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Levulan Kerastick

Last reviewed on RxList: 5/4/2018
Levulan Kerastick Side Effects Center

Last reviewed on RxList 5/4/2018

Levulan Kerastick (aminolevulinic acid HCl) is a photosensitizing agent used to treat warty overgrowths of skin (actinic keratoses) on sun-exposed areas of the face and scalp. Treatment involves application of Levulan, followed 14 to 18 hours later by exposure to a special blue light that causes the treated skin cells to die and slough off. Serious side effects of Levulan Kerastick are unlikely. You may experience:

  • tingling,
  • stinging,
  • prickling,
  • itching,
  • swelling, or
  • burning of the area treated with Levulan during the light treatment.

These side effects should improve at the end of the light treatment. Following treatment, you will experience temporary redness, swelling, and scaling of the lesions and surrounding skin. These side effects should completely resolve by 4 weeks after treatment.

Levulan Kerastick dose is determined by a physician and is administered in a medical setting. Levulan may interact with griseofulvin, oral diabetes medicines, phenothiazines, sulfa drugs, antibiotics, or diuretics (water pills). Tell your doctor all medications you use. During pregnancy, Levulan should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Levulan Kerastick (aminolevulinic acid HCl) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Ringworm is caused by a fungus. See Answer
Levulan Kerastick Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have severe stinging or burning that lasts longer than 4 weeks.

Common side effects may include:

  • pain, burning, redness, or swelling of treated skin;
  • itching, stinging, tingling, or prickly feeling;
  • scaling or crusting of the skin;
  • headache;
  • chills; or
  • puffy eyelids.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Levulan Kerastick (Aminolevulinic Acid)

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Levulan Kerastick Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in the other sections of the labeling:

Clinical 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 ≤ 1% of the vehicle group. Both erythema and edema resolved to baseline or improved by 4 weeks after therapy for face or scalp. Edema resolved by 4 weeks and erythema resolved to baseline by 8 weeks for upper extremities.

The application of LEVULAN KERASTICK topical solution to perilesional skin resulted in stinging, burning, erythema and edema similar to treated actinic keratoses [see WARNINGS AND PRECAUTIONS].

Other Localized Cutaneous Adverse Experiences

Table 2 depicts the incidence and severity of cutaneous adverse events in trials for the face and scalp.

TABLE 2 Post-PDT Cutaneous Adverse Events – ALA-018/ALA-019 For the Face and Scalp

  FACE SCALP
LEVULAN KERASTICK Topical Solution + PDT
(n=139)
Vehicle + PDT
(n=41)
LEVULAN KERASTICK Topical Solution + PDT
(n=42)
Vehicle + PDT
(n=21)
Degree of Severity Mild/ Moderate Severe Mild/ Moderate Severe Mild/ Moderate Severe Mild/ Moderate Severe
Scaling/Crusting 71% 1% 12% 0% 64% 2% 19% 0%
Pain 1% 0% 0% 0% 0% 0%` 0% 0%
Tenderness 1% 0% 0% 0% 2% 0% 0% 0%
Itching 25% 1% 7% 0% 14% 7% 19% 0%
Edema 1% 0% 0% 0% 0% 0% 0% 0%
Ulceration 4% 0% 0% 0% 2% 0% 0% 0%
Bleeding/Hemorrhage 4% 0% 0% 0% 2% 0% 0% 0%
Hypo/hyper-pigmentation 22% 20% 36% 33%
Vesiculation 4% 0% 0% 0% 5% 0% 0% 0%
Pustules 4% 0% 0% 0% 0% 0% 0% 0%
Oozing 1% 0% 0% 0% 0% 0% 0% 0%
Dysesthesia 2% 0% 0% 0% 0% 0% 0% 0%
Scabbing 2% 1% 0% 0% 0% 0% 0% 0%
Erosion 14% 1% 0% 0% 2% 0% 0% 0%
Excoriation 1% 0% 0% 0% 0% 0% 0% 0%
Wheal/Flare 7% 1% 0% 0% 2% 0% 0% 0%
Skin disorder NOS 5% 0% 0% 0% 12% 0% 5% 0%

Table 3 depicts the percentage of subjects with cutaneous adverse reactions by the most severe grade reported in course of the trial for the upper extremity lesions.

TABLE 3 Percentage of Subjects with Cutaneous Adverse Reactions by the Most Severe Grade Reported Post-Baseline – CP0108 For Upper Extremities

  LEVULAN KERASTICK Topical Solution + PDT
(N=135)
Vehicle + PDT
(N=134)
Degree of Severity Minimal/ Mild Moderate/ Severe Total Minimal/ Mild Moderate/ Severe Total
Edema 51% 4% 56% 7% 1% 8%
Erythema 35% 65% 100% 63% 12% 75%
Hyper-pigmentation 64% 9% 73% 57% 10% 66%
Hypo-pigmentation 46% 4% 50% 50% 5% 55%
Oozing/Vesiculation/ Crusting 36% 5% 41% 8% 2% 10%
Scaling and Dryness 65% 22% 87% 58% 7% 64%
Stinging/Burning 23% 73% 96% 23% 0% 23%

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 (≥2%, <10%) local cutaneous adverse reactions for face, scalp and upper extremities in the LEVULAN KERASTICK topical solution group included wheal, scabbing, pustules, ulceration, bleeding, tenderness and dysesthesia.

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 (≥2%, <10%) adverse reactions not limited to the application site for upper extremities and occurring more frequently in the LEVULAN KERASTICK topical solution group than in the vehicle group were sinusitis, squamous cell carcinoma, and squamous cell carcinoma of skin.

Postmarketing 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

Read the entire FDA prescribing information for Levulan Kerastick (Aminolevulinic Acid)

Related Resources for Levulan Kerastick

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© Levulan Kerastick Patient Information is supplied by Cerner Multum, Inc. and Levulan Kerastick Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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Ringworm is caused by a fungus. See Answer

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