OGIVRI™ LYOPHILIZED POWDER FOR INJECTION 440MG PER VIAL

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

(Powder) Trastuzumab

Available from:

ZUELLIG PHARMA PTE. LTD.

ATC code:

L01XC03

Pharmaceutical form:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Composition:

(Powder) Trastuzumab 440 mg/vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Biocon Biologics Limited (Powder and Diluent)

Authorization status:

ACTIVE

Authorization date:

2019-11-04

Summary of Product characteristics

_Following adjuvant chemotherapy with doxorubicin and
cyclophosphamide, in combination with paclitaxel or docetaxel._
_Following surgery, chemotherapy (neoadjuvant or adjuvant) and
radiotherapy (if applicable) (see section "Pharmacodynamic
properties")._
_In combination with adjuvant chemotherapy consisting of docetaxel and
carboplatin._
_In combination with neoadjuvant chemotherapy followed by adjuvant
Ogivri™ therapy, for locally advanced (including inflammatory)
disease or tumours > 2 cm in diameter (see section "Warnings and
Precautions" and _
_"Pharmacodynamic properties")._
_Ogivri™ is indicated for the treatment of adult patients with HER2
positive early breast cancer (EBC)._
_Ogivri™ should only be used in patients with metastatic or EBC
whose tumours have either HER2 overexpression or HER2 gene
amplification as determined by an accurate and validated assay._
_As monotherapy for the treatment of those patients who have received
at least one chemotherapy regimens for their metastatic disease._
_In combination with an aromatase inhibitor for the treatment of
postmenopausal patients with hormone-receptor positive MBC, not
previously treated with trastuzumab._
_In combination with paclitaxel for the treatment of those patients
who have not received chemotherapy for their metastatic disease._
_This indication is based on data from one Phase III trial which
studied the use of Herceptin in combination with anastrozole (see
Clinical Studies). Experience with other aromatase inhibitors is
limited._
_Ogivri™ is indicated for the treatment of adult patients with HER2
positive metastatic breast cancer (MBC):_
_Ogivri should only be used in patients with metastatic gastric cancer
(MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a
confirmatory FISH result, or by an IHC 3+ result. Accurate and
validated assay _
_methods should be used (see section "Warnings and Precautions" and
"Pharmacodynamic properties")_
_Ogivri in combination with capecitabine or 5-fluorouracil and
cisplatin is indicated