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One dose, one less thing
 to worry about

Pelgraz® offers one dose per cycle administration

Prescribing Information Adverse Event Reporting

AboutPelgraz®

Helps maintain the planned chemotherapy treatment regimen by reducing the incidence of severe neutropenia, dose reduction and treatment delay when compared to filgrastim1

Pelgraz® is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).2

Pelgraz® SmPC Pelgraz® PIL

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Completing the chemotherapy dose is a major factor

in increasing survival rates3

Impact of delayed cycles on overall survival3

Cumulative Proportion Survival

≤2 Delayed Cycles (n=581)

>2 Delayed Cycles (n=212)

p=0.0008

Overall Survival (Years)

Neutropenia can delay or interrupt chemotherapy treatment, reducing relative dose intensity and impairing the effect of treatment3

Adapted from Chirivella et al. 2009

Pegfilgrastim can ease worry by reducing the chance

of severe neutropenia compared to filgrastim1

Comparison of febrile neutropenia, severe neutropenia and treatment delivery in breast cancer patients receiving dose - dense adjuvant chemotherapy and supported by either pegfilgrastim or filgrastim1

  Filgrastim
n=529
(95 % Cl) 		Pegfilgrastim
n=529
(95 % Cl) 		p value
Febrile neutropenia 3.4 (2.0-5.3 %) 4.3 (2.8-6.4 %) 0.500
Severe neutropenia 32.3 (28.4-36.5 %) 10.4 (7.9-13.3 %) < 0.001
Treatment delays (>2 days) 42.0 (37.7-46.3 %) 27.6 (23.8-31.6 %) < 0.001
Dose reduction 18.5 (15.3-22.1 %) 10.8 (8.3-13.7 %) < 0.001

Patients receiving pegfilgrastim had a significantly lower rate of severe neutropenia as well as dose reduction or treatment delay, therefore achieving a higher dose density in comparison to the filgrastim group1

Pegfilgrastim reduces disruption

to a patient’s everyday routine versus daily filgrastim4

Mean number of injections administered to breast cancer patients treated with filgrastim and pegfilgrastim4

Treatment
type 		Cycle 1 Cycle 2 Cycle 3 Cycle 4
Daily dose
filgrastim
(5 μg/kg) 		10.6
injections 		10.2
injections 		10.4
injections 		11
injections
Pelgraz® 1 injection 1 injection 1 injection 1 injection

One dose per cycle pegfilgrastim provides neutrophil support comparable to daily dose filgrastim helping to simplify the management of chemotherapy induced neutropenia for healthcare professionals and patients4

One dose per cycle pegfilgrastim

can help to improve guideline adherence5

Timing of initiation of G-CSF dosing relative to the end of chemotherapy for daily G-CSF cycles and pegfilgrastim cycles5

  • Pegfilgrastim (n=446)
  • Daily G-CSF (n=718)
y-axis
x-axis
value
line black
line red

* Italian Association of Oncology Medicine (AIOM) Guidelines

In contrast to daily G-CSF, pegfilgrastim was administered according to Italian clinical guidelines (within 24–72 hours after chemotherapy end)* in over 90% of cycles5

Biosimilarity

Pelgraz® Phase III study confirms biosimilarity with Neulasta®

for expected safety and efficacy endpoints.6

A Phase III, randomised, active controlled, assessor-blinded study comparing efficacy and safety of Pelgraz®
versus the US and EU licensed Neulasta®6

Treatment Group Neulasta® US Neulasta® EU Pelgraz®
Number of Subjects 148 147 294
Duration of severe neutropenia in cycle 1, LS* Mean in days 95% CI** 1.4
1.17 - 1.61 		1.6
1.38 - 1.83 		1.6
1.47 - 1.79 		Primary
Efficacy
Endpoints
Frequency of febrile neutropenia following treatment in cycle 1 95% CI** 4.1%
1.5 - 8.6 		3.4%
1.1 - 7.8 		5.1%
2.9 - 8.3 		Secondary
Efficacy
Endpoints

* LS, least squares
** CI, confidence interval

"The evidence acquired over 10 years of clinical experience shows that biosimilars approved through EMA can be used as safely and effectively in all their approved indications as other biological medicines”7

Pelgraz® has demonstrated

biosimilarity with Neulasta®8

Two Phase I studies with a total of 410 healthy adult subjects* presented no significant difference in terms of safety and immunogenicity profiles, supporting the biosimilarity of Pelgraz® and Neulasta®8,9

Pelgraz® Pharmacokinetics (PK) study profile8

Arithmetic mean serum concentration-time profiles of pegfilgrastim after subcutaneous administration of 6 mg Pelgraz® or with Neulasta®

  • legend redPelgraz® 6mg
  • legend blackNeulasta® 6 mg
    (n=172)

Serum Pegfilgrastim Concentration (ng/ml)

y-axis
x-axis
black dots
red dots
line black
line red

Time (hours)

Pelgraz® Pharmacodynamics (PD) study profile8

Arithmetic mean baseline-adjusted neutrophil count-time after 6 mg Pelgraz®or with Neulasta®

  • legend redPelgraz® 6mg
  • legend blackNeulasta® 6 mg
    (n=172)

Absolute Neutophil Count (x1000/microL)

y-axis
x-axis
black dots
red dots
line black
line red

Time (hours)

* Includes 3 mg and 6 mg exposure (safety analysis set)

One dose, one less thing to worry about

  • Helps maintain the planned chemotherapy treatment regimen by reducing the incidence of severe neutropenia, dose reduction and treatment delay when compared to filgrastim1
  • One dose per cycle reduces the burden of daily injection4
  • Proven biosimilarity with Neulasta®6,8,9

Quality assured tamper
evident hologram sticker

2D matrix code on the carton flap
and syringe label facilitates product
traceability

Barcode on the carton
and on the syringe label
allows product tracking
from manufacture to
administration

Pelgraz pharmace

Alcohol swab included
in the box for patient
convenience

Passive needle guard system

  • - Easy one-handed application
  • - Smooth injections
  • - Helps to minimise the risk of needle-stick
    injuries and blood borne infections10

Stable for a single
period of up to 72
hours at room
temperature
(not above 25 ± 2°C)

thermometer

Smaller pack size
than Neulasta®

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