PHESGO Nurse Administration Brochure Final Version - 210916 - 065152
PHESGO Nurse Administration Brochure Final Version - 210916 - 065152
PHESGO Nurse Administration Brochure Final Version - 210916 - 065152
HSA APPROVED
NURSE GUIDE
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.
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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
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PHESGO in brief
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
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P: PERJETA
H: Herceptin
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Loading
Dose (max)
P + H IV 150 60
PHESGO 30
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Maintenance
Doses (max) P + H IV infusion
P + HIV 90 60 Observation time
PHESGO 15 PHESGO administration
5
Time (minutes)
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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.
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• 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
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Ask the patient to sit back in a The injection site should be To perform the injection, pinch the The injection should also be slowed
reclining chair or bed and to make alternated between the left and skin of the thigh with one hand to or paused if the patient
the thigh area accessible. Be sure right thigh only. It is never create a fold. Inject and maintain experiences a significant
to arrange your chair at the right administered in the abdomen, the needle at an angle of about 30 injection-related reaction. The
level so that your feet are flat on the because this may lead to a lower degrees. Note that the injection can injection should be discontinued
floor and you are able sit up concentration of PHESGO in the be somewhat stiff and tough at the immediately if the patient
straight without twisting, bending, blood. Do not split the dose start because the solution is thick. experiences a serious
or reaching to administer the between two syringes or between Using a butterfly needle makes hypersensitivity reaction (for
injection. You will be in this two sites of administration. administration easier. example, anaphylaxis).
position for approximately 5 to 8 Each new injection should be given The dose should be administered at After the loading dose, the patient
minutes, so be sure you are at least 1 inch, or 2.5 cm, from the a rate of no more than 2 milliliters should be observed for a minimum
comfortable and in a position that previous site. Choose an area of per minute, so you can expect the of 30 minutes, for signs of
you can maintain. healthy skin that is not red, bruised, loading dose to take approximately hypersensitivity symptoms or
The injection site should be tattooed, tender, or hard. During 8 minutes to administer, while the administration-related reactions.
alternated between the left and treatment with PHESGO, other maintenance doses will take After the maintenance doses, the
right thigh only. It is never subcutaneous medications should approximately 5 minutes. patient should be observed for a
administered in the abdomen, preferably be injected at different minimum of 15 minutes.
If at any point during the injection a
because this may lead to a lower sites.
patient feels pain or discomfort, take
concentration of PHESGO in the a break and ease off the injection
blood. Do not split the dose before continuing. Keep the needle
between two syringes or between in place and check to make sure
two sites of administration. that the needle is at the right 30
degree angle of injection. If the
discomfort continues, stop
completely and try again.
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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
Cardiac Toxicity 1
Contraindications1 Based on the pharmacological actions of HER2-targeted agents and
PHESGO is contraindicated in patients with known anthracyclines, the risk of cardiac toxicity might be expected to be higher
hypersensitivity to pertuzumab, or trastuzumab, or hyaluronidase, with concomitant use of PHESGO and anthracyclines than with sequential
or to any of its excipients. 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.
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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)
M-SG-0000432-08-2021