POLIVY over 90 minutes. Monitor patients forinfusion-related reactions during the infusion and for a minimum of 90 minutes followingcompletion of the initial dose. If the previous infusion was well tolerated, the subsequent dose ofPOLIVY may be administered as a 30-minute infusion and patients should be monitored duringthe infusion and for at least 30 minutes after completion of the infusion.
If a planned dose of POLIVY is missed, administer as soon as possible. Adjust the schedule ofadministration to maintain a 21-day interval between doses.
2.2 Management of Adverse Reactions
Table 1 provides management guidelines for peripheral neuropathy, infusion-related reaction,and myelosuppression.
Table 1 Management of Peripheral Neuropathy, Infusion-Related Reaction, andMyelosuppression
Event Dose Modification
Grade 2–3
Peripheral
Neuropathy
Hold POLIVY dosing until improvement to Grade 1 or lower.
If recovered to Grade 1 or lower on or before Day 14, restart POLIVY with
the next cycle at a permanently reduced dose of 1.4 mg/kg.
If a prior dose reduction to 1.4 mg/kg has occurred, discontinue POLIVY.
If not recovered to Grade 1 or lower on or before Day 14, discontinue
POLIVY.
Grade 4
Peripheral
Neuropathy
Discontinue POLIVY.
Event Dose Modification
Grade 1–3
Infusion-Related
Reaction
Interrupt POLIVY infusion and give supportive treatment.
For the first instance of Grade 3 wheezing, bronchospasm, or generalizedurticaria, permanently discontinue POLIVY.
For recurrent Grade 2 wheezing or urticaria, or for recurrence of anyGrade 3 symptoms, permanently discontinue POLIVY.
Otherwise, upon complete resolution of symptoms, infusion may beresumed at 50% of the rate achieved prior to interruption. In the absenceof infusion related symptoms, the rate of infusion may be escalated inincrements of 50 mg/hour every 30 minutes.
For the next cycle, infuse POLIVY over 90 minutes. If no infusionrelatedreaction occurs, subsequent infusions may be administered over30 minutes. Administer premedication for all cycles.
Grade 4
Infusion-Related
Reaction
Stop POLIVY infusion immediately.
Give supportive treatment.
Permanently discontinue POLIVY.
Grade 3–4
Neutropeniaa,b
Hold all treatment until ANC recovers to greater than 1000/microliter.
If ANC recovers to greater than 1000/microliter on or before Day 7, resume
all treatment without any additional dose reductions. Consider granulocyte
colony stimulating factor prophylaxis for subsequent cycles, if not
previously given.
If ANC recovers to greater than 1000/microliter after Day 7:
restart all treatment. Consider granulocyte colony stimulating factor
prophylaxis for subsequent cycles, if not previously given. Ifprophylaxis was given, consider dose reduction of bendamustine.
if dose reduction of bendamustine has already occurred, considerdose reduction of POLIVY to 1.4 mg/kg.
Grade 3–4Thrombocytopeniaa,bHold all treatment until platelets recover to greater than 75,000/microliter.
If platelets recover to greater than 75,000/microliter on or before Day 7,resume all treatment without any additional dose reductions.
If platelets recover to greater than 75,000/microliter after Day 7:
restart all treatment, with dose reduction of bendamustine.
if dose reduction of bendamustine has already occurred, considerdose red |
