Trastuzumab

Therapeutic Trastuzumab antibody from the original Herceptin® commercial drug

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HER2
Monoclonal Antibody
Herceptin®
21 mg/mL
95 µL
2 mg
-80°C
08/2020
277,00 
HER2
Monoclonal Antibody
Herceptin®
21 mg/mL
95 µL
2 mg
-80°C
02/2021
277,00 
HER2
Monoclonal Antibody
Herceptin®
21 mg/mL
95 µL
2 mg
-80°C
08/2021
277,00 
HER2
Monoclonal Antibody
Herceptin®
21 mg/mL
95 µL
2 mg
-80°C
11/2019
277,00 
HER2
Monoclonal Antibody
Herceptin®
21 mg/mL
95 µL
2 mg
-80°C
12/2020
277,00 
HER2
Monoclonal Antibody
Herceptin®
21 mg/mL
95 µL
2 mg
-80°C
01/2022
518,00 
HER2
Monoclonal Antibody
Herceptin®
21 mg/mL
95 µL
2 mg
-80°C
02/2024
277,00 

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Herceptin® / Trastuzumab Reference Product

Drug nameHerceptin®
INNTrastuzumab
API typeOne vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures
Pharmacotherapeutic group
Antineoplastic agents, monoclonal antibodies
ATC code
L01XC03
Target of antibody
HER2; Synonyms: CD340, HER-2, HER-2/neu, MLN 19, NEU, NGL, TKR1, Erbb-2, Neu, c-erbB2, c-neu, mKIAA3023, wu:fv70f10, zgc:63601, erb2
General function
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
The pharmacokinetics of trastuzumab were evaluated in a population pharmacokinetic model analysis using pooled data from 1,582 subjects, including patients with HER2 positive MBC, EBC, AGC or other tumor types, and healthy volunteers, in 18 Phase I, II and III trials receiving Herceptin IV. A two-compartment model with parallel linear and non-linear elimination from the central compartment described the trastuzumab concentration-time profile. Due to non-linear elimination, total clearance increased with decreasing concentration. Therefore, no constant value for half-life of trastuzumab can be deduced. The t1/2 decreases with decreasing concentrations within a dosing interval (see Table 16).
MBC and EBC patients had similar PK parameters (e.g. clearance (CL), the central compartment volume (Vc)) and population-predicted steady-state exposures (Cmin, Cmax and AUC). Linear clearance was 0.136 L/day for MBC, 0.112 L/day for EBC and 0.176 L/day for AGC. The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92 μg/mL for the Michaelis-Menten constant (Km) for the MBC, EBC, and AGC patients. The central compartment volume was 2.62 L for patients with MBC and EBC and 3.63 L for patients with AGC.
In the final population PK model, in addition to primary tumor type, body-weight, serum aspartate aminotransferase and albumin were identified as a statistically significant covariates affecting the exposure of trastuzumab. However, the magnitude of effect of these covariates on trastuzumab exposure suggests that these covariates.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)n/a
Original license holder
Marketing authorisation numbers
EU/1/00/145/001 - 003
Marketing authorisation holder
Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
Name of the manufacturer of the biological active substance
Roche Diagnostics GmbH
Pharma Biotech Penzberg
Nonnenwald 2
D-82377 Penzberg
Germany

Genentech Inc.
1000 New Horizons Way
Vacaville, CA 95688
USA

Roche Singapore Technical Operations Pte. Ltd.
10 Tuas Bay Link
637394 Singapore
Singapore

Lonza Biologics Tuas Pte Ltd
35 Tuas South Ave. 6
637377 Singapore
Singapore
Name and address of the manufacturer(s) responsible for batch releaseRoche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Max shelf life
48 months
Storage conditions
2°C – 8°C
List of excipients
L-histidine hydrochloride
L-histidine
α,α-trehalose dihydrate
polysorbate 20
Evidentic Support
+49 (0) 30 959 99 8831

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