Usual Adult Dose for Chronic Lymphocytic Leukemia

100 mg/m2 IV on Days 1 and 2 of a 28-day cycle
Duration of Therapy: Up to 6 cycles

Comments:

• Administer this drug via IV infusion over 30 minutes; consult the manufacturer product information for specific IV infusion time period.
• Efficacy of this drug relative to first-line therapies other than chlorambucil has not been established.
• This drug is available in two formulations, a solution and a lyophilized powder; do not mix or combine the two formulations.

Use: For the treatment of patients with chronic lymphocytic leukemia

Usual Adult Dose for non-Hodgkin's Lymphoma

120 mg/m2 IV on Days 1 and 2 of a 21-day cycle
Duration of Therapy: Up to 8 cycles

Comments:

• Administer this drug via IV infusion over 60 minutes; consult the manufacturer product information for specific IV infusion time period.
• This drug is available in two formulations, a solution and a lyophilized powder; do not mix or combine the two formulations.

Use: For the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen

Renal Dose Adjustments

• Mild to Moderate Renal Dysfunction: Use with caution.
• Severe Renal Dysfunction (CrCl less than 30 mL/min): Not recommended.

Liver Dose Adjustments

• Mild Liver Dysfunction: Use with caution.
• Moderate Liver Dysfunction (AST or ALT 2.5 to 10 x Upper Limit of Normal and Total Bilirubin 1.5 to 3 x ULN): Not recommended.
• Severe Liver Dysfunction (Total Bilirubin greater than 3 x ULN): Not recommended.

Dose Adjustments

Chronic Lymphocytic Leukemia (CLL) or Non-Hodgkin Lymphoma (NHL):
Grade 4 Hematologic Toxicity or Clinically Significant Grade 2 or Greater Non-Hematologic Toxicity: Delay treatment; reinitiate therapy at a physician's discretion once non-hematologic toxicity has recovered to Grade 1 or less and/or absolute neutrophil count (ANC) 1 x 10(9)/L or greater and platelets 75 x 10(9)/L or greater; dose reduction may be warranted.

CLL:
Grade 3 or Greater Hematologic Toxicity: Reduce dose to 50 mg/m2 on Days 1 and 2 of each cycle.

• If Grade 3 or greater toxicity recurs, reduce dose to 25 mg/m2 on Days 1 and 2 of each cycle.
• Dose re-escalation in subsequent cycles may be considered per physician discretion.

Clinically Significant Grade 3 or Greater Non-Hematologic Toxicity: Reduce dose to 50 mg/m2 on Days 1 and 2 of each cycle.

• Dose re-escalation in subsequent cycles may be considered per physician discretion.

NHL:
Grade 4 Hematologic Toxicity or Grade 3 or Greater Non-Hematologic Toxicity: Reduce dose to 90 mg/m2 on Days 1 and 2 of each cycle.

• If Grade 4 hematologic or Grade 3 or greater non-hematologic toxicity recurs, reduce dose to 60 mg/m2 on Days 1 and 2 of each cycle.

Precautions

CONTRAINDICATIONS:
Patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to the active component

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

Consult WARNINGS section for additional precautions.

Dialysis

This drug is dialyzable to a small extent; however, no dose adjustment guidelines have been reported.

Other Comments

Administration Advice:

• Allow the drug vial to reach room temperature, 15C to 30C (59F to 86F) prior to use.
• Consult the manufacturer product information for IV infusion administration technique and timing.

Storage Requirements:

• Store the solution under refrigeration at 2C to 8C (36F to 46F) and retain in original carton to protect from light.
• Store the lyophilized powder at controlled room temperature, up to 25C (77F) with excursions permitted up to 30C (86F) and retain in original carton to protect from light.

Reconstitution/Preparation Techniques:

• Consult the manufacturer product information.

IV Compatibility:

• Consult the manufacturer product information for compatible diluents.

General:

• There is no specific antidote for overdosage. Effective countermeasures to control hematological side effects include bone marrow transplantation, transfusions (platelets, concentrated erythrocytes), or hematological growth factors.
• If this drug comes into contact with skin, mucous membranes, or eyes, immediately wash skin thoroughly with soap and water, flush contaminated mucous membranes thoroughly with water, and rinse eyes with physiological saline solution.

Monitoring:

• Skin reactions
• CBC and blood chemistry
• IV infusion site reactions
• Fever and other signs of infection or reactivation of infections
• Liver function
• New or worsening neurological, cognitive or behavioral signs or symptoms

Patient Advice:

• This drug may cause side effects such as drowsiness that can affect your ability to perform certain activities; avoid driving and activities such as operating machinery until you know how this drug affects you.
• Advise female patients of reproductive potential to use effective contraception during treatment and for at least 6 months after the last dose.
• Advise males with female partners of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose.
• Advise females not to breastfeed during treatment and for at least 1 week after the last dose.
• Advise males of reproductive potential that this drug may impair fertility.
• Advise patients to undergo regular skin cancer screenings, and to report any changes to their healthcare provider.
• Advise patients to immediately contact their health care provider if signs of liver failure occur, including jaundice, anorexia, bleeding, or bruising.
• Advise patients to immediately report to their healthcare provider if they experience confusion, memory loss, trouble thinking, difficulty talking or walking, vision loss, or other neurological or cognitive symptoms.
• Advise patients to immediately report severe or worsening rash or itching.
• Advise patients to report any diarrhea, nausea, or vomiting.
• Advise patients to report shortness of breath, significant fatigue, bleeding, fever, or other signs of infection.

Frequently asked questions

• Are lung nodules common after Bendeka & Rituxan therapy?
• How is Bendeka different to Treanda?
• Why has Bendeka replaced Treanda?
• How often is Bendeka given and how long does treatment last?
• Does Treanda cause hair loss?
• What is Treanda used for and how does it work?
• What is Bendeka used for?