Concise Prescribing Info
In combination w/ Herceptin & docetaxel in patients w/ HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for metastatic disease. In combination w/ Herceptin & chemotherapy for the neoadjuvant treatment of patients w/ HER2-positive, locally advanced, inflammatory or early stage breast cancer as part of complete treatment regimen.
Dosage/Direction for Use
In combination w/ Herceptin Initially Perjeta 840 mg administered as 60-min IV infusion, followed every 3 wk thereafter by a dose of 420 mg administered over a period of 30-60 min + Herceptin 8 mg/kg followed every 3 wk thereafter by a dose of 6 mg/kg following a 3 wkly schedule. In combination w/ docetaxel Initially Perjeta 840 mg administered as 60-min IV infusion, followed every 3 wk thereafter by a dose of 420 mg administered over a period of 30-60 min + docetaxel 75 mg/m2, may be increased to 100 mg/m2 if initial dose is well tolerated. Docetaxel dose should be administered after Perjeta. Neoadjuvant treatment of breast cancer Administer Perjeta, Herceptin & docetaxel doses as part of the following regimens: For 3 cycles following FEC therapy, for 4 cycles prior to FEC therapy, for 6 cycles w/ carboplatin (escalation of docetaxel >75 mg/m2 is not recommended). Patients should be treated w/ adjuvant Heceptin to complete 1 yr treatment following surgery.
Special Precautions
Closely observe patient for hypersensitivity reactions. Patients who received prior anthracyclines or radiotherapy to the chest area may be at higher risk of decreased left ventricular ejection fraction (LVEF). Patients w/ pre-treatment LVEF value ≤50%; prior history of CHF; decrease in LVEF to <50% during prior Herceptin (trastuzumab) adjuvant therapy; conditions that could impair left ventricular function eg, uncontrolled HTN, recent MI, serious cardiac arrhythmia requiring treatment or a cumulative prior anthracycline exposure to >360 mg/m2 of doxorubicin or its equiv. Assess LVEF prior to initiation of therapy & at regular intervals (eg, every 3 mth in the metastatic setting & every 6 wk in the neoadjuvant setting). Withhold & repeat LVEF assessment w/in approx 3 wk if LVEF is <40% or 40-45% associated w/ ≥10% points below the pretreatment value. Closely observe patient for 60 min after 1st infusion & for 30 min following subsequent infusions. Permanently discontinue in patients w/ severe infusion reaction. Hepatic impairment. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Neutropenia, anaemia, leukopenia, febrile neutropenia; diarrhoea, nausea, vomiting, stomatitis, constipation; fatigue, mucosal inflammation, asthenia, pyrexia, peripheral oedema; upper resp tract infection, nasopharyngitis; decreased appetite; myalgia, arthralgia; headache, dysgeusia, peripheral neuropathy; insomnia; alopecia, rash, nail disorder. Left ventricular dysfunction; increased lacrimation; drug hypersensitivity; hypersensitivity, paronchia; dizziness, peripheral sensory neuropathy; dyspnoea, pleural effusion; pruritis, dry skin.
ATC Classification
L01XC13 - pertuzumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Perjeta soln for infusion 30 mg/mL
(single-use vial) 14 mL x 1's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in