Levulan Kerastick

DRUG DESCRIPTION

LEVULAN KERASTICK (aminolevulinic acid HCl) for Topical Solution, 20%, contains the hydrochloride salt of aminolevulinic acid (ALA), an endogenous 5-carbon aminoketone.

Aminolevulinic acid HCl (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:

LEVULAN  KERASTICK®  (aminolevulinic acid HCl)  Structural Formula Illustration

The LEVULAN KERASTICK (aminolevulinic acid) 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 ALA 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 (aminolevulinic acid) applicator. The term “ALA HCl” refers to unformulated active ingredient, “LEVULAN KERASTICK (aminolevulinic acid) for Topical Solution” refers to the drug product in its unmixed state, “LEVULAN KERASTICK (aminolevulinic acid) Topical Solution” refers to the mixed drug product (in the applicator tube or after application), and “LEVULAN KERASTICK (aminolevulinic acid) ” refers to the applicator only.

What are the possible side effects of aminolevulinic acid (Levulan Kerastick)?

Serious side effects are not likely to occur. Stop using aminolevulinic acid and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

You may experience some tingling, stinging, prickling, or burning of the area treated with aminolevulinic acid during the special light treatment. These feelings of discomfort should improve at the end of the light treatment. Following treatment, you will experience some redness,...

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What are the precautions when taking aminolevulinic acid (Levulan Kerastick)?

Consult your...

Read All Potential Precautions of Levulan Kerastick »


Levulan Kerastick Consumer (continued)

SIDE EFFECTS: Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Consult your pharmacist.


Levulan Kerastick Patient Information Including Side Effects

Brand Names: Levulan Kerastick

Generic Name: aminolevulinic acid (Pronunciation: a MEE no le vue lih nick)

  • What is aminolevulinic acid (Levulan Kerastick)?
  • What are the possible side effects of aminolevulinic acid (Levulan Kerastick)?
  • What is the most important information I should know about aminolevulinic acid (Levulan Kerastick)?
  • Who should not use aminolevulinic acid (Levulan Kerastick)?
  • How should I use aminolevulinic acid (Levulan Kerastick)?
  • What happens if I miss a dose (Levulan Kerastick)?
  • What happens if I overdose (Levulan Kerastick)?
  • What should I avoid while using aminolevulinic acid (Levulan Kerastick)?
  • What other drugs will affect aminolevulinic acid (Levulan Kerastick)?
  • Where can I get more information?

What is aminolevulinic acid (Levulan Kerastick)?

Aminolevulinic acid causes skin cells to become much more sensitive to certain types of light. Skin cells treated with aminolevulinic acid and exposed to a special light die and then slough off.

Aminolevulinic acid is used to treat warty overgrowths of skin (actinic keratoses) on sun-exposed areas of the face and scalp. Treatment involves application of aminolevulinic acid, followed 14 to 18 hours later by exposure to a special blue light.

Aminolevulinic acid may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of aminolevulinic acid (Levulan Kerastick)?

Serious side effects are not likely to occur. Stop using aminolevulinic acid and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

You may experience some tingling, stinging, prickling, or burning of the area treated with aminolevulinic acid during the special light treatment. These feelings of discomfort should improve at the end of the light treatment. Following treatment, you will experience some redness, swelling, and scaling of the lesions, and to some degree, the surrounding skin. These changes are temporary and should completely resolve by 4 weeks after treatment. If these side effects are excessive, talk to your doctor.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about aminolevulinic acid (Levulan Kerastick)?

Only a qualified doctor or other healthcare professional should apply aminolevulinic acid. Aminolevulinic acid is not intended for application by the patient.

After aminolevulinic acid has been applied, wear sunlight-protective clothing such as a wide-brimmed hat or similar head covering. Sunscreens will not protect you. Avoid exposure to sunlight or bright indoor light (examination lamps, operating room lamps, tanning beds, or very close lights). If you experience stinging or burning of the treated skin, reduce your exposure to light. It has not been determined if perspiration can spread aminolevulinic acid outside the treatment site to the eyes or surrounding skin.

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