Perjeta 420 mg concentrate for solution for infusion

Manufacturer
ROCHE DIAGNOSTICS GMBH
 
Contents
Pertuzumab
 
Indication
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.
 
Instruction
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.
 
Drug interaction
A sub-study in 37 patients in the pivotal trial CLEOPATRA, showed no evidence of drug-drug interaction between Perjeta and Herceptin and between Perjeta and docetaxel.In addition no clinical relevant pharmacokinetic interaction of co- administered docetaxel or Herceptin on Perjeta was evident, based on the population pharmacokinetics analysis. This lack of drug-drug interaction was confirmed by pharmacokinetic data from the NEOSPHERE and APHINITY studies.
Five studies have evaluated the effects of Perjeta on the pharmacokinetics of co- administered cytotoxic agents, docetaxel, paclitaxel, gemcitabine, capecitabine, carboplatin and erlotinib. There was no evidence of any pharmacokinetics interaction between Perjeta and any of these agents. The pharmacokinetics of Perjeta in these studies were comparable to those observed in single-agent studies.