Zuellig Pharma
Concise Prescribing Info
In combination w/ trastuzumab & docetaxel for patients w/ HER2 +ve metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for metastatic disease. In combination w/ trastuzumab & chemotherapy for neoadjuvant treatment of patients w/ HER2 +ve, locally advanced, inflammatory or early stage breast cancer (either >2 cm in diameter or node +ve) as part of complete treatment regimen for early breast cancer. In combination w/ trastuzumab & chemotherapy for adjuvant treatment of patients w/ HER2 +ve early breast cancer at high risk of recurrence.
Dosage/Direction for Use
Metastatic & early breast cancer Initially 840 mg as 60-min IV infusion followed by 420 mg every 3 wk over 30-60 min. In combination w/ trastuzumab Initially 8 mg/kg IV infusion followed by 6 mg/kg every 3 wk, or 600 mg SC every 3 wk. In combination w/ docetaxel Initially 75 mg/m2. Neoadjuvant early breast cancer 3-6 cycles depending on chosen regimen in combination w/ trastuzumab & chemotherapy. Adjuvant early breast cancer In combination w/ trastuzumab to complete 1 yr treatment. Max: 18 cycles, or until disease recurrence or unmanageable toxicity, whichever occurs first.
Special Precautions
Not to be administered as IV push or bolus. Hypersensitivity reactions. Slow down or interrupt infusion if severe infusion-related reactions occur. Increased risk of symptomatic left ventricular dysfunction including CHF; conditions impairing left ventricular function eg, uncontrolled HTN, recent MI, serious cardiac arrhythmia. Assess left ventricular ejection fraction prior to & at regular intervals during treatment. May affect ability to drive & use machines. Hepatic & severe renal impairment. Women of childbearing potential & male partners should use effective contraception during & 6 mth after last dose. Avoid use during pregnancy. Lactation. Childn & adolescents <18 yr.
Adverse Reactions
Neutropenia, anemia, febrile neutropenia, leukopenia; increased lacrimation; diarrhea, nausea, vomiting, stomatitis, constipation, dyspepsia, abdominal pain; fatigue, mucosal inflammation, asthenia, pyrexia, peripheral edema; nasopharyngitis; decreased appetite; arthralgia, myalgia, pain in extremity; dysgeusia, headache, peripheral sensory neuropathy, peripheral neuropathy, dizziness, paresthesia; insomnia; epistaxis, cough, dyspnea; alopecia, rash, nail disorder, pruritus, dry skin; hot flush. Left ventricular dysfunction; hypersensitivity, drug hypersensitivity; URTI, paronychia.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FD02 - pertuzumab ; Belongs to the class of HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors. Used in the treatment of cancer.
Perjeta soln for infusion 420 mg/14 mL
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