Ameluz (aminolevulinic acid HCl)
Actinic Keratoses Agents Topical Gel (GRAM)
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
Drug class: Actinic Keratoses Agents
Therapeutic class: Dermatological
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Ameluz
Indications
The following indications are listed for Ameluz:
- Actinic Keratosis On The Face Or Scalp
- Superficial Basal Cell Carcinoma
Also known as: Superficial Basal Cell Epithelioma, Superficial Basalioma, Superficial Bcc, Superficial Bce.
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.
- Porphyria
- Skin photosensitivity
- Increased risk of bleeding due to coagulation disorder
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.
Less Frequent
- Application site bleeding
- Squamous cell carcinoma
- Urticaria
Rare or Very Rare
- Angioedema
- Hypersensitivity drug reaction
- Hypertension
- Hypertensive crisis
- Macular retinal edema
- Transient cerebral ischemia
- Vitreous detachment
More Frequent
- Abnormal desquamation
- Blistering skin
- Contact dermatitis
- Dry skin
- Dyschromia
- Dysesthesia
- Edema
- Erythema
- Induration of skin
- Pain
- Pruritus of skin
- Skin crusting
- Skin irritation
- Skin scaling
- Superficial skin ulcer
Less Frequent
- Application site skin reactions
- Chills
- Dry eye
- Exfoliative dermatitis
- Eyelid edema
- Headache disorder
- Phototoxicity
- Sinusitis
- Skin fissure
- Skin photosensitivity
- Skin ulcer
- Solar lentigines
- Vision impairment
Rare or Very Rare
- Allergic dermatitis
- Application site infection
- Blurred vision
- Conjunctival hyperemia
- Diplopia
- Eczema
- Facial edema
- Fatigue
- Fever
- Keratitis
- Localized edema
- Nervousness
- Ocular irritation
- Petechiae
- Photophobia
- Sensation of warmth
- Transient global amnesia
Precautions
No enhanced messaging available.
No enhanced messaging available.
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.
No enhanced messaging available.
ICD codes
| Code | Type | Description |
|---|---|---|
| Actinic keratosis on the face or scalp | ||
| L57.0 | ICD10CM | Actinic keratosis |
| Superficial basal cell carcinoma | ||
| C44.01 | ICD10CM | Basal cell carcinoma of skin of lip |
| C44.11 | ICD10CM | Basal cell carcinoma of skin of eyelid, including canthus |
| C44.111 | ICD10CM | Basal cell carcinoma of skin of unspecified eyelid, including canthus |
| C44.112 | ICD10CM | Basal cell carcinoma of skin of right eyelid, including canthus |
| C44.1121 | ICD10CM | Basal cell carcinoma of skin of right upper eyelid, including canthus |
| C44.1122 | ICD10CM | Basal cell carcinoma of skin of right lower eyelid, including canthus |
| C44.119 | ICD10CM | Basal cell carcinoma of skin of left eyelid, including canthus |
| C44.1191 | ICD10CM | Basal cell carcinoma of skin of left upper eyelid, including canthus |
| C44.1192 | ICD10CM | Basal cell carcinoma of skin of left lower eyelid, including canthus |
| C44.21 | ICD10CM | Basal cell carcinoma of skin of ear and external auricular canal |
| C44.211 | ICD10CM | Basal cell carcinoma of skin of unspecified ear and external auricular canal |
| C44.212 | ICD10CM | Basal cell carcinoma of skin of right ear and external auricular canal |
| C44.219 | ICD10CM | Basal cell carcinoma of skin of left ear and external auricular canal |
| C44.31 | ICD10CM | Basal cell carcinoma of skin of other and unspecified parts of face |
| C44.310 | ICD10CM | Basal cell carcinoma of skin of unspecified parts of face |
| C44.311 | ICD10CM | Basal cell carcinoma of skin of nose |
| C44.319 | ICD10CM | Basal cell carcinoma of skin of other parts of face |
| C44.41 | ICD10CM | Basal cell carcinoma of skin of scalp and neck |
| C44.51 | ICD10CM | Basal cell carcinoma of skin of trunk |
| C44.510 | ICD10CM | Basal cell carcinoma of anal skin |
| C44.511 | ICD10CM | Basal cell carcinoma of skin of breast |
| C44.519 | ICD10CM | Basal cell carcinoma of skin of other part of trunk |
| C44.61 | ICD10CM | Basal cell carcinoma of skin of upper limb, including shoulder |
| C44.611 | ICD10CM | Basal cell carcinoma of skin of unspecified upper limb, including shoulder |
| C44.612 | ICD10CM | Basal cell carcinoma of skin of right upper limb, including shoulder |
| C44.619 | ICD10CM | Basal cell carcinoma of skin of left upper limb, including shoulder |
| C44.71 | ICD10CM | Basal cell carcinoma of skin of lower limb, including hip |
| C44.711 | ICD10CM | Basal cell carcinoma of skin of unspecified lower limb, including hip |
| C44.712 | ICD10CM | Basal cell carcinoma of skin of right lower limb, including hip |
| C44.719 | ICD10CM | Basal cell carcinoma of skin of left lower limb, including hip |
| C44.81 | ICD10CM | Basal cell carcinoma of overlapping sites of skin |
| C44.91 | ICD10CM | Basal cell carcinoma of skin, unspecified |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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