Page 26 - PHESGO (PERTUZUMAB-TRASTUZUMAB) - Product Monograph

ABBREVIATED PRESCRIBING INFORMATION

PHESGO ® (Pertuzumab and trastuzumab)
Active ingredients: Pertuzumab, Trastuzumab & hyaluronidase.
Solution for subcutaneous injection
Please refer to locally approved Product Information prior to the use of Phesgo.
Indications:
Early Breast Cancer (EBC): Phesgo is indicated in combination with chemotherapy for the:
• neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either >2 cm in diameter or node
positive) as part of a complete treatment regimen for early breast cancer.
• adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence
Metastatic Breast Cancer (MBC): Phesgo is indicated in combination with docetaxel for patients with HER2-positive metastatic or locally recurrent
unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
Dosage and Administration:
Patient Selection: Patients treated with Phesgo should have HER2-positive tumor status assessed by a validated test. Administration: Phesgo therapy
should only be administered under the supervision of a healthcare professional experienced in the treatment of cancer patients. Substitution by any
other biological medicinal product requires the consent of the prescribing physician. Patients currently receiving intravenous pertuzumab and
trastuzumab can switch to Phesgo
Phesgo is for subcutaneous (SC) use in the thigh only. Do not administer intravenously.
Recommended dosing and administration

Dose (irrespective of body weight) Approximate duration of SC injection Observation time ab
Loading dose 1200 mg pertuzumab/600 mg trastuzumab) 8 minutes 30 minutes
Maintenance dose 600 mg pertuzumab/ 600 mg trastuzumab 5 minutes 15 minutes
(every 3 weeks)

a Patients should be observed for injection-related and hypersensitivity reactions b Observation period should start following administration of Phesgo
and be completed prior to any subsequent administration of chemotherapy.
No dose adjustments for Phesgo are required for patient body weight or for concomitant chemotherapy regimen. Patients currently receiving
intravenous pertuzumab and trastuzumab can transition to Phesgo. In patients receiving intravenous pertuzumab and trastuzumab with < 6 weeks
since their last dose, administer Phesgo as a maintenance dose of 600 mg pertuzumab/600 mg trastuzumab and every 3 weeks for subsequent
administrations. In patients receiving intravenous pertuzumab and trastuzumab with ≥ 6 weeks since their last dose, administer Phesgo as an initial
dose of 1,200 mg pertuzumab/600 mg trastuzumab, followed by a maintenance dose of 600 mg pertuzumab/600 mg trastuzumab every 3 weeks for
subsequent administrations.
Assess left ventricular ejection fraction (LVEF) prior to initiation of Phesgo and at regular intervals during treatment. Refer to the full prescribing
information for dose modification in the event of LVEF dysfunction.
Discontinue the injection immediately if the patient experiences a serious hypersensitivity reaction (e.g. anaphylaxis).

Delayed or missed doses: For delayed or missed doses of Phesgo, if the time between two sequential injections is less than 6 weeks, administer the
maintenance dose of 600 mg, 600 mg, and 20,000 units/10 mL. Do not wait until the next planned dose.
If the time between two sequential injections is 6 weeks or more, re-administer the initial dose of 1,200 mg, 600 mg, and 30,000 units/15 mL, followed
every 3 weeks thereafter by a maintenance dose of 600 mg, 600 mg, and 20,000 units/10 mL.
Contraindications:
Phesgo is contraindicated in patients with a known hypersensitivity to pertuzumab, trastuzumab, or hyaluronidase or any of the excipients.

Warning and Precautions:
Cardiomyopathy: Phesgo can cause hypertension, arrhythmias, left ventricular cardiac dysfunction, disabling cardiac failure, cardiomyopathy, and
cardiac death. Phesgo can cause asymptomatic decline in LVEF. An increased incidence of LVEF decline has been observed in patients treated with
intravenous pertuzumab, intravenous trastuzumab, and docetaxel. A 4-6 fold increase in the incidence of symptomatic myocardial dysfunction has
been reported among patients receiving trastuzumab, with the highest absolute incidence occurring when trastuzumab was administered with an
anthracycline. Patients who receive anthracycline after stopping Phesgo may also be at increased risk of cardiac dysfunction. Prior to initiation of
Phesgo, conduct a thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA
scan. During treatment with Phesgo, assess LVEF at regular intervals. 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. Following completion of Phesgo, continue to
monitor for cardiomyopathy and assess LVEF measurements every 6 months for at least 2 years as a component of adjuvant therapy. Embryo-Fetal
Toxicity: Phesgo can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior
to the initiation of Phesgo. Advise pregnant women and females of reproductive potential that exposure to Phesgo during pregnancy or within 7
months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for
7 months following the last dose of Phesgo. Pulmonary Toxicity: Phesgo can cause serious and fatal pulmonary toxicity. Patients with symptomatic
intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity. Exacerbation
of Chemotherapy-Induced Neutropenia: Phesgo may exacerbate chemotherapyinduced neutropenia. Hypersensitivity and Administration-Related
Reactions: Severe administration-related reactions (ARRs), including hypersensitivity, anaphylaxis, and events with fatal outcomes, have been
associated with intravenous pertuzumab and trastuzumab. Patients experiencing dyspnea at rest due to complications of advanced malignancy and
comorbidities may be at increased risk of a severe or of a fatal ARR. Closely monitor patients during and for 30 minutes after the injection of initial dose
and during and for 15 minutes following subsequent injections of maintenance dose of Phesgo. If a significant injection-related reaction occurs, slow
down or pause the injection and administer appropriate medical therapies. Permanently discontinue with Phesgo in patients who experience

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