Perjeta

Perjeta

pertuzumab

Manufacturer:

Roche

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Pertuzumab
Indications/Uses
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.
Contraindications
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.
Presentation/Packing
Form
Perjeta soln for infusion 420 mg/14 mL
Packing/Price
1's
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