Concise Prescribing Info
In combination w/ Herceptin (trastuzumab) & docetaxel for patients w/ HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. In combination w/ Herceptin and chemotherapy for the neoadjuvant treatment of patients w/ HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either >2 cm in diameter or node positive) as part of complete treatment regimen for early breast cancer; adjuvant treatment of patients w/ HER2-positive 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 a dose of 420 mg over a period of 30-60 min every 3 wk. In combination w/ Herceptin: Initially Herceptin 8 mg/kg as IV infusion followed every 3 wk thereafter by 6 mg/kg dose, or initially Herceptin 600 mg as SC inj & every 3 wk thereafter. In combination w/ docetaxel: Initially docetaxel 75 mg/m2. Administer docetaxel after Perjeta & trastuzumab. Neoadjuvant & adjuvant treatment of early breast cancer Neoadjuvant setting: 3-6 cycles depending on the regimen chosen in combination w/ Herceptin & chemotherapy. Adjuvant setting: In combination w/ Herceptin to complete 1 yr treatment. Max: 18 cycles, or until disease recurrence, or unmanageable toxicity, whichever occurs first. Perjeta & trastuzumab should start on day 1 of 1st taxane-containing cycle.
Special Precautions
Hypersensitivity reactions/anaphylaxis. Do not administer as an IV push or bolus. Higher incidence of symptomatic left ventricular systolic dysfunction (LVD [CHF]) in patients treated in combination w/ Herceptin & chemotherapy. High risk of decreased left ventricular systolic dysfunction in patients who received prior anthracyclines or radiotherapy to the chest area. 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 cumulative prior anthracycline exposure to >360 mg/m2 of doxorubicin or its equiv. Assess LVEF prior to initiation of therapy & at regular intervals during treatment. Consider discontinuation if LVEF declines; patients w/ severe infusion reaction. Closely observe for infusion reaction during & for 60 min after 1st infusion, & during & for 30 min following subsequent infusions. Hepatic impairment. Women of child-bearing potential including partners of male patients should use effective contraception during & 6 mth after therapy. Pregnancy & lactation. Childn <18 yr. Elderly ≥65 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, paraesthesia; insomnia; epistaxis, cough, dyspnea; 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/vial
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