is life threatening or leads to
Recommended Starting Dose Modification for Velcade in Patients with Hepatic Impairment
This chart shows how the starting dose of Velcade should be modified in patients with liver (hepatic) impairment.
Level of impairment*
SGOT (AST) level
Modification of Velcade starting dose
≤ 1.0 x ULN
> 1.0 x – 1.5 x ULN
> 1.5 x – 3.0 x ULN
First cycle: Reduce Velcade to 0.7 mg/m2 Subsequent cycles: Consider raising dose to 1.0 mg/m2 if tolerated well, or reducing dose further if necessary
> 3.0 x ULN
Abbreviations: AST = aspartate aminotransferase; SGOT = serum glutamic oxaloacetic transaminase; ULN = upper limit of the normal range.
*Liver impairment is noted by increased levels of certain substances that can be measured in the blood. These include bilirubin, a breakdown product of red blood cells that is normally removed by the liver, and the liver enzyme SGOT, which is also called AST.
Most common side effects seen in relapsed or refractory studies
APEX Trial - Most Common Side Effects (all grades)