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A - Regimen Name

BEND Regimen
Bendamustine


Disease Site
Hematologic - Lymphoma - Non-Hodgkin's Low Grade

Intent
Palliative

Regimen Category
Evidence-Informed :

Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR).  Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.


Rationale and Uses

Relapsed indolent B-cell non-Hodgkin Lymphoma (NHL)  patients who did not respond to or progressed during or shortly following treatment with a rituximab regimen.

 
B - Drug Regimen

bendamustine
120 mg /m² IV Days 1 and 2
(This drug is not currently publicly funded for this regimen and intent)
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C - Cycle Frequency

REPEAT EVERY 21 DAYS

For up to 8 cycles unless disease progression or unacceptable toxicity occurs

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Moderate

Other Supportive Care:

Also refer to CCO Antiemetic Summary

Hypertension should be controlled prior to starting treatment.

Pre-medication (only for patients with Grade 1 or 2 reactions with prior infusion):

  • Analgesic/antipyretic (e.g. acetaminophen), corticosteroid and an antihistamine (e.g. diphenhydramine) should be considered in subsequent cycles.
 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations have been adapted from clinical trials or product monographs and could be considered. Do not re-escalate after dose modification for toxicity.

Dosage with toxicity

Dose levels: 120 mg/m2, 90 mg/m2, 60 mg/m2
Toxicity
Modification
Grade 4 Hematologic toxicities
Delay until ANC ≥ 1 x 109/L, platelets ≥ 75 x 109/L then reduce by 1 dose level
≥ Grade 3 Hypersensitivity reaction
Discontinue
≥ Grade 2 clinically significant Non-hematologic toxicities;
≥ Grade 3 Non-hematologic toxicities
Delay until recovered to ≤ grade 1, then reduce by one dose level



Hepatic Impairment

Bilirubin
AST or ALT or ALP
Bendamustine dose
≤ –1.5 x ULN
≤ 2.5 x ULN
Caution
> 1.5  x ULN
> 2.5 x ULN
Do not use

Renal Impairment

Creatinine Clearance (mL/min)
Bendamustine dose
>80
100%
40 - 80
Caution
< 40
Do not use

Dosage in the Elderly

No dose adjustment required. No clinically significant differences in efficacy and safety were observed in those aged 65 and older and younger patients.


 
F - Adverse Effects

Refer to bendamustine drug monograph(s) for additional details of adverse effects

 


Very common (≥ 50%)

Common (25-49%)

Less common (10-24%)

Uncommon (< 10%),

but may be severe or life-threatening

  • Nausea, vomiting
  • Fatigue

 

  • Diarrhea
  • Fever, chills
  • Constipation

 

 

  • Anorexia, weight loss
  • Mucositis
  • Headache
  • Edema
  • Cough, dyspnea (may be severe)
  • Musculoskeletal pain
  • Rash (may be severe)
  • Abdominal pain
  • Immunosuppression, atypical infections
  • Abnormal electrolytes
  • Dizziness
  • Dysgeusia
  • Dyspepsia
  • Insomnia

 

  • Arrhythmia, Prolonged QT
  • Arterial thromboembolism
  • Cardiotoxicity
  • Hypertension
  • Hepatotoxicity
  • Infusion-related reaction
  • Renal failure
  • Secondary malignancy
  • Tumour lysis sydrome
  • Myelosuppression
  • ARDS

 

 
G - Interactions

Refer to bendamustine drug monograph(s) for additional details


  • CYP1A2 inhibitors my increase bendamustine concentration and toxicity; use with caution
  • CYP1A2 inducers (including cigarette smoking) may reduce bendamustine concentration and/or efficacy
 
H - Drug Administration and Special Precautions

Refer to bendamustine drug monograph(s) for additional details


Administration:

  • NHL - infuse over 60 minutes
  • Bendamustine infusions should be administered in a setting where full resuscitation facilities are immediately available, and under the close supervision of someone experienced and capable of dealing with severe infusion-related reactions.
  • DO NOT administer as an IV push or bolus.
  • Dilute to a final concentration of 0.2 - 0.6 mg/mL in 500 mL infusion bag of 0.9% sodium chloride or 2.5% dextrose/0.45% sodium chloride.
  • Reconstituted solution must be transferred to infusion bag within 30 minutes of reconstitution.
  • Administer bendamustine through a dedicated line.
  • Compatible with PVC or polyethylene bags.
  • Do not admix with other drugs.

Contraindications:

  • Patients who have a hypersensitivity to this drug or any of its components (including mannitol)
  • Patients with CrCl < 40 mls/min or moderate/severe hepatic impairment
  • Patients with serious infections

Other warnings/precautions:

  • Avoid live vaccines, since they may result in serious or fatal infections in patients immunocompromised by bendamustine.
  • Avoid in patients with relapsed indolent NHL who did not tolerate prior therapies (including other alkylating agents)
  • Use with caution in patients with hypertension and patients with mild renal and hepatic impairment

Pregnancy and lactation:

  • Bendamustine is not recommended for use in pregnancy. Adequate contraception should be used by both sexes 2 weeks before, during treatment, and for at least 4 weeks after the last dose.
  • Breastfeeding is not recommended
 
I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Recommended Clinical Monitoring

  • CBC; Baseline and before each cycle
  • Blood pressure; Baseline and before each dose
  • Electrolytes, including sodium, potassium, magnesium and uric acid; Baseline and before each cycle
  • Hepatitis B surface antigen; Baseline and as clinically indicated
  • Liver function tests; Baseline and before each cycle
  • Renal function tests; Baseline and before each cycle
  • Clinical toxicity assessment for infection (including CMV and herpes zoster), renal, cardiac, hepatic and skin toxicity , infusion reactions and secondary malignancies; at each visit
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

Suggested Clinical Monitoring

  • Blood glucose; Baseline and periodic
  • ECG; As clinically indicated; periodic in the setting of cardiac disorders and electrolyte imbalances
  • HIV status; Baseline
  • CMV testing in febrile patients; as clinically indicated

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J - Administrative Information

Approximate Patient Visit
0.5 to 1 hour
Pharmacy Workload (average time per visit)
19.35 minutes
Nursing Workload (average time per visit)
36.667 minutes
 
K - References

Bendamustine drug monograph, Cancer Care Ontario.

Garnock-Jones, K. Bendamustine: a review of its use in the management of indolent Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma. Drugs 2010; 70(13):1703-1718.

Van der Jagt R, Lnaeuville P, MacDonald D, et al. A Canadian perspective on bendamustine for the tratment of chronic lymphocytic leukemia and non-Hodgkin lymphoma. Curr Oncol 2012; 19(3):160-167.

October 2017 added not publicly funded to drug regimen


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M - Disclaimer

Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph.  Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.