Metvix 160mgg Cream

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Methyl 5-aminolevulinate hydrochloride 20%w/w eq. to Methyl 5-aminolevulinate

Available from:

GALDERMA SINGAPORE PRIVATE LIMITED

ATC code:

L01XD03

Dosage:

20% w/w

Pharmaceutical form:

CREAM

Composition:

Methyl 5-aminolevulinate hydrochloride 20%w/w eq. to Methyl 5-aminolevulinate 16% w/w

Administration route:

TOPICAL

Prescription type:

Prescription Only

Manufactured by:

Laboratoires GALDERMA

Authorization status:

ACTIVE

Authorization date:

2008-02-15

Patient Information leaflet

Page 1 of 4 

METVIX 160MG/G CREAM   
(METHYL AMINOLEVULINATE)     

POM ONLY FOR TOPICAL USE ONLY     

COMPOSITION 

Each gram of Metvix cream contains 160mg of
methyl aminolevulinate (as hydrochloride), in a vehicle base 
composed of
self-emulsifying glyceryl monostearate, cetostearyl alcohol,
poloxyl 40 stearate, methyl 
parahydroxybenzoate, propyl parahydroxybenzoate,
disodium edetate, glycerol, white soft paraffin, 
cholesterol, isopropyl myristate, arachis oil, refined almond oil,
oleyl alcohol and purified water.     

PHARMACOLOGICAL PROPERTIES     

PHARMACODYNAMICS PROPERTIES     

Pharmacotherapeutic group: 

Antineoplastic agent, ATC Code: LOIX D03     

Mechanism of Action: 

After topical application of methyl aminolevulinate,
porphyrins will accumulate intracellularly in the treated 
skin lesions. The intracel1ular porphyrins (including PpIX) are
photoactive, fluorescing compounds and, upon 
light activation in
the presence of oxygen, singlet oxygen is formed which causes
damage to cellular 
compartments, in particular
the mitochondria. Light activation of accumulated porphyrins
leads to a 
photochemical reaction and thereby phototoxicity to
the light-exposed target cells.     

PHARMACOKINETIC PROPERTIES   

In vitro
dermal absorption of radio-labeled methyl aminolevulinate applied to
human skin has been studied. 
After 24 hours the mean cumulative absorption through
human skin was 0.26% of the administered dose. A 
skin depot containing 4.9% of the dose was formed.
No corresponding studies in human skin with damage 
similar to actinic keratosis lesions
and additionally roughened surface or without stratum
corneum were 
performed.   

In humans, a higher degree of accumulation of porphyrins
in lesions compared to normal skin has been 
demonstrated w

Summary of Product characteristics

Page
1
of
6
METVIX 160MG/G CREAM
(METHYL AMINOLEVULINATE)
PRESCRIPTION MEDICINE FOR TOPICAL USE ONLY
COMPOSITION
Each gram of Metvix cream contains 160mg of methyl aminolevulinate (as
hydrochloride), in a vehicle base
composed
of
self-emulsifying
glyceryl
monostearate,
cetostearyl
alcohol,
polyoxyl
40
stearate,
methyl
parahydroxybenzoate, propyl parahydroxybenzoate, disodium edetate,
glycerol, white soft paraffin, cholesterol,
isopropyl myristate, arachis oil, refined almond oil, oleyl alcohol
and purified water.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS PROPERTIES
Pharmacotherapeutic group:
Antineoplastic agent, ATC Code: L01X D03
Mechanism of Action
•
_Metvix with red light in actinic keratoses (AK), basal cell carcinoma
(BCC) and Bowen's disease _
After topical application of methyl aminolevulinate, porphyrins will
accumulate intracellularly in the treated skin
lesions. The intracel1ular porphyrins (including PpIX) are
photoactive, fluorescing compounds and, upon light
activation in the presence of oxygen, singlet oxygen is formed which
causes damage to cellular compartments, in
particular the mitochondria. Light activation of accumulated
porphyrins leads to a photochemical reaction and
thereby phototoxicity to the light-exposed target cells.
•
_Metvix with daylight in AK _
After topical application of methyl aminolevulinate, porphyrins are
produced intracellularly in the treated skin
lesions. The intracellular porphyrins (including PpIX) are
photoactive, fluorescing compounds and, upon daylight
activation in the
presence of oxygen, singlet oxygen is formed which causes damage to
cellular compartments, in
particular the mitochondria. When Metvix is used with daylight, PpIX
is continuously being produced and activated
within the target cells during the 2 hours of daylight exposure
creating a constant micro-phototoxic effect. Daylight
may not be sufficient for Metvix daylight treatment during winter
months in certain parts of Europe. Metvix
daylight photodynamic therapy is feasible all year long in souther