Usual Adult Dose for Lymphoma

12 mg/kg IV (based on actual body weight; Administer in combination with lenalidomide 25 mg orally for a maximum of 12 cycles, then continue this drug as monotherapy until disease progression or unacceptable toxicity:
CYCLE 1: 12 mg/kg IV on Days 1, 4, 8, 15, and 22
CYCLE 2: 12 mg/kg IV on Days 1, 8, 15, and 22
CYCLE 3: 12 mg/kg IV on Days 1 and 15

• NOTE: Each therapy cycle is 28 days.
• For the first infusion, use an infusion rate of 70 mL/h for the first 30 minutes, then increase the rate so that the infusion is administered within 1.5 to 2.5 hours; administer all subsequent infusions within 1.5 to 2 hours.

Comments:

• Refer to the lenalidomide prescribing information for lenalidomide dosage recommendations.
• Administer premedications 30 minutes to 2 hours prior to starting infusion to minimize infusion-related reactions.
• Premedications may include acetaminophen, histamine H1 receptor antagonists, histamine H2 receptor antagonists, and/or glucocorticosteroids.
• For patients not experiencing infusion-related reactions during the first 3 infusions, premedication is optional for subsequent infusions.
• If a patient experiences an infusion-related reaction, administer premedications before each subsequent infusion.

Use: This drug in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT)

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

DOSE MODIFICATIONS FOR ADVERSE REACTIONS:
INFUSION RELATED REACTIONS (IRRS):

• GRADE 2: Interrupt therapy and treat the IRR; when resolved to Grade 1, resume infusion at no more than 50% of the rate at which the reaction occurred; if the patient does not experience further reaction within 1 hour and vital signs are stable, the infusion rate may be increased every 30 minutes as tolerated to rate at which the reaction occurred.
• GRADE 3: Interrupt therapy and treat the IRR; when resolved to Grade 1, resume infusion at no more than 25% of the rate at which the reaction occurred; if the patient does not experience further reaction within 1 hour and vital signs are stable, the infusion rate may be increased every 30 minutes as tolerated to a maximum of 50% of the rate at which the reaction occurred; if after rechallenge the reaction returns, stop the infusion immediately.
• GRADE 4: Permanently discontinue therapy.

MYELOSUPPRESSION:

• Platelet count 50,000/mcL or less: Withhold this drug and lenalidomide and monitor complete blood count (CBC) weekly until platelet count is 50,000/mcL or higher; resume this drug at the same dose and lenalidomide at a reduced dose (refer to lenalidomide prescribing information for dose modifications).
• Neutrophil count of 1000/mcL or less for at least 7 days OR neutrophil count of 1000/mcL or less with an increase of body temperature to 100.4F (38C) OR neutrophil count less than 500/mcL: Withhold this drug and lenalidomide and monitor CBC weekly until neutrophil count is 1000/mcL or higher; ; resume this drug at the same dose and lenalidomide at a reduced dose (refer to lenalidomide prescribing information for dose modifications).

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

Administration advice:

• Infuse the entire contents of the bag.
• Do not coadminister other drugs through the same infusion line.
• No incompatibilities have been observed between this drug with infusion containers made of polypropylene (PP), polyvinylchloride (PVC), polyethylene (PE), polyethyleneterephthalate (PET), or glass and infusion sets made of polyurethane (PUR) or PVC.

Storage requirements:

• Store unopened product refrigerated at 36F to 46F (2C to 8C) in the original carton to protect from light. Do not shake. Do not freeze.
• Use the reconstituted solution immediately.
• If needed, store the reconstituted solution in the vial for a maximum of 12 hours either refrigerated at 36F to 46F (2C to 8C) or room temperature at 68F to 77F (20C to 25C) before dilution. Protect from light during storage.

Reconstitution/preparation techniques:

• Reconstitute and dilute this drug prior to infusion.
• The manufacturer product information should be consulted.

IV compatibility:

• Sodium chloride injection

General:

• This drug should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support to manage infusion-related reactions (IRRs).