Levulan (aminolevulinic acid HCl)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Aminolevulinic acid hydrochloride is the hydrochloride salt of 5-aminolevulinic acid, an endogenous precursor of protoporphyrin IX, which is a photosensitizer.
Aminolevulinic acid hydrochloride is the hydrochloride salt of 5-aminolevulinic acid, an endogenous precursor of protoporphyrin IX, which is a photosensitizer.
The formation of aminolevulinic acid from glycine and succinyl-coenzyme A (succinyl CoA) is the first step in the heme synthesis pathway; the final step is the incorporation of iron into protoporphyrin IX to form heme, which occurs under the action of ferrochelatase. The synthesis of aminolevulinic acid normally is tightly controlled by feedback inhibition of the enzyme aminolevulinic acid synthase, presumably by intracellular heme levels. Therefore, when exogenous aminolevulinic acid is provided to the cell through topical application of aminolevulinic acid hydrochloride, protoporphyrin IX accumulates because of the limited capacity of ferrochelatase to convert protoporphyrin IX into heme.
When exposed to light of appropriate wavelength and energy, the accumulated protoporphyrin IX produces a photodynamic reaction, a cytotoxic process dependent upon the simultaneous presence of light and oxygen. The absorption of light by protoporphyrin IX results in an excited state of the molecule and subsequent generation of cytotoxic singlet oxygen atoms, which can react further to form superoxide and hydroxyl radicals. The tissue-specific phototoxic effects resulting from local application of aminolevulinic acid hydrochloride and light irradiation are the basis of photodynamic therapy for actinic keratoses.
Generic name: aminolevulinic acid HCl
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Levulan
Indications
The following indications are listed for Levulan:
- Actinic Keratosis Of The Upper Extremity
- Actinic Keratosis On The Face Or Scalp
Also known as: Actinic Keratosis Of The Upper Limb.
Dosing
No dosing information is available for this tab.
Aminolevulinic acid hydrochloride solution is applied topically. The solution is intended for direct application to individual lesions diagnosed as actinic keratoses and not to perilesional skin. Aminolevulinic acid hydrochloride topical solution is not intended for application by patients or unqualified medical personnel. Application should involve either scalp or face lesions, but not both simultaneously.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
No formal drug interaction studies have been performed. The manufacturer states that no drug-specific interactions were noted during any of the controlled clinical trials.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
Known cutaneous photosensitivity at wavelengths of 400-450 nm, porphyria or known allergies to porphyrins, or known sensitivity to aminolevulinic acid hydrochloride or any ingredient in the formulation.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Transient local stinging and/or burning, itching, erythema, and edema were observed in all clinical trials of aminolevulinic acid hydrochloride topical solution plus BLU-U(R) blue light treatment. Severe stinging/burning of one or more lesions was reported in at least 50% of patients at some time during treatment, with most patients reporting at least slight stinging/burning of treated lesions. Less than 3% of patients in clinical trials discontinued light treatment because of stinging and/or burning. Erythema and edema at some or all lesions were reported in 99 or 35%, respectively, of patients shortly after treatment.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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Category C. (See Users' Guide.)
It is unknown whether aminolevulinic acid or its metabolites are distributed in breast milk; therefore, caution should be exercised when aminolevulinic acid hydrochloride solution is used in a nursing woman.
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ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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