Usual Adult Dose for Lymphoma

0.15 mg/kg IV over 30 minutes on Day 1 of each cycle (every 3 weeks) for 2 cycles, then 0.075 mg/kg IV over 30 minutes every 3 weeks for subsequent cycles

Comments:

• Premedicate with dexamethasone 4 mg orally or IV 2 times a day for 3 days beginning the day before this drug.
• If dexamethasone administration does not begin the day before this drug, dexamethasone should begin at least 2 hours prior to administration of this drug.

Use: For the treatment of adult patients with relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild hepatic impairment (total bilirubin upper limit of normal [ULN] or less and aspartate aminotransferase (AST) greater than ULN or total bilirubin greater than 1 to 1.5 x ULN and any AST): No adjustment recommended; monitor patients for increased adverse reactions and modify the dose if needed.
Moderate or severe hepatic impairment (total bilirubin greater than 1.5 x ULN and any AST): Data not available

Dose Adjustments

DOSE DELAYS OR MODIFICATIONS:
HEMATOLOGIC ADVERSE REACTIONS:

• Neutropenia (absolute neutrophil count less than 1 x 10(9)/L): Withhold this drug until neutrophil counts return to 1 x 10(9)/L or higher.
• Thrombocytopenia (platelet count less than 50,000/mcL): Withhold this drug until platelet count returns to 50,000/mcL or higher.

NONHEMATOLOGIC ADVERSE REACTIONS:
Edema or Effusion:

• Grade 2 or higher: Withhold this drug until the toxicity resolves to Grade 1 or less.

Other Adverse Reactions:

• Grade 3 or higher: Withhold this drug until the toxicity resolved to Grade 1 or less.

If dosing is delayed by more than 3 weeks due to toxicity related to this drug, reduce subsequent doses by 50%; if toxicity reoccurs following dose reduction, consider discontinuation.
NOTE: If toxicity requires dose reduction following the second dose of 0.15 mg/kg (Cycle 2), the patient should receive the dose of 0.075 mg/kg for Cycle 3.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Storage requirements:

• Store refrigerated at 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.

Reconstitution/preparation techniques:

• Reconstitute and further dilute this drug prior to infusion.
• Use appropriate aseptic technique.
• The manufacturer product information should be consulted.