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; 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 IV infusion over 60 min followed by 420 mg every 3 wk over 30-60 min thereafter. In combination w/ trastuzumab Initially 8 mg/kg IV infusion followed by 6 mg/kg every 3 wk thereafter. 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
Hypersensitivity reactions. Discontinue use if infusion-related reactions occur. Increased risk of symptomatic left ventricular dysfunction including CHF. Assess left ventricular ejection fraction prior to initiation & at regular intervals during treatment. Hepatic & severe renal impairment. Women of childbearing potential should use effective contraception. Avoid use during pregnancy. Lactation. Childn & adolescents <18 yr.
Adverse Reactions
Neutropenia, anemia, febrile neutropenia, leukopenia; increased lacrimation; GI disorders; fatigue, mucosal inflammation, asthenia, pyrexia, peripheral edema; nasopharyngitis; decreased appetite; arthralgia, myalgia, pain in extremity; dysgeusia, headache, peripheral sensory neuropathy, peripheral neuropathy, dizziness, paresthesia; psychiatric disorders; alopecia, rash, nail disorder, pruritus, dry skin; hot flush. Left ventricular dysfunction; hypersensitivity, drug hypersensitivity, upper resp tract infection, paronychia.
ATC Classification
L01XC13 - pertuzumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Perjeta soln for infusion 420 mg/14 mL
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