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A - Regimen Name

ERIB Regimen
eriBULin


Disease Site
Breast

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

Treatment of metastatic or incurable locally advanced breast cancer patients meeting the following criteria:

  • have had previous treatment with a taxane and an anthracycline, and
  • whose disease has progressed following at least two chemotherapy regimens for metastatic or locally recurrent disease, and
  • whose disease has progressed after the last therapy, and
  • have good performance status (ECOG ≤2)

Supplementary Public Funding

eriBULin
New Drug Funding Program (Eribulin - Metastatic or Incurable Locally Advanced - Breast Cancer) (NDFP Website)

 
B - Drug Regimen

eriBULin

1

1.4 mg /m² IV Days 1 and 8

1 as eriBULin mesylate

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C - Cycle Frequency

REPEAT EVERY 21 DAYS

Until disease progression, no evidence of further response, or unacceptable toxicity.

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Low

 
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 start the first dose until platelets are > 100 x 109/L and ANC ≥ 1.5 x 109/L. Correct electrolyte abnormalities prior to treatment, especially potassium, calcium and magnesium. Do not re-escalate a dose reduced for toxicity.

Starting Dose *
Dose level -1 *
Dose level -2 *
Dose level -3 *
1.4 mg/m2
1.1 mg/m2
0.7 mg/m2
Discontinue
*as eriBULin mesylate
 
 
 
 

Dosage with toxicity

Dose adjustments on Day 1 or Day 8:

Worst toxicity in previous period / on day of dosing

Day 1*
Day 8 */#

Platelets < 75-100 x 109/L or ANC <1-1.5 x 109/L on day of dosing

Do not treat *

Delay for one week; if no recovery, omit for that cycle

 

Grade 4 ANC > 7 days, Grade 4 thrombocytopenia, Febrile neutropenia, Platelets < 50 requiring transfusion or Thrombocytopenic bleeding

Hold until recovered*, then ↓ 1 dose level

Delay for one week; if no recovery, omit for that cycle

 
≥ grade 3 non-hematologic

Hold until recovered*,  then ↓ 1 dose level

Delay for one week until ≤ grade 2;   if no recovery, omit for that cycle

 

Delay or dose modification for day 8 in previous cycle

↓ one dose level for all subsequent doses

* Do not treat until ANC ≥ 1 x 109/L and platelets ≥ 75 x 109/L and other toxicity ≤ grade 2.
# If delay day 8, the cycle length is also increased (next cycle must be ≥2 weeks after the delayed "day 8").



Hepatic Impairment

eriBULin exposure is increased in mild and moderate hepatic impairment.  Starting doses should be reduced and patients monitored closely for toxicity. 

 Hepatic function
Recommended Dose on Days 1 and 8 (mg/m2)
Normal (bilirubin < 1.5 x ULN, transaminases ≤ 3 x ULN)
1.4
Mild impairment (Child Pugh A)
1.1
Moderate impairment (Child Pugh B)
0.7
Severe impairment (Child Pugh C)
OMIT

 

 


Renal Impairment

Mild or moderate renal impairment may decrease eriBULin clearance. Exposure may increase up to 1.5-fold in moderate or severe renal impairment.  Monitor for adverse effects, especially myelosuppression.

Renal impairment Starting dose
Mild (50-80 mL/min) No change in starting dose
Moderate or severe (15-50 mL/min) Caution; ↓ starting dose to 1.1 mg/m2
End-stage (<15 mL/min) No data; OMIT

Dosage in the Elderly

No dose adjustments required.

 


 
F - Adverse Effects

Refer to eribulin 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

  • Increased LFTs (may be severe)
  • Myelosuppression +/- infection, bleeding (may be severe)
  • Fatigue
  • Alopecia
  • Abnormal electrolytes
  • Nausea, vomiting
  • Neuropathy (may be severe)
  • Constipation
  • Musculoskeletal pain
  • Anorexia, weight loss
  • Headache
  • Diarrhea
  • Cough, dyspnea
  • Increased creatinine (may be severe)
  • Atrial fibrillation 
  • QT prolongation
  • Venous thromboembolism
  • Disseminated intravascular coagulation
  • Rash (SJS, TENS)
  • Hypersensitivity
  • Hand-foot syndrome
  • Pancreatitis
  • Pneumonitis 
 
G - Interactions

Refer to eribulin drug monograph(s) for additional details


  • Avoid drugs that prolong QT interval, where possible. Monitor with ECG if used together. 
  • Caution and monitor ECG with drugs that disrupt electrolyte levels.
  • Caution and monitor for toxicity with inhibitors of P-gp (i.e. quinidine, verapamil, cyclosporine). 
 
H - Drug Administration and Special Precautions

Refer to eribulin drug monograph(s) for additional details


Administration
 

  • Give IV over 2 to 5 minutes
  • Dose may be administered in a syringe without dilution or may dilute in up to 100mL NS.
  • Does not require premedications with steroids and/or antihistamines for hypersensitivity.

 

  • Do not admix eriBULin with other medicinal products.
  • Do not dilute or administer with dextrose-containing solutions.

 

  • Store unopened vials at room temperature in their original cartons.
  • Diluted solutions may be stored for up to 48 hours refrigerated, or for up to 24 hours at room temperature.

 


Contraindications

 

  • Patients who have a hypersensitivity to this drug, halichondrin B or any of its components
  • Severe hepatic impairment
  • End-stage renal disease

 

Precautions

  • Avoid use in patients with congenital long QT syndrome.
  • Avoid concomitant use of QT-prolonging drugs, where possible (see Drug Interactions). 
  • Correct any hypocalcemia, hypokalemia and hypomagnesemia prior to starting eriBULin.
  • Exercise extreme caution with significant cardiovascular impairment (congestive heart failure > grade 2, unstable angina or myocardial infarction within the last 6 months) as the safety of eriBULin in this population has not been established.
  • Use with caution in patients with pre-existing neuropathy as eriBULin may aggravate the condition.

 

Pregnancy & lactation

  • eriBULin is not recommended for use in pregnancy.  Adequate contraception should be used by both sexes during treatment, and for at least 3 months after the last dose. Breastfeeding is not recommended. 
  • Fertility effects may be irreversible. Male patients should seek advice on conservation of sperm prior to treatment. 

 

 
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 dose; more frequent in patients who develop severe myelosuppression.
  • ECG in patients with risk factors for torsade de pointes (i.e. patients with cardiac disease or concomitant QT-prolonging medications); Baseline and as clinically indicated
  • Liver and renal function tests, including electrolytes; Baseline and before each dose
  • Clinical toxicity assessment for neuropathy, cardiotoxicity, hepatic, musculoskeletal, fatigue, GI symptoms and thromboembolism; At each visit
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version


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J - Administrative Information

Approximate Patient Visit
30 minutes
Pharmacy Workload (average time per visit)
15.15 minutes
Nursing Workload (average time per visit)
36.667 minutes
 
K - References

Cortes J, O’Shaughnessy J, Loesch D, et al. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet 2011; 377: 914–23.

Eribulin drug monograph, Cancer Care Ontario.

 

January 2018 updated adverse effects; added interactions, admin & precautions


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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.