Generic Name
Aminolevulinic
Brand Names
Levulan Kerastick, Ameluz, Gleolan
FDA approval date: September 04, 2000
Classification: Optical Imaging Agent
Form: Kit, Powder, Gel
What is Levulan Kerastick (Aminolevulinic)?
Gleolan is indicated in patients with glioma [suspected World Health Organization Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery. Gleolan is an optical imaging agent indicated in patients with glioma as an adjunct for the visualization of malignant tissue during surgery.
Approved To Treat
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Brand Information
LEVULAN KERASTICK (aminolevulinic acid hydrochloride)
1INDICATIONS AND USAGE
The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities.
2DOSAGE FORMS AND STRENGTHS
For topical solution: 354 mg of aminolevulinic acid hydrochloride as a powder in a plastic applicator device. Upon mixture, LEVULAN KERASTICK is a topical solution containing 20% aminolevulinic acid hydrochloride (ALA HCl) by weight.
3CONTRAINDICATIONS
The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is contraindicated in patients with:
- Cutaneous photosensitivity at wavelengths of 400-450 nm
- Porphyria or known allergies to porphyrins
- Known sensitivity to any of the components of the LEVULAN KERASTICK.
4ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in the other sections of the labeling:
- Transient Amnestic Episodes
- Increased Photosensitivity
- Irritation
- Coagulation defects
4.1Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials, no non-cutaneous adverse events were found to be consistently associated with LEVULAN KERASTICK photodynamic therapy.
Photodynamic Therapy Response:The constellation of transient local symptoms of stinging and/or burning, itching, erythema and edema as a result of LEVULAN KERASTICK photodynamic therapy (PDT) was observed in all clinical trials for actinic keratoses treatment. Stinging and/or burning subsided between 1 minute and 24 hours after the BLU-U Blue Light Photodynamic Therapy Illuminator was turned off, and appeared qualitatively similar to that perceived by patients with erythropoietic protoporphyria upon exposure to sunlight. There was no clear drug dose or light dose dependent change in the incidence or severity of stinging and/or burning.
Local skin reactions at the application site were observed in 99% of subjects treated with LEVULAN KERASTICK topical solution and BLU-U Blue Light Photodynamic Therapy Illuminator. The most common local adverse reactions (incidence ≥ 10%) were application site stinging/burning, erythema, edema, scaling/crusting, hypo/hyperpigmentation, itching, erosion, oozing/vesiculation/crusting, dryness.
In the trials for face and scalp lesions, severe stinging and/or burning at one or more lesions during light treatment was reported by at least 50% of subjects. Severe stinging and/or burning also occurred during light treatment in 9% of subjects receiving treatment for upper extremity lesions. The majority of subjects reported that all lesions treated exhibited at least slight stinging and/or burning. In trials of the face and scalp, the sensation of stinging/burning appeared to reach a plateau at 6 minutes into the treatment. Less than 3% of subjects receiving treatment for face or scalp lesions discontinued light treatment because of stinging/burning. No subjects discontinued light treatment in the trial for upper extremity lesions.
In trials for the face or scalp lesions, 99% of the active treatment group and 79% of the vehicle group experienced erythema shortly after treatment. In the trial for the upper extremity lesions, 99% of LEVULAN KERASTICK topical solution treatment group and 52% of the vehicle group experienced erythema on visit Days 2-3. Approximately 35% of LEVULAN KERASTICK topical solution group had edema, while edema occurred in
The application of LEVULAN KERASTICK topical solution to perilesional skin resulted in stinging, burning, erythema and edema similar to treated actinic keratoses
Other Localized Cutaneous Adverse Experiences:Table 2depicts the incidence and severity of cutaneous adverse events in trials for the face and scalp.
Table 3depicts the incidence of other cutaneous adverse events in Phase 3 studies for the upper extremities.
In the trial for upper extremity lesions, itching and scabbing occurred in 8% and 4%, respectively, of the subjects in the LEVULAN KERASTICK photodynamic therapy group. No subjects in the vehicle group reported itching or scabbing.
Common (
Uncommon (<2%) local cutaneous adverse reactions for face, scalp and upper extremities in the LEVULAN KERASTICK topical solution group were flaking, pain, peeling, perilesional pruritic rash, excoriation and blistering.
Common (
4.2Postmarketing Experience
The following adverse reactions have been reported during post-approval use of LEVULAN KERASTICK. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Nervous system disorders: transient amnestic episodes
5DRUG INTERACTIONS
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 during any of the controlled clinical trials. 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
6DESCRIPTION
LEVULAN KERASTICK (aminolevulinic acid HCl) for topical solution, 20%, a porphyrin precursor, contains the hydrochloride salt of aminolevulinic acid (ALA), an endogenous 5-carbon aminoketone.
ALA HCl is a white to off-white, odorless crystalline solid that is very soluble in water, slightly soluble in methanol and ethanol, and practically insoluble in chloroform, hexane and mineral oil.
The chemical name for ALA HCl is 5-amino-4-oxopentanoic acid hydrochloride (MW = 167.59). The structural formula is represented below:
The LEVULAN KERASTICK for topical solution applicator is a two-component system consisting of a plastic tube containing two sealed glass ampules and an applicator tip. One ampule contains 1.5 mL of solution vehicle comprising alcohol USP (ethanol content = 48% v/v), water, laureth-4, isopropyl alcohol, and polyethylene glycol. The other ampule contains 354 mg of aminolevulinic acid HCl as a dry solid. The applicator tube is enclosed in a protective cardboard sleeve and cap. The 20% topical solution is prepared just prior to the time of use by breaking the ampules and mixing the contents by shaking the LEVULAN KERASTICK applicator. “LEVULAN KERASTICK for topical solution” refers to the drug product in its unmixed state, “LEVULAN KERASTICK topical solution” refers to the mixed drug product (in the applicator tube or after application), and “LEVULAN KERASTICK” refers to the applicator only.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Transient Amnestic Episodes
Transient episodes of amnesia have been reported with LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Advise patients and their families or caregivers to contact their healthcare provider if memory impairment, confusion, or disorientation is observed
Photosensitivity
Transient episodes of amnesia have been reported with LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Advise patients and their families or caregivers to contact their healthcare provider if memory impairment, confusion, or disorientation is observed
Advise patients that after LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and that they should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours. Exposure may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions
Advise patients to protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material, and/or a long-sleeved shirt and/or gloves. Advise patients sunscreens will not protect against photosensitivity reactions caused by visible light. It has not been determined if perspiration can spread the LEVULAN KERASTICK topical solution outside the treatment site to the eye or surrounding skin
If for any reason the patient cannot return for blue light treatment during the prescribed period after applying LEVULAN KERASTICK topical solution, advise patients to call the doctor. Advise patient to continue to avoid exposure of the photosensitized lesions to sunlight or prolonged or intense light for at least 40 hours. If stinging and/or burning is noted, exposure to light should be reduced
Advise patients to avoid certain medications that may enhance the phototoxic reaction to PDT
Common Adverse Reactions
Inform patients that treatment with LEVULAN KERASTICK topical solution plus BLU-U Blue Light Photodynamic Therapy Illuminator may result in sensitivity to light, skin irritation and local skin reactions including erythema, edema, stinging/burning, scaling, crusting, oozing, vesiculation, wheal, scabbing, pustules, ulceration, itching, erosion, hypo/hyperpigmentation, bleeding, tenderness, dysesthesia, and dryness.
Inform patients that treatment with LEVULAN KERASTICK topical solution plus BLU-U Blue Light Photodynamic Therapy Illuminator may result in sensitivity to light, skin irritation and local skin reactions including erythema, edema, stinging/burning, scaling, crusting, oozing, vesiculation, wheal, scabbing, pustules, ulceration, itching, erosion, hypo/hyperpigmentation, bleeding, tenderness, dysesthesia, and dryness.
LEVULAN, KERASTICK, KERASTICK KRUSHER, BLU-U, and DUSA are registered trademarks of DUSA Pharmaceuticals, Inc., a Sun Pharma company © 2020 Sun Pharmaceutical Industries, Inc. All rights reserved.
- Manufactured by: Sun Pharmaceutical Industries, Inc.
- Billerica, MA, 01821
- LAB-0530AW, Revision: F
Sun Pharmaceutical Industries, Inc.
Princeton, NJ
1-877-533-3872
8PACKAGE LABEL
LEVULAN
(aminolevulinic acid HCl) for Topical Solution, 20%
SINGLE USE APPLICATOR 1.5 mL
NDC 67308-101-01
A
↑
CRUSH
HERE
↓
A
LOT NO.:
EXP. DATE:
B
↑
CRUSH
HERE
↓
B
MANUFACTURED BY:
Sun Pharmaceutical Industries, Inc.
Billerica, MA 01821
LAB-0528 AW REV F
(aminolevulinic acid HCl) for Topical Solution, 20%
SINGLE USE APPLICATOR 1.5 mL
NDC 67308-101-01
A
↑
CRUSH
HERE
↓
A
LOT NO.:
EXP. DATE:
B
↑
CRUSH
HERE
↓
B
MANUFACTURED BY:
Sun Pharmaceutical Industries, Inc.
Billerica, MA 01821
LAB-0528 AW REV F
NDC 67308-101-06
6 SINGLE USE APPLICATORS, 1.5 ML EACH
Carefully follow the step by step directions provided in the package insert to prepare Levulan ®Kerastick ®for application. Please note the locations of the crush points “A” and “B” which are indicated by the red diamonds “♦” on each Kerastick ®.
Carefully follow the step by step directions provided in the package insert to prepare Levulan ®Kerastick ®for application. Please note the locations of the crush points “A” and “B” which are indicated by the red diamonds “♦” on each Kerastick ®.
NDC 67308-101-01
NDC 67308-101-02
Levulan® Kerastick
(aminolevulinic acid HCl) for Topical Solution, 20%
2 SINGLE USE APPLICATORS, 1.5 mL EACH
SAMPLE
NOT FOR SALE
For Topical Use Only
Not For Use in Eyes
FOR ADMINISTRATION BY HEALTH PROFESSIONAL ONLY
Rx only
Carefully follow the step by step directions provided in the package to prepare Levulan ®Kerastick ®for application. Please note the locations of the crush points "A" and "B" which are indicated by the red diamonds "♦" on each Kerastick ®.
CAT. NO.:
LOT NO.:
EXP. DATE:
Sun Pharmaceutical Industries, Inc.
Billerica, MA 01821
1-877-533-3872
LAB-1462AW REV. C
Each applicator contains:
Active Ingredient: 354mg aminolevulinic acid HCl
Inactive Ingredients: Alcohol, USP (ethanol content-48% v/v), water, laureth-4, isopropyl alcohol, and polyethylene glycol.
Usual Dose:
For indications, dosage, precautions, etc., see enclosed package insert.
Store between 20°25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F)
[See USP Controlled Room Temperature]
Use and discard within two hours after activation.
Levulan® Kerastick
(aminolevulinic acid HCl) for Topical Solution, 20%
2 SINGLE USE APPLICATORS, 1.5 mL EACH
SAMPLE
NOT FOR SALE
For Topical Use Only
Not For Use in Eyes
FOR ADMINISTRATION BY HEALTH PROFESSIONAL ONLY
Rx only
Carefully follow the step by step directions provided in the package to prepare Levulan ®Kerastick ®for application. Please note the locations of the crush points "A" and "B" which are indicated by the red diamonds "♦" on each Kerastick ®.
CAT. NO.:
LOT NO.:
EXP. DATE:
Sun Pharmaceutical Industries, Inc.
Billerica, MA 01821
1-877-533-3872
LAB-1462AW REV. C
Each applicator contains:
Active Ingredient: 354mg aminolevulinic acid HCl
Inactive Ingredients: Alcohol, USP (ethanol content-48% v/v), water, laureth-4, isopropyl alcohol, and polyethylene glycol.
Usual Dose:
For indications, dosage, precautions, etc., see enclosed package insert.
Store between 20°25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F)
[See USP Controlled Room Temperature]
Use and discard within two hours after activation.
