PHESGO SOLUTION FOR SUBCUTANEOUS INJECTION 600 MG600 MG 10 ML

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

Pertuzumab; Trastuzumab

Saatavilla:

ROCHE SINGAPORE PTE. LTD.

ATC-koodi:

L01XY02

Lääkemuoto:

INJECTION, SOLUTION

Koostumus:

Pertuzumab 600 mg; Trastuzumab 600 mg

Antoreitti:

SUBCUTANEOUS

Prescription tyyppi:

Prescription Only

Valmistaja:

F. Hoffmann-La Roche Ltd

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

2021-06-22

Valmisteyhteenveto

1
Please visit www.roche.com.sg/pharma/phesgo for a printable version of
this leaflet.
INJ-PHE-2021 05-0
PHESGO
®
pertuzumab and trastuzumab
_ _
_____________________________________________________________________
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Antineoplastic agents, recombinant humanized IgG1 monoclonal
antibodies
ATC code: L01XY02
1.2
TYPE OF DOSAGE FORM
Solution for subcutaneous injection
1.3
ROUTE OF ADMINISTRATION
Subcutaneous injection
1.4
STERILE / RADIOACTIVE STATEMENT
Sterile Product
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient(s):_
pertuzumab (Perjeta), trastuzumab (Herceptin)
Phesgo is a clear to opalescent solution, colourless to slightly
brownish solution
supplied in sterile, preservative-free, non-pyrogenic single-dose
vials.
Single dose vials contain:
1200 mg Perjeta/600 mg Herceptin/15 mL solution in a vial
600 mg Perjeta/600 mg Herceptin/10 mL solution in a vial
_Excipients:_
rHuPH20,
L-Histidine,
L-Histidine
Hydrochloride
Monohydrate,
α,α-
Trehalose Dihydrate, Sucrose, Polysorbate 20, L-Methionine, Water for
Injection
Phesgo contains vorhyaluronidase alfa (recombinant human hyaluronidase
rHuPH20),
an enzyme used to increase the dispersion and absorption of
co-formulated drugs when
administered subcutaneously.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
EARLY BREAST CANCER (EBC)
Phesgo is indicated for use in combination with chemotherapy for the:

neoadjuvant
treatment
of
patients
with
HER2-positive,
locally
advanced,
inflammatory, or early stage breast cancer (either greater than 2 cm
in diameter
or node positive) as part of a complete treatment regimen for early
breast cancer
(
_see 3.1.2 Clinical studies_
). This indication is based on demonstration of an
improvement in pathological complete response rate. No data are
available
demonstrating improvement in event-free survival or overall survival.

adjuvant treatment of patients with HER2-positive early breast cancer
at high risk
of recurrence (
_see 3.1.2 Clinical Studies_
)