All the Active Ingredient Drugs
Monoclonal Antibody. Trastuzumab 440 mg/ml. VIALS (+20 ml. solv.): 1 x 440 mg.
Dose must be individ. ajust. accord. to
pt. med. cond.
Metastat. breast cancer with tumors that
overexpress HER2, as single agent for pts.
who have received 1 or more chemother.
regimens, or in comb. with paclitaxel or
docetaxel for pts. who have not received
chemother. In comb. with aromatase
inhibit. for tmt. of postmenopaus. pts.
with hormone-recept.positive metastat.
breast cancer. To be used in tumors with
HER2 overexpress or HER2 gene
amplification as determined by accurate
and validated assay. Early breast cancer
with HER2 pos. foll. surg. and chemother.
(neoadjuv./ adjuv.) either alone or in
comb. with chemother. exclud.
anthracyclines. Metastat. gastric cancer
(MGC): In comb. with capecitabine or
5-fluorouracil and cisplatin, for tmt. pts.
with HER2 +ive metastat. adenocarc. of
stomach/gastroesophag. junct. who have
not received prior anti-cancer tmt. Only in
pts. with MGC whose tumors have HER2
overexpress. as defined by IHC2+ and a
confirm. FISH+ result, or IHC3+, as
determ. by accurate and validat. assay.
C/I: Hypersens., Sev. dyspnoea at rest
due to complic. of advanced malign. or
requiring supplemen. oxygen ther.
Monoclonal Antibody. Trastuzumab 600 mg / 5 ml. VIAL (Sol. for inj.): 1 × 600 mg/5ml: 600 mg admin. as a s.c. inj. only over 2-5 min.every three wks. The inj. site should be alternated between the left and right thigh. New inj. should be given at least 2.5 cm from the old site and never into areas where the skin is red, bruised,
tender, or hard. See lit.
Tmt. of adult pts. with HER2 Positive MBC:nAs Monother. for the tmt. of those pt. who have received at least two chemother. regimens for their metast.dis. Prior chemother. must have included at least an
anthracycline and a taxane unless pts. are unsuitable for these tmts. Hormone receptor positive pts. must also have failed hormon. therapy, unless pts. are unsuitable for these tmts. In comb. with paclitaxel for the tmt. of those pts. who have not received chemother. for their metastatic dis. and for
whom an anthracycline is not suitable. In comb. with docetaxel for the tmt. of those pts. who have not received chemother. for their metastatic dis.. In comb.with an aromatase inhib. for the tmt. of postmenopausal pts. with hormonereceptor positive MBC, not previously treated with Early breast cancer: Tmt. of adult patients with HER2 positive EBC. Follow. surgery, chemother. (neoadjuvant or adjuvant) and radiother. (if applicable).Follow. adjuvant chemother. with doxorubicin and cyclophosphamide, in comb.with paclitaxel or docetaxel. In comb. with adjuvant chemother. consisting of docetaxel and carboplatin. In comb. with neoadjuvant chemother. followed by adjuvant Trastuzumab therapy, for locally advanced (includ. inflammatory) disease or tumours > 2 cm in diameter. Trastuzumab should only be used in pts. with metast. or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
C/I: Hypersens. Severe dyspnoea at rest due to complic. of advanced malign./ requiring supplementary oxygen therapy.
Monoclonal Antibody. Trastuzumab 150, 420 mg. VIAL (Pwdr. for concentrate for sol. for infus.): 1. Dosage must be ajust. individ accord. pt. med. cond. and indication.
Tmt. of pts. with metast. breast canc. who have tumors that overexpress HER2;
As a single agent, for the tmt. of those pts. who have received one or more chemother. regim. for their metast. dis.
In comb. with Paclitaxel or Docetaxel for the tmt. of those pts. who have not received chemother. for their metast. dis.
In comb. with an aromatase inhib. for the tmt. of postmenopaus. pt. with hormonereceptor positive metast. breast canc.
Early breast cancer (EBC) – pts. with HER2 positive early breast cancer follow. surg. and chemother. (neoadjuv./ adjuvant) either alone or in comb. with chemother. exclude. anthracyclines.
The drug should only be used in pts. whose tumors have either HER2 overexpres. or HER2 gene amplificat. as determ. by an accurate and validated assay. HER2 Metastat. gast. cancer (MGC)- in comb. with capecitabine or 5-fluorouracil and cisplatin is indic. for the tmt. of pts. with HER2-positive metast. adenocarcinoma of the stomach or gastroesophag. junction who have not received prior anti-cancer tmt. for their metastat. dis.
Trastuzumab should only be used in pts. with metastat. gast. cancer (MGC) whose tumours have HER2 overexpres. as defined by IHC 2+ and a confirmatory FISH+ result, or IHC 3+, as determ. by an accurate and validated assay.
C/I: Hypersens. Severe dyspnea at rest due to complicat. of advanced malig. or require. supplement. oxygen ther.