Indications and Clinical Use:

METVIX cream in combination with 630 nm wavelength red light illumination using the Aktilite CL 128 lamp (conventional photodynamic therapy [c-PDT]) is indicated for the:

• treatment of thin or non-hyperkeratotic and non-pigmented actinic keratosis on the face and scalp when other therapies are considered less appropriate.
• treatment of primary superficial basal cell carcinoma outside the H-zone of the face (e.g. ears, nose) when other therapies are considered less appropriate. The lesions should have been confirmed previously by biopsy.

METVIX cream in combination with daylight (daylight photodynamic therapy [DL-PDT]) is indicated for the:

• treatment of thin or non-hyperkeratotic and non-pigmented actinic keratosis on the face and scalp when other therapies are considered less appropriate.

Contraindications:

• Patients who are hypersensitive to aminolevulinic acid or peanut and almond oil, or any of the ingredients in Metvix or porphyrins.
• Patients with cutaneous photosensitivity/porphyria, or known allergies to porphyrins
• Patients with morpheaform basal cell carcinoma.

Most Serious Warnings and Precautions:

• METVIX cream is intended for topical use. Do not apply to the eyes or to mucous membranes.
• METVIX should be administered by trained healthcare professionals only.
• Care should be taken when applying METVIX cream to avoid inadvertent skin contact.
• Patients with sBCC treated with METVIX c-PDT must have regular follow- up of the treatment site since the efficacy is generally less than with surgery.
• The long-term efficacy of METVIX c-PDT for the treatment of sBCC has not been established. Data from studies performed with a different lamp showed that the sBCC lesion complete response (CR) at 12 months was similar to that observed with the Aktilite CL128 lamp, but decreased to 29- 60% at 60 months post-treatment.

Other Relevant Warnings and Precautions:

• Discontinue UV-therapy before treatment
• Direct eye contact should be avoided
• Photosensitivity during time between cream application and exposure to red light illumination — advise patient to protect/cover treated area appropriately from light/cold
• After light exposure cover treated area and protect from light for at least 48 hours
• Apply to the skin lesion and perilesional skin within 5 mm of the lesion — redness, swelling, burning and stinging are expected, if symptoms increase in severity, persist longer than 3 weeks, advise patient to contact physician

• All individuals present during red light treatment should wear protective goggles that screen out red light with wavelengths from 570 to 670 nm
• Red light treatment is only intended for use with the approved lamp: Aktilite CL
• If red light treatment after cream application is not possible, rinse cream off, protect area from sunlight, prolonged or intense light for two days
• Avoid prolonged exposure for greater than 4 hours
• Daylight may not be sufficient for Metvix daylight photodynamic therapy in November to March in Canada
• Carcinogenesis and mutagenesis — no long-term studies exist to evaluate carcinogenic potential
• Pain during illumination may increase blood pressure
• Acute post-procedure hypertension and hypertensive crisis associated with pain during Metvix-PDT have been reported. Severe hypertension reported more frequently in patients with baseline hypertension, those with severe pain or those treated with large lesion area on the head. Measure blood pressure in patients with severe pain — interrupt illumination if severe hypertension is also present — take specific measures when needed
• Hematologic — not tested on patients with inherited or acquired coagulation defects
• Adverse events in immumocompromised organ transplant recipients similar to those reported for immunocompetent patients. Efficacy in immunocompromised patients has not been well established.
• Application site eczema or allergic contact dermatitis or more severe reactions such as angioedema have been reported. Nitrile gloves should be worn when applying and removing the cream. Vinyl and latex gloves do not provide adequate protection when using this product.
• Cetostearyl alcohol and peanut oil may elicit local skin reactions in rare cases, while methylparaben and propylparaben may cause allergic reactions
• Contact sensitization (Allergenicity has been observed. Angioedema, eyelid edema, and face edema have been reported). Discontinue in patients who experienced severe hypersensitivity reactions
• Thick (hyperkeratotic) actinic keratosis should not be treated with METVIX cream
• Not recommended during pregnancy — should be given only if the benefit risk ratio is favourable
• Nursing - risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued for 48 hours after application
• Pediatrics — not recommended for use

For more Information:

Please consult the Product Monograph at https://www.galderma.com/sites/g/files/jcdfhc196/files/inline-files/Metvix-PM-E.pdf for important information relating to adverse reactions, drug interactions, and dosing information, which have not been discussed in this piece. The product monograph is also available by calling 1-800-467-2081.