Hertraz Drug Interactions

No formal drug interaction studies have been performed. As per the published literature on another trastuzumab product, clinically significant interactions with the concomitant medication used in clinical trials have not been observed.
Effect of Trastuzumab on the Pharmacokinetics of Other Antineoplastic Agents: As per published literature on another trastuzumab product, Pharmacokinetic data from studies in women with HER2-positive MBC suggested that exposure to paclitaxel and doxorubicin (and their major metabolites 6-hydroxylpaclitaxel, POH, and doxorubicinol, DOL) was not altered in the presence of trastuzumab (8 mg/kg or 4 mg/kg IV loading dose followed by 6 mg/kg q3w or 2 mg/kg q1w IV, respectively). However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13 dihydrodoxorubicinone, D7D). The bioactivity of D7D and the clinical impact of the elevation of this metabolite was unclear.
As per published literature on another trastuzumab product data, a single-arm study of trastuzumab (4 mg/kg IV loading dose and 2 mg/kg IV weekly) and docetaxel (60 mg/m² IV) in Japanese women with HER2- positive MBC, suggested that concomitant administration of trastuzumab had no effect on the single dose pharmacokinetics of docetaxel. As per published literature on another trastuzumab product, a clinical study performed in male and female Japanese patients with advanced gastric cancer to study the pharmacokinetics of capecitabine and cisplatin when used with or without trastuzumab. The results of this substudy suggested that the exposure to the bioactive metabolites (e.g. 5-FU) of capecitabine was not affected by concurrent use of cisplatin or by concurrent use of cisplatin plus trastuzumab. However, capecitabine itself showed higher concentrations and a longer half-life when combined with trastuzumab. The data also suggested that the pharmacokinetics of cisplatin were not affected by concurrent use of capecitabine or by concurrent use of capecitabine plus trastuzumab.
As per published literature on another trastuzumab product, pharmacokinetic data from Study in patients with metastatic or locally advanced inoperable HER2-positive cancer suggested that trastuzumab had no impact on the PK of carboplatin.
Effect of Antineoplastic Agents on Trastuzumab Pharmacokinetics: By comparison of simulated serum trastuzumab concentrations after trastuzumab monotherapy (4 mg/kg loading/2 mg/kg q1w IV) and observed serum concentrations in Japanese women with HER2- positive MBC no evidence of a PK effect of concurrent administration of docetaxel on the pharmacokinetics of trastuzumab was found.
As per published literature on another trastuzumab product, comparison of PK results from two Phase II studies and one Phase III study in which patients were treated concomitantly with trastuzumab and paclitaxel and two Phase II studies in which trastuzumab was administered as monotherapy, in women with HER2-positive MBC indicates that individual and mean trastuzumab trough serum concentrations varied within and across studies but there was no clear effect of the concomitant administration of paclitaxel on the pharmacokinetics of trastuzumab. Comparison of trastuzumab PK data from a study in which women with HER2-positive MBC were treated concomitantly with trastuzumab, paclitaxel and doxorubicin to trastuzumab PK data in studies where trastuzumab was administered as monotherapy or in combination with anthracycline plus cyclophosphamide or paclitaxel, suggested no effect of doxorubicin and paclitaxel on the pharmacokinetics of trastuzumab.
Pharmacokinetic data suggested that carboplatin had no impact on the PK of trastuzumab.
The administration of concomitant anastrozole did not appear to influence the pharmacokinetics of trastuzumab.