Usual Adult Dose for Follicular Lymphoma

60 mg via 1-hour IV infusion on Days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule (3 weeks on and 1 week off).

Duration of Therapy: Until disease progression or unacceptable toxicity

Comments: Accelerated approval was granted based on overall response rate; continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Use: Treatment of relapsed follicular lymphoma (FL) in patients who have received at least 2 prior systemic therapies.

Renal Dose Adjustments

Data not available.

Liver Dose Adjustments

Data not available.

Dose Adjustments

CONCOMITANT USE WITH STRONG CYP450 3A INDUCERS: Not recommended.

CONCOMITANT USE WITH STRONG CYP450 3A INHIBITORS: Reduce dose to 45 mg.

TOXICITY MANAGEMENT:
INFECTIONS:

• Grade 3 or Higher: Withhold this drug until resolution.
• Suspected Pneumocystis Jiroveci Pneumonia (PJP) Infection of Any Grade: Withhold this drug; if PJP confirmed, treat infection until resolution then resume this drug at previous dose with concomitant PJP prophylaxis.

• Pre-Dose Fasting Blood Glucose 160 mg/dL or More OR Random/Non-Fasting Blood Glucose of 200 mg/dL or More: Withhold this drug until fasting glucose is 160 mg/dL or less or a random/non-fasting blood glucose of 200 mg/dL or less.
• Pre-Dose OR Post-Dose Blood Glucose 500 mg/dL or More: Withhold this drug until fasting glucose is 160 mg/dL or less or a random/non-fasting blood glucose of 200 mg/dL or less; then reduce dose:
• First Occurrence: Reduce dose from 60 mg to 45 mg and maintain.
• Second Occurrence: Reduce dose from 45 mg to 30 mg and maintain.
• If Hyperglycemia Persistent at 30 mg: Discontinue this drug.

• Pre-Dose Blood Pressure (BP) 150/90 or Greater: Withhold this drug until BP is less than 150/90 based on 2 consecutive BP measurements at least 15 minutes apart.
• Post-Dose BP 150/90 or Greater (Non-Life-Threatening):
• Anti-Hypertensive Treatment Not Required: Continue this drug at previous dose.
• Anti-Hypertensive Treatment Is Required: Consider dose reduction from 60 mg to 45 mg OR from 45 mg to 30 mg.
• If BP Remains Uncontrolled (Greater than 150/90) Despite Anti-Hypertensive Treatment OR Post-Dose Elevated BP with Life-Threatening Consequences: Discontinue this drug.

• Grade 2: Withhold this drug and treat NIP; resume this drug at 45 mg if NIP recovers to Grade 0 or 1.
• Grade 2 Recurrence OR Grade 3 or Higher: Discontinue this drug.

• Absolute Neutrophil Count (ANC) 0.5 to 1 x 10(3) cells/mm3: Maintain dose, and monitor ANC at least weekly.
• ANC Less Than 0.5 x 10(3) cells/mm3: Withhold this drug. Monitor ANC at least weekly until ANC 0.5 x 10(3) cells/mm3 or greater, then resume at previous dose.
• Recurrence of ANC 0.5 x 10(3) cells/mm3 or Less: Reduce dose to 45 mg.

• Grade 3: Withhold this drug until toxicity is resolved, and reduce dose from 60 mg to 45 mg OR from 45 mg to 30 mg.
• Life-Threatening: Discontinue this drug.

• Less Than 25 x 10(9)/L: Withhold this drug; resume when platelet levels return to 75 x 10(9)/L or greater.
• If Recovery Occurs Within 21 Days: Reduce dose from 60 mg to 45 mg OR from 45 mg to 30 mg.
• If Recovery Does Not Occur Within 21 Days: Discontinue this drug.

• Grade 3: Withhold this drug until toxicity is resolved, and reduce dose from 60 mg to 45 mg OR from 45 mg to 30 mg.

Precautions

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:

• Following reconstitution and dilution, administer this drug as a single agent immediately or refrigerate and use within 24 hours.
• After refrigeration, allow this drug product to adapt to room temperature before use.

• Refrigerate drug vials at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit).
• Avoid exposure of the diluted solution to direct sunlight.

• Mix this drug only with 0.9% sodium chloride (NaCl) solution; do not mix or inject with other drugs or other diluents.
• Consult the manufacturer product information for reconstitution and dilution instructions.

• Cardiovascular: Blood pressure (pre- and post-infusion)
• Endocrine: Blood glucose (before each infusion)
• Hematologic: Blood counts (at least weekly during treatment)
• Infections/Infestations: Infection signs/symptoms (during treatment)

• Avoid taking grapefruit/grapefruit juice and/or St. John's Wort during treatment with this drug.