Vectibix Concentrate for Solution for Infusion 100 mgvial

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Panitumumab

Available from:

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

ATC code:

L01XC08

Dosage:

100 mg/vial

Pharmaceutical form:

INFUSION, SOLUTION CONCENTRATE

Composition:

Panitumumab 100 mg/vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Amgen Manufacturing Limited

Authorization status:

ACTIVE

Authorization date:

2014-01-27

Patient Information leaflet

1 
VECTIBIX
® 

CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/VIAL 

QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each ml of concentrate contains 20 mg panitumumab. 

Each vial contains 100 mg of panitumumab in 5 ml. 

When prepared according to the instructions given
in SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER 
HANDLING SECTION, the final panitumumab concentration should
not exceed 10 mg/ml. 

Panitumumab is a fully human monoclonal IgG2 antibody produced
in a mammalian cell line (CHO) 
by recombinant DNA technology.  

Excipient with known effect: 
Each ml of concentrate contains 0.150 mmol sodium,
which is 3.45 mg sodium.

For a full list of excipients, see LIST OF EXCIPIENTS
SECTION. 

PHARMACEUTICAL FORM 

Concentrate for solution for infusion (sterile concentrate).  

Colourless solution that may contain, translucent to
white, visible amorphous, proteinaceous 
panitumumab particles. 

CLINICAL PARTICULARS 

THERAPEUTIC INDICATIONS 

Vectibix is indicated for the treatment of adult patients with
wild-type _RAS_ metastatic colorectal 
cancer (mCRC): 
• 
in first-line in combination with FOLFOX  
• 
in second-line in combination with FOLFIRI for patients who
have received first-line 
fluoropyrimidine-based chemotherapy (excluding irinotecan).   
• 
as monotherapy after failure of fluoropyrimidine-, oxaliplatin-,
and irinotecan-containing 
chemotherapy regimens. 

POSOLOGY AND METHOD OF ADMINISTRATION 

Vectibix treatment should
be supervised by a physician experienced in the use of anti-cancer therapy. 
Evidence
of wild-type _RAS_ (_KRAS_ and _NRAS_) status is required
before initiating treatment with 
Vectibix. Mutational status should
be determined by an experienced laboratory using a validated
test 
method for detection of _KRAS_ (exons 2, 3 and
4) and _NRAS_ (exons 2, 3 and 4)

Summary of Product characteristics

1
VECTIBIX
® CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/VIAL
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate contains 20 mg panitumumab.
Each vial contains 100 mg of panitumumab in 5 mL.
When prepared according to the instructions given in Special
precautions for disposal and other handling
section, the final panitumumab concentration should not exceed 10
mg/mL.
Panitumumab is a fully human monoclonal IgG2 antibody produced in a
mammalian cell line (CHO) by
recombinant DNA technology.
Excipient with known effect:
Each mL of concentrate contains 0.150 mmol sodium, which is 3.45 mg
sodium.
For the full list of excipients, see List of excipients section.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Colourless, pH 5.6 to 6.0 solution that may contain translucent to
white, visible amorphous, proteinaceous
panitumumab particles.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Vectibix is indicated for the treatment of adult patients with
wild-type
_RAS_
metastatic colorectal cancer
(mCRC):
•
in first-line in combination with FOLFOX or FOLFIRI.
•
in second-line in combination with FOLFIRI for patients who have
received first-line
fluoropyrimidine-based chemotherapy (excluding irinotecan).
•
as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and
irinotecan-containing
chemotherapy regimens.
POSOLOGY AND METHOD OF ADMINISTRATION
Vectibix treatment should be supervised by a physician experienced in
the use of anti-cancer therapy.
Evidence of wild-type
_RAS_
(
_KRAS_
and
_NRAS_
) status is required before initiating treatment with Vectibix.
Mutational status should be determined by an experienced laboratory
using validated test methods for
detection of
_KRAS_
(exons 2, 3 and 4) and
_NRAS_
(exons 2, 3 and 4) mutations.
Posology
The recommended dose of Vectibix is 6 mg/kg of bodyweight given once
every two weeks.
Modification of the dose of Vectibix may be necessary in cases of
severe (≥ grade 3) dermatological
reactions as follows:
2
OCCURRENCE OF
SKIN