®

HSA APPROVED

NURSE GUIDE

THE NEW FIXED-DOSE

COMBINATION OF
PERTUZUMAB AND
TRASTUZUMAB IN ONE:
FOR SUBCUTANEOUS USE

This medical product is subject to additional monitoring. This will allow quick
identification of new safety information. Healthcare professionals are asked to
report any suspected adverse reactions.
 ®

Introduction
This brochure offers step-by-step guidance on the preparation,
administration and post-administration monitoring of PHESGO, the
new fixed-dose combination of PERJETA® (pertuzumab) and Herceptin®
(trastuzumab) for subcutaneous (SC) use.

It contains information that will help you optimise the care for patients
Important Safety Information living with HER2 positive breast cancer and help make their treatment
journey as comfortable as possible.
Decreases in left ventricular ejection fraction
(LVEF) have been reported with drugs that
block HER2 activity, including pertuzumab and
trastuzumab. The incidence of symptomatic left
ventricular systolic dysfunction (LVD [congestive
heart failure]) was higher in patients treated with
pertuzumab in combination with trastuzumab
and chemotherapy compared with intravenous
pertuzumab in combination with trastuzumab
and chemotherapy.1
Cardiac risk should be carefully considered
and balanced against the medical need of the
individual patient before use of PHESGO with
an anthracycline. Based on the pharmacological
actions of HER2-targeted agents and
anthracyclines, the risk of cardiac toxicity might
be expected to be higher with concomitant use of
PHESGO and anthracyclines than with sequential
use.1
PHESGO is not recommended during pregnancy
and lactation. Exposure to PHESGO can result
in embryo-fetal death and birth defects. Advise
patients of these risks and the need for effective
contraception.1

HER2 = human epidermal growth factor receptor

3
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PHESGO in brief

PHESGO is the first formulation in oncology to combine

two monoclonal antibodies in one ready-to-use vial 1

Contents
PHESGO in brief
PHESGO contains the same antibodies as approved for
intravenous PERJETA® and Herceptin®, but is administered
How could PHESGO help as an SC injection into the thigh over 5–8 minutes1
optimise care?

Treatment scheduling
with PHESGO

Preparing and
administering PHESGO: PHESGO is formulated with recombinant human
A step-by-step guide hyaluronidase to allow subcutaneous administration of
higher drug volumes (15mL loading dose; 10mL
maintenance dose).1-3
Monitoring and managing
adverse events
PHESGO indications
PHESGO is indicated for use in combination with chemotherapy in:1

Early breast cancer (EBC):

• The neoadjuvant treatment of adult patients with HER2+, locally
advanced, inflammatory, or early stage breast cancer at high risk of
recurrence (either greater than 2 cm in diameter or node-positive)
• The adjuvant treatment of adult patients with HER2+ early breast cancer
at high risk of recurrence

Metastatic breast cancer (MBC):

• For use in combination with docetaxel in adult patients
with HER2+ metastatic or locally recurrent unresectable
breast cancer, who have not received previous anti-HER2
therapy or chemotherapy for their metastatic disease

5
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Intravenous (IV) infusion of pertuzumab and PHESGO is a faster treatment option

trastuzumab is well established for the treatment
of HER2+ breast cancer, but can present
for you and your patients:
challenges to patients, healthcare professionals
(HCPs) and healthcare systems: PERJETA® +
Herceptin® IV
(PH IV)9,10 PHESGO1
• Establishing IV access can be particularly
burdensome for patients 3 P IV H IV
• In-dwelling venous access associated with
discomfort and a significant risk of infection P IV: Concentrate for solution
or thrombosis 4,5 for infusion
Ready-to-use vial for
Patient needs • Lengthy appointments can create disruption H IV: Powder for concentrate
Pharmaceutical subcutaneous injection
and affect the quality of life 6 form for solution for infusion by a healthcare
P and H are delivered as two professional
separate IV infusions

Long infusion and observation times occupy a

Loading dose* 840 mg 8 mg/kg 1200 mg pertuzumab
great deal of staff capacity, reducing flexibility and 600 mg trastuzumab
in managing workload and putting pressure (15 mL)
on treatment capacity7
Healthcare
professional
(HCP) needs Administration
60 minutes 90 minutes 8 minutes
time

• Long appointment times result in

congestion at clinics and hospitals 7 30–60 15-30
Observation time 30 minutes
minutes minutes
• Long preparation times mean high resource
utilisation and associated costs 7,8
• Herceptin IV dose must be calculated to 600 mg pertuzumab and
Maintenance
match patient weight, introducing the 420 mg 6 mg/kg 600 mg trastuzumab
Healthcare dose
possibility of errors in calculation and (10 mL)
system needs
wastage of drug when a vial cannot be
completely used8,9
Administration 30–60
30 minutes 5 minutes
time minutes

The benefits of subcutaneous (SC) administration have previously been

demonstrated with Herceptin SC. 7 30–60 15-30
Observation time 15 minutes
Compared with IV administration, Herceptin® subcutaneous (SC) minutes minutes
shortened active HCP time required for preparation and administration
and reduced patient chair time for shorter appointments and improved
patient access to care. 7 Need for IV
Yes Yes No
access
As a fixed-dose subcutaneous combination of two monoclonal antibodies
in one single-use vial, PHESGO has the potential to further improve HER2+
breast cancer treatment efficiency for patients and staff.

P: PERJETA
H: Herceptin

7
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Treatment scheduling with PHESGO PHESGO dosing and administration

PHESGO has the same treatment schedule than PERJETA + Herceptin-
based IV therapy
Patients currently receiving IV PERJETA® + trastuzumab can be
transitioned to PHESGO if eligible1
®
Important:
PHESGO has different dosage and administration instructions than
PERJETA, Herceptin IV or Herceptin SC when administered alone.1 PHESGO
should be administered via subcutaneous injection in the thigh only.
PHESGO is not intended for intravenous administration.1

Loading
Dose (max)
P + H IV 150 60

PHESGO 30
8

Maintenance
Doses (max) P + H IV infusion
P + HIV 90 60 Observation time
PHESGO 15 PHESGO administration
5

0 20 40 60 80 100 120 140 160 180 200 220

Time (minutes)

Benefits of PHESGO include:1 In order to prevent medication errors, it is important to

check the vial label to ensure that the drug being prepared
• NO reconstitution
and administered is PHESGO.1
• NO dilution
• NO weight adjustments
• NO IV loading dose
• NO port access with a subcutaneous injection

In early breast cancer:

Eligible patients should receive PHESGO as part of a complete treatment
regimen, every 3 weeks for a total of 1 year (up to 18 cycles)1 or until disease
recurrence or unmanageable toxicity
• Patients who begin PHESGO-based therapy in the neoadjuvant setting
should receive 3-6 cycles before surgery and should continue with
PHESGO after surgery if patient achieves PCR, every 3 weeks, to
complete 1 year (up to 18 cycles).1
• Patients who begin treatment in the adjuvant setting should receive a
Medications to treat such reactions, as well as emergency
total of 1 year (up to 18 cycles) of PHESGO-based therapy, every 3 weeks1
equipment, should be available for immediate use.1

In metastatic breast cancer:

Eligible patients should receive PHESGO alongside docetaxel as first-line
treatment, every 3 weeks until disease progression or unmanageable
toxicity1
Treatment with PHESGO may continue until disease progression or
unmanageable toxicity even if treatment with docetaxel is discontinued.1
Additional dosing considerations and
dose modifications
Dose sequencing
In patients receiving an anthracycline-based regimen for early breast
cancer, administer PHESGO following completion of anthracycline.1
In patients receiving PHESGO for early breast cancer with docetaxel or
paclitaxel, administer docetaxel or paclitaxel after PHESGO.1
In patients receiving PHESGO for metastatic breast cancer with docetaxel,
administer docetaxel after PHESGO.1

9
Transitioning from IV PERJETA® Preparing and
Herceptin to PHESGO administering Watch the
PHESGO training
PHESGO:A step- video for a more detailed
Dose administrations of PHESGO overview on PHESGO, how
In patients receiving IV PERJETA + Herceptin with less than 6 weeks since by-step guide to prepare it and
their last dose, administer PHESGO as a maintenance dose (pertuzumab administer it to patients
600 mg/trastuzumab 600 mg) and every 3 weeks for subsequent HERE
Vial storage1
administrations.1
PHESGO is supplied in sterile,
In patients receiving IV PERJETA + Herceptin with 6 weeks or more since
preservative-free, single-dose vials
their last dose, administer PHESGO as a loading dose (pertuzumab 1,200
for subcutaneous administration.
mg/trastuzumab 600 mg), followed by a maintenance dose (pertuzumab
Store PHESGO vials in the refrigerator
600 mg/trastuzumab 600 mg) every 3 weeks for subsequent
at 2°C to 8°C in the original carton to
administrations.1
protect from light, until time of use. Do not
freeze.1
Delayed or missed doses of PHESGO
Once transferred from the vial to the syringe the medicinal product is
If the time between 2 sequential injections is less than 6 weeks, do not physically and chemically stable for 28 days at 2 - 8°C protected from
wait until the next planned dose. light and for 24 hours (cumulative time in the vial and the syringe) at
The maintenance dose of 600 mg/600 mg should be administered as ambient temperature (maximum 30 °C) in diffused daylight.1
soon as possible. Thereafter, continue with the 3-weekly schedule.1
If the time between 2 sequential injections is 6 weeks or more,
re-administer the loading dose followed every 3 weeks thereafter by the
maintenance dose.1
Store PHESGO vials in the refrigerator at 2 to
8C o

Dosing adjustments
No dose adjustments for PHESGO are required for patient body weight.1
For chemotherapy dose modification, see relevant prescribing
information.
If the patient experiences a significant injection-related reaction, slow
down or pause the injection and administer appropriate medical
therapies. Evaluate and carefully monitor patients until complete
resolution of signs and symptoms.1
If the patient experiences a serious hypersensitivity reaction (e.g.,
anaphylaxis), discontinue injection immediately.1
Checking the vial1
• To prevent medication errors, it is important to check the vial labels to
ensure the drug being prepared and administered is PHESGO and not
PERJETA®, or Herceptin® IV or SC.
• PHESGO is clear to opalescent and colourless to slightly brownish.
Inspect the vial for particulate matter and discoloration prior to
administration, whenever solution and container permit.
• Do not use vial if particulates or discoloration is present. Do not shake.
• Select the right vial depending on whether this is a loading dose or
maintenance dose, and check the expiration date.

11
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Preparing and administering PHESGO: Preparing and administering PHESGO

A step-by-step guide1,11
Preparing the injection
• PHESGO is for single-use only. Both the loading and maintenance dose
strengths are ready to use for subcutaneous injection, and should not be
diluted
• Allow PHESGO to warm up at room temperature (maximum 30 °C) for 2
hours before preparing it for administration. This will make the process
easier for you as the solution is quite viscous
Providing guidance for patients prior to hospital visits
Prior to the appointment let your patient know what to expect from their
visit to the clinic. Encourage her to keep a diary of how she is feeling and
to write down her questions for the doctor or for you and to bring them to
her appointment.
Advise your patient to:
• Bringing a snack, drink, entertainments like a book, magazine or tablet
• Wearing loose clothes (skirt or shorts)

• The first step is to transfer PHESGO from the vial to the injection syringe • Arriving to the clinic rested, fed, and hydrated

• Start by attaching a transfer needle (e.g. 21 gauge) to the syringe. A • Planning a ride home as the treatment might make the patient’s travel
luer-lock syringe might be better, since the solution is thick by herself a bit difficult

• Remove and discard the vial cap and wipe the vial stopper with an • Take a rest as soon as possible after the injection, taking only gentle
alcohol swab. Allow the stopper to dry naturally. exercise on the day, like going for a walk.

• And then, holding the syringe by the barrel, insert the transfer needle to
the centre of the vial at a 90- degree angle
• Invert the vial and slowly pull back the plunger until you’ve withdrawn
the contents of the vial. A slight vacuum will be formed in the vial, so
ensure that the plunger does not get pulled back into the barrel. Also be
careful to avoid completely removing the plunger from the barrel
• Discard any unused portion remaining in the vial
• Once the contents are withdrawn from the vial, remove the needle from
the vial. Then remove the transfer needle from the syringe
• Label the syringe with the included peel-off sticker
• If the solution will not be injected right away, replace the transfer needle
with a syringe closing cap. Do not attach a hypodermic needle until the
time of administration to avoid needle clogging
• After filling the syringe, PHESGO can be stored in the refrigerator for up
to 24 hours, and at room temperature (maximum 30 °C) for up to 4 hours
• The solution should be administered at room temperature, so remove it
from the fridge enough time in advance for it to warm up
• At the time of administration, detach the transfer needle or syringe
stopper and discard, replacing it with a sterile injection needle
• The suitable injection needle for this solution is between 23 and 27
gauge with length 3/8-5/8”, 10-16mm

13

Preparing and administering PHESGO:
A step-by-step guide1,11
Step 1
Ask the patient to sit back in a
reclining chair or bed and to make
the thigh area accessible. Be sure
to arrange your chair at the right
level so that your feet are flat on the
floor and you are able sit up
straight without twisting, bending,
or reaching to administer the
injection. You will be in this
position for approximately 5 to 8
minutes, so be sure you are
comfortable and in a position that
you can maintain.
The injection site should be
alternated between the left and
right thigh only. It is never
administered in the abdomen,
because this may lead to a lower
concentration of PHESGO in the
blood. Do not split the dose
between two syringes or between
two sites of administration.
Step 2
The injection site should be
alternated between the left and
right thigh only. It is never
administered in the abdomen,
because this may lead to a lower
concentration of PHESGO in the
blood. Do not split the dose
between two syringes or between
two sites of administration.
Each new injection should be given
at least 1 inch, or 2.5 cm, from the
previous site. Choose an area of
healthy skin that is not red, bruised,
tattooed, tender, or hard. During
treatment with PHESGO, other
subcutaneous medications should
preferably be injected at different
sites.
Preparing and administering PHESGO:
A step-by-step guide1,11
Step 3
To perform the injection, pinch the
skin of the thigh with one hand to
create a fold. Inject and maintain
the needle at an angle of about 30
degrees. Note that the injection can
be somewhat stiff and tough at the
start because the solution is thick.
Using a butterfly needle makes
administration easier.
The dose should be administered at
a rate of no more than 2 milliliters
per minute, so you can expect the
loading dose to take approximately
8 minutes to administer, while the
maintenance doses will take
approximately 5 minutes.
If at any point during the injection a
patient feels pain or discomfort, take
a break and ease off the injection
before continuing. Keep the needle
in place and check to make sure
that the needle is at the right 30
degree angle of injection. If the
discomfort continues, stop
completely and try again.
®
Step 4
The injection should also be slowed
or paused if the patient
experiences a significant
injection-related reaction. The
injection should be discontinued
immediately if the patient
experiences a serious
hypersensitivity reaction (for
example, anaphylaxis).
After the loading dose, the patient
should be observed for a minimum
of 30 minutes, for signs of
hypersensitivity symptoms or
administration-related reactions.
After the maintenance doses, the
patient should be observed for a
minimum of 15 minutes.
15
 ®

Monitoring and managing adverse Monitoring and managing adverse

events events
Advise your patient that she may experience an injection site reaction up Assess left ventricular ejection fraction (LVEF) prior to initiation of
to 24 hours after receiving PHESGO, and she should contact you or the PHESGO and at regular intervals during treatment.1
doctor if she feels any symptoms.1 If after a repeat assessment within approximately 3 weeks, the LVEF
has not improved, has declined further, and/or the patient is
symptomatic, permanently discontinue PHESGO.1
Important information:
Dose modification and monitoring for left ventricular dysfunction1

Withhold PHESGO for Resume PHESGO

Most common adverse events1 Pre-treatment LVEF: at least 3 weeks for after 3 weeks if LVEF
The most common adverse events (>5%) were: an LVEF decrease to: had recovered to:
• Diarrhoea Either
• Injection site reaction
• Infusion-related reactions <10%
Early Breast Cancer <50% with a fall of points
• Asthenia (EBC) ≥10% points below below
• Fatigue ≥55%* pre-treatment value ≥50%
pre-
• Rash treatment
• Ejection fraction decreased value
• Anaemia.[SPC]
Either Either

40%-45% 40%-45%
with a fall with a fall of
Metastatic Breast Cancer of ≥10% <10% points
(MBC)
Reduced left ventricular ejection fraction1 ≥50%* <40%
points
>45%
below
pre-treatment
below value
Decreases in left ventricular ejection fraction (LVEF) have been pre-
reported with drugs that block HER2 activity, including treatment
pertuzumab and trastuzumab. The incidence of symptomatic left valu e
ventricular systolic dysfunction (LVD [congestive heart failure])
was higher in patients treated with pertuzumab in combination
with trastuzumab and chemotherapy compared with intravenous *For patients receiving anthracycline-based chemotherapy, an LVEF of
pertuzumab in combination with trastuzumab and ≥50% is required after completion of anthracyclines before starting
chemotherapy. PHESGO

Contraindications1
PHESGO is contraindicated in patients with known
hypersensitivity to pertuzumab, or trastuzumab, or hyaluronidase,
or to any of its excipients.
Cardiac Toxicity 1
Based on the pharmacological actions of HER2-targeted agents and
anthracyclines, the risk of cardiac toxicity might be expected to be higher
with concomitant use of PHESGO and anthracyclines than with sequential
use.
Febrile Neutropenia1
Patients treated with PHESGO in combination with a taxane are at
increased risk of febrile neutropenia. Patients treated with intravenous
pertuzumab in combination with trastuzumab and docetaxel are at
increased risk of febrile neutropenia compared with patients treated with
placebo, trastuzumab and docetaxel, especially during the first 3 cycles of
treatment.
In the CLEOPATRA trial in metastatic breast cancer, nadir neutrophil
counts were similar in pertuzumab-treated and placebo-treated patients.
The higher incidence of febrile neutropenia in pertuzumab-treated
patients was associated with the higher incidence of mucositis and
diarrhoea in these patients. Symptomatic treatment for mucositis and
diarrhoea should be considered. No events of febrile neutropenia were
reported after cessation of docetaxel.

17
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Monitoring and managing adverse

events 1

Management of common adverse events

Adverse event Recommended Action

• Close observation of the patient during and for 30 minutes
after administration of the loading dose, and for 15 minutes
following the administration of the maintenance dose is
recommended1
Injection-related • Patients should also be advised to self-monitor for up to
reactions 24h post-administration and report any adverse events to
(Systemic or local their healthcare team
• If a significant injection-related reaction occurs, the
reaction with fever, injection should be slowed down or paused and
chills, or headache appropriate medical therapies should be administered1
within 24 hours • If fever or redness is localised, apply an ice-pack to the
of administration) affected area
• Patients should be evaluated and carefully monitored until
complete resolution of signs and symptoms
• Permanent discontinuation should be considered in
patients with severe injection-related reactions1
• Recommend the avoidance of eating greasy, fried, sweet,
or spicy foods
• Recommend cold foods that do not have strong smells,
or suggest letting food cool down before eating it.
Nausea Recommend drinking plenty of water and fluids
• If nausea persists, anti-nausea drugs or anti-emetics may be
prescribed by the attending physician in order to prevent or
reduce nausea and vomiting1
• Diarrhoea is most frequent during concurrent administration
with taxane therapy1
• Elderly patients (≥ 65 years) have a higher risk of diarrhoea
compared with younger patients (< 65 years)
• Treat according to standard practice and guidelines.
Early intervention with loperamide, fluids and electrolyte
Diarrhoea replacement should be considered, particularly in elderly
patients, and in case of severe or prolonged diarrhoea, the
physician may prescribe anti-diarrhoea drugs1
• Interruption of treatment with PHESGO should be
considered by the physician if no improvement in the
patient’s condition is achieved. When the diarrhoea is under
control, treatment may be reinstated1
• Recommend the patient eats food high in protein or iron,
takes short naps during the day, and does a light exercise
Anaemia every day or goes for walk [cancer.gov]
• You may also want to recommend supplements to help
bring your patients’ iron level back to normal levels
• Patients treated with PHESGO in combination with a
taxane are at increased risk of febrile neutropenia1
• Patients treated with PHESGO in combination with
docetaxel are at increased risk of febrile neutropenia
compared with patients treated with placebo, trastuzumab
and docetaxel, especially during the first 3 cycles of
treatment1
Neutropenia • The higher incidence of febrile neutropenia in pertuzumab-
treated patients was associated with the higher incidence
of mucositis and diarrhoea in these patients1
• Symptomatic treatment for mucositis and diarrhoea
should be considered1
• No events of febrile neutropenia were reported after
cessation of docetaxel1
• Advise the patient to take short naps of less than 1 hour
during the day. Suggest that the patient meets with a
registered dietitian to learn about foods and drinks that
can increase energy levels
Fatigue • Remind the patient to stay well hydrated, though limiting
caffeine and alcohol intake
• The patient may benefit from seeing a counsellor,
psychologist, or psychiatrist in order to manage stress levels
• Refer patient for assessment of LVEF prior to initiation of
PHESGO and at regular intervals during treatment (e.g.
once during neoadjuvant treatment and every 12 weeks
Reduced ejection in the adjuvant and metastatic setting) to ensure that LVEF
fraction is within normal limits1
• If the LVEF has declined and has not improved, the
physician my consider discontinuation of PHESGO, unless
the benefits for the individual patient outweigh the risks1

19
References
1. PHESGO Singapore Prescribing information. Last updated May
2021.
2. Locke K et al. Drug Delivery 2019; 26: 98-106.
3. Thomas J et al. J. Palliat. Med. 2007;10: 1312-20.
4. Fallowfield L et al. Breast 2015; 24: 166-70.
5. Jackisch C et al. Geburtsh Frauenheilk 2014; 74: 343–49.
6. Pivot X et al. Ann Oncol 2014 25: 1979–87.
7. De Cock E et al. Cancer Med 2016; 5: 389–97.
8. Maniadakis N et al. Journal of Cancer Policy May 2017; 19.1016
9. Herceptin Singapore Prescribing information. Last updated
Feb 2021.
10. PERJETA Singapore Prescribing information. Last
updated Feb 2021.
11. Roche, data on file (FDC Administration Tool)

PHESGO Prescribing Information:

Before prescribing Phesgo, please consult the full local prescribing

information by visiting www.roche.com.sg/en/pharma/phesgo.html or
by scanning the following QR code.
The safety and efficacy of alternating or switching between Phesgo and
products that are biosimilar but not deemed interchangeable to Phesgo
has not been established. Therefore, the benefit/risk of alternating or
switching needs to be carefully considered.

ENHANCED SAFETY REPORTING FOR POTENTIAL PHESGO-EXPOSED

Pregnancy: If a pregnancy occurs while using Phesgo or within 7
months following the last dose of Phesgo, please immediately
report pregnancy to the local Roche Adverse Event email at
singapore.drugsafety@roche.com or call (65) 6735 0550.
Additional information will be requested during a
Phesgo-exposed pregnancy and the first year of
the infant’s life. This will enable Roche to better
understand the safety of
Phesgo and to provide
appropriate information to
Health Authorities, Healthcare
Providers and patients.

Roche Singapore Pte. Ltd.

1 Paya Lebar Link, #09-03 PLQ 1,
Paya Lebar Quarter, Singapore 408533
© August 2021
All trademarks mentioned herein are protected by law.
www.roche.com.sg

M-SG-0000432-08-2021