Levulan Kerastick

What is Levulan kerastick?

• Levulan kerastick (Aminolevulinic acid hydrochloride) a porphyrin precursor, plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator used in photodynamic therapy to treat actinic keratosis.

Aminolevulinic acid

What are the uses of this medicine?

• Levulan kerastick (Aminolevulinic acid hydrochloride) is a prescription medicine used on the skin (topical) with blue light treatment (BLU-U Blue Light Photodynamic Therapy or PDT) for the treatment of minimally to moderately thick actinic keratoses (AK’s) of the face, scalp, or upper arms.

How does this medicine work?

• Levulan kerastick Photodynamic Therapy of actinic keratoses is the combination of photosensitization by application of the Levulan kerastick topical solution to the lesions and subsequent illumination with BLU-U Blue Light Photodynamic Therapy Illuminator.
• Following the application of Levulan kerastick topical solution, photosensitization occurs through the metabolic conversion of aminolevulinic acid to protoporphyrin IX (PpIX), a photosensitizer, which accumulates in the skin.
• 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 photoreactive porphyrins to molecular oxygen generates singlet oxygen, which can further react to form superoxide and hydroxyl radicals.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to aminolevulinic acid HCl or to any of the ingredients in Levulan kerastick.
• have porphyria or are allergic to porphyrins
• have a skin sensitivity to blue light

What drug interactions can this medicine cause?

• There have been no formal studies of the interaction of Levulan kerastick topical solution with any other drugs, and no drug-specific interactions were noted.
• It is, however, possible that concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines might increase the photosensitivity reaction of actinic keratoses treated with Levulan kerastick topical solution.

Is this medicine FDA approved?

• Initial U.S. Approval: 1999

How should this medicine be used?

Recommended dosage:

• The recommended treatment frequency is: one application of the Levulan kerastick topical solution and one dose of illumination per treatment region per 8-week treatment session.
• Each individual Levulan kerastick applicator should be used for only one patient.

Administration:

• Apply the drug product to the target lesions.
• Illuminate with blue light using the BLU-U® Blue Light Photodynamic Therapy Illuminator after the incubation time of:
• 14 to 18 hours for scalp or face
• 3 hours for upper extremities, with occlusion
• Levulan kerastick photodynamic therapy may be repeated a second time for lesions that have not completely resolved after 8 weeks
• For topical use only.

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

This medicine is available in fallowing doasage form:

• As topical solution contains 20% aminolevulinic acid hydrochloride (ALA HCl) by weight in a plastic applicator device.

This medicine is available in fallowing brand namesː

• Levulan kerastick

What side effects can this medication cause?

The most common side effects of this medicine include:

• Local skin reactions including redness
• swelling
• stinging and burning
• scaling
• crusting
• oozing
• pustules
• welts
• scabbing
• itching
• erosion
• changes in skin color
• bleeding
• tenderness
• changes in the sense of touch
• dryness

Levulan kerastick may cause serious side effects, including:

• Temporary memory problems
• photosensitivity
• Skin irritation

What special precautions should I follow?

• Transient amnestic episodes have been reported during postmarketing use of Levulan kerastick in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Inform patients and their caregivers that Levulan kerastick in combination with PDT may cause transient amnestic episodes. Advise them to contact the healthcare provider if the patient develops amnesia after treatment.
• Avoid exposure of the photosensitive actinic keratoses to sunlight or bright indoor light prior to blue light treatment. Protect treated lesions from sunlight exposure. Sunscreens will not protect the patient against photosensitivity reactions.
• The Levulan kerastick for topical solution should be used by a qualified health professional. To avoid unintended photosensitivity, Levulan kerastick topical solution should be applied to no more than 5 mm of perilesional skin surrounding each target actinic keratosis lesion.
• Irritation may be experienced if this product is applied to eyes or mucous membranes. Do not apply to the eyes or to mucous membranes. Excessive irritation may be experienced if this product is applied under occlusion longer than 3 hours.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• The consequences of exceeding the recommended topical dosage are unknown.

Management of overdosage:

• In the event that the drug is ingested, monitoring and supportive care are recommended.
• The patient should be advised to avoid incidental exposure to intense light sources for at least 40 hours after ingestion.

Can this medicine be used in pregnancy?

• Limited available data with Levulan kerastick topical solution use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes.

Can this medicine be used in children?

• The safety and effectiveness in pediatric patients below the age of 18 have not been established.
• Actinic keratosis is not a disease generally seen in the pediatric population.

What are the active and inactive ingredients in this medicine?

• Active ingredient: aminolevulinic acid HCl
• Inactive ingredients: alcohol USP (ethanol content = 48% v/v), water, laureth-4, isopropyl alcohol, polyethylene glycol

Who manufactures and distributes this medicine?

Manufactured by:

• Sun Pharmaceutical Industries, Inc., Billerica, MA

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

• Store between 20° - 25 °C (68° - 77 °F); excursions permitted to 15°- 30 °C (59° - 86 °F).
• The Levulan kerastick topical solution should be used immediately following preparation (dissolution).
• Solution application must be completed within 2 hours of preparation.
• An applicator that has been prepared must be discarded 2 hours after mixing (dissolving) and a new Levulan kerastick applicator used, if needed.

• Dailymed label info on Levulan Kerastick
• FDA Levulan Kerastick

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