Drugs List

Therapeutic Indications

Uses

Mild actinic keratoses in combination with photodynamic therapy

Single use treatment of mild actinic keratoses lesions with a maximum diameter of 1.8cm on the face and scalp (hairless areas).

No recommended for very thick, red, scaly indurated actinic keratosis lesions.

Contraindications

Children under 18 years
No response to previous PDT with 5-aminolevulinic acid containing products
Photoactive disorder
Within 2 weeks of discontinuing St John's Wort
Porphyria

Precautions and Warnings

Breastfeeding
Pregnancy

Discontinue UV therapy before starting treatment
Treatment to be initiated and supervised by a specialist
Avoid concurrent use of photosensitising agents
Avoid other topical preparations
Avoid use in or near eyes
For single use only
Staff & patients: Protective goggles for the lamp spectrum used to be worn
Evaluate the patient 3 months after treatment
Advise patient not to take St John's wort concurrently
Breastfeeding: Do not breastfeed & discard milk for 48 hours after therapy
Avoid sun exposure for 48 hours after treatment

Do not repeat treatment if patient is not lesion free 3 months after application of plaster. There is no data on efficacy and safety for repeated treatment. Use alternative therapy.

The success and assessment of treatment may be impaired if the treatment areas are affected by the presence of skin diseases (skin inflammation, located infection, psoriasis, eczema, and benign or malignant skin cancers) as well as tattoos. No experience exists with these situations.

There is no experience of treating dark brown or black skin (skin sun sensitivity type V or VI according to Fitzpatrick classification system) with 5-aminolevulinic acid medicated plasters.

Pregnancy and Lactation

Pregnancy

Use 5-aminolevulinic acid with caution in pregnancy.

At the time of writing there is insufficient data regarding use in pregnancy. The potential risk to humans is unknown. There are insufficient animal studies. The manufacturer advises 5-aminolevulinic acid should not be used during pregnancy unless necessary.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use 5-aminolevulinic acid with caution in breastfeeding.

It is not known if 5-aminolevulinic acid is excreted in breast milk. There are insufficient animal studies. Manufacturer advises discontinue breastfeeding for 48 hours after 5-aminolevulinic acid application.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Alanine aminotransferase increased
Application site reaction
Bleeding skin
Burning sensation (local)
Crusting of skin
Desquamation
Discharge (application site)
Emotional upsets
Epistaxis
Erosion
Erythema
Excoriation
Formation of pustules
Headache
Hyperpigmentation
Hypopigmentation
Inflammation (application site)
Irritation (localised)
Local pain
Localised exfoliation
Oedema
Pruritus
Pyoderma
Skin discolouration
Skin discomfort
Skin infection
Skin reactions
Swelling(localised)
Ulceration (application site)
Vesicles

Presentation

Medicated plaster containing 5-aminolevulinic acid.

Drugs List

Therapeutic Indications

Uses

Mild actinic keratoses in combination with photodynamic therapy

Single use treatment of mild actinic keratoses lesions with a maximum diameter of 1.8cm on the face and scalp (hairless areas).

No recommended for very thick, red, scaly indurated actinic keratosis lesions.

Dosage

Adults

Contraindications

Children under 18 years
No response to previous PDT with 5-aminolevulinic acid containing products
Photoactive disorder
Within 2 weeks of discontinuing St John's Wort
Porphyria

Precautions and Warnings

Breastfeeding
Pregnancy

Discontinue UV therapy before starting treatment
Treatment to be initiated and supervised by a specialist
Avoid concurrent use of photosensitising agents
Avoid other topical preparations
Avoid use in or near eyes
For single use only
Staff & patients: Protective goggles for the lamp spectrum used to be worn
Evaluate the patient 3 months after treatment
Advise patient not to take St John's wort concurrently
Breastfeeding: Do not breastfeed & discard milk for 48 hours after therapy
Avoid sun exposure for 48 hours after treatment

Do not repeat treatment if patient is not lesion free 3 months after application of plaster. There is no data on efficacy and safety for repeated treatment. Use alternative therapy.

The success and assessment of treatment may be impaired if the treatment areas are affected by the presence of skin diseases (skin inflammation, located infection, psoriasis, eczema, and benign or malignant skin cancers) as well as tattoos. No experience exists with these situations.

There is no experience of treating dark brown or black skin (skin sun sensitivity type V or VI according to Fitzpatrick classification system) with 5-aminolevulinic acid medicated plasters.

Pregnancy and Lactation

Pregnancy

Use 5-aminolevulinic acid with caution in pregnancy.

At the time of writing there is insufficient data regarding use in pregnancy. The potential risk to humans is unknown. There are insufficient animal studies. The manufacturer advises 5-aminolevulinic acid should not be used during pregnancy unless necessary.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use 5-aminolevulinic acid with caution in breastfeeding.

It is not known if 5-aminolevulinic acid is excreted in breast milk. There are insufficient animal studies. Manufacturer advises discontinue breastfeeding for 48 hours after 5-aminolevulinic acid application.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Alanine aminotransferase increased
Application site reaction
Bleeding skin
Burning sensation (local)
Crusting of skin
Desquamation
Discharge (application site)
Emotional upsets
Epistaxis
Erosion
Erythema
Excoriation
Formation of pustules
Headache
Hyperpigmentation
Hypopigmentation
Inflammation (application site)
Irritation (localised)
Local pain
Localised exfoliation
Oedema
Pruritus
Pyoderma
Skin discolouration
Skin discomfort
Skin infection
Skin reactions
Swelling(localised)
Ulceration (application site)
Vesicles

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: February 2018

Reference Sources

Summary of Product Characteristics: Alacare 8mg medicated plaster. Medac GmbH. Revised September 2016.