Paclitaxel Albumin Abraxane Breast Cancer V1.1

Systemic Anti Cancer Therapy Protocol

Paclitaxel Albumin (ABRAXANE)

Breast Cancer
PROTOCOL REF: MPHAALPABR
(Version No. 1.1)
Approved for use in:

Breast cancer in the neoadjuvant, adjuvant or advanced/metastatic setting - when it is no
longer safe to continue with paclitaxel or docetaxel due to allergic reactions, but taxanes
are indicated.
OR
Interim COVID19 guidance – Paclitaxel albumin instead of either paclitaxel or docetaxel in
neoadjuvant, adjuvant or advanced/metastatic setting- to reduce the toxicity of treatment
and/or to reduce the number of admissions required for administration of treatment during the
COVID19 crisis.
ECOG performance status 0 to 2 is required for both indications

*******Blueteq form required for both indications*******
Note: Paclitaxel albumin (Abraxane) is time consuming to prepare, therefore patients must be
booked for a go ahead appointment the day before treatment to prevent delays.
Dosage:
Drug Dose Route Frequency

Albumin paclitaxel
260mg/m² IV Every 21 days
(Abraxane)
Issue Date: 20th May 2022

Page 1 of 7 Protocol reference: MPHAALPABR
Review Date: 1st May 2025
Author: Gabriella Langton Authorised by: Drugs & Therapeutics Committee Version No: 1.1
Neoadjuvant or adjuvant use – treatment is given to replace the planned number of taxane
cycles.
Palliative treatment – continue until disease progression, or unacceptable toxicity with
review after 6 cycles in total to ensure ongoing clinical benefit
Extravasation risk:
Albumin Paclitaxel (Abraxane) is a VESICANT
Refer to the CCC policy for the ‘Prevention and Management of Extravasation Injuries’.
Emetogenic risk:
Mildly emetogenic.
Supportive treatments:
Metoclopramide 10mg tablets, to be taken up to three times a day as required for nausea and
vomiting for maximum 5 consecutive days
For neoadjuvant/adjuvant patients:
 Weight <70kg – Filgrastim 300 micrograms s/c once a day for 7 days starting on day 3
of cycle
 Weight ≥ 70kg – Filgrastim 480 micrograms s/c once a day for 7 days starting on day 3
of cycle
Dosing in renal and hepatic impairment:

GFR ≥ 30ml/min- no dose adjustment required
Renal GFR <30ml/min or Haemodialysis - no need for dose adjustment is
expected. Use with caution as not tested in this patient group.
Patients with hepatic impairment may be at increased risk of toxicity,

particularly from myelosuppression.
Mild hepatic impairment

Hepatic
total bilirubin > 1 to ≤ 1.5 x ULN and AST ≤ 10 x ULN- no dose adjustments
required.
Moderate to severe hepatic impairment

Total bilirubin > 1.5 to ≤ 5 x ULN and AST ≤ 10 x ULN)- 20% reduction in
dose is recommended. The reduced dose may be escalated to full dose if
the patient is tolerating the treatment for at least two cycles
Abraxane is not recommended in patients that have total bilirubin > 5

x ULN or AST > 10 x ULN.
Interactions:
Paclitaxel toxicity may be increased with medicines known to inhibit either CYP2C8 or CYP3A4
(e.g. ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil,
clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, ritonavir and nelfinavir)- use with caution
Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or

CYP3A4 (e.g. rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine) is not
recommended- paclitaxel efficacy may be compromised.
Refer to the SmPC for full details on interactions.
Treatment schedule:
Day Drug Dose Route Diluent and rate
1 30 minutes before
Dexamethasone 8mg PO
chemotherapy
Albumin Paclitaxel
260mg/m2 IV Administer over 30 minutes
(Abraxane)
Hypersensitivity: routine prophylaxis against infusion related reactions is not required with
Paclitaxel Albumin (Abraxane). However, monitor during the infusion and treatment given if
necessary (antihistamines, steroids etc.).
Please refer to the CCC Hypersensitivity; Management Prevention Policy
Main toxicities:
Cardiac and vascular Tachycardia, arrhythmia, supraventricular tachycardia are
disorders common
Haematological Neutropenia, anaemia, thrombocytopenia,
Gastrointestinal Nausea, vomiting, diarrhoea, constipation, mucositis
Musculoskeletal Arthralgia, myalgia
Nervous system Peripheral neuropathy
Hepatobiliary Elevation of liver transaminases, alkaline phosphatase and
bilirubin.
Skin and subcutaneous Alopecia
tissue disorders Allergic skin rash frequently associated with pruritus
General disorders and Fatigue
administration site Infertility, early menopause
conditions

Investigations and treatment plan:
Pre Cycle 1 Cycle 2 Cycle 3 Cycle 4 Ongoing
Informed Consent x
Alternate cycles or as
Clinical Assessment x x x
clinically indicated
SACT Assessment
(to include PS and x x x x x Every cycle
toxicities)
On treatment review /
x x x x x Day before treatment
Go ahead
FBC x x x x x Every cycle
U&E & LFTs x x x x x Every Cycle
3 monthly or as clinically
CT scan x indicated for metastatic
patients only
Repeat if clinically
Full observations x
indicated
Weight recorded x x x x x Every cycle
Height x

Dose Modifications and Toxicity Management:
Haematological toxicity:
Proceed on cycle 1 day 1 ONLY if-
ANC ≥ 1.5 x 109/L Plt ≥ 100 x 109/L
Proceed on day 1 of cycle 2 onwards if-

ANC ≥ 1.0 x 109/L Plt ≥ 100 x 109/L
Delay 1 week on day 1 of cycle 2 onwards if-

ANC ≤ 0.9 x 109/L Plt ≤ 99 x 109/L
These haematological guidelines assume that patients are well with good performance
status, that other acute toxicities have resolved and the patient has not had a previous
episode of neutropenic sepsis.
Non-haematological toxicity:
Neuropathy:
1st occurrence of grade 2 sensory neuropathy- dose reduced to 220 mg/m² for
subsequent courses.
Recurrence of grade 2 sensory neuropathy- additional dose reduction should be made
to 180 mg/m2.
Grade 3 sensory neuropathy- hold treatment until resolution to Grade 1 or 2, followed by
a dose reduction for all subsequent courses if continuing treatment.
References:
Abraxane 5 mg/ml powder for dispersion for infusion SmPC, Bristol-Myers Squibb
Pharmaceuticals limited. Last updated 6th October 2021.

NAB1CV_v1.1 – Interim COVID19 Blueteq Form – Paclitaxel as albumin-bound
nanoparticles (nab-paclitaxel) instead of either paclitaxel or docetaxel in breast cancer
regimens (accessed 8th March 2023)
NAB1_v1.2 NHS England – Initial Funding Application Blueteq Form – Paclitaxel as

albumin-bound nanoparticles (nab-paclitaxel) for breast cancer (accessed 8th March
2023)
Supplement to: Krens S D, Lassche, Jansman G F G A, et al. Dose recommendations

for anticancer drugs in patients with renal or hepatic impairment. Lancet Oncol 2019;
20: e201–08.
Circulation/Dissemination
Date added into Q-Pulse 22nd June 2022
Date document posted on the Intranet N/A
Version History
V
e
D
r
a Author name and designation Summary of main changes
s
t
i
e
o
n
Helen Flint New Regimen Protocol V1.0
Gabriella Langton
Routine protocol update V1.1
Breast SRG Pharmacist


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Systemic Anti Cancer Therapy Protocol

Paclitaxel Albumin (ABRAXANE)

Approved for use in:

ECOG performance status 0 to 2 is required for both indications

Drug Dose Route Frequency

Issue Date: 20th May 2022

Dosing in renal and hepatic impairment:

Patients with hepatic impairment may be at increased risk of toxicity,

Mild hepatic impairment

Moderate to severe hepatic impairment

Abraxane is not recommended in patients that have total bilirubin > 5

Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or

Refer to the SmPC for full details on interactions.

Issue Date: 20th May 2022

Pre Cycle 1 Cycle 2 Cycle 3 Cycle 4 Ongoing

Issue Date: 20th May 2022

Proceed on day 1 of cycle 2 onwards if-

Delay 1 week on day 1 of cycle 2 onwards if-

Issue Date: 20th May 2022

NAB1_v1.2 NHS England – Initial Funding Application Blueteq Form – Paclitaxel as

Supplement to: Krens S D, Lassche, Jansman G F G A, et al. Dose recommendations

Date added into Q-Pulse 22nd June 2022

Date document posted on the Intranet N/A

Helen Flint New Regimen Protocol V1.0

Issue Date: 20th May 2022

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