Page 24 - PHESGO (PERTUZUMAB-TRASTUZUMAB) - Product Monograph

ABBREVIATED PRESCRIBING INFORMATION

Perjeta ® (Pertuzumab)
Active ingredient: Pertuzumab, for intravenous infusion
Please refer to locally approved Product Information prior the use of Pertuzumab IV.
Excipients: Glacial acetic acid, L histidine, sucrose, polysorbate 20 (produced from genetically modified maize), water for injection. Therapeutic
indications: Metastatic Breast Cancer (MBC): PERJETA is indicated for use in combination with trastuzumab and docetaxel for the treatment of patients
with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. Early Breast
Cancer (EBC): PERJETA is indicated for use in combination with trastuzumab and chemotherapy for:1) 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. 2) The adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence
Posology and method of administration: The initial dose of PERJETA is 840 mg administered as a 60-minute intravenous infusion, followed every 3
weeks by a dose of 420 mg administered as an intravenous infusion over 30 to 60 minutes. When administered with PERJETA, the recommended initial
dose of trastuzumab is 8 mg/kg administered as a 90-minute intravenous infusion, followed every 3 weeks by a dose of 6 mg/kg administered as an
intravenous infusion over 30 to 90 minutes. Administration: PERJETA, trastuzumab, and taxane should be administered sequentially. PERJETA and
trastuzumab can be given in any order. Taxane should be administered after PERJETA and trastuzumab. An observation period of 30 to 60 minutes is
recommended after each PERJETA infusion and before commencement of any subsequent infusion of trastuzumab or taxane . In Metastatic Breast
Cancer (MBC), the recommended initial dose of docetaxel is 75 mg/m2 administered as an intravenous infusion. The dose may be escalated to 100
mg/m2 administered every 3 weeks if the initial dose is well tolerated. In Neoadjuvant Treatment of Breast Cancer, PERJETA should be administered
every 3 weeks for 3 to 6 cycles as part of one of the following treatment regimens for early breast cancer: Four preoperative cycles of PERJETA in
combination with trastuzumab and docetaxel followed by 3 postoperative cycles of fluorouracil, epirubicin, and cyclophosphamide(FEC) as given in
NeoSphere. Three or four preoperative cycles of FEC alone followed by 3 or 4 preoperative cycles of PERJETA in combination with docetaxel and
trastuzumab as given in TRYPHAENA and BERENICE, respectively. Six preoperative cycles of PERJETA in combination with docetaxel, carboplatin, and
trastuzumab (TCH) (escalation of docetaxel above 75 mg/m2 is not recommended) as given in TRYPHAENA. Four preoperative cycles of dose-dense
doxorubicin and cyclophosphamide (ddAC) alonefollowed by 4 preoperative cycles of PERJETA in combination with paclitaxel andtrastuzumab as given
in BERENICE. Following surgery, patients should continue to receive PERJETA and trastuzumab to complete 1 year of treatment (up to 18 cycles). In
Adjuvant Treatment of Breast Cancer: PERJETA should be administered in combination with trastuzumab every 3 weeks for a total of 1 year (up to 18
cycles) or until disease recurrence or unmanageable toxicity, whichever occurs first, as part of a complete regimen for early breast cancer, including
standard anthracycline- and/or taxane-based chemotherapy as given in APHINITY. PERJETA and trastuzumab should start on Day 1 of the first
taxane-containing cycle. Contraindications: PERJETA is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its
excipients. Special warnings and precautions for use: Infusion-associated reactions: Hypersensitivity, anaphylactic reaction, acute infusion reaction, or
cytokine release syndrome occurring during an infusion or on the same day as the infusion. Observe patients closely for 60 minutes after the first
infusion and for 30 minutes after subsequent infusions of PERJETA. If a significant infusion-related reaction occurs, slow or interrupt the infusion, and
administer appropriate medical therapies. Monitor patients carefully until complete resolution of signs and symptoms. Consider permanent
discontinuation in patients with severe infusion reactions. Hypersensitivity reactions/anaphylaxis: Patients should be observed closely for
hypersensitivity reactions. Severe hypersensitivity, including anaphylaxis, has been observed in clinical trials with treatment of PERJETA. Medications to
treat such reactions, as well as emergency equipment, should be available for immediate use. PERJETA is contraindicated in patients with known
hypersensitivity to pertuzumab or to any of its excipients. Left ventricular dysfunction: Decreases in LVEF have been reported with drugs that block
HER2 activity, including PERJETA. Assess LVEF prior to initiation of PERJETA and at regular intervals during treatment to ensure that LVEF is within
normal limits. If the LVEF declines and has not improved, or has declined further at the subsequent assessment, discontinuation of PERJETA and
trastuzumab should be strongly considered. Advise patients to contact a health care professional immediately for any of the following: new onset or
worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours,
dizziness or loss of consciousness . Embryo-Fetal Toxicity: PERJETA can cause fetal harm when administered to a pregnant woman. PERJETA is a
HER2/neu receptor antagonist. Cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities,
and neonatal death have been reported with use of another HER2/neu receptor antagonist (trastuzumab) during pregnancy. Verify the pregnancy
status of females of reproductive potential prior to the initiation of PERJETA. Advise pregnant women and females of reproductive potential that
exposure to ERJETA in combination with trastuzumab during pregnancy or within 7 months prior to conception can result in fetal harm, including
embryo-fetal death or birth defects. Advise females of reproductive potential to use effective contraception during treatment and for 7 months
following the last dose of PERJETA in combination with trastuzumab Pregnancy and lactation: Pregnancy: PERJETA can cause fetal harm when
administered to a pregnant woman. use of another HER2/neu receptor antagonist (trastuzumab) during pregnancy resulted in cases of
oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Monitor women
who received PERJETA in combination with trastuzumab during pregnancy or within 7 months prior to conception for oligohydramnios. If
oligohydramnios occurs, perform fetal testing that is appropriate for gestational age and consistent with community standards of care. Pregnancy
testing & Contraception: Verify the pregnancy status of females of reproductive potential prior to the initiation of PERJETA and advise to use effective
contraception during treatment and for 7 months following the last dose of PERJETA in combination with trastuzumab Lactation: data suggest that
human IgG is present in human milk but does not enter the neonatal and infant circulation in substantial amounts. Consider the developmental and
health benefits of breast feeding along with the mother’s clinical need for PERJETA treatment and any potential adverse effects on the breastfed child
from PERJETA or from the underlying maternal condition. Adverse Reactions: The most common adverse reactions were diarrhea, nausea, alopecia,
fatigue, rash, peripheral neuropathy, vomiting , thrombocytopenia, anemia, constipation, headache, myalgia and mucosal inflammation
Full prescribing information is available upon request. In case of any adverse event occurring with Pertuzumab, please forward details to e-mail:
dubai.drug_safety@roche.com or call +971544409415
Mode of Prescription: POM

Presentation: Vial with 14 ml concentrate for solution for infusion.contains 420 mg pertuzumab.
Marketing Authorization Holder: F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Date of preparation: 24th May 2018.
Leaflet: PI based on the US text dated Dec 2017.
WARNING: LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY
See full prescribing information for complete boxed warning.
• Left Ventricular Dysfunction: PERJETA can result in subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF.
Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left
ventricular function.
• Embryo-fetal Toxicity: Exposure to PERJETA can result inembryo-fetal death and birth defects. Advise patients of these risks and the need for
effective contraception.

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