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COVID-19: Obtenez les dernières mises à jour ou faites une autoévaluation.

Les traitements par chimiothérapie et autres traitements systémiques pourraient être modifiés en raison de la COVID-19. Vous trouverez de plus amples renseignements à la page Traitements systémiques pendant la pandémie de la COVID-19.

Certaines de ces informations ou toutes, dans certains cas, n’apparaissent qu’en Anglais. Vous pouvez demander la version française

A - Regimen Name

NPAC(W) Regimen
Nab-Paclitaxel (weekly)


Disease Site
Breast

Intent
Palliative
(June 2020: copied details from NPAC(W) melanoma regimen)

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

For the treatment of metastatic breast cancer in patients who cannot tolerate paclitaxel or docetaxel therapy (acute reactions to cremophor/polysorbate 80 or severe toxicity to taxane/premedication).


Supplementary Public Funding

nab-PACLitaxel
New Drug Funding Program (Nab-Paclitaxel - Metastatic Breast Cancer) (NDFP Website )

 
B - Drug Regimen

Do not substitute for or with other paclitaxel formulations.

nab-PACLitaxel
100-150 mg /m² IV Days 1, 8, 15
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C - Cycle Frequency

REPEAT EVERY 28 DAYS until disease progression, no evidence of further response, or unacceptable toxicity

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Low

Other Supportive Care:

Also refer to CCO Antiemetic Summary

No premedication to prevent hypersensitivity is required.

 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated.  

Do not substitute for or with other paclitaxel formulations.

Nab-paclitaxel should only be administered if neutrophils ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L on day 1 of each treatment cycle.

Dosage with toxicity

Worst Toxicity / Counts (x 109/L)
Nab-paclitaxel % of previous dose

ANC < 0.5 ≥ 7 days

OR

febrile neutropenia 

OR

Delay of next cycle due to persistent neutropenia (ANC < 1.5)  
Hold*†^, then 80%
Grade 3 or 4 thrombocytopenia or bleeding
Hold*†^, then 80%. Discontinue if recurs.
Grade 2 or 3 cutaneous toxicity Hold*†^, then 80%
Grade 3 mucositis or diarrhea  Hold*†^, then 80%
Grade 3 or 4 sensory neuropathy Hold*†^, then 80%
Other grade 3 related organ/non-hematologic toxicity (except nausea/ vomiting /alopecia) Hold*†^, then 80%^

Other grade 4 related organ/non-hematologic toxicity

OR

Severe hypersensitivity

OR

Any cystoid macular edema

Discontinue
Pneumonitis Hold and investigate; discontinue if confirmed

*On day 1 of each cycle do not treat until ANC ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L. On days 8 and 15, do not treat until ANC ≥ 1 x 109/L and platelets ≥ 75 x 109/L.

Do not treat until non-hematologic toxicity ≤ grade 2 (or ≤grade 1 for mucositis, diarrhea, neuropathy or cutaneous toxicity).

^Discontinue treatment if there is a third occurrence of toxicity that would require dose reduction​​​​​​.



Hepatic Impairment

Patients with hepatic impairment may be at increased risk of myelosuppression and should be closely monitored.

Bilirubin

 

AST

Nab-paclitaxel*

 (% previous dose - suggested)

>1 to ≤ 1.5 x ULN

and

≤ 10 x ULN

100%

>1.5 to ≤ 5 x ULN

and

≤ 10 x ULN

↓ to 80% **

> 5 x ULN

or

> 10 x ULN

Discontinue (has not been studied).

*Based on clinical judgment. Patients with elevated baseline bilirubin were excluded from clinical trials. Less conservative adjustments can be considered if hepatic changes are secondary to metastases rather than hepatic cirrhosis or hepatitis. 
**Reduced dose may be escalated to 100% if treatment is tolerated for at least 2 cycles at the reduced dose.

 

Renal Impairment

Creatinine Clearance (mL/min)

Nab-paclitaxel*

(% previous dose - suggested)

≥ 30 to < 90

100%

< 30

Discontinue (has not been studied).

*Based on clinical judgment. Patients with elevated baseline creatinine were excluded from clinical trials.


Dosage in the Elderly

No dose adjustment is required.


 
F - Adverse Effects

Refer to nab-PACLitaxel 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

  • Alopecia
  • Myelosuppression +/- infection, bleeding (may be severe)
  • Sensory neuropathy (may be severe)

 

  • Fatigue
  • Musculoskeletal pain
  • Increased LFTs (may be severe)
  • ECG changes
  • Nausea/vomiting
  • Diarrhea (may be severe)
  • Eye disorders
  • Cough, dyspnea
  • Constipation
  • Anorexia
  • Increased creatinine (may be severe)
  • Edema
  • Injection site reaction
  • Hypersensitivity
  • Cardiotoxicity
  • Arrhythmia
  • Autonomic neuropathy
  • Cranial neuropathy
  • Arterial/venous thromboembolism
  • Hemolytic uremic syndrome / TTP
  • Acute renal failure
  • GI obstruction / perforation
  • Pancreatitis
  • Pneumonitis
  • Lung fibrosis
  • Keratitis / cystoid macular edema
  • Optic neuritis
 
G - Interactions

Refer to nab-PACLitaxel drug monograph(s) for additional details


No drug interaction studies have been conducted with nab-paclitaxel, but are likely to be similar to those reported for paclitaxel (refer to the paclitaxel drug monograph).

 
H - Drug Administration and Special Precautions

Refer to nab-PACLitaxel drug monograph(s) for additional details


Administration

  • Refer to the product monograph for full instructions on reconstitution.

  • The reconstituted suspension should be milky and homogenous without visible particulates.

  • Avoid shaking drug suspension in order to minimize foaming.

  • No further dilution is required after reconstitution. Transfer reconstituted drug to an empty, sterile IV PVC or non-PVC infusion bag.

  • Infuse intravenously over 30 minutes. Slower infusion rates may increase the likelihood of infusion-related reactions.

  • DEHP-free containers or administration sets may be used but are not required.

  • Do not admix with other drugs.

  • Use of syringes and IV bags containing silicone oil as lubricant may cause formation of proteinaceous strands. If strands are observed by visual inspection of IV bag, administer reconstituted suspension through filter of at least 15 µm pore size. If this is not possible, discard the product.

  • Store unopened vial at 20-25⁰C in its original carton; protect from light.

 

Contraindications

  • Patients who have a hypersensitivity to this drug or any of its components (such as albumin) in the formulation or container

  • Patients with baseline ANC of < 1.5 x 109/L on day 1 of each treatment cycle

 

Other Warnings / Precautions

  • Do not give nab-paclitaxel to patients with platelets < 100 x 109/L.

  • The use of nab-paclitaxel in patients exhibiting hypersensitivity to paclitaxel or human albumin has not been studied.

  • Patients with elevated baseline bilirubin or elevated baseline creatinine were excluded from clinical trials.

  • The use of albumin-containing solutions is associated with a remote risk of viral transmission, including CJD.

  • Radiation recall and pneumonitis have been reported in patients with concurrent radiotherapy.

  • Nab-paclitaxel is not recommended for use in patients with a history of interstitial lung disease, multiple allergies, progressive dyspnea or unproductive cough (cases of serious pneumonitis were reported in those treated with combination nab-paclitaxel and gemcitabine).

  • Caution is recommended prior to driving or operating machinery if fatigue, weakness or dizziness are present.

 

Pregnancy / Lactation

  • Nab-paclitaxel is not recommended for use in pregnancy. Adequate contraception should be used by both sexes during treatment and for at least 6 months after the last dose in males and for at least 1 month after the last dose in females.

  • Breastfeeding is not recommended.

  • Fertility effects: Probable

    • Irreversible male infertility has been observed in animal studies.

 
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

  • Liver function tests; Baseline, before each cycle and as clinically indicated

  • Closely monitor the injection site for possible infiltration; regular
  • Renal function tests; Baseline and as clinically indicated

  • ECG monitoring especially in patients who have cardiac risk factors; Baseline and as clinically indicated

  • Clinical toxicity assessment of fatigue, neuropathy, infection and bleeding, hypersensitivity, musculoskeletal, GI, ophthalmic, thromboembolism, local reactions and pneumonitis; 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
1 hour
Pharmacy Workload (average time per visit)
32.929 minutes
Nursing Workload (average time per visit)
35 minutes
 
K - References

Gradishar WJ, Krasnojon D, Cheporov S, et al. Significantly longer progression-free survival with nab-paclitaxel compared with docetaxel as first-line therapy for metastatic breast cancer. J Clin Oncol. 2009 Aug 1;27(22):3611-9.

Gradishar WJ, Krasnojon D, Cheporov S, et al. Phase II trial of nab-paclitaxel compared with docetaxel as first-line chemotherapy in patients with metastatic breast cancer: final analysis of overall survival. Clin Breast Cancer. 2012 Oct;12(5):313-21.

Mirtsching B, Cosgriff T, Harker G, et al. A phase II study of weekly nanoparticle albumin-bound paclitaxel with or without trastuzumab in metastatic breast cancer. Clin Breast Cancer 2011;11(2):121-8.

nab-Paclitaxel drug monograph, Cancer Care Ontario. 

June 2020 Removed NPAC(W)+TRAS - Delisted from ST-QBP March 2020; Updated dose modifications, adverse effects, administration and special precautions and monitoring sections


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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.