Usual Adult Dose for Lymphoma

1.8 mg/kg IV every 21 days for 6 cycles in combination with bendamustine and rituximab; administer this drug, bendamustine, and rituximab in any order on Day 1 of each cycle

• The recommended dose of bendamustine is 90 mg/m2/day IV on Days 1 and 2 of each cycle
• The recommended dose of rituximab is 375 mg/m2 IV on Day 1 of each cycle.

• Premedicate with an antihistamine and antipyretic at least 30 minutes prior to therapy.
• Administer the initial dose of this drug over 90 minutes.
• Monitor patients for infusion-related reactions during the infusion and for a minimum of 90 minutes following completion of the initial dose. If the previous infusion was well tolerated, the subsequent dose may be administered as a 30-minute infusion and patients should be monitored during the infusion and for at least 30 minutes after completion of the infusion.
• If a dose of this drug is missed, administer as soon as possible. Adjust the schedule of administration to maintain a 21-day interval between doses.

Renal Dose Adjustments

Mild to moderate renal impairment (CrCl 30 to 89 mL/min): No adjustment recommended.
Severe renal impairment (CrCl 15 to 29 mL/min) or end-stage renal disease with or without dialysis: Data not available

Liver Dose Adjustments

Mild hepatic impairment (AST or ALT greater than 1.5 x ULN or total bilirubin greater than 1 to 1.5 x ULN: No adjustment recommended.
Moderate to severe hepatic impairment (AST or ALT greater than 2.5 x ULN or total bilirubin greater than 1.5 x ULN) or liver transplantation: Data not available

Dose Adjustments

DOSE ADJUSTMENTS FOR PERIPHERAL NEUROPATHY:
GRADE 2 or 3:

• Withhold therapy until improvement to Grade 1 or lower.
• If recovered to Grade 1 or lower on or before Day 14, restart therapy 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 therapy.
• If not recovered to Grade 1 or lower on or before Day 14, discontinue therapy.

• Interrupt the infusion and give supportive treatment.
• For the first instance of Grade 3 wheezing, bronchospasm, or generalized urticaria, permanently discontinue therapy.
• Upon complete resolution of symptoms, infusion may be resumed at 50% of the rate achieved prior to interruption. In the absence of infusion related symptoms, the rate of infusion may be escalated in increments of 50 mg/hour every 30 minutes. For the next cycle, infuse over 90 minutes. If no infusion-related reaction occurs, subsequent infusions may be administered over 30 minutes.
• For recurrent Grade 2 wheezing or urticaria, or for recurrence of any Grade 3 symptoms, permanently discontinue therapy.
• Administer premedication for all cycles.

• Stop the infusion immediately.
• Give supportive treatment.
• Permanently discontinue therapy.

• Withhold therapy until ANC recovers to greater than 1000/microliter.
• If ANC recovers to greater than 1000/microliter on or before Day 7, resume therapy 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 therapy. Consider granulocyte colony stimulating factor prophylaxis for subsequent cycles, if not previously given. If prophylaxis was given, consider dose reduction of bendamustine. If dose reduction of bendamustine has already occurred, consider dose reduction of polatuzumab to 1.4 mg/kg.

• Withhold therapy until platelets recover to greater than 75,000/microliter.
• If platelets recover to greater than 75,000/microliter on or before Day 7, resume therapy without any additional dose reductions.
• If platelets recover to greater than 75,000/microliter after Day 7: Restart therapy with dose reduction of bendamustine. If dose reduction of bendamustine has already occurred, consider dose reduction of polatuzumab to 1.4 mg/kg.

• If not already premedicated rituximab, administer an antihistamine and antipyretic at least 30 to 60 minutes prior to polatuzumab for potential infusion-related reactions.
• Administer prophylaxis for Pneumocystis jiroveci pneumonia and herpesvirus throughout treatment with polatuzumab.
• Consider prophylactic granulocyte colony stimulating factor administration for neutropenia.
• Administer tumor lysis syndrome prophylaxis for patients at increased risk of tumor lysis syndrome.

Precautions

CONTRAINDICATIONS:

• None

Dialysis

Data not available

Other Comments

Administration advice:

• Administer this drug IV only.
• This drug should be administered using a dedicated infusion line equipped with a sterile, non-pyrogenic, low-protein binding in-line or add-on filter (0.2- or 0.22-micron pore size) and catheter.

• Store unopened product in the refrigerator 2C to 8C (36F to 46F) in original carton to protect from light.
• Do not use beyond the expiration date shown on the carton.
• Do not freeze.
• Do not shake.

• Reconstitute immediately before dilution.
• Consult the manufacturer product information for reconstitution instructions.

• Sodium chloride 0.9% injection
• Dextrose 5% injection

• This drug is cytotoxic. Follow applicable special handling and disposal procedures.