Methyl aminolevulinate hydrochloride

What is Methyl aminolevulinate hydrochloride?

• Methyl aminolevulinate hydrochloride (metvixia) is an oil in water emulsion used as a sensitizer in photodynamic therapy.

Methyl aminolevulinate

What are the uses of this medicine?

• Methyl aminolevulinate hydrochloride (metvixia) is a prescription cream used with PDT (light treatment) to treat skin growths on the face and scalp called actinic keratosis (AK). Metvixia Cream is only used for AK skin growths that are thin and not dark colored.
• AK skin growths are not cancer. AK skin growths are caused partly by too much sun exposure.
• Metvixia Cream and PDT work together to treat AK skin growths.
• Metvixia Cream has not been studied in children for any condition and should not be used in children.

How does this medicine work?

• Photosensitization following application of Metvixia Cream occurs through the metabolic conversion of methyl aminolevulinate (prodrug) to photoactive porphyrins (PAP), which accumulates in the skin lesions to which Metvixia Cream has been applied. When exposed to light of appropriate wavelength
• and energy, the accumulated photoactive porphyrins produce a photodynamic reaction, resulting in a cytotoxic process dependent upon the simultaneous presence of oxygen. The absorption of light results in an excited state of porphyrin molecules, and subsequent spin transfer from photoactive porphyrins to
• molecular oxygen generates singlet oxygen, which can further react to form superoxide and hydroxyl radicals.

• Metvix cream is applied topically and some time later the skin is illuminated with a proprietary red light (630 nm) source (medical lamp 'Aktilite') to activate the photosensitiser.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• your skin over reacts to sun or light (photosensitivity)
• you are allergic to porphyrins or to any of the ingredients in Metvixia Cream. The active ingredient is methyl aminolevulinate hydrochloride. Metvixia Cream also contains peanut and
• almond oil.

What drug interactions can this medicine cause?

• It is not known if Metvixia Cream and other medicines can affect each other.

Is this medicine FDA approved?

• Initial U.S. Approval: 2008

How should this medicine be used?

Recommended dosage:

• Two treatment sessions 7 days apart should be conducted.
• Not more than one gram (half a tube) of Metvixia Cream should be applied per treatment session.

Administration:

• Metvixia Cream and PDT treatment is only done by trained doctors.
• You will receive 2 treatments with Metvixia Cream and PDT 7 days (1 week) apart. Your doctor will check you three months after treatment to see if the treatment worked for you your skin over reacts to sun or light (photosensitivity) you are allergic to porphyrins or to any of the ingredients in Metvixia Cream.
• Metvixia Cream is for skin use only.
• Do not get Metvixia Cream in your eyes, mouth, or nose.
• Tell your doctor right away if this happens.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As methyl aminolevulinate Cream, 16.8%

This medicine is available in fallowing brand namesː

• Metvixia

What side effects can this medication cause?

The most common side effects of this medicine include:

• Common side effects of Metvixia Cream with PDT treatment include the following skin reactions at the treated site:
• burning feeling
• redness
• pain
• stinging
• swelling
• crusting, peeling, blisters, bleeding, itching, ulcers
• infection

What special precautions should I follow?

During the 3 hours that Metvixia Cream is on your skin:

• Avoid exposure to sunlight or bright indoor light during the 3 hours that Metvixia Cream is on your skin. Wear a protective hat and clothing if you need to be outside in the sun.
• Avoid exposure to cold temperatures during the 3 hours that Metvixia Cream is on your skin. Wear warm clothing and keep your treated skin site covered if you are in cold temperatures.

• If for some unavoidable reason you are not treated with the lamp you should
• Carefully rinse off the Cream.
• Avoid exposure to sunlight, prolonged or intense light for two days after treatment.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Metvixia Cream overdose has not been reported.
• If the patient for any reason cannot have the red light treatment during the prescribed period after application (the 3 hour timespan), the cream should be rinsed off, and the patient should protect the exposed area from sunlight, prolonged or intense light for two days.

• There is no information on overdose of red light following Metvixia Cream application.

Management of overdosage:

• In case of red light overexposure and skin burn occurs, the patient should be treated according to standard of practice guidelines for treatment of cutaneous burns.

Can this medicine be used in pregnancy?

• Teratogenic effects
• Pregnancy Category C
• Metvixia Cream should be given to a pregnant woman only if clearly needed.

Can this medicine be used in children?

• It is not recommended that Metvixia Cream be used in pediatric patients.
• Actinic keratosis is rarely found in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: methyl aminolevulinate hydrochloride
• Other Ingredients: Glyceryl monostearate, cetostearyl alcohol, poloxyl stearate, cholesterol, oleyl alcohol glycerin, white petrolatum, isopropyl myristate, refined peanut oil, refined almond oil, edetate disodium, methylparaben and propylparaben. The color of the product is cream to pale yellow.

Who manufactures and distributes this medicine?

• Metvixia Cream is a registered trade name of PhotoCure ASA.
• PhotoCure ASA, Hoffsveien 48, Oslo, Norway

• Manufacturer: Penn Pharmaceutical Services Ltd., Tafarnaubach Industrial Estate, Tredegar, Gwent,

What should I know about storage and disposal of this medication?

• Store refrigerated, 2-8°C (36-46°F).
• Use contents within one week after opening.
• Should not be used after 24 hours out of refrigerator.

• Dailymed label info on Methyl aminolevulinate hydrochloride
• FDA Methyl aminolevulinate hydrochloride

Methyl aminolevulinate hydrochloride Resources
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Methyl aminolevulinate hydrochloride Resources
Latest articles Most recent articles Ongoing trials	Wikipedia