VECTIBIX 20 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PANITUMUMAB

Available from:

AMGEN EUROPE B.V.

ATC code:

L01XC08

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

PANITUMUMAB 20 MG / 1 ML

Administration route:

I.V. INFUSION

Prescription type:

Required

Manufactured by:

AMGEN EUROPE B.V., NETHERLANDS

Therapeutic area:

PANITUMUMAB

Therapeutic indications:

In combination with chemotherapy for the treatment of unresectable, advanced or recurrent colorectal cancer (mCRC) with wild-type RAS.Monotherapy for the treatment of patients with metastatic colorectal carcinoma with wild-type RAS after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Authorization date:

2015-02-28

Patient Information leaflet

לירפא
8
201
ML
MG/
20
)
ANITUMUMAB
P
(
VECTIBIX CONCENTRATE FOR SOLUTION FOR INFUSION
,ה/דבכנ ת/חקור ,ה/דבכנ ה/אפור
לע ךעידוהל תשקבמ ,םושירה תלעב ,יו יב
הפוריא ן'גמא
ולעב םינוכדע
אפורל ן
רישכתל
סקיביטקו
.
דבלב הרמחה םיווהמה םייונישה םיניוצמ
וז העדוהב
.
:תורשואמה תויוותהה
In combination with chemotherapy for the treatment of unresectable,
advanced or
recurrent
colorectal cancer (mCRC) with wild-type RAS.
Monotherapy for the treatment of patients with metastatic colorectal
carcinoma with
wild-type
RAS after failure of fluoropyrimidine-, oxaliplatin-, and
irinotecan-containing
chemotherapy
regimens.
:אפורל ןולעב תורמחה
4.8
UNDESIRABLE EFFECTS
….
Tabulated summary of adverse reactions
The data in the table below describe adverse reactions reported from
clinical studies in
patients with mCRC who received panitumumab as a single agent or in
combination with
chemotherapy (n = 2,224) and spontaneous reporting. Within each
frequency grouping,
undesirable effects are presented in order of decreasing seriousness.
ADVERSE REACTIONS
MEDDRA SYSTEM
ORGAN CLASS
VERY COMMON
(≥ 1/10)
COMMON
(≥ 1/100 TO < 1/10)
UNCOMMON
(≥ 1/1,000 TO< 1/100)
Infections and
infestations
Conjunctivitis
Paronychia
1
Rash pustular
Cellulitis
1
Urinary tract infection
Folliculitis
Localized infection
Eye infection
Eyelid infection
Blood and
lymphatic system
disorders
Anemia
Leukopenia
Immune system
disorders
Hypersensitivity
1
Anaphylactic reaction
2
Metabolism and
nutrition
disorders
Hypokalemia
Hypomagnesemia
Decreased appetite
Hypocalcemia
Dehydration
Hyperglycemia
Hypophosphatemia
Psychiatric
disorders
Insomnia
Anxiety
ADVERSE REACTIONS
MEDDRA SYSTEM
ORGAN CLASS
VERY COMMON
(≥ 1/10)
COMMON
(≥ 1/100 TO < 1/10)
UNCOMMON
(≥ 1/1,000 TO< 1/100)
Nervous system
disorders
Headache
Dizziness
Eye disorders
Blepharitis
Growth of eyelashes
Lacrimation increased
Ocular hyperemia
Dry eye

Summary of Product characteristics

1
_Revised in November 2021 according to MoHs guidelines._
1.
NAME OF THE MEDICINAL PRODUCT
Vectibix 20 mg/mL concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate contains 20 mg panitumumab.
Each vial contains either 100 mg of panitumumab in 5 mL, or 400 mg of
panitumumab in 20 mL.
When prepared according to the instructions given in section 6.6, 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 section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Colorless, pH 5.6 to 6.0 solution that may contain
translucent-to-white, visible amorphous,
proteinaceous panitumumab particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In combination with chemotherapy for the treatment of unresectable,
advanced or recurrent colorectal
cancer (mCRC) with wild-type RAS.
Monotherapy for the treatment of patients with metastatic colorectal
carcinoma with wild-type RAS
after failure of fluoropyrimidine-, oxaliplatin-, and
irinotecan-containing chemotherapy regimens.
4.2
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 body weight 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 SYMPTOM(S):
≥
GRADE 3
1